EBM2017 winter

ISSN 2364-2351 | A 60711 |

Life Sciences and Industry Magazine Winter Edition 2017 | Volume 16 | 20 €

Interview Waldemar Kütt, DG Research, breaks down the bioeconomy strategy review and financial incentives

The inner universe of health

Miraculous Microbiome Synthetic biology

Plastic recycling

Pharma packaging

Biofairs Compass

DNA-based apps for cell diagnostics and therapeutics

Can enzymes solve the world’s biggest waste problem?

How digitalisation saves costs through improved compliance

The ultimate guide to relevant life science events in H1/2018

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Intro

European Biotechnology | Winter Edition | Vol. 16 | 2017

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Biotech enabling Europe to reach UN SDGs The UN Sustainable Development Goals (SDGs) provide a powerful blueprint for coordinating global efforts to end poverty through economic growth, reducing inequality, and providing better education, health, job opportunities, and environmental protection.

John Brennan is the Secretary General of EuropaBio. He has nearly 30 years’ experience in the healthcare sector, the last thirteen of which were spent in the policy environment in Brussels, both working at the European Commission and in European trade associations for the healthcare industry. Prior to that he worked in the Irish National Standards Authority.

Born in Ireland, John is a science graduate from Dublin, with post-graduate studies in quality management and environmental engineering.

The OECD defines biotechnology as “the application of scientific and engineering principles to the processing of materials by biological agents.” More simply, it is the application of biology for the benefit of humanity and the environment. As such, sustainability is inherent in biotechnology. This makes biotechnology an innately sustainable approach when looking at addressing many of the Sustainable Development Goals. Biotechnology is capable of tackling diseases through innovative medicines, improving energy and food security, and helping to mitigate climate change, while at the same time creating high-quality jobs and growth.

Only for the Climate Action goal, and by enabling smarter, more sustainable products and materials, the CO2 mitigation potential of industrial biotechnology is between 1–2.5 billion tonnes of CO2 equivalent per year by 2030, according to a 2011 OECD study. This potential is equivalent to emissions from 490 million cars, in addition to the 10 million cars equivalent emissions mitigated through agricultural biotechnology if we take into account data from PG Economics.

According to the International Service for the Acquisition of Agri-biotech Applications, agricultural biotechnology also contributes to goals around hunger and poverty by enabling farmers to grow more crops with fewer inputs, for example by making them resistant to certain pests.

Through innovative biologic medicines, healthcare biotechnology contributes to health-oriented Sustainable Development Goals by reducing the health and social burden of common diseases like cancers, cardiovascular diseases, diabetes, and chronic respiratory diseases, but also rare diseases, such as cystic fibrosis or spinal muscular atrophy. This in turn reduces the pressure on healthcare services and contributes to a healthier and more productive labour force, less hospitalisations, career interruptions, and work and school absenteeism.

Picture: EuropaBio

The European Union itself has committed to implement the Sustainable Development Goals internally and externally. Given the contributions outlined above, biotech innovations must play a key role in Europe’s and the world’s response to the Sustainable Development Goals.

L

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Contents

European Biotechnology | Winter Edition | Vol. 16 | 2017

Cover Story

Insight Europe

regional news

6 BEAM alliance calls for SMEspecific support

58 Northern Europe: Sweden, Denmark, Norway and Finland

8 Stakeholders want European bioeconomy to move to the next level 10 EU Ombudsman soft-sells safety concerns on HPV jabs 12 Interview: Dr. Waldemar Kütt, Head Unit DG RTD F1 Bioeconomy Strategy at the European Commission

Economy 20 Spanish biotech sector attracting investors

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Multiple sclerosis and the microbiome It’s growing increasingly clear – the bacteria that colonise your skin and gut from birth on are key sensors that can act as environmental triggers for many chronic diseases of civilisation, including MS. Gold rush fever has hit food manufacturers, pharma companies and independent teams. Everyone it seems wants to grab a piece of the pie with novel therapies or probiotics aimed at rebalancing patient gut microbiomes that have been thrown out of whack. But how far are we from seeing real cures? Here’s an overview.

22 Study sees new wave of optimism for European biotech stocks 23 Update on clinical trials

60 Western Europe:

France, Belgium, The Netherlands

and the UK

62 Central Europe:

Germany, Switzerland

and Austria 64 Southern Europe: Italy, Spain, Slovenia and Portugal 66 Eastern Europe:

Poland, Czech Republic

and Lithuania

Science & Technology 67 New horizons in malaria research: Trapping the parasite in red blood cells

26 CPHi embraces biologics space 27 Analyst commentary 28 Euro Biotech Stocks 30 Focus topic: Pharma packaging sector faces sea change 32 Focus topic: Tamper-resistant labels, Bähren-Druck 34 Interview: Connectivity is the future, Paul Jansen, Haselmeier 36 Focus topic: Ready for future challenges, Datwyler Sealing Solutions

79 Psoriasis: Irish groups find alternative to IL-17 targeting; IL-6 variant triggers asthma

Service 73 News from partner associations: Swiss Biotech Association, Drug Information Association, Medicines for Europe, BIO Deutschland, Europa­Bio 80 Events 81 New products 81 Company index 82 Encore

IMPRINT European Biotechnology (ISSN 2364-2351) is published quarterly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, Email: service@european-biotechnology.com, Internet: www.european-biotechnology.com; Publisher: Andreas Mietzsch; Editorial Team: Thomas Gabrielczyk (Editor in Chief), Derrick Williams (Co-editor), Uta Mommert, Dr. Martin Laqua, Sandra Wirsching, Helene Märzhäuser; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149, Andreas Macht, +49-30-2649-2154; Distribution: Marcus Laschke, +49-30-2649-2148; Graphic Design: Oliver-Sven Reblin; Production editor: Benjamin Röbig; Printed at: Königsdruck, Berlin; European Biotechnology Life Sciences & Industry Magazine is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 80.00, Students € 40.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within two weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least six weeks before the date of expiry. Failures of delivery, which BIOCOM AG is not responsible for, do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: ©Naked Biome Inc/Charis Tsevis; Supplement: EuropaBio; ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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Picture: nerthuz/fotolia.com

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Contents

European Biotechnology | Winter Edition | Vol. 16 | 2017

Bioeconomy

Synthetic Biology

Editorial

Follow food fads

The plastic problem The oceans are full of it, landfills are overflowing with it – characteristics like durability and lightness, which make plastic so attractive in packaging, also prevent its degradation in the environment. Recycling plastics is energy-intensive, and recyclates are usually low quality. Could enzymes be able to break down polymers for re-synthesis provide a solution to this most pressing of problems?

Pictures: BIOCOM collage, Originals from Ellen11/istockphoto.com (circuit board), luismmolina/istockphoto.com (e. coli) (left) (top), aryfahmed/fotolia.com (middle), Robert Kneschke/fotolia.com (bottom)

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Cellular apps

54

5

Since the earliest attempts at genetic engineering, scientists have sought to influence cell behaviour and development.

Synthetic biologists are now taking the idea to a whole new level with ‘genetic circuits’ that can turn cells into diagnostic sensors, therapeutic entities or tissue generators.

SPECIAL EU Event Compass 39 Intro: EU events update 40 Medtech Forum, Brussels 42 PharmaPack Europe, Paris 44 Berlin Conference on Life Sciences 46 BIO-Europe Spring, Barcelona 48 Nano and MicroFormulations –

Joint Conference, Berlin 50 Swiss Biotech Day, Basel 52 Chemspec Europe, Cologne

The minutes from the 27 November meeting of the EU’s High Level Group on Nutrition and Physical Activity sound a little like a Christmas wish list: “In 2030, all citizens will have the motivation, ability and opportunity to consume a healthy diet from a variety of foods, have healthy levels of physical activity and the incidence of dietrelated diseases will have decreased significantly.” There’s no question that something needs to happen. Six of the seven biggest risk factors for premature death in Europe relate to how we eat, drink and move. A growing number of high-income consumers have already altered buying behaviours, and now pursue vegan, vegetarian, organic or “does-not-contain” lifestyles. But are they real­ly healthy?

Recent research does indeed suggest that certain diets could prevent auto­ immune reactions by rebalancing the stressed gut microbiome. In our cover story (p. 14), we investigate how the body’s microbiota could help control the onset of multiple sclerosis by preventing the activation of the auto­ reactive T-helper cells that everyone carries sleeping in their lymph nodes.

Are probiotics set to become the pharmaceuticals of the future? Will the right foods soon become the best medicine of all?

All of us here at the European Biotech Magazine wish you a merry Christmas (meal) and the happiest of New Years!

Thomas Gabrielczyk Editor-in-Chief

07.12.2017 11:41:54 Uhr

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Insight europe

European Biotechnology | Winter Edition | Vol. 16 | 2017

New momentum for SMEs Antimicrobial resistance In 2017, the development of new drugs and diagnostics to

combat multidrug-resistant pathogens gained momentum in Europe. Small and medium-sized companies (SMEs) successfully raised financings and grants – and some new start-ups entered the scene. To continue this trend, specific support for SMEs is needed, says the BEAM Alliance.

About €218m has been raised from public or private sources by European SMEs active in the field of antimicrobial resistance (AMR) in 2017 (see table below).

Among them were German-French Allecra, which convinced new investors or listed British Motif Bio, which secured a US$20m debt financing with Hercules Capital, and Austrian Nabriva, which went public with a secondary listing on Nasdaq, raising US$80m. Danish AntibioTX and Spanish Stat Diagnostics benefited from the InnoFin instrument of the European Investment Bank; others received fundings from US-based organisations such as CARB-X or BARDA. Another success for the European community was the market approval of a viral drug developed by German Aicuris in November, securing long-term turnover to further develop the companies antibiotics pipeline. With Phagomed (Austria), Lumobiotics (Germany), Vaxdyn (Spain), AGiLebiotics (Netherlands), and MetaLinear (UK), the AMR field also experienced a new wave of start-ups. These develop-

ments demonstrate that there is a growing dynamic in the AMR market, fueled by SMEs and funding programmes targeted to support smaller companies with risky R&D projects. In 2017, several further initiatives have been established so that experts expect more growth in the future.

“Addressing the specific requirements of SME-driven innovation within current AMR initiatives is key in order to provide patients with effective drugs that can win the fight against AMR,” says Marc Lemonnier, CEO of Antabio. The French biotech company is among the 40 members of the European BEAM Alliance, which represents SMEs active in AMR.

How to support SMEs? In mid-November, the association published a position paper calling on policymakers to implement ten recommendations to support SME-driven innovation.

The alliance points out that to design effective PUSH and PULL mechanisms requires understanding the specific nature

and needs of SMEs. “It is of enormous importance to ultimately revive R&D in AMR by developing compelling surveillance data, encouraging out-of-the-box thinking, rewarding R&D evidence, and strengthening existing scientific expertise,” says Marc Gitzinger, CEO of Swiss BioVersys AG and Vice-President of the BEAM Alliance.

But how should public support be organised to provide the best environment for SMEs to grow in an area where traditional market mechanisms don't work?

This question will be among the key topics of the upcoming Berlin Conference "Novel Antimicrobials & AMR Diagnostics" to which the BEAM alliance, together with Berlin-based BIOCOM AG, invites all interested parties in March 2018 (see p. 44). More than 20 speakers have already confirmed their attendance for the one-day conference. The event will offer a discussion platform for the more than 200 expected high-level representatives from policy, academia, industry, and the finance sector.

L s.wirsching@biocom.eu

Company

Amount of capital raised

Investors

Date

› Allecra, Germany/France

€9m

Financing round with new investors XerayaCapital and BioMedPartners

12/2017

› Motif Bio, UK

US$20m

Debt financing via stock exchange

11/2017

› AntibioTX, Denmark

€20m

European Investment Bank, InnoFin Programme

10/2017

› Antabio, France

€7.3m

Private investors iXO Private Equity, IRDI SORIDEC Gestion, Galia Gestion

10/2017

› Da Volterra, France

€20m

European Investment Bank, InnoFin Programme

09/2017

› Nabriva, Austria

US$80m

IPO Nasdaq

09/2017

› Antabio, France

€7.6m

CARB-X grant, US

07/2017

› Basilea, Switzerland

US$54.8m

BARDA grant, US

06/2017

› Stat Diagnostica, Spain

€20m

European Investment Bank, InnovFin Programme

06/2017

› Mobidiag, Finland

€4m

300 investors via crowdfunding platform Kansalaisrahoitus Oy

04/2017

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Table: BIOCOM

Selected financings of European SMEs active in the AMR field in 2017

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Insight Europe

European Biotechnology | Winter Edition | Vol. 16 | 2017

European bioeconomy entering the next level BIOECONOMY A series of high-level conferences held in autumn and winter focused on current

“Is this industry delivering?” Tom van Aken provocatively asked the audience.

The CEO of biochemical company Avantium, which debuted in a €100M IPO at Euronext, was one of the keynote speakers during this year's European Forum for Industrial Biotechnology (EFIB) in Brussels, organized by EuropaBio, the European Association for Bioindustries. Van Aken drew mixed conclusions from the past decade. According to him, although environmental challenges such as plastic waste and climate change enjoy high visibility, market entry for bio-based innovations such as PEF or FDCA are by no means a self-runner. “You have to consider the retailers’ side to understand their needs and put in place efficient strategic partnerships from R&D to industrial production,” he pointed out. With about 600 participants, the 10th edition of EFIB continued to offer a high-level discus-

sion platform on how to operationalise the scale-up of European bioeconomy sector in the future. Industrial stakeholders from different sectors such as LEGO, IKEA, and L’OREAL reported on their progress in recent years. Daniel Calleja Crespo, Director-General DG Environment of the European Commission (EC) underscored the huge potential within the circular economy: “Every waste is a wasted opportunity.”

First review of the EC’s Bioeconomy Strategy published In mid-November 2017, the EC presented a first review of the 2012 Bioeconomy Strategy, which will pave the way for an detailed revision of the Strategy expected in 2018. At a high-level Bioeconomy Policy Day meeting, Commissioner Carlos Moedas said: “Faced with the

In early October, EFIB debuted a conference series for stakeholders from policy and industry to discuss how to facilitate progress of the European bioeconomy.

08_EB_winter_2017_Insight_bioeconomy_sw.indd 8

current challenges of food security, climate change and industrial transformation, we have the responsibility to figure out how to best deal with the biological resources we have and how to put them to the best use.” The review shows that dedicated EU funding for the bioeconomy has more than doubled from €1.9bn in FP7 to €4.52bn in Horizon 2020. It also recognises that further mobilisation of investments and a stable regulatory environment are still needed to scale-up the sector. In a manifesto, industry representatives, NGOs, and researchers demanded a holistic policy that considers people, planet, and profit. “To achieve this, the revision must put in place a coherent policy and financial framework to support access to sustainably produced biomass, foster investments, and further develop the market for bio-based products,” said Joanna Dupont Inglis, EuropaBio’s Director for Industrial Biotech.

In June, the European Investment Bank proposed a thematic investment platform focused on the circular bioeconomy to mobilise additional investors. The EC will provide up to €100m for the fund, with money drawn from Horizon 2020. Additional funds will be sought from other funding sources, public and private. In a workshop in December and during the European Bioeconomy Investment Summit in Helsinki more details will be discussed. Financial issues will also be on the agenda of the Global Bioeconomy Summit 2018, to which the German Bioeconomy Council invites stakeholders to Berlin from 19–20 April 2018.

L s.wirsching@biocom.eu

Picture: BIOCOM

challenges to implementing an industrial scale bioeconomy in Europe. In November, the European Commission unveiled a new stock-take of progress in its Bioeconomy Strategy, ahead of an official revision planned in 2018. In a manifesto, stakeholders demand a holistic policy framework.

06.12.2017 14:42:42 Uhr

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Insight Europe

European Biotechnology | Winter Edition | Vol. 16 | 2017

EU ombudsman soft-sells safety concerns on HPV jabs EU A complaint against the EMA’s handling of a referral procedure related to potential side

effects of Sanofi/MSD’s HPV vaccine Gardasil and GSK’s HPV jab Cervarix, filed by the Nordic Cochrane Centre and physicians, has been rejected by the European Ombudsman.

According to the plaintiffs, as of August 2015 there were 94 documented cases of vaccine-related reports for CRPS as well as 147 jab-associated POTS cases – 65 and 117, respectively, described as “serious“ – following clinical testing.

Documented cases of SAEs

EU Ombudsman Emily O'Reilly announced that her findings point to no maladministration in the European Medicines Agency’s (EMA) handling of questions related to HPV vaccines. In a referral procedure dating back to 2015, the Agency’s PRAC Committee assessed two serious potential adverse effects – complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) – that plaintiffs alleged were caused by the marketed preventive Human Papilloma Virus (HPV) cervical cancer vaccines Gardasil and Cervarix.

The Committee looked into whether there was a causal link between

10_11_EB_Winter_2017_Insight_tg.indd 10

the HPV vaccination and the two syndromes and concluded that there was no evidence of a correlation. The plaintiffs expressed concerns relating to a lack of transparency, and suspected lack of impartiality of the PRAC Committee.

Specifically, Lars Jørgensen, head of the Cochrane Centre, and Tom Jefferson, from Oxford-based Centre for Evidence-based Medicine, suggested that “the outcome of the EMA’s review process was decided prior to its initiation“ and that the “PRAC seems to have reproduced the manufacturers’ responses to five questions without undertaking an independent analysis of the evidence.“

Everything all right?

EU Ombudsman Emily O’Reilly now says that the Committee's examination of the scientific evidence was complete and independent. She found the PRAC’s undisclosed members had no conflicts of interest and that the assessment thus was “deemed to have been conducted in full independence of the relevant sci-

Picture: European Parliament/Alexis Haulat

EU ombudsman Emily O' Reilly sees no indication of conflict of interest with the EMA’s panel members who assessed the AEs relating to pediatric cervical cancer vaccines.

Saying the case series would “represent a highly selected sample of patients, apparently chosen to fit a pre-specified hypothesis of vaccine-induced injury,“ the PRAC assessment, however, focused largely on case reports, ignored 12% of the manufacturers data set, and did not assess one quarter of the trials that contributed data to the analysis of potential CRPS and POTS cases. Furthermore, the plaintiffs allege that the PRAC sent the result of its consultation with stakeholder advisory group to the manufacturers and then “reached its scientific recommendation by consensus following plenary discussion.“ The final 40-page assessment report, which was published online, “is in large part based on the manufacturers’ reviews,“ say the plaintiffs, except where it concerns "recommendations in relation to further evaluation of CRPS and POTS.“

08.12.2017 11:02:57 Uhr

Insight Europe

European Biotechnology | Winter Edition | Vol. 16 | 2017

entific experts." She suggested, however, that the EMA should provide as much information as possible on the scientific work of its committees.

Plaintiffs’ comments The plaintiffs disagree: “We found many examples of scientific maladministration,“ they stressed in a statement issued in November on the website of the Cochrane Centre.“ As long as the Ombudsman is not willing to comment on scientific maladministration, even when it is apparent to people without a scientific background, there is, in reality, no public safeguard against poor conduct by the EMA. As far as we know, there is no disciplinary committee in the European Union that can take appropriate action against EMA. We find this deeply concerning.“ The five underwriters claim that the Ombudsman backed questionable practices at the EMA “on many occasions.“ In addition, they criticised the Ombuds-

man for not challenging the assessment of a possible relation between a drug or a vaccine and serious harms, provided by the vaccine producers and for not ordering an independent re-analysis of the underlying raw data and scrutiny of the methods used to reach the conclusions.

"The evidence is, however, that […] it has been documented, both to EMA and to the Ombudsman, that Sanofi Pasteur/ MSD, one of the HPV vaccine manufacturers, on two occasions, both in Sweden and Denmark, had seriously underreported neurological harms associated with its HPV vaccine to the authorities,” claim the plaintiffs. “It […]appears to be acceptable to dismiss the results of independent researchers and the Uppsala WHO Monitoring Centre, which found signals that suggested neurological harms. We believe it is important for the public to know about the many problems there are with EMA’s substandard approach to science,” they say.

L t.gabrielczyk@biocom.eu

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Call for more Bioeconomy On the EU Bioeconomy Policy Day (16 November), EU biotech industry voice EuropaBio called for an ambitious revision of the European Bioeconomy Strategy. The asssociation's Industrial Biotech Director, Joanna Dupont Inglis, said a holistic policy and financial framework is needed to support access to sustainably produced biomass, foster investments, and further develop the market for bio-based products. “We have yet to see impactful progress on commercialisation of bio-based products," she said.

Specifically, EuropaBio called on policy makers to put a biomass-driven circular bioeconomy at the centre of EU frameworks and policies; increase funding and improve financing instruments; continue the 3.7bn Bio-Based Industries Joint Undertaking; create market incentives; and promote visibility of bio-based products.

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Insight Europe

European Biotechnology | Winter Edition | Vol. 16 | 2017

Merging industries Bioeconomy In mid-November, the European Commission tabled the long-awaited review of

its Bioeconomy Strategy and Action Plan. European Biotechnology spoke with Waldemar Kütt, Head of Unit Bioeconomy Strategy, about the development the bioeconomy has made since its launch in 2012 by the European Commission and the instruments needed to attract investments, make it circular, and create a stable policy environment for companies and investors.

had reached the mid-term of the Action Plan and Strategy. Furthermore, the Circular Economy Action Plan of December 2015 requested that the bioeconomy review should assess the contribution of the bioeconomy to the circular economy.

So basically the review evaluates the progress in the 54 actions within the Bioeconomy Action Plan and determines the contribution of the bioeconomy to the circular economy.

EuroBiotech_What will be the new goals of a renewed Strategy and Action Plan going forward?

Kütt_ At the beginning of November, we

were still working on the review of the Strategy. We finalised it on 16 November.

The review looks at the Bioeconomy Action Plan which has focussed on three major areas: investment in research and innovation; policy coherence and stakeholder engagement; and markets and competitiveness. There were 12 major action lines and 54 actions. So, with the help of an expert group we looked at progress in all of the 54 actions over the last five years. That was the major focus of the review. The review, however, doesn’t talk in any way about the future.

It just reflects the past.

EuroBiotech_What can you say about the results and what can be made better in the future?

12-13_EB_Winter_2017_Insight_Interview_tg.indd 12

Waldemar Kütt Since January 2017, Waldemar Kütt heads the Unit DG RTD F1 Bioeconomy Strategy at the European Commission. Previously, he was the Head of DG RTD F2 BioBased Products and Processes (2014–2017), Head (2014) and Deputy Head of the Cabinets of Commissioners Máire Geoghegan-Quinn (2010–2014) and Janez Potocnik (2008–2010).

Kütt _We definitely achieved major

progress concerning research and innovation investment into the bioeconomy through Horizon 2020, the current EU research and innovation programme – we almost doubled it compared to the previous FP7. It’s close to €4.5bn now; and

we have started major initiatives such as the BBI, the bio-based industry joint undertaking. We have made significant progress concerning stakeholder engagement and the uptake of the strategy itself: we have seen that a lot of countries followed the 2012 path and developed their own strategies, not only member states but also globally. At the time the Commission published its Bioeconomy Strategy, Germany was the only EU country that already had its own national strategy. Over the past few years, other member states, such as recently Norway, Italy and France, have followed with national strategies. We have learned that it’s important to create a more supportive and stable political environment. Future avenues and scope are currently discussed internally with the relevant Directorate Generals and I cannot say very much about that until next year, except that the bioeconomy is a vast field and we would like to see more symbiosis between the different industries and value chains that contribute to the bioeconomy.

EuroBiotech_There will also be significant investments to foster the bioeconomy with money from the European Investment Bank …

Kütt _This is something that will be de-

veloped in 2018-2020. We are working with the EIB to develop a circular bioeconomy financial instrument, which will be run by an external fund manager, not the EIB itself. We are currently in the process of talking to potential investors and fund managers, but it will be a couple of months before we know more.

Picture: European Commission, DG RTD

EuroBiotech_Mr Kütt, could you please briefly outline the process that led to the decision to review the EC’s Bioeconomy Strategy and Action Plan?

Kütt_The review was done because we

07.12.2017 12:10:25 Uhr

European Biotechnology | Winter Edition | Vol. 16 | 2017

EuroBiotech_When the Circular Economy Strategy was launched, some stakeholders had the feeling it would come at the cost of the Bioeconomy Strategy. How will the new strategy connect the EC’s circular economy and bioeconomy?

Kütt_I think there is an overlap and also

complementarity. If you look at the material aspects of the circular economy – i.e. rare metals – that has little to do with the bioeconomy. On the other hand, a number of areas in the bioeconomy do not necessarily have too much to do with the circular economy, i.e. innovative bio products with new functionalities. Though it’s very important, I think, to combine them as not every process of the circular economy will be 100% circular; you will always need to renew and replenish, a positive effect the circular bioeconomy can offer as it is based on renewable biological resources. The Circular Economy Strategy also picks up on a number of elements of the 2012 Bioeconomy Strategy that are related to circularity. In the 2012 Bioeconomy Action Plan, we already noted the importance of cascading use, which is now addressed more concretely in the Circular Economy Action Plan. But as I said, if you build a circular economy based on renewable resources – a circular bioeconomy – it has the potential to be much more sustainable. That is where you get the most out of the Bioeconomy and Circular Economy Strategies.

EuroBiotech_One question raised by the Commission was how can biorefineries contribute to the sustainability goals?

Kütt_The review doesn’t look at the fea-

sibility of biorefineries. I think it’s much too early; we have to do this in the longer term. Back in 2012, bio-based resources were thought to replace fossil fuels and resources. I think the technologies today have emerged from a pure substitution viewpoint to one, where basically you create innovations from biomass; extract value from bio-based waste and side streams, and add to circularity. So bio-based technologies create added val-

12-13_EB_Winter_2017_Insight_Interview_tg.indd 13

ue in terms of recycling valuable materials from waste. That makes a major contribution to a more resource-efficient society.

EuroBiotech_What must be done in Europe to remain competitive in terms of bio-based production compared to Asia and the Americas?

Kütt_It’s hard to say, because there are a

lot of factors affecting the viability of biobased production, i.e. of bioplastics.

However, I guess we have a good technological basis in Europe set by the BBI JU, which attracts investment. Bio-based production is not only about bio refineries and industrial biotechnology, but also about innovations in more classical biobased industries, such as wood construction, more sustainable alternatives to cotton from wood cellulose or new plant based products.

EuroBiotech_Considering the current discussion on further funding of public-private partnerships/joint undertakings in FP9 and the lack of appropriate financial support for bioeconomy innovators in Europe vs other parts of the world, what are the EC’s plans to foster bioeconomy?

Kütt_We have a lot of these partnerships,

some of them already going for the third round. It’s too early yet to say what will happen to the public-private partnerships until the Commission has finished its reflection process on this issue. First we will present our proposal for FP9 – or whatever it will be called – by mid-next year.

A proposal for the partnerships will come later; there is still sufficient time to discuss this, as the new programme will only start in 2021.

EuroBiotech_What would you personally like to see implemented in the new strategy?

Kütt_There is no personal wish list. But I

think we have to more closely link policy areas such as research and innovation, agriculture, marine & fisheries, environment, energy, climate, etc., in coherent ways to best profit from the huge potential the bioeconomy has to offer.

L t.gabrielczyk@biocom.eu

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07.12.2017 12:10:31 Uhr

14

Rubrik

European Biotechnology | Winter Edition | Vol. 16 | 2017

Morphochem is a clinical stage biopharmaceutical company developing its lead program MCB3681 as an intravenous (i.v.) treatment of Clostridium difficile infections for which currently no approved i.v. treatment option exists. MCB3681, showing a higher in-vitro activity against C. difficile than fidaxomicin, vancomycin, and metronidazole (Rashid MU et al., 2014), is a representative of a novel class of small molecule antibacterials addressing four targets. It is a narrow-spectrum Gram-positive...

The Paleo diet is also central to the The Wahls Protocol, created by Dr. Terry Wahls after she was diagnosed with MS in 2000. The Wahls Protocol adopted the nutrientrich Paleo diet for its vitamins, minerals, antioxidants and essential fatty acids, and integrated into a regimen of neuromuscular stimulation. She claims that this protocol has “allowed her to reverse many

Pictures: xxx

I am a professor of medicine at the University of Iowa and for most of my career, I believed wholeheartedly in the power of modern medicine, in our latest greatest drugs, in our ever more expert procedural interventions.

For many years, I focused on treating disease, not on creating health, because that is what I was taught to do.

I didn’t know any better, but I was certainly not a “physician of the future.” (That’s the term Thomas Edison used to describe the doctor who “will give no medication, but will interest his patients in the care of the human

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 14

07.12.2017 12:11:36 Uhr

Cover Story

European Biotechnology | Winter Edition | Vol. 16 | 2017

15

Learning to listen to your gut Microbiome The adage ‘you are what you eat’ is more than folk wisdom. Evidence that the

food you ingest has a major impact on your health grows by the day. It’s now clear the bacteria that colonise the skin and gut from birth on are key sensors for environmental triggers in chronic diseases of civilisation. Ever since research showed that restoring microbiome balance cures 90% of all Clostridium difficile infections, food manufacturers, pharma companies and independent teams have been tracking it in other indications – including multiple sclerosis.

Pictures: nerthuz/fotolia.com (left), Sergio Baranzini (right),

W

hen Dr. Terry Wahls was diagnosed with remittingrelapsing multiple sclerosis (MS) in 2000, she did what you would expect a professor for internal medicine at the University of Iowa to do. She began taking one of the ‘ABC’ medicines (Avonex/Betaseron/Copaxone, see p. 19) – compounds to suppress the auto­immune reaction in her Central Nervous System (CNS) that was targeting the myelin insulation that covered her neurons – and hoped for the best. When she ended up in a tilt-recline wheelchair three years later after developing the untreatable secondary progressive form of MS, she decided she had to find a way out on her own.

The “strictly science-driven” expert for clinical trials began to comb scientific literature for alternatives to mainstream immuno-suppressive drugs (see p. 19), which are able to slow but not cure her neurodegenerative disorder. She ended up conducting experiments on herself.

Through a combination of electro­ stimulation and a ‘paleo-like’ menu that cut down on gluten-rich foods and increased non-processed foods in her diet, the physician was back on her own feet in a year. She also no longer suffered from the heat intolerance and fatigue that are top causes of MS disability. Inspired by the recovery, she set up a foundation that eventually attracted 90,000 followers, then wrote a book to bring her message to

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 15

the 2.5 million people who suffer from MS globally. In it she says, “medication can’t take away your autoimmune disease, but your body can heal itself.”

Probiotics are the golden goal Interestingly, the approach the physician takes to treating the neuro­degenerative disease through the ‘Wahls Protocol’ comes at a time when public and science

Sergio Baranzini Director Human Genetics UC San Francisco and initiator of the International Multiple Sclerosis Microbiome Study (IMSMS)

? !

Is there industry interest vis-a-vis your new MS approach?

I ndustry is interested, but in my view they’d like to see more evidence before jumping into it full force.

are ready to listen. Around 70% of European consumers now say they believe healthy food positively impacts on health.

A huge number of scientific publications have also linked the composition of an individual’s gut bacteria, or “microbiome”, to susceptibility for chronic diseases as different as diabetes, autism, chronic bacterial infections, cancer, Crohn’s disease, psoriasis, arthritis – and multiple sclerosis.

When studies showed that fecal micro­bial transplants (FMT) can cure recurrent infections with antibiotic-resistant Clostridium difficile bacteria in nine out of ten cases, researchers and companies were hit with gold rush fever. A new area of endeavour was thrown open; it’s aimed at understanding which factors in the microbiome interact with the body to trigger diseases that have a feature in common – chronic, low-threshold inflammation.

As imbalances in the microbiome – scientifically dubbed ‘dysbiosis’ or ‘dysbacteriosis’ – are clearly dependent on what you eat, food companies have entered the space along with pharma firms. While AstraZeneca and Merck, Sharp & Dohme, and DuPont Nutrition have all installed large microbiome research centres and joint ventures in Europe, other big players are trying to cherry-pick best approaches from a growing number of microbiome SMEs (see p. 17).

In December 2015, Swiss pharma major Novartis and global food giant Danone

07.12.2017 12:11:43 Uhr

16

Cover Story

acquired interests in Seventure’s €160m Health for Capital Life fund, the only VC fund so far dedicated exclusively to investments in microbiome-related companies. “The next five years will see the first microbiome products coming out of clinical studies and onto the markets,” says Seventure partner Eric de la Fortelle. “We already have some products in Phase IIb and III. These will become medical or nutritional products, and the range of indications will keep expanding,” he believes. Analysts agree. They predict the microbiome market could become as big as biotech in the next 20 years. One projects a market value of

European Biotechnology | Winter Edition | Vol. 16 | 2017

US$658m for microbiome-derived medicines by 2030.

No microbiome = No MS “There’s huge hype around micro­biome research. In the past two years, vast amounts of money have been channeled into the field,” says Christine Lang, CEO of Novozymes subsidiary Organobalance, a specialist for lactobacterial interventions. ”Last year, about US$700m were invested in the US and €600m in Europe. I’m convinced that we’re currently just seeing the tip of the iceberg. However, understanding of the microbiome is early-stage, and

the next step is to investigate what happens in the gut mechanistically. Nobody currently knows whether microbial products or an accumulation of certain bacterial species triggers disease,” she adds.

To date the only commercial provider of germ-free mice and customised microbiome solutions globally, Taconic Bio­ sciences has re­ported a growing interest from a wide range of for-profit and nonprofit groups. “Demand has expanded expo­nentially in the last few years,” says Randi Lundberg, the head of the firm’s Field Applications Scientist Microbiome Products & Serv­i ces. Back in 2011, a mouse model proved beyond doubt that

“Expanding range of indications” Microbiome Gold rush European Biotechnology met Seventure

Partner Eric de La Fortelle at BIO-Europe in Berlin to talk about his vision of a future in microbiome-inspired treatments and food products.

fund, which closed in December 2015 with €160m, is the first and only fund dedicated to microbiome-related pharma and nutrition companies. We have Novartis and Danone as limited partners. They have a strategic interest in the field. Our CEO Isabelle de Crémoux invented the concept between 2008 and 2010 because she realised that the range of indications in which research into the microbiome can help consumers or patients will keep expanding. It’s a very high motivator for us that applications range from immuno­ oncology, dermatology and neurology to metabolic and autoimmune diseases.

EuroBiotech_Food and pharma products in one portfolio – can that really work?

De La Fortelle_Microbiome-related pro-

ducts will not simply address a single market, but many. There’s a lot of new thinking around the role of the micro­ biome, since it’s becoming clearer and clearer that what we eat has a significant

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 16

impact on our health. Food and pharma companies have complementary knowledge. Combining it could be very useful.

In the future, your doctor might prescribe you a drug and tell you to change your diet or unhealthy lifestyle. Accordingly, Seventure has a highly diversified portfolio of investments.

EuroBiotech_Could you characterise it?

De La Fortelle_Typically, we invest be-

tween €3-10m per transaction but also smaller amounts into seed companies.

Our first microbiome company, back in 2011, was Paris-based Enterome. It’ll soon enter Phase II with a small molecule targeting pro-inflammatory gut bacteria to prevent Crohn’s disease. Additionally, they are active in the immuno-oncology space.

Today, Health for Life has 16 investments, including cancer companies such as Anaero­pharma or MaaT Pharma, personalised nutrition companies such as DayTwo, or the gut-brain axis player TargEDys, as well as companies that develop microbiome ­rebalancing products such as Eligo, BiomX and Vedanta.

Eric de la Fortelle has been Venture Partner with Seventure Partners since 2014. The structural biologist has more than 20 years of experience in the bio-pharma sector, and worked earlier in his career at Roche and Delenex.

EuroBiotech_Given the diversity and complexity of these approaches, what is the biggest challenge for Big Pharma?

De La Fortelle_The pharmaceuticals in-

dustry has been very focused on finding individual molecular targets that they can intervene with to get the system back to work. In the future, complex rebalancing of an ecosystem such as the microbiome will also be an important tool to restoring health.

L

Pictures: Fotolia.com/crevis Picture: Seventure

EuroBiotech_Why did Seventure get into the microbiome area so early?

De La Fortelle_Our Health for Life Capital

07.12.2017 12:11:55 Uhr

Cover Story

European Biotechnology | Winter Edition | Vol. 16 | 2017

MS genesis is tied to microbiome developments. “We know more than 200 genes that make people susceptible to multiple sclerosis,” says Hartmut Wekerle, a top MS researcher at the Munich-based Max Planck Institute of Neurobiology. “For onset, however, it needs a trigger.” Since the digestive tract is actually the most intimate connection between the outside world and the immune system, his team investigated whether the microbiome could play the role of trigger in immune-related conditions and environment. But to find that out, they had to solve another problem first. “Current models of experimental auto­immune encephalitis (EAE) didn’t work for that purpose, because they externally supply the mice with the human myelin protein to induce brain inflammation.

So we designed a model that mimicked many aspects of spontaneously developing MS. Our mice express a transgenic T cell receptor that detects myelin auto­ antigens, and makes the animals develop EAE spontaneously after 6–8 weeks.” Using this model, Wekerle’s team proved that MS cannot develop in the absence of the microbiome. “When we reared such mice in a germ-free environment, they didn’t develop EAE. When we transplanted a microbiome into them, they did,” Wekerle explains. “This was the ultimate proof that a factor linked to the microbiome triggered MS in animals. We hypothesise that the gut microbiome pushes the intial activation of auto­reactive T cells, which might initiate MS.” (see p. 18). If this hypothesis holds true in humans, microbiome-derived pre- or probiotics, defined fecal microbial transplants or therapies that correct dys­ biosis could in the future completely transform the current US$22bn MS market.

Companies active in the microbiome area and proprietary products. CDI: Clostridium difficile infections, UC: ulcerative colitis, FMT: fecal microbial transplant

Company

Business

Stage

› Anaeropharma Science (Tokyo)

Cancer-targeted intestinal bacteria producing cytotoxic compounds, APS001F, or antibodies

clinical (Phase I)

› Artizan Biosciences (Durham)

small molecules targeting IBD microbiota

preclinical

› Axial Biotherapeutics (Boston)

gut-selective CNS disorders (autism, PD)

n.a.

› biomX (Ness Ziona, Israel)

bacteriophages targeting acne (BX001), IBD (BX002), GI cancer, immuno-oncology

preclinical

› Caelus Health (Amsterdam)

Metabolic syndrome (CP01)/diabetes (CP02)

clinical (Phase I)

› C3J Therapeutics (Los Angeles)

dental caries, i.e. C16G2 (antimicrobial)

clinical (Phase II)

› Caelus Health (Amsterdam)

FMT reversing metabolic syndrome (CP01)/ insulin resistance (CP02)

clinical (Phase I)

› DayTwo (Ayer, US)

Low glyc nutrition app based on microbiome

commercial

› Eligo Bioscience (Paris)

microbiome editing for pharma, cosmetics and functional nutrition

research

› Enterome (Paris)

gut-selective drugs to treat Crohn’s disease (EB88018), IBD (licensed), immuno-oncology (licensed) and glioma (EO2315)

clinical (Phase I)

› Epibiome (San Francisco)

anti-infective phage therapy

n.a.

› Evelo Biosciences (Boston)

microbial drugs in oncology and inflammatory diseases announced to go Phase I in 2018

preclinical

› LNC Therapeutics (Bordeaux)

gut-microbiome-targeted nutrition vs obesity

n.a.

› MaaT Pharma (Lyon)

Autologous FMT Maat001.3 to treat AML

clinical (Phase I)

› Metabogen (Mölndal, S)

Microbiome CRo for pharma and probiotics

n.a

› Microbiotica (Cambridge, UK)

CDI FCM, IBD, immuno-oncology

n.a

› Microbiome Therapeutics (New Orleans)

Prebiotics vs. IBD and metabolic diseases,i.e.

NM504

pilot studies

› Naked Biome (San Francisco)

skin-derived probiotic therapy, acne

clinical (Phase I)

› Rebiotix (Roseville)

FMT vs CDI (RBX2660, RBX7455), UC, UTI, etc

clinical (Phase III)

› Seres Therapeutics (Boston)

oral microbiome therapeutics vs. CDI (SER109, Ser 262) and colitis ulcerose (Ser278)

clinical (Phase II)

› Second Genome (San Francisco)

small microbiome-targeted inhibitor vs. IBD (SGM-1019), metabolic diseases

clinical (Phase I)

› Synlogic (Boston)

microbiome-targeted inhibitors (Synb1020) vs urea cycle disorder + hepatic encephalopathy

clinical (Phase I)

› TargeDys (Longjumeau, F)

appetite regulating probiotics targeting ClpB

preclinical

› Ubiome (San Francisco, US)

metagenomics, microbiome sequencing

n.a.

› Vedanta Biosciences (US)

defined microbials vs. CDI, UC (CE02, VE03)

preclinical

Searching for the nuggets Since Wekerle’s groundbreaking study, many teams have begun classifying disease-relevance of gut bacteria in MS patients according to abundance – with limited success. A very recent study carried out by Wekerle’s US partner group led

by Sergio Baranzini at UC San Francisco, however, is the first to add functional relevance to the data flood. Investigat-

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 17

17

07.12.2017 12:12:11 Uhr

Cover Story

European Biotechnology |Winter Edition | Vol. 16 | 2017

Periphery

CNS

Thymus a4b1 integrin allows infiltration

Memory B cell

B cell

CD8+ cell 3

2 T H1 cell

T H17 cell

1B T reg cell

autoreactive CD4+ cell

CD4+ cell

Mucosa epthelium

Peptide MHC 1A Bac teria

Monocyte Lymph node

Innate immune celll

Viruses

To date, researchers don’t know whether MS is triggered primarily by a CNS-intrinsic or a CNS-extrinsic event. While nobody has discovered exactly what factors lead to the increase of CNS-intrinsic microglia and astrocytes in early to late disease stages, researchers have found putative triggers affecting the peripheral immune response.

Based on findings that infections with the Epstein Barr and cytomegalo virus, smoking or vitamin D deficiency increase disease susceptibility, the current model is that MS starts with factors (1A) that trigger the activation of autoreactive helper T-cells (CD4+) or which (1B) lead to a breakdown of Treg-mediated peripheral immune tolerance.

According to this model, microbial proteins mimicking i.e. the human myelin basic protein or myelin oligodendrocyte glycoprotein (or altered T-cell-receptor sensitivity) eventually activate previously sleeping autoreactive CD4-cells, which in turn (2) activate B- and memory B cells as well as monocytes, TH1, TH17, and killer T cells (CD8+) against the autoantigen. They enter the blood and lymphatic system, and infiltrate the CNS (3).

ing the microbiomes of 71 MS patients and 71 healthy volunteers, the US team found that two bacteria species enriched in the MS group vs. controls – Akkermansia muciniphila and Acinetobacter calcoaceticus – triggered immune cells in vitro to become pro-inflammatory. At the same time, a species that was reduced in MS patients (Parabaxteroides distasonis) boosted immune-dampening responses. When transplanted into germ-free mice that had no micro­biome, lead author Egle Cekanaviciute found the same effect. To investigate how the differences in gut bacteria modulate the immune system’s attack on myelin, the researchers performed fecal transplants on mice with induced EAE. Analyses revealed that mice carrying the microbiome of MS patients caused them to lose regulatory T cells, to produce less of the immune­ -regulatory messenger interleukin-10, and to develop more serious neurodegenera-

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 18

tion. “It looks like these microorganisms could be making the disease progression worse or better,” Cekanaviciute interprets.

“If proven safe and effective, a fecal microbial transplant could be a first-line option for many patients,” says Baranzini. “We’re working to get IND approval from the FDA, and expect to start a Phase I trial early next year.” In collaboration with the International Microbiome Study (IMSMS), a consortium of leading US, German, Spanish, UK and Argentine MS research teams, founder Baranzini will recruit 2,000 patients with all forms of MS/MS treatments and 2,000 healthy controls to systematically compare differences in the microbiota or its physiology that could be linked to MS. Also in October, Wekerle and clinical partner Reinhard Hohlfeld, Director at the Institute for Clinical Neuroimmunology in Munich, examined whether findings in mice also apply to humans. To this end,

they recruited 34 identical twins, each with one diseased and one non-affected sibling, and transplanted their respective intestinal microbiomes into germ-free mice that mimick the spontaneous development of MS. “When the stool of MS-affected twins was transplanted, we observed the spontaneous development of the disease significantly more often and more pronounced,” says Hohlfeld. The German researchers next want to find out whether the activation of the autoimmune reaction against the myelin protein in MS patients is set in motion by bacteria in the small intestine, which most often trigger pro­-inflammatory responses, or whether it occurs in the large intestine, where immune­-regulatory processes are dominant. Their first results, which have yet to be confirmed in further studies, seem to corroborate the Baranzini team findings: that reduced immuno­regulatory activity in MS patients might trigger the activation of autoreactive T cells that marks the onset of MS.

Diet vs. fecal transplants Wekerle hopes his work will encourage not only probiotic therapies, but also noninterventional approaches to the effects of nutrition on MS. “While the golden goal of probiotic or dietetic therapy is still a

A Phase I assessment of fecal microbial transplantation in MS patients within the IMSMS is expected to start in H1/2018.

Pictures: MPI for Neurobiology (bottom, BIOCOM. source: Nature Rev. Immunology doi: 10.1038/nri3871

18

07.12.2017 12:12:41 Uhr

Cover Story

Source: Vfa

European Biotechnology | Winter Edition | Vol. 16 | 2017

long way off,” he adds, “FMT is also difficult. Nobody currently knows what makes a healthy fecal transplant. Additionally, a lot of obscure providers are offering wild transplants. It’s essential for the safety of patients to distiguish serious researchers from that groups.”

The new field has also seen setbacks.

Published 12-month results of an open­ label clinical pilot study enrolling 20 MS patients to prove efficacy of the Wahls Protocol reported only partial success. While patients with moderate motor defects benefited, those with severe disability didn’t respond (Degen Neurol Neuromuscular Disease, doi: 10.2147/DNND.S128872).

At the end of October, however, a team of Scottish, US and French researchers added further insight into the potentially critical immune regulatory pathway that is defective in patients with MS. Led by Siobhan Ni Choileain from the University of Edinburgh, the team reported that an altered glycosylation pattern of the CD46 protein blocked TH1 cells from properly developing into IL-10-secreting type 1 regulatory T (Tr1) cells, which tamp down inflammation and prevent autoimmunity (Science Signal., doi: 10.1126/scisignal.aah6163).

Researchers will now be able to investigate microbiome impact on the newly identified trigger.

L

t.gabrielczyk@biocom.eu

14_19_EB_Winter_2017_Cover_Neurogut_tg.indd 19

19

Approved therapies for multiple sclerosis (BBB: blood-brain barrier)

Drug/INN (Company)

Approved

Drug class

MoA

› Betaferon/interferon b1b (Bayer) › Extavia/same (Novartis)

11/1995 05/2008

immunosuppressive cytokine

reduction of neuroinflammation and BBB leakage

› Avonex/interferon b1a (Biogen) › Rebif/same (Merck Serono)

03/1997 05/1998

immunosuppressive cytokine

reduction of neuroinflammation and BBB leakage

› Imurek/azathioprine (Wellcome Laboratories); today a generic medicine

09/2000 (only in Germany)

immunosupp. cytostatic (ic)

blocks T/B cell proliferation

by DNA/RNA synthesis

› Copaxone/Glatirameracetat (Teva)

immuno­ suppressant

not known

› Clift/same (Mylan dura)

11/2000 (UK) 09/2001 (D) 05/2016

› Ralenova/Mitoxantron (Wyeth)

02/2003

immuno­ suppressant

DNA intercalator and RNA topoisomerase II blocker

› Tysabri/natalizumab (Biogen)

06/2006

lymphocyte invasion blocker

Integrin a4 blocker, stops migration to inflamed tissue

› Gilenya/fingolimod (Novartis)

03/2011

immuno­ suppressant

spingosine 1 phosphate analogon prevents lymphocytes from leaving lymph nodes

› Aubagio/teriflunomid (Sanofi)

08/2013

immuno­ suppressant

DHODH blocks T/B cell proliferation

› Lemtrada/alemtuzumab (Genzyme)

09/2013

immuno­ suppressant

kills CD52+ lymphocytes

› Tecfidera/dimethyl fumarate (Biogen)

02/2014

immuno­ suppressant

activation of the immunomodulatory Nrf2-pathway

› Ocrevus/ocrelizumab (Roche/ Biogen)

12/2017

immuno­ suppressant

kills CD20+ B lymphocytes RRMS + PPMS

07.12.2017 12:14:19 Uhr

20

economy

European Biotechnology | Winter Edition | Vol. 16 | 2017

Spanish biotech sector attracts investors Spanish biotech sector European investors more and more often take a look at Southern

“Spain is definitely a region to watch,” says Giovanni Mariggi, Partner at UKbased Medicxi, who in June 2017 enlarged its investment strategy and launched its first $300m late stage life science fund for European life science companies. In Autumn, the VC manager was among the 50 Spanish, French, Swiss, and British investors invited to a one-day conference organised by Spanish biotech organisation ASEBIO in the Barcelona Science Parc.

The ASEBIO Investor Day demonstrated that foreign investors, such as Merck Ventures, Sofinnova Partners, and Novartis Venture Fund, are increasingly interested to see what the Spanish biotech companies have in their pipelines. “During the last ten years, the sector significantly improved in terms of maturity and financings,” said Ion Arocena, CEO of ASEBIO. According to the latest Spanish biotech report, 26 deals with €63.6m took place in 2016, 158 alliances were announced and 43 startups were founded. From his per-

spective, these numbers demonstrate the huge development the sector has made since 2008, when the Spanish government decided to put extra money into the life sciences. “Back than, some people believed that the life sciences were not a real industry. Today, we have successfully established a dynamic ecosystem, which is the basis for a strong local investors community and, which, in turn, increasingly attracts international investors,” Arocena pointed out. For this year, the numbers also indicate further growth.

Arocena: “We already now obtained the level of the whole year of 2016.“

Strong investor community One of the key players in the Spanish biotech sector is Catalonia. 82% of the capital of Spanish biomedical companies are in the hands of Catalan investors, such as Barcelona-based Ysios Capital. Founded in 2008, the VC has €191.4m in as-

The Spanish biotech sector in 2016

sets under management through its two funds. It invested in 11 Spanish companies, which have raised a total of €300m to date. “Only €15m came from us – this demonstrates the value local investors can have,” said Raul Marin-Ruiz, Principal in Ysios Capital. Publicly supported research areas such as Barcelona Science Parc are very attractive. "We started 20 years ago and today, we are home to four R&D science centers and more than 50 life science companies,” said Ignasi Belda, CEO of the parc.

However, new technologies are developed all over the country, as demonstrated by the 30 startups showcased on the Investors Day. The expertise ranged from novel drugs to combat antimicrobial resistance (Remab, Vaxdyn), cancer (Ability Pharma, Leadartis), Alzheimer’s disease (Tetraneuron) or inner ear disorders (Spiral Therapeutics); to innovative diagnostic solutions (NBS Newborn solutions) or drug discovery technologies (Aniling); regenerative medicine approaches (Regemat3D, Qrem); and algae-based products for the use in cosmetics or agriculture (AlgaeEnergy, Neoalgae).

BIOSPAIN 2018 in Sevilla

650+

108

companies

43

new start-ups

new product launches

26

158

financing deals, totaling €63.6m

alliances agreed

According to numbers published by ASEBIO, the Spanish biotech sector offers a prosperous financial environment for life science companies.

20_EB_winter_2017_economy_asebio_spain_sw.indd 20

One of the next opportunities to meet Spanish stakeholders will be from 25–27 September 2018 in Sevilla. “We expect around 3,000 people to join us for BIOSPAIN 2018,” said David Fernández from ASEBIO. The previous event in 2016 hosted about 230 exhibitors and attracted 700 companies from 29 countries.

L s.wirsching@biocom.eu

Picture: Icons from fotolia.com: rath0013 (house + hand with plant), MicroOne (DNA), vendakr (hand shake)

European biotech companies. Spain, in particular, is now harvesting the fruits of long-term public support started a decade ago, which stimulated the establishment of a dynamic ecosystem. Today, foreign investments are at an all-time high and start-ups find a well-prepared basis for growth.

06.12.2017 15:14:49 Uhr

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22

economy

New wave of optimism for European biotech stocks Stock market The European biotech stock market witnessed an increase in IPO and follow-

on financing volumes in 2017. According to the new BIOCOM capital market report, published in November during BIO-Europe in Berlin, more than half the money was raised on the US Nasdaq.

Within Europe, Euronext is still is the most attractive location – but Stockholm is catching up.

Nordic IPO experience In 2016, Swedish Cyxone AB took the IPO route in Stockholm. For Kjell Stenberg and his management team, the company is the first result of a virtual company building strategy. “Our focus is

22_EB_Winter_2017_Kapitalmarktstudie_sw.indd 22

Capital raised via IPOs

Capital raised via follow-on-financings

Total financial proceeds

€529m

1–3Q17 +23%

€2.49bn

€1.93bn €429m

1–3Q16

1–3Q17

+29%

€1,965m +31%

1–3Q16

€1,501m

1–3Q16

1–3Q17

Financial proceeds of listed European biotech companies in 2017, compared to 2016

promising patented assets at mid-size academic research institutes,” he said.

Cyxone was founded based on a promising oral medication approach for multiple sclerosis with cyclotides, developed by physiologist Christian Gruber at MedUni Vienna and Carsten Gründemann from Freiburg University Hospital. To accelerate clinical development, the company raised €9m with the IPO in Stockholm. “For our virtual company model, it offers a perfect platform for further capital increases," Stenberg says.

The report supports this trend: the overall situation for follow-on-financings in 2017 has recovered significantly compared to 2016. A total of €1.96bn was dropped into European biotech companies (+33%). This, however, is particularly true for the US Nasdaq, which saw an 176% increase compared to 2016 (€1.1bn) in follow-on-financings, including three secondary listings (Verona Pharma, ar-

genx, Zealand Pharmaceuticals) which alone amounted to €251.5m.

During a panel discussion at BIOEurope, Ulrica Slane Bjerke of Artic Fund Management said that sometimes VC companies “dress up the bride maybe too early.” Furthermore, she added, company leaders in Europe should have a longterm strategy: “Plan for a life as a public stock.” There is no lack of money in Europe, as the rise of new funds demonstrates.

In November, Dutch BioGeneration Ventures (BGV) closed its third fund, BGV III, at €82m, exceeding the original target by €32m. New investors include Bristol-Myers Squibb, Johnson & Johnson Innovation, private equity investor Schroder Adveq, and MAN Pension Trust. According to partner Oskar Slotboom, the early stage fund will invest in 15 companies in Central Europe, focusing on innovative therapeutics (80%) and diagnostics (20%). L s.wirsching@biocom.eu

Picture: BIOCOM – Analysis of European Biotech Companies on the Stock Markets 2017/18

Taking all indicators into account – number and volumes of IPOs, follow-on financings, and secondary listings – the 228 European biotech companies raised €2.49bn by Q3/2017, 29% more than during the same period in 2016 (€1.93bn).

More than half the money (54%, €1.34bn) was raised on the US Nasdaq. According to the report, published in November during BIO-Europe in Berlin, this highlights the power of biotech-focused investors available across the Atlantic.

In terms of numbers, however, Europe is in the forefront. A majority of 11 firms opted for one of the 14 European trading centres, with three firms floating on the US Nasdaq instead. All IPOs together yielded a total amount of €529m (+23%).

Among the European trading centres, Paris (45) and London (43) are the top locations with the highest number of listed biotech companies. As stated in the report, cross-border stock market Euronext is still among the most attractive stock exchanges for European biotech companies. Three of this year’s listings took place here. The analysis also reveals that in 2017, a new wave of listings took place in Scandinavia, among them one in Oslo and five in Stockholm. The Swedish capital has now caught up to Paris and London with a total of 40 listed biotech companies.

08.12.2017 11:03:55 Uhr

European Biotechnology | Winter Edition | Vol. 16 | 2017

Update of ongoing clinical trials Crohn’s Disease

Pfizer Inc. published new data suggesting that switching patients with Crohn’s disease to its biosimilar infliximab CTP13 (Inflectra, licensed from South Korean Celltrion) from Johnson & Johnson’s original blockbuster infliximab (Remicade) led to comparable efficacy, safety, and tolerability over six months of treatment. The outcomes from a Phase III trial of Inflectra, announced in October at the 25th United European Gastroenterology (UEG) Week, are part of an ongoing dispute between Pfizer Inc. and Johnson & Johnson. In its complaint, Pfizer alleges that J&J violated antitrust laws by engaging in anticompetitive practices aiming at blocking sales of the biosimilar drug. J&J threatened to withhold significant rebates from health insurers unless they agreed to “biosimilar-exclusion” contracts that effectively block coverage for Pfizer’s Inflectra infliximab bio­similars. Furthermore, J&J offered providers contracts that gave discounts on Remicade in exchange for not purchasing biosimilars to Remicade. The biosimilar price is 20% lower than the original.

In October, Celgene Corp. discontinued a Phase III study of mongersen, an antisense oligonucleotide targeting SMAD7 to treat active Crohn’s disease, due to poor efficacy results. There were no “meaningful safety imbalances,” according to the data monitoring committee. Celgene has suspended the start of Phase III trials in this indication. Currently, mongersen is also being tested in an ongoing Phase III study of patients with ulcerative colitis.

Celgene licenced the global commercialisation rights for mongersen in 2014 from Irish Nogra Pharma Ltd. NSCLC

England’s second largest pharma company, AstraZeneca plc, received FDA priority review in response to its sBLA for its PD-L1 checkpoint inhibitor durvalumab as palliative treatment for non-resectable non-small cell lung cancer (NSCLC)

23-25_EB_Winter_2017_Trial_tg.indd 23

in patients not progressing following chemo- and radiotherapy. In the pivotal Phase III trial enroling 709 patients, Imfinzi improved progression-free survival (PFS) by more than 11 months (to 16.8 months) compared to the current standard of care. The 18-month progression-free survival rate was 44.2% versus 27.0%. Median time to death or distant metastasis was longer with durvalumab than with placebo (23.2 months vs. 14.6 months).

Combination partners for checkpoint inhibitors are urgently needed to expand cancer patient populations responding to cancer immunotherapies. In November, Merck KGaA (Darmstadt) and Debiopharm S.A. (Lausanne) enrolled the first patients into a Phase Ib dosefinding study in NSCLC that combines Merck’s PD-L1 blocker avelumab with Debio 1143, a mimetic of second mitochondrial-derived activator of caspases (SMAC), which boosts apoptosis in cancer cells. The trial, enroling 61 patients with advanced metastatic NSCLC, is being conducted under a clinical collaboration agreement announced last year between Debiopharm International SA and the Merck-Pfizer Alliance. Primary endpoints include assessment of the maximum tolerated dose of Debio 1143 when combined with the standard dose of avelumab, and objective response rate.

In October, multi-kinase blocker Entrectinib (Ignyta Inc./Nerviano Medical Sciences s.r.l.) reached the Phase II endpoint of objective response rate (ORR) in patients with NSCLC. The small molecule drug, which targets NTRK 1–3 fusions or ROS1 fusions, achieved an ORR of 78% over 28.6 months and showed a median progression-free survival of 29.6 months.

Entrectinib, which Ignyta licensed from Nerviano Medical Sciences in 2013, has EU prime and FDA breakthrough status.

Ignyta hopes to file a Biologics Licence Application in 2018.

08.12.2017 11:05:20 Uhr

24

Regulatory Affairs

European Biotechnology | Winter Edition | Vol. 16 | 2017

News Sensitising cancer

No bleeding Ergomed plc’s first-in-class peptide-based fibrinogen-binding coagulant PeproStat has met the primary endpoint of superiority over standard of care (gelatin sponge) in time to haemostasis in a Phase II study.

PeproStat reduced the time to haemostasis by 1.55 minutes across all surgery types investigated.

First-in-class therapy In November, Advicenne SA (Nimes) reported positive six month follow-up data from an ongoing pivotal Phase III study (B22CS) assessing ADV7103 in adults and children suffering from distal Renal Tubular Acidosis (dRTA) that can lead to renal failure. Efficacy was shown to be maintained at six months, with blood bicarbonate levels above 21 mM in 79% of the patients. The company said it intends to file for European market approval now.

23-25_EB_Winter_2017_Trial_tg.indd 24

Antibiotic-resistant, Gram-negative bacteria, such as Multidrug-resistant Klebsiella pneumoniae, are known to cause severe hospital-acquired infections.

Antimicrobials

Spero Therapeutics LLC (Cambridge, US) and its Finnish partner Northern Antibiotics Ltd (Helsinki) have proved safety of single and ascending doses of its injected, positively charged polymyxin B derivative SPR741 designed to perforate the membranes of Gram-negative bacteria and boost the effect of common antibiotics used to fight Gram-negative pathogens. Phase II trials starting next year will combine such broadband antibiotics with the potentiator of permeablitiy, SPR741, to treat complicated urinary tract infections (cUTIs).

British Motif Bio plc has announces topline Phase III results for iclaprim showing that the diamino-pyrimidine met the primary endpoint in 305 patients with acute bacterial skin and skin structure infections (ABSSSI) vs placebo. Iclaprim was non-inferior compared to vancomycin, the current standard of care, 48 to 72 hours after administration. The antibiotic also met the secondary endpoint – non-inferiority regarding near resolution at end of therapy compared to patients receiving vancomycin (treatment difference: -0.83%). REVIVE-2 was a 600-patient double-blinded, active-controlled, global trial in patients with AB-

SSSI that compared the safety and efficacy of an 80mg intravenous dose of iclaprim with a 15mg/kg intravenous dose of vancomycin. Treatments were administered every 12 hours for five to 14 days. The trial involved over 40 clinical centres in the U.S., South America, and Europe.

Pancreatic cancer

Norwegian Targovax ASA reported a 100% one-year survival rate in patients with resected adenocarcinoma of the pancreas receiving TG01/GM-CSF in combination with gemcitabine as adjuvant therapy. In the main cohort, Targovax had previously reported an overall survival of 33.1 months in 19 patients. In a modified cohort of 13 patients, which was designed to build on the positive findings from the main cohort in order to further optimise the TG01 treatment regimen and safety profile of the combination therapy, Targovax now reported that 100% of patients (13/13) were alive one year after surgery. Normally, it is 20%. Furthermore, TG01/GM-CSF generated an immune response in 85% of patients (11/13), and no serious adverse events related to allergic reactions were reported. TG01 is an injectable antigen-specific cancer immunotherapy targeted to treat patients with

Picture: David Dorward, PhD, National Institute of Allergy and Infectious Diseases

In November, small molecule specialist 4SC AG (Martinsried) enroled the first patient into a Phase Ib/II combination study (NCT03278665) of patients with unresectable advanced cutaneous melanoma refractory to checkpoint inhibitor monotherapy. In 40 patients, the company will assess safety, immunological biomarkers, and anti-tumor activity of MSD’s PD1 checkpoint inhibitor pembrolizumab (MSD) plus 4SC-202, a blocker of lysine-spezific demethylase (LSD1) and histone deacetylases 1–3. 4SC expects topline results to be available in H2 2018.

07.12.2017 12:17:47 Uhr

European Biotechnology | Winter Edition | Vol. 16 | 2017

KRAS mutations, found in more than 85% of pancreatic adenocarcinomas. TG01 consists of a mixture of seven synthetic peptides that represent seven of the most common codon 12 and 13 mutations in p21RAS associated with human cancer.

TG01 induces RAS mutant-specific T-cell responses, which are enhanced by coadministration of GM-CSF (recombinant human granulocyte macrophage-colony stimulating factor). TG01 was the first therapeutic peptide vaccine targeting RAS that entered clinical trials.

Hepatocellular carcinoma

French Ipsen Group and its US partner Exilixis Inc. for cabozantinib have stopped a pivotal Phase III efficacy study enrolling 760 patients with hepatocellular carcinoma. According to the companies, the drug candidate targetting AXL, c-met, and RET receptor tyrosine kinases and VEGF receptors 1-3 met the primary endpoint of overall survival vs placebo.

The companies gave no further details.

Ipsen Group expects to file for EU market authorisation in Q1/2018.

Bristol-Myers Squibb has been granted FDA accelerated approval for its PD1 checkpoint blocker nivolumab (Opdivo) to treat hepatocellular carcinoma (HCC) The approval was based on the Phase I/ II CheckMate 040 trial of Opdivo in 154 HCC patients refractory to sorafinib with and without HBV or HCV co-infections.

In the trial, 14.3% (22/154) of patients responded to treatment with Opdivo. Three patients showed a complete response while 19 were partial responders. Among responders, 91% of those patients had responses of six months or longer and 55% had responses of 12 months or more.

French cancer med developer Transgène SA (Illkirch-Graffenstaden, France) has started a Phase I/IIa study (NCT03071094) enrolling 30 treatment-naive patients with hepatocellular carcinoma (HCC) to assess safety and dose-limiting toxicities of a combination of two cancer immunotherapies that have already been proven to be efficient: Trangenes’ intratumourally injected oncolytic virus therapy pexas-

timogene devacirepvec (three doses), and Bristol-Myers Squibb’s intravenously (biweekly) administered checkpoint inhibitor nivolumab. In the Phase IIa part of the study, the company will assess the overall response rate (ORR), disease control rate (DCR) at four months, and overall survival at 12 months.

In a Phase III trial, Paris-based Onxeo S.A.’s nanoparticle formulation of docorubicin missed the overall survival endpoint in 397 sorafenibrefractive patients with unresectable hepatocellular carcinoma vs. standard of care. According to Onxeo, survival in the control arm was unexpectedly high.

Esophagitis

Getting the job done right means starting with the right partner.

Sanofi’s/Regeneron Pharmaceutical’s IL4/ IL13-receptor-binding antibody duplimab has met the endpoint in a Phase II study of 47 patients with eosinophilic esophagitis, a chronic allergic reaction leading to a swollen and damaged esophagus. Patients’ ability to swallow was significantly improved as well as the number of eosinophils in epithelia vs. placebo. Duplimab has already been approved as a treatment for atopic dermatitis and is set to be submitted as asthma therapy.

What can you do to help smooth your compound’s path to clinic and beyond?

With Vetter, you work with a partner who knows how to take your compound from preclinical to commercial manufacturing:

Hepatitis

Expertise in the development of a broad range of drugs

M e divir AB (Stockholm) re p or te d Phase IIb data on JNJ-4178, a combo of simeprevir, AL-335, and odalasvir, at the AASLD Liver Meeting 2017 (Washington) in mid-October. 181 of 183 non-cirrhotic patients with HCV genotypes 1, 2, 4, 5, and 6 treated for six weeks achieved non-inferiority to historic controls.

Transgène SA’s (Strasbourg) viral vaccine TG1050 is well tolerated and induced a strong specific immune response in patients with chronic hepatitis B, according to preliminary results from a Phase Ia/b study on 96 patients. Data presented at AASLD Liver Meeting 2017 suggest that patients who received a single dose of TG1050 along with standard antiviral therapy produced antibodies against HBV core protein, polymerase, and envelope protein.

L

Technology and resources to achieve decisive milestones Clinical manufacturing facilities in the US and Germany When it comes to your injectable compound, turn to the partner trusted by top biopharmaceutical companies. Turn to Vetter.

The right partner for your ongoing clinical trial

Answers that work www.vetter-pharma.com

infoUS@vetter-pharma.com infoAsiaPacific@vetter-pharma.com • info@vetter-pharma.com • •

23-25_EB_Winter_2017_Trial_tg.indd 25

07.12.2017 12:17:53 Uhr

26

Economy

European Biotechnology | Winter Edition | Vol. 16 | 2017

CPhI embraces the biologics space CPHI The world’s largest event for pharma professionals will see an expansion to the rapidly-

growing field of biologics next year in Madrid. In Frankfurt, CPHI Worldwide organiser UBM saw a new record of 44,500 visitors and 2,598 small molecule API, packaging, manufacturing, formulation, and analytics exhibitors. Its biologics extension, bioLIVE, aims to add the 600 European CDMOs to the show to foster collaboration between small and large molecule specialists.

The initial feedback from CDMOs appears to be positive. Whether at BIOEurope or at other major biotech events, European CDMOs, such as Polpharma, Eurogentec, Rentschler, and Celonic, were positive about the new scope on biologics.

“Frankfurt was good preparation for the New York Marathon,” an exhausted business developer told European Biotechnology, in a nod to the long distances between the halls.

“It’s a brilliant idea,” said Pierric Marchand. The founder and CEO of Holodiag, a specialist contract research organisation (CRO) for antibody-drug conjugate (ADC) linkers and payloads, is actively seeking collaboration with antibody specialists. “This is where biotechnology and chemistry will come together,“ he said. Until now, biomanufacturers and bioprocessing specialists met at meetings such as Bioprocess International Europe, which are ideal for niche players, but are not designed to link decision-makers from the small molecule and the biologics world. “BioLIVE has the potential to fill that gap,” said Vikram Rao, Head of Business Development at UBM.

26_EB_Winter_2017_CPHI_tg.indd 26

Starting next year (October 9-11 in Madrid), bioLive is scheduled to complement the CPhI Worldwide, ICSE, InnoPack, P-MEC and FDF. According to UBM’s Brand Director Rutger Oudejans, BioLive will be a platform for CDMOs to showcase products to potential partners and differentiate themselves from competitors in a consolidating market environment. “It’s a hugely exciting time for the bioindustry globally and we expect rapid growth in what is now a maturing supply chain,“ he told European Biotechnology, which has been selected to be bioLIVE’s media partner. BioLive will offer a conference/exhibition mix including matchmaking and product and service launches.

As currently 80% of the global clinical pipeline comprise biologics, CPhI can no longer ignore that revenues are shifting to biologics makers: In 2016, 50% of the 20 top-selling drugs were biological therapies. Oudejans is convinced that an eco­system that brings together the bio development and manufacturing sectors will benefit “the full pharma value chain of both small and large molecule drugs, and can contribute to the development of new strategies in bioprocessing and biomanufacturing.” bioLIVE may also support bio­similar and biologics makers, which aim to expand their products’ reach into the European and international markets.

At CPhI in Frankfurt, representatives from pharma packaging and serialisation data onboarding specialists, such as Recipharma and Tracelink, told European Biotechnology that CDMOs that can’t provide serialisation to pharma customers won’t be competitive in the European market. According to Jean Marie Aulnette from Tracelink, 50% are not yet prepared to meet the 2019 serialisation deadline.

L t.gabrielczyk@biocom.eu

Picture: BIOCOM

Time to take action

07.12.2017 12:18:17 Uhr

European Biotechnology | Winter Edition | Vol. 16 | 2017

Stock Markets

27

Play it safe with sales guidances Frédéric Gomez Equity Research Analyst, Pharmium Securities_In one day, the market cap

of Celgene dropped by US$15bn – an amount equal to the combined value of Genmab and Galapagos! Even if very few European biotechs are exposed to this commercial risk, it does exist.

After reaching again 3,500 point s, the Nasdaq Bio­ technology Index (NBI) has lost nearly 7.8% since early October. To find an expla­ nation, we should not look at small-cap or mid-cap bio­ tech companies – a volatile subsector subject to correc­ tion – but rather at big-caps (> US$10bn in market ca­p italisation).

Within this group, Q3 financial results coming from one member of the Big 4, Celgene, were extremely disappointing, triggering a 16% drop of the share price (loss of US$15bn in market cap). The problem is not total sales or cash flow numbers, but revenue guidance provided by the company itself. US big-caps are all world leaders in their field (multiple my­ eloma for Celgene, HCV for Gilead, cyst­ ic fibrosis for Vertex, multiple sclerosis

for Biogen). All these com­ panies share a common fea­ ture: They posted very high growth rates for several years with attractive earnings per share. This growth, which is higher than in many other sectors, warrants premium and high valuation multiples in the minds of investors, es­ pecially generalists. The challenge they face is to maintain these high rates to sat­ isfy investors. As a consequence, some companies adopt an aggressive attitude in their sales/profit guidance; therefore they are exposed to the wrath of fund managers if the results are below expec­ tations.

Unfortunately, Europe has not been spared: Its locomotive Genmab went down 6% on October 17 after partner Johnson&Johnson released figures show­

ing weaker-than-expected sales of the multiple myeloma blockbuster Darzalex; and Zealand Pharma went down 18% af­ ter the announcement of lower-than-ex­ pected royalties from Sanofi on its diabe­ tes franchise Soliqua/Suliqua. In contrast, the figures announced by SOBI were above expectations, driven by its haemo­ philia franchise (mostly Elocta), and the company has raised its revenue guidance for 2017. Although it is unlikely that Abl­ ynx will provide revenue estimates for its flagship product, it is the next biotech in Europe that investors will scrutinise with great attention. Approval of caplacizum­ ab for acquired thrombotic thrombocy­ topenic purpura is expected in Europe in 2018 and the US in 2019.

The Celgene hiccup reminds us that bio­tech companies are not only exposed to a clinical/regulatory risk; they also face commercial challenges.

L

Picture: Pharmium Securities

News from the floor Valneva SE French-Austrian vaccine company Valneva SE (FP:VLA) has an­ nounced strong Q3 results, says Samir Devani of Rx Securities, beating his and consensus forecasts. Following the positive news regarding a one year US military contract for Japanese en­ cephalitis vaccine Ixiaro, these results are seen as a further welcome devel­ opment. Devani raised his forecasts and maintained his “buy” rating. Lis­ ting at €3 in late November, Devani’s calculated fair value is €4.8/share.

27_EB_Winter_2017_Analyst_ml.indd 27

Novo Nordisk A /S Danish Novo Nordisk A/S (NYSE:NVO) was upgraded by analyst house Morgan Stanley from an “equal weight” rating to an “overweight” rating in a research note issued in early December. Its diabetes drug semaglu­ tide is about to be approved by the FDA. Novo also revealed it plans to position the drug as a obesity treatment.

DBV Technologies SA Liisa Bayko of JMP Securities started coverage of French allergy specialist DBV Technolo­

gies. Her rating is “outperform” with a US$30 price target. Since the release of PEPITES data on peanut allergies in children, she has engaged with regula­ tory experts and doctors to assess the chances for approval and any changes in the intent to treat with DBV’s failed therapy Viaskin Peanut. In summary, Bayko still thinks there is a path to ap­ proval and assigns a 60% probability of success. Shares had dropped from US$48 to US$22 after the endpoint of the Phase III trial PEPITES was missed. 

06.12.2017 15:18:56 Uhr

28

Euro Biotech Stocks

COMPANY

QUOTE

4D Pharma plc 4SC AG

M-Cap

European Biotechnology | Winter Edition | Vol. 16 | 2017

52 weeks indicator low high

COMPANY

3.83

251,000k

C4X Discovery Holdings plc

QUOTE

M-Cap

0.9

5.3

161,200k

Cantargia AB

0.71

23,100k

A1M Pharma AS

1.26

10,500k

Carbios SAS

9.08

41,200k

AB Science SA

8.71

358,700k

Cassiopea SpA

28.75

288,800k

AB-Biotics SA

1.72

21,700k

Cellectis SA

20.86

745,500k

Abcam plc

11.17

2,239,100k

Cellink AB

11.81

88,800k

Abivax SA

9.5

88,100k

Celon Pharma SA

7.33

310,100k

Ablynx NV

19.64

1,462,000k

35.49

337,700k

Abzena plc

0.36

76,500k

Cerenis Therapeutics SA

Acarix AB

1.52

35,000k

Circassia Pharmaceuticals plc

Celyad SA

Co.don AG

Final spurt

Cosmo Pharmaceuticals NV Curetis AG

Antibodies Shares of Ghent-based biotech group ArgenX

climbed by more than 10% in late November to reach an all-time record level of €26. The company had presented itself at several investor conferences in New York and London – and obviously stirred interest. Listed on Euronext Brussels since 2014, the antibody developer made its debut on the US Nasdaq earlier this year, cashing in gross proceeds of US$114.7m. Within less than a year, the market capitalisation of ArgenX has more than doubled, from €300m to €700m.

L

1.93

35,200k

1.2

381,500k

3.08

158,200k

120.64

1,798,400k

4

63,400k

Cytotools AG

10.1

21,300k

Cyxone AB

1.21

21,600k

37.24

919,700k

DBV Technologies SA Deinove SA

1.74

19,400k

Destiny Pharma plc

1.49

62,900k

Diamyd Medical AB Diasorin SpA Diaxonhit Therapeutics SA

0.36

19,700k

79.05

4,347,000k

4.6

44,200k

3.71

26,000k

e-Therapeutics plc

0.11

28,200k

Ellen AB

0.02

3,000k

Enzymatica AB

0.42

30,200k

Epigenomics AG

4.06

96,100k

24

426,800k

Elanix Technologies AG

Erytech Pharma SA Active Biotech AB

0.33

31,400k

Esperite NV

0.55

10,000k

Addex Therapeutics Ltd

1.84

27,900k

Eurofins Cerep SA

5999

30,300k

Eurofins Scientific SE

513.5

9,037,000k

Adocia SAS

15.02

103,500k

ALK-Abelló A/S

116.9

1,231,700k

Allergy Therapeutics plc

0.32

Alligator Bioscience AB Annexin Pharmaceuticals AB Aqua Bio Technology ASA

Evgen Pharma plc

0.19

13,800k

191,400k

Evolva SA

0.27

211,000k

2.52

178,600k

Evotec AG

12.5

1,789,000k

0.81

4,800k

Expres2ion Biotech Holding AB

1.14

11,100k

0.81

5,300k

Faron Pharmaceuticals Oy

9.51

277,300k

Argenx SE

26.4

701,200k

Fermentalg SA

3.47

58,600k

Arocell AB

0.46

13,200k

Fit Biotech Oy

0.03

2,600k

3.9

50,100k

Formycon AG

30.64

282,200k 3,754,000k

Asit Biotech SA Avacta Group plc

0.74

50,500k

Galapagos NV

73.86

Avantium Holding NV

8.91

228,300k

Genedrive plc

0.41

7,600k

Basilea Pharmaceutica AG

66.31

782,600k

Geneuro SA

5.81

85,000k

Bavarian Nordic A/S

31.38

1,007,400k

2.27

106,300k

Genmab A/S

Bergenbio ASA

Genfit SA

22.71

707,500k

163.67

9,956,500k

Bio-On SpA

28.31

524,800k

Genomed SA

4.21

5,800k

Biocartis NV

12.6

622,500k

Genomic Vision SA

3.36

18,800k 20,500k

Biofrontera AG Biogaia AB Bioinvent International AB Biomed-Lublin SA Biomérieux SA

3.9

152,500k

Genovis AB

0.34

29.97

520,500k

Genoway SA

1.91

11,400k

0.22

67,100k

Gensight Biologics SA

5.17

123,100k

0.29

15,800k

Genkyotex SA

69.88

8,246,000k

Genus plc

1.72

133,900k

26.38

1,631,700k

Bionaturis SA

3.49

16,300k

Global Bioenergies SA

16.85

70,700k

Biophytis

4.63

61,000k

Hansa Medical AB

23.32

813,900k

Bioporto Diagnostics A/S

0.48

73,100k

Herantis Pharma Oyj

5.65

29,300k

Biosearch Life SA

0.47

27,100k

Hofseth Biocare ASA

0.18

41,100k

Biotec Pharmacon ASA

0.72

33,100k

Horizon Discovery Group plc

2.84

431,700k

29.38

151,000k

Hvivo plc

0.61

47,900k

1.33

11,500k

Hybrigenics SA

0.47

22,000k

9.4

64,400k

Idorsia Ltd.

19.34

2,267,300k

21.11

375,800k

Immunicum AB

0.98

24,400k

Bioventix plc Biovica International AB Bone Therapeutics SA Brain AG

28-29_EB_Winter_2017_stock_list_ml.indd 28

52 weeks indicator low high

41,800k

07.12.2017 12:19:19 Uhr

Euro Biotech Stocks

European Biotechnology | Winter Edition | Vol. 16 | 2017

COMPANY Immunodiagnostic Systems plc

QUOTE

M-Cap

52 weeks indicator low high

COMPANY

3.12

91,900k

Immunovia AB

9.18

156,000k

Immupharma plc

1.46

191,100k

0.5

31,000k

Probi AB

Index Pharm. Holding AB

Plant Advanced Technologies SA

QUOTE

M-Cap

24.27

22,500k

Poxel SA

6.81

155,000k

Premaitha Health plc

0.07

22,300k

32.73

377,600k

Infant Bacterial Therapeutics AB

10.21

67,900k

Probiodrug AG

11.9

98,200k

Innate Pharma SA

4.89

278,800k

Promore Pharma AB

1.46

29,600k

Integragen SA

2.56

17,000k

Proteome Sciences plc

0.04

11,700k

Intervacc AB

0.81

13,100k

Qiagen NV

26.72

5,989,000k 32,600k

Inventiva SA

5.9

98,500k

Quantum Genomics SAS

2.98

Isofol Medical AB

2.29

72,400k

Relief Therapeutics Holding AG

0.01

17,100k

ISR Holding AB

0.62

12,900k

Reneuron Group plc

0.02

69,200k

Kancera AB

0.22

32,000k

Salvarx Group plc

0.27

9,800k

Karo Pharma AB

3.89

315,700k

Saniona AB

3.45

72,100k

Santhera Pharmaceuticals AG

Kiadis Pharma BV

8

139,000k

25.24

160,200k

Kuros Biosciences AG

10.61

86,700k

Sareum Holdings plc

0.01

24,900k

Lysogene SA

4.09

49,500k

Scancell Holdings plc

0.14

43,400k

Mabion Ltd

22.58

269,700k

Selvita SA

13.25

184,900k

MDxHealth SA

3.9

191,400k

Sensorion SA

2.83

22,200k

Medical Prognosis Institute A/S

1.2

29,000k

Shield Therapeutics plc

1.33

155,300k

Medigene AG

11.4

259,200k

Silence Therapeutics plc

2.32

158,500k

Medivir AB

5.4

113,100k

1.1

10,400k

Mereo Biopharma Group plc

3.61

254,300k

Metabolic Explorer SA

2.27

53,000k

Stallergenes Greer plc

Simris Alg AB Skinbiotherapeutics plc

0.11

13,500k

39.92

790,300k

Midatech Pharma plc

0.48

29,500k

Summit Therapeutics plc

2.04

144,400k

Molecular Partners AG

20.96

452,400k

Swedish Orphan Biovitrum AB

11.52

3,114,400k

Molecular Medicine SpA

0.45

205,800k

Sygnis AG

1.58

75,300k

Mologen AG

2.52

86,300k

Synairgen Research Ltd

0.12

11,200k

80.51

2,366,000k

Targovax ASA

1.62

85,200k

Morphosys AG Motif Bio plc

0.39

102,500k

Theradiag SA

2.5

21,700k

Nanobiotix SA

14.2

276,000k

Thrombogenics NV

4.5

164,100k

NEL ASA

0.31

323,500k

Tigenix NV

0.95

257,800k

Neo Biosolutions SA

0.25

2,300k

Tissue Regenix Group plc

0.08

95,600k

Neovacs SA

0.55

33,900k

Tiziana Life Sciences plc

1.7

210,400k

Neuron Biopharma SA

0.3

4,700k

Transgene SA

2.72

168,200k

Neurosearch A/S

0.49

12,000k

Txcell SA

1.43

30,900k

Neurovive Pharmaceutical AB

0.38

19,300k

Valirx plc

0.01

3,100k

Newron Pharmaceuticals SpA

9.75

171,700k

Valneva SE

2.93

228,400k

Nicox SA

10.21

302,100k

Vectura Group plc

1.1

751,100k

Nordic Nanovector ASA

8.27

402,200k

Veloxis Pharmaceuticals A/S

0.11

186,200k

45.42

13,918,000k

Vernalis plc

0.14

73,200k

6.75

15,400k

Verona Pharma plc

1.24

130,600k 39,300k

Novozymes Biopharma DK A/S Noxxon Pharma NV Nuevolution A/S

1.79

76,300k

Vita 34 AG

9.36

Oncimmune Holdings plc

1.39

76,800k

Wilex / Heidelberg Pharma AG

2.75

61,100k

11.64

79,400k

Wilson Therapeutics AB

11.11

282,500k

8.11

326,700k

Xbrane Biopharma AB

0.32

8,800k

1.1

55,800k

Xintela AB

8.96

273,900k

Zealand Pharmaceuticals A/S

12.03

367,800k

Oncodesign Biotechnology SA Oncopeptides AB Onxeo SA Optibiotix Health plc

0.78

61,700k

Orphazyme A/S

10.21

202,200k

3

100,800k

Oryzon Genomics SA OSE Pharma SA

3.55

52,500k

Oxford Biodynamics plc

2.32

199,900k

Oxford Biomedica plc

0.1

315,800k

Paion AG

2.47

151,000k

PCI Biotech Holding ASA

2.19

55,600k

Pharma Mar SA

2.39

529,900k

Pharming Group NV

1.25

679,900k

Pharnext SA

8.65

93,900k

Photocure ASA

2.71

56,500k

Physiomics plc

0.1

5,300k

28-29_EB_Winter_2017_stock_list_ml.indd 29

29

52 weeks indicator low high

All quotes are listed in euro. All data is provided without guarantee. The effective date is 04 December 2017.

These dedicated biotech companies are listed on European stock markets.

07.12.2017 12:19:27 Uhr

30

Focus

European Biotechnology | Winter Edition | Vol. 16 | 2017

Pharma packaging sector faces sea change Pharmapack 2018 Focus The dawning age of digital healthcare is expected to transform

Serialisation will be just one of the hot topics discussed at Pharmapack Europe (profile see p. 42) at the Paris Expo. Preparing for the 9 February 2019 EU deadline to onboard serialisation data into the European Hub is currently the main focus for companies such as Recipharm, which provides contract manufacturing and development organisations (CDMOs) with full range solutions preventing drug counterfeit. “Fifteen of our 200 customers have their data onboard,” Staffan Widengren, Director of Corporate Projects at Recipharm, told European Biotechnology. Because serialisation requires a lot of investment, Widengren expects it to drive consolidation in the market. “About 50% of the 600 CDMOs in Europe are not prepared to meet the 9th February deadline, and not all CDMOs will be able to onboard.” To remain competitive, it’s crucial that CDMOs offer serialisation. “We need

30_EB_Winter_2017_Pharmapack_Intro_intro_tg.indd 30

six months for connecting companies to the hub,” says Jean-Marie Aulnette, VP EMEA Sales at Recipharm’s partner company, Tracelink, which offers cloud-based services for onboarding. Giving pharmacies digital access to drug developers’ packaging documentation, however, is only one of the advantages offered by digitalisation.

Connecting drug delivery devices such as autoinjectors to sensors measuring disease parameters will completely transform the current way of administering, assessing, and reimbursing medicines. Therapies in which strict regimen adherence is critical to long-term health, and where the treatment is complex, uncomfortable, or invasive may benefit in particular. Better compliance, data-based therapy adjustment, and outcome-based reimbursement are only few impacts digitilisation will bring to med-

icine. “I am absolutely convinced that failure to enter this field will make you irrelevant,” says Paul E. Hansen, Member of the Board at Haselmeier AG (see interview p. 34).

In mid-November, the US FDA demonstrated where the development is going: The agency approved Abilify (Otsuka Pharmaceutical Co. Ltd.), the very first schizophrenia pill embedded with a digital sensor that (theoretically) sends out a signal when it comes into contact with gastric acid to a patch, which then passes the information to a smartphone app. The FDA said that digitally monitored therapy could be particularly useful to treat certain mental diseases. The technology, however, is still in an early stage: Sometimes the signal doesn’t come through; sometimes it takes 60 mins; sometimes 120 min.

L

t.gabrielczyk@biocom.eu

Picture: UBM EMEA

the pharma packaging and drug delivery sector. At the 21st edition of Pharmapack Europe (7–8 February, 2018, Paris), an expected 5000+ professionals and 400+ exhibiting companies – the industry’s largest meeting ever – will discuss the latest innovations in serialisation, connected devices, and digitalised meds.

07.12.2017 12:20:09 Uhr

Please visit us at Pharmapack, Paris February 7 – 8, 2018 Booth No. D26

IMPROVING PATIENTS‘ LIVES THROUGH OUR INNOVATIVE HEALTH CARE SOLUTIONS IS THE CORE OF OUR BUSINESS. BECAUSE WE CARE. Datwyler Sealing Solutions is a leading industrial supplier and a key player in the health care world. Our state-the-art solutions for drug packaging and medical devices are built on over 100 years of experience.

We provide a unique range of products and services including the most advanced elastomer formulations, coatings, aluminum seals, and processing technologies.

Partnering up with the world’s top pharmaceutical and medical companies, we stand by our mission to improve patients’ lives.

www.sealing.datwyler.com

31_EB_Winter_2017_Datwyler.indd 1

06.12.2017 15:20:45 Uhr

32

FOCUs

European Biotechnology | Winter Edition | Vol. 16 | 2017

Tamper-resistant labels Pharma Packaging Serialisation dominates the discussion about how to implement the Falsi-

fied Medicines Directive (2011/62/EU). However, to meet the February 2019 deadline, companies must also pay attention to the second required safety feature: the anti-tampering device. The use of tamper-evident labels is widespread. But beware! There are many challenges associated with these popular tamper-evident devices. › Philip Falkenstein, Product Manager Serialisation & Tamper-Verification, Bähren Druck

Many variables to be defined With the deadline about a year away, many companies have chosen clear filmic labels with perforation as their anti-tampering device. These labels have several advantages: they allow easy machine processing; have little or no effect on the package’s artwork; and, in many cases, can be attached to existing folding box layouts and stocks.

However, in order to realise these advantages without difficulty right from the beginning, the right label set-up has to be defined. This starts with the selection of the right material. There are a variety of specifications including the glue, face­ stock, and backing (see graphic).

This is complicated by the fact that each material manufacturer has its own solution, terminology, and combinations.

Aspects such as format, shape, and labelroll finishing are also affected by the labelling machine requirements.

32_EB_Winter_2017_Pharmapack_Baehren-Druck_tg.indd 32

Representation of layers. 16679 Labels by Bähren Druck: tamper-evident labels for your serialisation project.

Another important issue is the opening support by perforation. There is a fine difference between a stable unbroken sealing and an easy-to-open/patient-friendly opening support. This depends on the face material, the type of perforation and, of course, the package design. All these factors influence each other too.

Naturally, the focus is on the glue, or rather the adhesive force of the label on the folding box. In order to verify manipulation on the folding box, tampering must result in visible and irreversible damage to the cardboard. But this damage does not always occur in everyday practice.

The main challenge is the varnish on the folding box. These coatings can weaken the bond between the glue and the carton surface. But the carton type and printed area can also influence adhesive strength. Standard permanent glue reaches it limits.

Before adapting varnish-free areas on the folding box as a result, it is more con-

venient and recommended to choose selected and proven materials which are specially developed for use as a tamperverification feature. They do not require varnish-free areas. Furthermore, the label material must be subject to the pharmaceutical change management. Changes that are not noted by the pharma company may endanger the functionality and/ or safety.

Some pharmaceutical companies exert a strong influence on the connection between package and label; others do not.

Contract manufacturing organisations (CMOs) in particular may face the challenge of dealing with packaging from several folding box manufacturers — each with a different type of varnish.

Choose your tamper-evident label with caution and you will avoid expensive product recalls in the supply chain due to peeling, missing, or ineffective labels.

L www.16679-labels.com

Picture: Bährenb Druck

The EU regulation does not specify how to implement an anti-tampering device.

Both the directive 2011/62/EU and delegated regulation 2016/161 stipulate the safety feature but do not define any details. For this reason, stakeholders prepared the CEN standard EN 16679 entitled "Tamper-verification features for medical product packaging,“ which will be upgraded to ISO 21296. This standard presents tamper-evident methods for compliance with EU requirements.

Pharmaceutical companies can use this standard as a guideline and choose between labelling, gluing, folding box construction, and wrapping.

08.12.2017 11:06:52 Uhr

D-Flex . Just One. ÂŽ

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Working together to inspire your patients. haselmeier.com

Inserat_215.9x279_9mm.indd 1 33_EB_Winter_2017_Haselmeier.indd 1

24.08.17 16:01 06.12.2017 15:25:51 Uhr

34

Focus

European Biotechnology | Winter Edition | Vol. 16 | 2017

“Connectivity is the future” PharmaPack 2018 The promises of digitalised medicine don’t stop at injection pens or

autoinjectors. One of the early adopters in the field is Swiss Haselmeier AG (Pharmapack: hall 7.1, booth L19). European Biotechnology spoke with Paul E. Jansen, Member of the Board, from Haselmeier’s Boston office about how connected devices could define a new paradigm in therapy compliance and control of chronic diseases, and how they will shape the market.

to understand the impact of injection devices transmitting data is to look at what is happening when a patient uses a selfinjection device. Capturing the data is the easy part. Technologies to transmit them by near field communication (NFC), for example, to other devices such as a blood glucose sensors are already in place. But turning the data into meaningful information is what really matters. As in most industries, data can help recognise trends, predict outcomes, and understand results or – in the case of healthcare – adjust treatment regimes.

Data captured from a clinical trial with diabetes patients, for example, showed their doctors that a majority weren’t appropriately dosed and treated. As the data didn’t show a snapshot but a trend, the physicians were able to make adjustments to the therapy. I think the entire connectivity field is about to transform the way we treat patients. That’s why we want to do this.

EuroBiotech_What are the major benefits?

Jansen_We have already seen a transition

in how patients generally interact with the new technologies, including the availability of medical information on the Internet. The problem with this data is it’s not the patient’s data. Providing access to their own data gets patients really engaged. It allows them to see what hapens

Paul E. Jansen Since February 2017, Paul Jansen has been Senior Advisor and Member of the Board of Directors at Haselmeier AG. He brings nearly 30 years of experience in the medical device industry and has managed the development of multiple drug delivery systems, i.e. at Eli Lilly in the early 2000s, and in the Leadership of Global Medical Device Development Sanofi from 2006 to 2017.

when they change their treatment. This is a great opportunity to significantly improve treatment compliance. Today, more than 50% of patients do not take their prescription medicaments properly.

If we could convince this really large proportion of patients – through a reminder on their smartphone or a message to

34-35_EB_Winter_2017_Pharmapack_Interview_Paul-Jansen_Haselmeier_tg.indd 34

their caregivers – to take their drugs properly, it could have significant impact on outcomes. That’s interesting for the people who pay the bill. If you could collect data about what was taken, when it was taken, etc. and link it to the outcome or clinical efficacy, payors would be much happier to pay for a drug because they see they are getting value for their money. Payors have no problem paying for a biologic as long as they know it adds value. Vice versa: developers could demonstrate the value of a treatment. Finally, healthcare providers would also benefit, because they could add data analyses to their know-how to recognize new trends that would improve the quality of care. Data from global databases would help them to see how good a particular product, whether approved or in clinical trials, really is.

EuroBiotech_Why did Haselmeier adopted the trend as one of the first companies in the field?

Jansen _Haselmeier is absolutely con-

vinced that failure to enter this space will make you irrelevant. Every device in the future will be connected. It’s like in the automotive industry where today a car without electronics is inconceivable.

EuroBiotech_What is Haselmeier’s strategic goal relating to connected devices?

Jansen_Our strategic objective is to get a

product quickly into the marketplace.

We will start with an add-on device to our injection pen devices. In the longer term we will put connectivity into disposable devices which are preferred in the marketplace. There are several challenges before you can launch such a

Pictures: Paul Jansen, Haselmeier

EuroBiotech_Mr Jansen, two years ago Haselmeier announced it will add IOT connectivity to its self-injection devices.

How will connectivity impact healthcare systems, drug development, and patients’ lives?

Jansen_That is a broad question. The key

06.12.2017 15:27:09 Uhr

Focus

European Biotechnology | Winter Edition | Vol. 16 | 2017

product. You’ll need something that does not yet exist: low-cost sensors cheaper than 10 eurocents. We are also searching for alternatives to batteries to power the devices – energy captured by rotational movement, for example. We will seek partnerships to complement our existing technological capacities and patent pool.

EuroBiotech_What other challenges must be mastered to bring connected devices to the market?

Jansen_Our customers have recognised

where the development is going and they are 100% on board. However, everybody wants the technology but yet nobody wants to pay for it. Some of the cost could be absorbed by the product itself and by highly motivated patients or users. If you look at the the fertility market, you can expect that potential parents are highly motivated and will pay for a device because they are highly interested in a good outcome. In areas you may

call “the silent diseases,” such as diabetes, high blood pressure or high cholesterol, you might have a much harder job.

The patients won’t pay because they don’t feel bad unless they experience complications. Their motivation to use a connected device will drop rapidly, so it will become harder for the healthcare providers to establish that there is a beneficial outcome. Scaling technology platforms will keep cost in check but patient engagement will be key to make connected devices a success.

EuroBiotech_What unique selling points will determine who will be a leader in the field?

Jansen_I am convinced leaders will be

EuroBiotech_What about concerns regarding data privacy?

Jansen_There are two major issues we

the companies who can prove they have a safe and reliable system. I also believe we should keep things simple. Complex handling will block adoption.

have to solve to support market adoption: data privacy and preventing people from compromising your data by hacking into it. The data privacy issue is just a matter of the building the right system to meet the requirements. The issue of hacking is much more difficult because if you establish countermeasures someone will

35

find a way around it. You can make life harder for hackers, for example, when you transmit the original data by NFC to a device with advanced encryption technology. If you only have a one metre distance in which the data could be transmitted, a hacker must be in the room to access them.

EuroBiotech_Where does Haselmeier want to be in the future?

Jansen_Haselmeier wants to be the part-

ner of choice for a connected injection system. However, a lot of water must go under the bridge until we achieve that.

We have to make it reality.

L

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* For almost two decades, European Biotechnology has been the first and foremost information platform reporting on the life sciences in Europe. european-biotechnology.com is ranked No. 1 on Google.com, search terms biotechnology+europe.

34-35_EB_Winter_2017_Pharmapack_Interview_Paul-Jansen_Haselmeier_tg.indd 35

06.12.2017 18:47:39 Uhr

36

focus

European Biotechnology | Winter Edition | Vol. 16 | 2017

Ready for future challenges CEO Outlook Torsten Maschke, CEO of leading international supplier Datwyler Sealing Solutions,

takes a look at the developments and challenges the industry will face in the coming year. Global networks and the production in and for international markets will increase in importance, and further specialisation in the healthcare market will be required to ensure a future-proof business model. › Torsten Maschke, CEO, Datwyler Sealing Solutions

The pharma and health care market is continuously facing diverse challenges and changes, which are directly linked to the transforming needs of health care. Therefore, it's of utmost impor tance to have a deep understanding of the industry’s current and upcoming requirements, and opportunities for future growth. Within this context, 2017 was a very important year for Datwyler. The launch of our new specialised health care offering was a pioneering step for us and for our customers. The new offering especially underlines our strong sense for future trends to advance global health care.

Furthermore, Datwyler is growing. In line with our principle “To be a reliable partner, wherever our customers need

us” we have been investing in additional facilities to better provide customers with locally produced components of the highest quality. A capacity expansion is currently in process in Pune, India to support our goal to offer our First Line standard globally. Operation will begin in the second half of 2018. In addition, we are building a new state-of-the-art health care plant in Delaware, USA with the start of production in the second half of 2018. Both facilities will manufacture components and coatings in a cleanroom environment and will be aligned with our First Line manufacturing standard. The process flow, gowning protocols, personnel, and material flow result in the lowest endotoxin, bio­burden, particulate, and defect levels available in the industry.

Adding these two new operations to our existing First Line aligned site in Alken, Belgium will enable us to introduce the First Line manufacturing standard to global and regional markets alike.

R&D is key Especially in the health care industry, developments and new products are emerging fast. To us, it is very important to not only know trends but to shape them.

Therefore, investments in research and development are essential. As new innovative drugs emerge, there is also a need for the development of new and compliant packaging materials. Also, companies will need to advance to be able to cater to the new, more individualised ways of drug administration. This particularly applies to the growing field of digital health, which includes wearables, sensors, and new ways of monitoring patients. To further these developments, partnerships are key. One main objective is always to make the whole approval process for new drugs or products as lean and efficient as possible.

Advanced manufacturing standard First Line will be introduced to further regional and global markets.

36_EB_Winter_2017_Pharmapack_Datwyler_tg.indd 36

The next years will be very interesting for the global health care and pharmaceutical market. We certainly have several changes and developments that we must take on. Trends like digital health, the increasing demand for highly sensitive drugs, individualised ways of treatment – just to name a few – are casting a long shadow into the future. In 2017, Datwyler laid the foundation to take on all the challenges of 2018 and beyond. L

Picture: Datwyler

Positive outlook for 2018

07.12.2017 12:21:03 Uhr

Euro BioFairs Compass Winter Edition 2017/18

II Guide to Life Sciences Events

SPECIAL 37_EB_Winter_2017_Compass_Title_tg.indd 41

06.12.2017 15:29:05 Uhr

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08.12.2017 11:09:44 Uhr

European Biotechnology | Winter Edition | Vol. 16 | 2017

Euro Biofairs Compass

39

European event update EuroBiofairs Compass Every manager, scientist, and business developer has their own individual,

Picture: UBM

specific network — and so, too, their must-attend events vary significantly. Where to meet potential new partners and how to widen one’s scope beyond well-known terrain can be quite difficult to determine. Euro Biofairs Compass will help you navigate the European meeting jungle in H1/2018.

In Brussels, MedTech Forum 2018 (23– 25 January 2018), the largest medtech event in Europe, will spotlight future trends in the sector. In 2018, the event will offer new thematic tracks, more keynote sessions, and a brand new exhibition area (p. 40).

Pharmapack 2018 (7–8 Februar y 2018) is a must-go for experts in pharma packaging, serialisation hardware and equipment, who will gather in Expo Paris (see p. 42).

The worldwide threat of antimicrobial resistance in medicine will be the focus of the 11th edition of the Berlin Conference in Life Sciences (2 March 2018, Fraunhofer Forum Berlin). Decision makers from Big Pharma, and biotech SMEs, policy makers, regulators, payors, business developers, and investors will meet in Berlin to explore how to incentivise companies to develop novel an-

39_EB_Winter_2017_Compass_intro_tg.indd 39

tibiotics that can break drug resistance of multiresistant strains (see p. 44).

The sister meeting to biotech industry’s largest partnering event, EBD’s Bio-Europe Spring 2018 (12–14 March), on the other hand, will provide the perfect partnering point for biotechs, investors, and pharma executives in Amsterdam (see p. 46).

For researchers in the formulation field, a visit to Berlin might be unavoidable. This year’s Nano and Micro Formulation conference (13–14 March 2018) will present innovations in manufacturing, characterisation, and control of the next generation of nanoformulations and drug-release mechanisms (see p. 48).

A meeting with major impact kicks off on 3 May at Congress Centre Basel, which will host what has become the nation’s most important biotech event,

the Swiss Biotech Day (3 May 2018, see p. 50). As in previous years, the new Swiss biotech report will shine a light on the industry’s status in the country.

Due to the growing visitor numbers (500+), the Swiss Biotech Day moved to Basel Congress Centre last year.

More than 400 exhibitors and 6,500+ visitors are expected to come to Chemspec Europe (20–21 June 2018, see p.

52), Europe’s premier sourcing and networking event for the fine and speciality chemicals industry. The exhibition is the central marketplace for manufacturers, suppliers, and distributors of fine and speciality chemicals to meet with purchasers and agents looking for specialised products and solutions.

Just turn the page to learn everything you need to know about Europe’s must-attend events in the biotech industry.

L

08.12.2017 11:10:32 Uhr

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Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

23–25 January, 2018 The EGG Brussels, Belgium

The Medtech Forum On January 23-25 2018 in Brussels, The MedTech

Forum, the biggest medical technology industry event in Europe that discusses the future trends in our sector, returns with an even better on-site experience.

MedTech Europe, the association represent­ing the in vitro diagnostic (IVD) and medical devices (MD) industry in Eu­ rope, is reshaping its annual Forum with the ambition to make it the main European medical technology event for anyone involved in medi­cal technology in Europe. New thematic tracks, more keynote sessions, “ask the experts” roundtables and a brand new exhibition area aim at enhancing business and networking opportunities with CEOs, healthcare disrup-

› Quick facts Registration: http://www.themedtechforum.eu MedTech Europe members benefit from special rates Programme highlights: ››CEO #nofilter discussions ››Digital developments ›› Business strategies ›› Market access ››New MD and IVD regulations

40_EB_Winter_2017_Compass_Mdtechforum_ml.indd 40

tors and key opinion leaders influencing the medtech environment. Participants will discover: [1] An expanded programme with worldclass industry experts speaking in 40 sessions, including plenaries, CEO #nofilter discussions, keynotes and more; [2] A specific track for start-ups and SMEs to discuss opportunities and challenges in an evolving European financial and regulatory environment; [3] New business opportunities for medtech companies, service providers, start-ups, and other industry stakeholders via this year’s brand new exhibition area; [4] Networking opportunities to connect with fellow participants via the networking mobile app or more casually during our evening events.

The new format of The MedTech Forum offers a programme in which all health technology stakeholders will find an interest – whether in the sessions or in the networking or sponsorship opportunities. 

A new vision GREETING I’m pleased to announce that the MedTech Forum enters a new era in 2018! At MedTech Europe, the association representing the in vitro diagnostic (IVD) and medical devices (MD) industry in Europe, we are reshaping our annual Forum with the ambition to make it the European medical technology event. We are driven by the objective to enlarge the program and offer a wider variety of topics, more networking opportunities and more occasions to collaborate and learn. I hope this new version of the Forum will bring you valuable insights about the new realities our industry can embrace. At the same time, we will also enlarge the target audience to a broader representation of our industry patients, hospital representatives, service providers, suppliers, scientific societies, national associations, policymakers, notified bodies, and consultants. We will create opportunities for SMEs, start-ups and investors and find effective ways to collaborate and innovate. Together with our partners, our sponsors, our supporters and our colleagues in the sector, we can shape how the med-tech industry can be an active and reliable partner in tackling today and tomorrow’s healthcare challenges. See you in Brussels on 23–25 January 2018!

Serge Bernasconi CEO, MedTech Europe

Pictures: MedTech Europe

Entering a new era

07.12.2017 12:24:26 Uhr

Join the largest medtech industry event in Europe

#MTF2018 www.themedtechforum.eu

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06.12.2017 15:32:22 Uhr

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Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

7–8 February, 2018 Paris Expo, Porte de Versaille

Pharmapack Europe The 21st edition of Pharmapack Europe will show-

case the evolution and revolution in packaging and drug delivery solutions.

The combination of a huge exhibition and comprehensive conference programme provides a unique opportunity for networking and partnering.

The comprehensive event programme for Europe’s dedicated annual pharmaceutical packaging and drug delivery conference (7–8 February, Paris Expo Porte de Versailles) will update participants on the latest developments in the sector with key note speeches from leading industry figures, a symposium, and educational workshops. Presentations at the learning lab will explore regulatory changes and impacts; address challenges in packaging and device de-

velopment (including biologics, materials, sustainability, and maintaining consistent quality); and demonstrate how new patient-centric innovations in drug delivery can revolutionise lives and improve treatment adherence. Start-Up Pitch, a new event at Pharmapack Europe 2018, will offer early stage companies a unique opportunity to present their ideas to industry experts.

Pharmapack Europe will feature the latest industry innovations in pharma-

Meet partners

sights from leading industry experts, practical guidance and workshops on challenges and opportunities, and networking and collaboration opportunities to enable visitors to share knowledge and experience to drive business forward. We kindly invite you to join us in Paris, together with 5290+ industry colleagues from all over the world.

GREETING The pharmaceutical packaging and drug deliver y industr y is on the crest of a new wave of innovation and opportunity. In the 21st year of Pharmapack Europe, we have once again developed an ex tensive programme to provide the industry with in-

42_EB_Winter_17_Compass_PharmaPack Europe_tg.indd 42

Anne Schumacher Brand Director Pharmapack Europe UBM EMEA

› Quick facts IN 2017

›› 5,290+ visitors ›› 411+ exhibitors ›› Over 100 countries represented CONTACT & Registration Pharmapack team pharmapack@ubm.com http://bit.ly/2z07bP9

Pictures: UBM EMEA

The future is now

ceutical packaging and drug delivery for small molecules and the expanding area of biologics, the latter representing 70% of drugs currently under development. Speakers at the conference will discuss key factors for successful collaboration on pharmaceutical packaging development and integrated designs of drug delivery platforms for biologics, as well as case studies on delivery options for injectable drugs.

Connectivity in drug delivery solutions along with innovations in packaging will be showcased.

In 2018, a new Start-up Hub will allow young companies to showcase their new technologies and pitch them to pharma and biopharma executives, and provide partnering opportunities between potential customers and investors. The Startup Hub and Start-up Pitch are organised in collaboration with Early Metrics, the pan-European rating agency for startups and innovative SMEs. L

07.12.2017 12:25:35 Uhr

EXHIBITION & CONFERENCE 7-8 FEBRUARY 2018 PARIS EXPO, PORTE DE VERSAILLES

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• Innovation Gallery • Pharmapack Awards • Innovation Tours • Pharmapack Start-up Hub

• Networking Areas

& Events • International Meetings Programme

EDUCATION

INNOVATION

NETWORKING

Pharma’s dedicated packaging & drug delivery event

• Conference • Symposium • Workshops • Learning Lab

REGISTER NOW! #PharmapackEU

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NEWS, WHITEPAPERS & EVENT PROGRAMME AT WWW.PHARMAPACKEUROPE.COM

08/11/2017 06.12.2017 15:32:5414:20 Uhr

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Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

SMEs in the spotlight Berlin Conference on life sciences In its 11th edition, the one-day

conference will highlight European small and medium-sized companies that are developing new therapeutics or diagnostics to fight antimicrobial resistance. Stakeholders in business, science, policy, and the finance sector will discuss major challenges faced by SMEs in the AMR arena.

How to bring novel antimicrobials and diagnostics from lab to market? How to finance risky clinical development?

Which regulatory frameworks do exist for new antibiotics and diagnostics?

Which incentives best support business models? Small and medium-sized en-

› Quick facts Why attend?

1,300+ attendees since 2008; 40+ high-level speakers in the AMR field (therapeutics & diagnostics); poster session; Start-up-pitch Registration Early bird rates available as well as special rates for BEAM Alliance members and academics. Please visit: www.berlin-conferences.com

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terprises (SMEs) constitute the major innovation engine in the AMR arena with the most significant pipelines of novel antimicrobials and diagnostics targeting multidrug-resistant bacteria.

Although European biotech companies with AMR activities raised more than €200m this year (see p. 6), sustainable business models and market prospects are still challenging.

At the same time, a series of global initiatives were started: the Interagency Consultative Group (IACG) established by the United Nations; the Global R&D Hub resulting from the 2017 G20 summit; international multimillion-euro funding bodies such as CARB-X and the Global Antibiotic Research and Development Partnership (GARDP); the AMR Call to Action initiative, and the InnoFin Infectious Disease program financed by the European Investment Bank. These initiatives are particularly

welcomed by SMEs; however, they call for implementing further supportive instruments. In November, the European BEAM Alliance, which represents 40 biotech companies involved in AMR drug development, published a position paper with ten recommendations for PUSH and PULL mechanisms.

Berlin-based BIOCOM AG together with the SME association and the Fraunhofer Society, invites key players to the Berlin Conference in March 2018. The conference will provide a discussion platform to address the specific challenges faced by SMEs with more than 40 speakers representing all facets of the industry: companies (Janssen Diagnostics, Basilea, Polyphor, BioVersys, SpinDiag, Curetis, MeMed); start-ups (AGIleBiotics, PhagoMed, Oppilotech, Vaxdyn); funding bodies (CARB-X, GARDP, Find Diagnotics); investors (Forbion Capital, European Investment Bank); and academic experts from the AMR centre and the Universities of Antwerp and Edinburgh.

The afternoon will feature pitching opportunities for investors, funders and start-ups. Posters highlighting promising R&D projects will be exhibited throughout the day. The event is further supported by the EU-funded European Gram Negative Anti-Bacterial Engine (ENABLE) consortium, Boehmert & Boehmert, and the British Department of International Trade.

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Picture: BIOCOM AG

2 March, 2018 Fraunhofer-Forum Berlin, Berlin, Germany

06.12.2017 15:33:43 Uhr

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/PWFM "OUJNJDSPCJBMT BOE ".3 %JBHOPTUJDT

Kevin Outterson

Jean-Pierre Paccaud

Jorge Villacian

Achim Plum

Catharina Boehme

Executive Director CARB-X

Director of Business Development GARDP

Chief Medical Officer Janssen Diagnostics, Pharmaceutical R&D, Johnson & Johnson

Chief Business Officer CURETIS N.V.

Chief Executive Officer Foundation for Innovative new Diagnostics (FIND)

Glenn Dale

Herman Goossens

Mark Jones

Alexander Belcredi

Henri-François Boedt

Head of Early Development, Antimicrobials Polyphor Ltd

Vaccine & Infectious Disease Institute University of Antwerp

Head of Project Management/ Head of Microbiology Basilea Pharmaceutica Ltd

Chief Executive Officer & Co-Founder PhagoMed

Senior Loan Officer Growth Capital & Innovation Finance, European Investment Bank

2 March 2018, Berlin, Germany The 11th Berlin Conference on Life Sciences provides a discussion platform for adressing the specific challenges of small and medium-sized enterprises (SME) in developing novel antimicrobials and AMR diagnostics. Join an exclusive event with high-level representatives from policy, academia, industry and the finance sector. Registration and programme at: www.berlin-conferences.com

Sponsor:

Supporting Partners:

Media Partner:

European Biotechnology NET WORK

Organisation: BIOCOM AG | Lützowstraße 33–36 | 10785 Berlin events@biocom.de | Tel. +49 (0)30 264921-53 | Fax +49 (0)30 264921-66

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07.12.2017 17:36:26 Uhr

46

Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

MARCH 12–14, 2018 // AMSTERDAM, THE NETHERLANDS

12–14 March, 2018 Amsterdam RAI Convention Center Amsterdam, the Netherlands

BIO-Europe Spring The 12th BIO-Europe Spring® international partnering

conference meets in Amsterdam 12–14 March, 2018. This premier annual event held in Europe’s most innovative bio­pharma clusters, brings together executive decision makers to access in-licensing and investment opportunities in one-to-one, private business development partnering meetings.

The 12 th annual BIO-Europe Spring international partnering conference will be held once again in Amsterdam, the Netherlands. The event is highly regar­ded among companies across the life sciences value chain, from large biotech and pharma companies to financiers and innovative start-ups.

BIO-Europe Spring offers powerful opportunities to network with the right partners, with over 2,500 attendees

from 1,400 companies and 54+ countries. With a focus on European innovation and global collaboration, the event is the premier springtime partnering conference bringing together a “who‘s who” from biotech, pharma, and finance in the most innovative bio­ pharma clusters in Europe. The event is also highly regarded for the variety and high calibre of presenting companies, ranging from academic innova-

World-class!

literally change the world. Home to 3,000+ bio­tech, pharma, and medtech companies and research organisations, including major multinationals like MSD, Amgen, Genmab, Astellas, GlaxoSmithKline and Medtronic, the Netherlands is a world-class destination offering opportunities for innovative partnering. See you in Amsterdam in the spring!

GREETING Join us at BIO-Europe Spring to expand your network and engage with the right partners. The event attracts a diverse range of highquality companies presenting licensing oppor tunitie s directly to potential p ar tner s , r e sulting in alliances that

46_EB_Winter_2017_Compass_BES18_ml.indd 46

Anna Chrisman Managing Director EBD Group and KNect365 Life Sciences

› Quick facts Online Registration Please visit: ebdgroup.knect365. com/bioeurope-spring/ The Early Bird Discount is available through 19 January, 2018.

Pre-Event Course On 10–11 March, you can attend the course "Negotiation Masterclass – Improving the Probability of Success" (additional registration fee).

Pictures: EBD Group

“Who‘s who” is here

tors and start-up biotech companies to mid-size pharma and biotech, which bring their innovative technologies, therapies, and solutions with the goal of securing development and commercialisation partners. BIO-Europe Spring also features a diverse list of industry leaders speaking at workshops and on panels.

Leading pharmaceutical companies – including all of the big names in pharma – sponsor the event, sending teams of scouts to engage with new and innovative products. Informal networking events held in stunning local venues lend further dealmaking opportunities. “Holland boasts one of the most concentrated life sciences regions in the world,” said Anna Chrisman, Managing Director of EBD Group and KNect365 Life Sciences. The 2017 event boasted over 15,000 scheduled one-to-one meetings with 3,500+ licensing opportunities posted.

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06.12.2017 15:34:27 Uhr

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06.12.2017 15:34:39 Uhr

48

Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

13–14 March, 2018 Steigenberger Hotel Berlin, Germany

Nano and MicroFormulations – Joint Conference Today, nanomedi-

cine has become a global area of investigation for both academia and the pharmaceutical industry. The new generation of therapeutics is designed to target only the source of the disease – the malignant tissues.

To deliver sufficient quantities of a drug to their pharmacological target, scientists already use nanocarriers, which release their cargo at the target site.

How to manufacture, characterise, and control the drug-release mechanism for the next generation of nanomedicines is the focus of investigation at the Research Center for Translational Medicine and Pharmacology (TMP) in Frankfurt, a collaboration between the Fraun-

› Quick facts Registration www.gmp-compliance.org Register before December 31 and get a €200 discount Highlights

›› Drug Release Testing ›› Development and Characterisation ›› Regulatory Requirements ›› Quality Considerations ›› Different Case Studies

48_EB_Winter_2017_Compass__Eco Nano Conference.indd 48

hofer-Institute for Molecular Biology and Applied Ecology, and Goethe University.

Researchers also hope to identify critical quality attributes and establish predictive models for in vivo applications.

An international team of scientists led

by Dr. Matthias G. Wacker developed an apparatus to analyse the release behavior of micro and nanodispersions under standardised conditions. This so-called dispersion releaser technology uses a dialysis cell that can be combined with compendial equipment. It can be easily integrated in formulation development and quality control. Besides the efficient separation of the drug substance and a reduced sedimentation during the dialysis process, the dispersion releaser ensures compliance with international standards – although there is a lack of consistent and reliable standards so far to test micro and nanodispersions. It also makes measurements under physiological conditions possible and therefore allows predictions for subsequent therapy. First prototypes of the new system have been tested successfully with several drug substances. 

Get nano!

GREETING As nano technology has become increasingly important for global industries, more research is required in this area to effectively translate innovations into products. Nanopharmaceuticals and medical devices take advantage of advanced manufacturing technology and functionalised biomaterials. In some cases, however, nanomedicines may present unexpected challenges in manufacturing and characterisation – and even pose a potential threat to human health and the environment.

Thus, to learn more about current technologies in the field of Nano Formulation, join us – the ECA, the Loewe Center of Translational Medicine and the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) ­– at the Nano and Micro Formulations conference. This comprehensive programme will address pressing legal and scientific issues: how to develop novel nanoproducts; characterise them for submission or registration; and deal with safety concerns. Take this unique opportunity to meet with your colleagues, our guest speakers, and members of regulatory bodies.

Axel H. Schroeder Operation Director, Concept Heidelberg

Picture: Concept Heidelberg GmbH

Innovations on top

07.12.2017 12:27:05 Uhr

Nano and Micro Formulations Bringing together Science, Authority and Industry 13/14 March 2018, Berlin, Germany

Registe Dece r before and be mber 31 â&#x201A;Ź 200 Enefit from arly discou -bird nt

Image: iStock #622777274; Dr_Microbe

Scan code to learn more

Nanotechnology has become increasingly important for global industries. But how can innovations be effectively translated into products? Join us, the ECA, the Loewe Center of Translational Medicine and the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) at the conference Nano and Micro Formulations to find out more about current and new technologies in the field of Nano Formulation. We will address the pressing concerns over how to develop novel nanoproducts, how to characterize them for submission or registration and how to deal with safety concerns. Use this unique possibility to discuss the legal and scientific aspects with colleagues, speakers and regulatory bodies.

Find out more at www.gmp-compliance.org/nanomicroformulations.

Co-sponsored by

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A joint conference of

Media Partner:

06.12.2017 15:44:25 Uhr

50

Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

3 May 2018, Swiss Biotech Day Congress Centre Basel Basel, Switzerland

Swiss biotech day The Swiss Biotech Day has long become the

standard annual get-together for the Swiss biopharmaceutical industry.

On 3 May 2018 entrepreneurs, investors, researchers, analysts, political decision-makers, and industry stakeholders will meet in Basel, celebrating the 20th anniversary of the Swiss Biotech Association.

The Swiss Biotech Day (SBD) is constantly growing: 2017 was a recordbreaking year, with more than 530 participants. Next year more than 600 experts from more than 20 countries are expected to meet in Basel. During this annual get-together the Swiss Biotech Association will celebrate its 20th anniversary.

There are only a few spaces in the world where so many life sciences jobs

are concentrated in one place with the density seen in Basel. From worldleading research groups, biotech entrepreneurs, start-ups and patent specialists – the region covers the entire value chain. That's why the Swiss Bio- tech Day 2018 will once again take place in the vivid heart of the Swiss life sciences industry.

On 3 May 2018, senior executives from Swiss and European biotech companies

Get together!

Assembly of the Swiss Biotech Association. It has become one of the key meeting points for biotech entrepreneurs, investors, researchers, analysts, political decision makers, and industry stakeholders in Switzerland.

In 2018, the Swiss Biotech Day will end with the celebration of the 20th anniversary of the Swiss Biotech Association.

Join us in Basel and celebrate with us!

GREETING As newly appointed Chief Executive Officer of the Swiss Biotech Association, I am very happy to invite you to the Swiss Biotech Day 2018 and to celebrate the 20th anniversary of the Swiss Biotech Association.

The SBD has proven to be a lot more than the Annual General

50_EB_Winter_2017_Compass_SBD 2018.indd 50

Michael Altorfer Assigned CEO, Swiss Biotech Association (effective 1 January 2018)

› Quick facts REGISTRATION www.swissbiotechday.ch Phone: +41-43-508-1121 register@swissbiotechday.ch Highlights

›› Keynote by Vasant Narasimhan, assigned CEO, Novartis

›› Swiss Biotech Report 2018 ›› One-on-one partnering ›› Exhibitions

Pictures: André Springer, SBA, SBA

Start a new decade

and senior scientists from leading academic institutions are invited to come together at the Congress Centre Basel.

Each year, the event traditionally begins with the General Assembly of the Swiss Biotech Association (SBA), which currently has more than 200 member companies representing the interests of SMEs within the biotechnology sector. In 2018, the Assembly will be followed by a keynote address from Vasant Narasimham, assigned CEO of Novartis. Next, the Swiss Biotech Report 2018 will be released, providing an opportunity for interesting discussions on potential future developments within the Swiss biotechnology field.

During the afternoon, partners of Swiss Biotech Day will present parallel sessions offering insights into specific life sciences topics such as analyses and predictions for publicly listed biotech companies, and financing opportunities in the Analyst and Investor track. L

06.12.2017 15:45:16 Uhr

SWISS BIOTECH DAY 2018

Join the Swiss Biotech Day, the leading biotechnology conference in Switzerland. Now in its 20th year, the event is not just the place to be for members of the Swiss Biotech Association, who traditionally meet there for the association’s Annual General Assembly. As always, the event brings together entrepreneurs, investors, researchers, analysts, political decision makers and industry stakeholders. ... ONE

22

Don’t miss the keynote by the assigned CEO of Novartis, Vasant Narasimhan, and meet around 600 experts from across Europe.

All information on programme, exhibitors, sponsoring and registration can be found at www.swissbiotechday.ch.

Supporting Partners:

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BIOTECH CLUSTER

3 MAY 2018 Basel Congress Center

“WHITE BIOTECHNOLOGY” WORKING GROUP

Sponsors:

Picture: © Rynacher/ https://commons.wikimedia.org/wiki/File:Basilisk_Wettsteinbrücke.JPG (CC BY-SA 3.0); GNU Free Documentation License

Picture: © Basel Tourismus

The leading Life Sciences Conference in Switzerland and Annual General Assembly of the Swiss Biotech Association

Leading chemical companies are exploring the opportunities that have been opened up by modern biotechnology, especially in the field of “white” or industrial biotechnology. And they are also applying these technologies, wherever it makes sense. The SBA takes such initiatives seriously and has formed a working group specifically dedicated to white biotechnology.

The Swiss Industrial Biocatalysis Consortium is an important partner in this effort. The group includes leading multinational companies that support white biotechnology as a pillar of economic growth. The planned activities are in agreement with OECD strategies.

In partnership with the Swiss Biotechnet (see pages 14/15) the SBA develops training programmes and useful support tools for the industry. It is of importance that the industry specifies its training needs so that the academic side can create tailor-made education.

This strategy ensures that the industry gets the right European workforce with the right education. The SBA profits Biotechnology from Nthe marketing alliance “Swiss Biotech” (see box) ETW ORK in a multiplied form. Thanks to Swiss Biotech, the

sector is internationally visible. The project-specific participating companies (most of them young and internationally less savvy) find a comprehensive partner which is helping to put them in the public window.

The participating Life Science Regions are important internal carriers of the dynamics in the Biotech sector, thus enhancing the common understanding of the industry. This and more knowledge is brought into

Europa Bio, the European Biotech Association, where the SBA is an active member.

Media Partners:

Domenico Alexakis is Executive Director of the Swiss Biotech Association.

SWISS BIOTECH...

...is an alliance of four leading Biotech regions of Switzerland (Bio Alps, BioPolo Ticino, Basel Area and Greater Zurich Area). They have combined efforts to streamline interests of the national biotech sector. The SWX Swiss Exchange holds a leading position in terms of lifescience listings and offers companies from that industry – be they located in Switzerland or abroad – access to an internationally recognised financial marketplace. The initiative was co-founded by the SBA which also manages Organised by: of Swiss Biotech. the executive office

@

For further information please visit www.swissbiotechassociation.ch www.swissbiotech.org

06.12.2017 18:42:39 Uhr

52

Euro Biofairs Compass

European Biotechnology | Winter Edition | Vol. 16 | 2017

20–21 June, 2018 Koelnmesse, Cologne, Germany

Chemspec Europe 2018 This fine and speciality chemicals exhibition

is a key event for manufacturers, suppliers, and distributors of fine and speciality chemicals to meet with purchasers and agents.

Chemspec Europe is renowned for its specialised focus on the fine and speciality chemicals industry. The 33rd edition takes place at Koelnmesse in Cologne, Germany, from 20–21 June 2018.

The show provides its attendees with access to blue chip and SME suppliers from around the globe, covering the whole spectrum of custom, fine and speciality chemicals for various applications, including pharma, agriculture, bio-based chemicals and biocatalysts, food and drink, cosmetics, household and industrial cleaning, water treat-

› Quick facts Contact Chemspec Europe info@chemspeceurope.com Phone: +44 (0)1727 814 400 Venue Koelnmesse Hall 8, Entrance North Messeplatz 1 50679 Cologne, Germany

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ment, adhesives and sealants, colourants and dyestuffs, polymers, and much more.

With a total of 401 exhibitors from 29 countries and 6,476 attendees from all over the world, the previous Chemspec Europe, held 2017 in Munich, was a big success.

With the REACH deadline approaching and buzzwords like “continuous flow chemistry” prompting extensive discussions, the next Chemspec Europe, held in Cologne, will, once again, be a central meeting point for international industry professionals to exchange views on current trends and expand reliable networks between manufacturers, suppliers, commodity traders, distributors, agents, purchasers, and business partners.

Discussions, exchange of expertise, and R&D are an integral part of Chemspec Europe. Various conferences on a wide range of subjects – from regulator y and pharma outsourcing to current market developments – are held alongside the exhibition. All conferences are free to attend for participants at Chemspec Europe.

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Welcome!

GREETING On behalf of the organisers of Chemspec Europe (20–21 June 2018, Cologne, Germany), I welcome you to our event, which covers the most comprehensive range of fine and speciality chemicals, including bio-based chemicals and biocatalysts. Chemspec Europe offers its visitors the possibility to meet with some 400 international suppliers. Extensive networking opportunities and a large number of conference sessions enable new partnerships and stimulate exchange of expertise. With its extensive product portfolio for a wide variety of different sectors, the event is a platform for synergies and innovation, and thus for new business opportunities – particularly for high potential sectors such as biotechnology.

With its international audience, Chemspec Europe reflects the global scale and structure of the fine and speciality chemicals industr y. The show offers excellent sourcing and trading opportunities and a place to network and learn about the complex mechanisms of this innovative industry sector.

Nicola Hamann, Managing Director, Mack Brooks Exhibitions Ltd

Pictures: Mack Brooks Exhibitions Ltd.

Focus on chemicals

07.12.2017 12:27:52 Uhr

33rd International Exhibition for Fine and Speciality Chemicals

The industry’s premier sourcing and networking event Some 400 international exhibitors offer bespoke solutions and specific substances to enhance products or develop new chemical solutions.

s Top conference s p ho and works insights er off valuable D & projects! into ongoing R

Lecture Theatre Agrochemical eers Clinic Chemspec Car e Theatre Pharma Lectur eatre ices Lecture Th Regulatory Serv tre ea Th RSC Lecture t-ups Innovative Star

Organisers:

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Fine and speciality chemicals for various industries: • pharmaceuticals • agrochemicals • petrochemicals • cosmetics • adhesives & sealants • paints & coatings • polymers • biotechnology • colourants & dyestuffs • food & drink • industrial cleaning • reprography & printing • water treatment and much more.

Koelnmesse Cologne, Germany

20 – 21 JUNE 2018 www.chemspeceurope.com

20 – 21 June 2018 | Koelnmesse Cologne, Germany 06.12.2017 15:46:2611:55 Uhr 06/12/2017

54

Bioplastics

European Biotechnology | Winter Edition | Vol. 16 | 2017

Biotech for breaking down a sea of waste it’s grown increasingly clear that where plastics end up is at least as important as how they’re made. Current recycling technologies are limited, bringing either low-quality recyclates or high processing costs. But enzymes now offer a glimmer of hope. Working with the common plastic PET, a French firm is trying to prove biotech approaches can close the loop in the material’s life cycle. They hope they’ll soon be able to recycle the plastic endlessly and affordably.

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Picture: aryfahmed/fotolia.de

Plastics Recycling While bio-based polymers have been a hot topic for some years now,

07.12.2017 12:30:10 Uhr

Bioplastics

European Biotechnology | Winter Edition | Vol. 16 | 2017

P

lastics are great materials,” says Martin Stephan, “they’re cheap and easy to manufacture, and they can have many different properties.” Of course, the debuty CEO of French green chemistry biotech Carbios SA is also very aware that there’s a flipside to all the practicality – nearly indestructible litter. “We’ve neglected the end-oflife in plastics for far too long,” he adds. In a recent perspective published in Science, US researchers Jeanette Garcia and Megan Robertson found that “although there are important incentives for plastics recycling, end-of-life treatment options are in practice quite limited.” They estimate that energy equivalent to 3.5 billion barrels of oil – currently worth approximately US$176bn – could be saved if we recycled all the plastic so­lid waste on the planet.

The most pressing problem is with plastic packaging materials, which make up nearly 60% of the mountain of plastic waste generated in Europe every year. Only 14% of polymer-based packaging waste is collected for recycling globally. Europe manages around 30–40%.

Graphic: Ellen MacArthur Foundation/BIOCOM

Closing the loop with PET There are a number of reasons why recycling isn’t more widespread. Sorting waste is costly and time-consuming, and recycling it is energy-intensive. Available recycling technologies also work only for a few different polymers. And most importantly – the quality of recycled materials is often worse than bio-based or oil-based originals. That’s where Carbios comes in.

The French company’s team of 19 claims it has developed a new technology for polyethylene terephthalate (PET) recycling that is truly circular. Stephan says the method takes care of the problem of quality loss, and believes Car­bios can “bring a lot of value to the PET value chain.”

Roughly half of all solid plastics produced annually are used just once before ending up in the trash. That’s 150 million tonnes wasted in the truest sense of the word. PET is one of the most common and important plastics out there. It’s mainly used for synthetic fibres and bottles. “Western Europe consumes around

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4.3 million tonnes of PET each year,” says Stephan. “Estimates say around 2.7 million tonnes are not recycled, but end up in landfills or are incinerated. We believe we’re tapping a huge unused feedstock source here.” He’s quick to point out that Car­bios is not competing with other currently available recycling technologies: “It‘s just another one on the list but this approach is the only one opening the path to infinite recycling.”

Cracking the plastics space What makes the Carbios process unique at this stage is that it’s based on enzymes.

“I think we are the first to create a new space for enzyme use, which is the plastics industry. We have the ambition to do that on a commercial scale,” Stephan says.

“I think we’re the most advanced with our technology. And there’s no question that we are the only company with a process that’s close to market.”

Enzymes in the recycling industry as a whole are not a new idea. Danish companies Novozymes and Ørsted have developed a waste-to-biogas conversion and recycling plant that relies on enzymes liquefying organic compounds in mixed-matter household wastes. There are no details about the enzyme mix as this is considered

55

commercially sensitive information, Hannes Reuter, Head of New Bio Solutions at Ørsted told European Biotechnology.

The biggest so-called Renescience plant, which will be able to process 15 tonnes of trash an hour, is getting ready to throw open its doors in Northwich (UK). Seve­ral other companies are working on biotech­ based strategies for recovering metals from electronic waste, or isolating carbon fibres from discarded composite materials. But enzymes that could break down plastics at a scale that addresses the current torrent of waste? Most in the industry would just shake their heads, because petroleum­ -based plastics are highly resistant to enzymatic degradation. It’s true that some newly developed bio-based plastics have been designed to ‘bio­degrade’ (see box p.

56) but production scales and use of those materials are still extremely limited. In Europe, over 80% of the plastics sold today are petroleum-based: polyethylene (PE), polypropylene (PP), polystyrene (PS), polyvinyl chloride (PVC), polyurethane (PEU), and of course PET. Among them are polymers that contain a pure carbon backbone (PE, PP, PS, PVC), which are especially hard to break down into monomers. The outlook turns out to be a bit more hopeful for PET and PUR, because both of those polymers have backbones that also con-

1 Create effective after-use for plastics

Other material streams

RECYCLING

Radically improved economics & quality

REUSE

DESIGN & PRODUCTION Renewably sourced virgin feedstocks

USE ting co m p o s Energy recovery l e a k age

Decouple plastics

2 from fossil feedstocks

Drastically reduce the leakage of plastics into

3 natural systems & other negative externalities

Source: The New Plastics Economy – Rethinking the Future of Plastics

Life cycle of plastics: “Reuse” includes for example returnable plastic bottles. “Recycling” means mechanical (grinding, separating, re-granulating and compounding), thermal (pyrolysis), chemical (solvolysis) and biological (enzyme-based) recycling.

07.12.2017 12:30:19 Uhr

Bioplastics

tain nitrogen or oxygen atoms. Some lipases, cutinases and esterases isolated from fungi or bacteria are able to depoly­merise PET. Speaking to European Biotechnology, Carbios manager Stephan did not want to disclose the type(s) of enzymes his company is working with, or the organisms they are sourced from. It’s possible that the process Carbios has discovered involves several enzymes that work in parallel or sequentially. A patent published in April 2017 suggests the PET is not treated with enzymes directly, but instead with microorganisms excreting a depolymerase. The enzyme(s) in question might have been tweaked and improved in the lab as well, as recombinant versions are also covered by the patent.

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It’s possible to depolymerise PET in several ways. One that likely plays a role in the company’s process degrades PET into terephthalic acid (TPA) and mono­ethylene glycol (MEG) very efficiently. “It‘s a lowtemperature biological process that runs at 60°-70°C,“ says Stephan. “It depolymerises any kind of PET...the transparent one used for bottles, of course, but also the coloured version and the opaque version as well as mixed PET articles. And it also works with polyester fibres – the type of PET used for textiles.”

The French Connection In mid-2017, Carbios started scaling up the technology from laboratory to pilot

The ‘bioplastics’ debate The bioplastics community is struggling to solve a problem rooted in semantics. The term ‘bioplastic’ is still used to describe a wide range of different products – from ‘bio-based’ to ‘bio­degradable’ to ‘compostable’ plastics. That has led consumers to routinely dump bio-based but non-biodegradable plastics in organic waste bins. In March, Dutch disposal and recycling company Attero called for a complete halt to the production of ‘bioplastics’, as non-degradable fractions ruin the recycling process for organic waste.

Although the concept of degradable plastics has been out there for roughly 50 years, no one can say with any certainty whether current approaches are really viable. The problem is that natural environments are so diverse in terms of temperature, humidity, oxygen, sunlight and microflora that it’s impossible to ensure universal complete degradation of a given ‘degradable’ plastic material. Another problem: the concept of ‘degradability’ is in some ways a direct contradiction of one of the most sought-after of plastic characteristics – durability. For those and other reasons,

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many bioplastics experts don’t see degradable plastics as the answer to the problem of plastic litter. Instead, they favor plastic waste collection followed by recycling or energy recovery. The most widely accepted and common degradable polymer at the moment is polylactide.

The European Parliament is currently planning a ban on conventional re­c yclable mulch film in European agriculture by refusing to give CE certification to products that are not degradable over five years in the field.

The association Plastic Recyclers Europe has hit back, saying the plans are neither scientifically nor economically sound. In most parts of Europe, it contends, agricultural plastic waste streams are managed well, and produce many different high-quality recyclates.

Bio-based plastics still account for just 1% of global plastics production – and growth remains sluggish. In late 2017, the European Bioplastics association and research analyst Nova Institute said they expect 20% growth in the next five years – up from 2.05 million to just 2.44 million tonnes.

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Martin Stephan Deputy Chief Executive Officer, Carbios SA

?

Enzyme production and running the bioreactors consumes energy – quite a bit of it. How sustainable is your recycling process?

!

Our biological process runs at low temperatures and doesn’t require as much energy as chemical processes. In such way, biology is far less demanding in terms of energy than other approaches. The life cycle analysis has not yet been completed. It‘s planned for next year. But this will be a challenge. We also plan to measure the carbon footprint. 2 kg of CO2 per kg of PET is the current standard. Our process has to be judged in light of these numbers.

plant. Within five years, the company says it hopes to be running it at the industrial scale. Support in the process is being provided by French cosmetics heavyweight L’Oréal. The two firms signed an agreement in late October to jointly establish a five-year consortium to bring Carbios’ technology to market. And the partnership remains open to companies from other industries. “Our technology brings value for the recycling companies as well as the brand owners,” Stephan points out. He’s convinced the Carbios model would also pay off for other consumer goods, and even non-brand industries. “One of the objectives of the consortium is to create demand for the first demonstration plant to be built until 2022,” he says. “Members of the consortium will be prioritised when production slots are assigned.”

Picture: Carbios SA

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Recycling is also a topic for emerging plastics producers. Amsterdam-based Synvina has received a preliminary OK from the European PET Bottle Platform allowing its new 100% bio-based poly­mer polyethylene furanoate (PEF) bottles to be fed in into the European PET bottle recycling system. The new bottles are expected to hit the market by around 2020.

Italian company Bio - On, on the other hand, is focussing on poly­ hydroxyalkanoates (PHA), a family of naturally occurring polymers that can be processed into hard or soft plastics, as well as into both crystalline and amorphous polymers. All of the members of the PHA family are biodegradable in industrial composting equipment, in the soil, and in both freshwater and seawater. In November, Bio-On installed two 100,000 litre fermenters at its newly built plant near Bologna – the first PHA plant in Europe. With an investment of €20m, the company’s Minerv Bio Cosmetics will produce a 100% PHA biodegradable and bio-based plastic designed to replace conventional micro­beads in cosmetics.

The plant will run with agricultural products such as molasses and sugar beet syrups. Other PHA companies are choosing to focus on wastewater, used cooking oil or household food waste as possible carbon sources. Although ideas like this have been around for decades, high production costs have always been an insurmountable barrier to success for these plastics.

But technological breakthroughs and rising investment are now shifting the landscape. According to European Bioplastics, PHA production is set to nearly triple over the next five years.

Picture: Ørsted

Diversity isn’t always good The wide variety of plastics out there on the market poses a serious problem for recyclers. In its 2017 report “The New Plastics Economy”, Britain’s Ellen MacArthur Foundation warned of “a threat from continued, unrestrained diversification, which, while often bringing important functional benefits, have lower value in the after-use recycling system and drive up costs.” The charity set up by the former solo long-dis-

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Bioplastics

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One of the two bioreactors at the Renescience plant in Northwich

tance yachtswoman sums up a problem that has dogged recyclers since the very earliest days of their industry. In the highly fragmented plastics recycling space, economies of scale are very hard to achieve.

The report also demands a rise in the percentage of high-quality recyclates, which would in turn enable more high-value applications.

Currently, plastic that’s collected for recycling is mainly processed into new, low grade products that are of limited use.

One example is the Fairy Ocean Plastic Bottle, which was created by consumer chemistry giant Procter & Gamble and recycling company Terracycle. Made of post-consumer recycled plastic (90%) and recycled beach and ocean plastics (10%), the bottle contains washing-up liquid. The problem with classic mechanical recycling methods is that quality deteriorates every cycle. Grinding PET waste into flakes and further regranulation will always provide a less pure recycling track than depolymerising PET into monomers. “With cascaded recycling you lose quality at every step,” Carbios’ Martin Stephan says. “It‘s good, but not good enough. Our recycled PET monomers can be reused to produce socalled virgin PET.” That sounds great in theory, but will biotech recycling really prove to be viable?

The French company is convinced it will.

They’re already thinking about the next

step. “When we’ll have scaled-up our PET recycling process, we’ll move on to another polymer,” says Stephan. “We see a lot of potential for enzymes to depolymerise plastics.”

Politics – help and hindrance That’s a positive attitude, but Car­bios and other companies at the forefront of the race to develop enzyme recycling technology still face big barriers. One major problem is that support from politics is fickle at best. When the European Parliament voted in favour of four legislative amendments in March to help the EU recycle 70% of all municipal waste and 80% of all packaging material by 2030, it received little support from the Council of the EU. European politics magazine Politico reports that the bloc’s other decision­making body also recently slashed a Commission recycling target for materials like plastic from 55% to 30% by 2025. Western European countries are in favour, while Eastern and Northern European countries are not. They still rely heavily on landfills or waste incineration, and lack the elaborate systems that are a prerequisite for achieving such ambitious goals. And without that infrastructure, even the most modern recycling technologies will struggle to prevail. L m.laqua@biocom.eu

07.12.2017 12:34:27 Uhr

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Orphazyme raises €80m in IPO

Cancer Vaccine Norwegian Targovax ASA (Oslo) emerged as one of the three winners of a Nordic Stars Award given out at the 2017 Nordic Life Science Days in Malmö (the other two being Herantis Pharma and Pelago Bioscience). As if to justify the distinction, the company reported positive clinical data this autumn.

Good results despite fewer injections TG01 is Targovax’s lead neoantigen-targeted cancer immunotherapy candidate.

Designed for difficult-to-treat RAS mutations found in 90% of pancreatic cancers, TG01 aims to recruit both CD4+ and CD8+ T-cells necessary to obtain a clinically efficient anti-cancer T-cell immune response. In the main cohort of the Phase I/II study of TG01 (together with GM-CSF) in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas, Targovax had reported an overall survival of 33.1 months in 19 patients. To reduce the occurrence of allergic reactions, a modified cohort received fewer TG01 injections overall than the main cohort.

The one-year survival rate and safety data in the modified cohort showed that 100% of patients (13/13) were alive one year after surgery – far better than historical oneyear overall survival rates. Furthermore, TG01/GM-CSF generated an immune response in 11 of 13 patients, and no serious adverse events related to allergic reactions were reported.

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The Orphazyme share belongs to the mid-cap segment of Nasdaq Copenhagen’s main market.

After the IPO, Orphazyme’s major shareholder Novo Holdings A/S owns 13.6% of the total share capital and voting rights; Orpha Pooling B.V. is second with 12.2%, followed by Sunstone Life Science Ventures with 9.1%, and Aescap Venture Management B.V. with 8.9% of the total share capital and voting rights.

Orphazyme is a Danish one-product company whose candidate drug, ari­ moclomol, is being tested in various trials in four indications with the lysosomal storage disease Niemann-Pick disease type C (NPC) being the most advanced programme. Other indications include Gaucher disease and the neuromuscular disorders sporadic Inclusion Body Myositis (sIBM) and Amyotrophic Lateral Sclerosis (ALS). Arimoclomol works by stimulating stressed cells to produce the Heat Shock Protein 70 (HSP70), which in turn helps cells to correctly process accumulated waste products that have reached toxic levels, and triggers refolding of proteins into their functional form. Orphazyme has fully recruited a Phase II/ III trial in NPC (trial results expected Q3 2018), initiated a Phase II/III trial in sIBM in August 2017 and plans to start a Phase II/III trial in ALS in H2 2018. All three Phase II/III trials are intended to form the basis for a single study filing in each respective indication. The first marketing authorisation is expected for 2020. The company was founded in 2009, is headquartered in Copenhagen, and currently has 30 employees.

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Tumbling milestones Antibodies In late November, Genmab A/S announced that its partner, Janssen Biotech, Inc. has triggered a US$20m milestone payment, based on progress made in the first Phase III study in a disease other than multiple myeloma. The payment relates to progress in the ongoing Phase III Andromeda (AMY3001) study of daratumumab in combination with cy-

clophosphamide, bortezomib, and dexamethasone in amyloidosis. Earlier that month, the biotech from Copenhagen received US$25m from Janssen after commercial sales of daratumumab started in Japan. Genmab also revealed that the US$1bn sales milestone has been met by Johnson&Johnson company Janssen – triggering a US$50m milestone payment. L

Picture: Nasdaq

100% survival

Capital Market Danish heat shock protein specialist Orphazyme raised €80m through an IPO at Nasdaq Copenhagen, adding momentum to the current upswing in European biotech. The admission to trading and the official listing was completed by mid-November. Trading of Orphazyme’s shares under the symbol ORPHA (ISIN DK0060910917) commenced on 21 November. Due to multiple oversubscription, Orphazyme A/S achieved a market capitalisation of €214m. In June, the company closed a €14m Series B financing series, including LSP and the ALS Investment Fund joining the investor syndicate comprised of Kurma Partners, Idinvest Partners, Novo A/S, Sunstone Capital and Aescap Venture.

06.12.2017 15:50:29 Uhr

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Picture: nicoletaionescu /fotolia.de

Hope for allergic tree huggers Allergen Immunotherapy A new tablet could soon bring relief for people suffering from tree-pollen-induced allergic rhinitis. Danish allergen immunotherapy (AIT) developer ALK-Abelló A/S said the pivotal Phase III clinical trial of its tree allergy sublingual immunotherapy (SLIT) tablet was a success. The primary endpoint of the trial was the daily total combined score, which is the sum of the allergic symptom score and the use of symptom-relieving medication, measured during the birch pollen season. Treatment with the tree SLIT-tablet reduced the total combined score (primary endpoint) by 39.6% compared to placebo. Henrik Jacobi, ALK’s Executive Vice President R&D, said, “We are extremely pleased to see such a clear and clinically meaningful treatment effect of the tree allergy immunotherapy tablet. In fact, the clinical effect seen in this trial was among the most significant that we have ever seen in field studies of allergy immunotherapy.” Allergic reactions are mediated by allergenspecific antibodies of the immunoglobulin E (IgE) type. The concept behind AIT

is to give repeated doses of an allergen, stimulating an immune response in the body, and encouraging the patient’s body to extend the bounds of immunological tolerance. This tolerance leads to the reduction, or even elimination, of allergy symptoms like itching or sneezing. Given the general acceptance of AIT in the field of allergic rhinitis, only about 10% of patients with these conditions are treated with the therapy. AIT is still underused due to a lack of agreement in documented efficacy, and insufficient data on costeffectiveness, among other reasons. L

Twisted path

R&D partners

Inflammation Gesynta Pharma AB signed an agreement with Orexo AB (both Sweden) to acquire their preclinical drug candidate to treat inflammatory diseases, with fewer side effects. The highly selective mPGES-1 inhibitor is the most advanced candidate within the prostaglandin E synthase inhibitor programme – an approach with a long history. Originally developed by Swedish biotech company Biolipox, German pharma company Boehringer started a collaboration on this asset in 2005. Biolipox was acquired by Orexo in 2007 and Boehringer returned the project to Orexo in 2014. With signing an asset purchase agreement, the programme now belongs to newly formed Gesynta. Orexo will receive a tiered double digit share of the future revenues. L

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News Xellia on growth track

Gene ther apy British Avac-

ta Group plc and Finnish FIT Biotech Oy have started a collaboration on a new gene therapy approach. Avacta’s affimer proteins are small, very simple in structure, and easy to produce. The companies believe they are therefore potentially ideal for being delivered as genes. FIT Bio­tech brings in its gtGTU (gene therapy, Gene Transport Unit) vector technology that is designed to ensure the stable and prolonged production of therapeutic proteins by the patient’s cells. The research collaboration with Nasdaq Helsinkilisted FIT is Avacta’s second in the area of gene therapy, with the same benefits of Affimer technology underpinning the company’s existing research collaboration with Moderna Therapeutics Inc. (US) started in 2015. L

Anti-infectives producer Xellia Pharmaceuticals ApS celebrated the start of the construction of a new US$25m expansion in October. The multi-story building is built near Xellia’s headquarters in Copenhagen.

Xellia has four other state-of-the-art manufacturing facilities (in Hungary, China, and two in the US). The company is wholly owned by Novo Holdings A/S since 2013.

Pharmalink is over After appointing Renée AguiarLucander as the new Chief Executive Officer in spring, Swedish specialty pharmaceutical company Pharmalink AB was rebranded in November. As Calliditas Therapeutics AB continues to seek capital to initiate its Phase III trial with Nefecon. The compound will become the first approved treatment for IgA nephropathy, Calliditas hopes.

Genovis enters China Enzyme producer Genovis is rapidly weaving its distribution network in Asia. After hooking up with Beijing Zhongyuan Ltd. in September, the company also signed a distribution agreement with Shanghai Titan Scientific Ltd. from Shanghai (China). Genovis sells several enzyme products known as Smartenzymes. They facilitate development and quality control of biological drugs. For instance, they are applied in analytical workflows of biotherapeutic proteins, including antibody subunit analysis using li­quid chromatography and mass spectrometry.

06.12.2017 15:50:36 Uhr

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Switching off autoimmunity

IPO Belgian nanobody producer Ablynx NV (Ghent) has closed an initial public offering of American Depositary Shares at Nasdaq and fully exercised a greenshoe option totalling in aggregate gross proceeds of US$230 (€195m).

The company said it will use the net gross proceeds of US$210.2m to push approval of its lead programme caplacizumab in the orphan blood clotting disorder acquired thrombotic thrombocytopenic purpura (aTTP). Autoimmune disease aTTP is caused by impaired activity of the ADAMTS13 enzyme, leaving ULvWF molecules uncleaved. These ULvWF molecules spontaneously bind to blood platelets, resulting in severe thrombocytopenia and clot formation in small blood vessels throughout the body, leading to ischemia and widespread organ damage. In early October, the Phase III efficacy study enroling 145 patients met relevant endpoints. The bivalent antibody targets the von Willebrand factor (vWF) in order to prevent formation of platelet micro-clots. Despite the current standard-ofcare treatment consisting of PEX and immunosuppression, episodes of aTTP are still associated with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis. Treatment with caplacizumab resulted in a 74% reduction in the percentage of patients with aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event during study drug treatment.

This February, Ablynx filed for EU market authorisation. The company said it will file a BLA next year.

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commercialisation partner Merck-Serono returned the rights to the peptides that filter myelin-destructive autoantibodies out of the cerebrospinal fluid. According to Apitope, the first-in-class treatment could potentially help 70% of patients with this form of MS. Furthermore, Apitope aims to advance clinical development of its Phase I product ATX-GD-59 for the treatment of Graves’ disease and futher early-stage products.

According to the company, its peptide-based apitopes can directly target the roots of autoimmune diseases while avoiding global immune suppression. L

How T-cells trigger MS Multiple Sclerosis French and British scientists have revealed insight into how a critical immune regulatory pathway contributes to the development of multiple sclerosis (MS), potentially paving the way toward future immunotherapies for the debilitating condition.

Though, it’s clear that T-cell dysfunction drives the autoimmune disease, mystery still surrounds the exact mechanism that causes the immune systems of people with MS to attack the protective myelin sheath surrounding neurons in the brain and spinal cord. No cures exist, but scientists have determined that MS and other chronic autoimmune conditions like asthma share one key immune defect – so-called T-helper cells (TH1) fail to develop into type 1 regulatory T-cells (Tr1), which tamp down inflammation and prevent overactivation of T-killer cells, which results in overshooting immune reactions against a person’s own tissues.

Lead author Siobhan Ni Choileain and colleagues from INSERM in Toulouse discovered that the transition of inflammatory effector cells into interleukin-10 (IL-10)– secreting type 1 regulatory T-(Tr1) cells is disturbed through modification of the regulatory protein CD46.

3D rendering of a T-lymphocyte

The researchers found that T-cell stimulation altered the O-glycosylation status of CD46, changing its mass and enabling its translocation to the immune synapse, the site of T-cell activation. The cell surface abundance of CD46 was reduced upon generation of Tr1 cells, which produced IL-10. In contrast, T-cells from MS patients showed a reduced change in CD46 abundance and continued to produce the inflammatory cytokine interferon-g. The authors believe that this might be a promising MS target.

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Picture: Blausen.com staff (2014)

Money boost

Drug Development AngloBelgian immuniotherapy company Apitope plc wants to raise capital needed for targeting the US$22bn multiple sclerosis (MS) market by an IPO at Euronext Brussels. The offering is expected to consist of a public offering in Belgium and private placements to institutional and qualified investors outside the United States. The spin-out of the University of Bristol with operations in Chepstow (Wales) and Hasselt (Belgium) said it will use the proceeds to foster Phase IIb development of ATX-MS-1467, its currently unpartnered lead programme in remitting-relapsing MS. In 2016, Apitope’s

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European Biotechnology | Winter Edition | Vol. 16 | 2017

Poisoning cancer

Payday for nuclear med firm resectable or metastatic progressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. In January 2018, the FDA will rule on a resubmitted NDA for Lutathera in GEP-NETs. Novartis markets everolimus, an oral mammalian target of rapamycin inhibitor, to treat several cancers, including gastrointestinal and pancreatic NETs. Afinitor was the comparator used in the Phase III NETTER-1 trial of Lutathera in GEP-NETs. Advanced Accelerator’s pipeline include preclinical prostate cancer candidate 177Lu PSMA-R2 and its CDx, 68GA PSMA-R2; and 177Lu-NeoBOMB1 and 68Ga-NeoBOMB1 to detect and treat gastrointestinal stromal tumors (GISTs), and prostate and breast cancer.

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Picture: fotolia.com/scyrus

French-Asian diabetes alliance Brexit French Poxel S.A. and Japanese Sumitomo Dainippon Pharma (Osaka) have inked a Development and Commercialization deal on the first-in-class oral diabetes drug imeglimin in Japan, China, South Korea, Taiwan, and nine other Southeast Asian countries. Imeglimin is an oxidative phosphorylation inhibitor designed to block hepatic gluconeogenesis, increase muscle glucose uptake, and restore normal insulin secretion. Under the deal, Poxel will receive €36m upfront and

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News

Headquarters of Advanced Accelerator Applications S.A.

cancer Swiss pharma major Novartis AG (Basel) intends to boost its cancer diagnostics and radiotherapeutics business. At the end of October, Novartis offered US$3.9bn to acquire all outstanding shares of French nuclear medicine theragnostics company Advanced Accelerator Applications S.A. (Saint-GenisPouilly). Novartis offered to pay US$41 per ordinary share and US$82 per American Depositary Share (ADS).

In September, Advanced Accelerator Applications S.A. gained EU market authorisation for lutetium Lu 177 dotatate (Lutathera®), a radiolabeled somatostatin analog that targets somatostatin receptors, and its companion diagnostics (CDx) SomaKit TOC edotreotide and Netspot, to treat un-

WESTERN EUROPE

potential milestones of up to €21m, plus double-digit royalties on net sales up to €195m. Sumitomo Dainippon Pharma will pay the cost for Phase III studies in Japan, which are expected to start this year, and commercialisation in the 13 Asian target markets. The Phase III programme in Japan will include three pivotal studies with approximately 1,100 patients. Diabetes drugs are a fast-growing market in Asia and Japan is the second largest single market for type 2 diabetes outside of the US. L

Swiss antibody drug conjugate expert ADC Therapeutics S.a.r.l.

(Epalinges) exercised an option under a 2016 deal with Dutch Synaffix B.V. (Oss) to use the company’s GlycoConnect and HydraSpace platform to develop an additional ADC. The companies neither named the target nor the financial rewards potentially resulting from the new ADC programme.

Funds for start-ups Dutch venture capital company BioGeneration Ventures (BGV) closed its third fund, BGV III, in October at €82m. The fund is dedicated to European early-stage developers of diagnostics, therapeutics and medical devices, particularly those located in Benelux countries and Germany. Five investments have already been made into German immuno-oncology company Catalym, and Dutch companies Escalier Biosciences, Scenic Biotech, Varmx, and Mellon Medical. New investors include Bristol-Myers Squibb, Johnson & Johnson Innovation JJDC, Inc. (JJDC), and Swiss private equity investor Schroder Adveq, as well as the MAN Pension Trust.

Going clinical French cancer specialist Nanobiotix S.A. (Paris, Boston) raised €27.2m through a placement of 1,941,789 new shares at €0.03 in October. The company will use the proceeds to launch Phase I combination trials of NBTXR3 plus checkpoint inhibitors and prepare EU market launch of the radio-enhancer.

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InflaRx debuted on Nasdaq Inflammation German drug developer Inflarx AG had an successful IPO on the US stock exchange Nasdaq in mid-November. The placement of more than 6.5 million common shares of Inflarx’ Dutch affiliate Inflarx NV yielded

Nouscom(er)

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Inflarx’ lead candidate IFX-1 (blue) binds to complement factor C (red).

Idorsia’s 1st deal Shake on it!

Licencing Janssen Biotech, Inc. exercised its option to enter into a collaboration agreement with Swiss biotech Idorsia Ltd. to jointly develop and commercialise Phase III-ready apro­citentan. Actelion spin-off Idorsia will receive a milestone payment of US$230m. US pharma Johnson & Johnson subsidiary Janssen, and Idorsia said they plan to share deve­ lopment costs equally. While the exclusive global commercialisation rights to aprocitentan (ACT-132577) belong to Janssen, the Basel-based biotech is entit­ led to receive royalties up to 35% of net annual aprocitentan sales. The drug is a metabolite of macitentan and is being developed for patients whose hypertension can not be controlled despite the use of at least three antihypertensives.

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R&D Collaboration MRNA cancer therapeutics specialist Curevac AG bagged US$50m upfront from a new R&D deal with Eli Lilly & Co. The US pharma company also made an equity investment of €45m. According to the partners, Curevac is also eligible to receive up to US$1.7bn in milestones, plus royalties for the development of five commercial cancer vaccines based on its proprietary RNActive technology. Curevac retains the option to co-promote the vaccines in Germany. The RNActive technology will be used to deliver mRNA that ultimately directs the human immune system to target the encoded neo­antigens. Neoantigen-based strategies are expected to induce a more robust anti-cancer immune response in combination approaches. L

Picture: Inflarx

Investment Swiss oncolytic virus and vaccine specialist Nouscom has closed a €42m Series B financing round led by new investor Abingworth. Co-investors include new 5AM Ventures, and existing investors LSP and Versant Ventures. The Basel-based company said it will use the proceeds to advance its pipeline of neoantigen-based cancer vaccines to the clinic. The company, founded in 2015, has its origins in Italy. The laboratories of Nouscom are located in Rome.

Mid-2016, the company succeeded in completing the Series A financing, raising €12m. The team is largely identical to the one from vaccine company Okairos, which was sold in 2013 for €250m to Bri­ tish pharma company GSK. Nouscom uses two platforms to induce T-cell responses to tumours: adenovirally encoded genes for cancer neo­antigens and oncolytic viruses. The company said it will start Phase I/II testing of its lead cancer vaccine NOUS-209 in 2018. NOUS-209 is designed to act as an prophylactic off-theshelf vaccine for Lynch Syndrome carriers, a genetically defined patient population with higher risk of deve­loping colorectal, endometrial, and gastric cancers, and as a therapeutic vaccine for cancers characterised by microsatellite instability. Additionally, Nouscom wants to further the development of NOUS-100-PV, a personalised neoantigen-based vaccine, also expected to enter clinical trails in 2018. Nouscom’s third programme is an oncolytic virus in discovery phase, which zeroes in on an undisclosed cancer target.

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US$100m (€86m). Starting off at US$15, the share price had climbed to almost US$21 by the end of November. The infection specialist has two first-in-class blockers of complement factor C5a, the essential component in terminal complement activation, which boosts inflammation, in its pipeline. IFX-1, a novel intravenously administered first-in-class anti-C5a mono­clonal antibody, is being tested in Phase II clinical trails for the treatment of hidradenitis suppurativa, a rare and chronic debilitating systemic inflammatory skin disease. The antibody is also in Phase I testing for ANCA-associated vasculitis, a rare and life-threatening autoimmune disease, and other chronic/autoimmune diseases. In October, Inflarx closed a Series D financing – consisting of a US$30m capital increase and a US$25m secondary share purchase – to fund further development of its lead compound, and concomitantly announced its intention to float. The company’s preclinical C5a inhibitor IFX2 targets yet undisclosed chronic inflammation-related diseases.

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Immatics closes Series E round Investment Cancer immunotherapy specialist Immatics Biotechnologies GmbH (Tuebingen, Germany) raised €49.3m in a Series E financing round led by German investors Dievini Hopp Bio­tech Holding and AT Impf, as well as Wellington Partners and new investor Amgen. The US bio­tech company partnered with Immatics in January 2017 in a potential US$1bn deal to combine its Micromet-unit’s BITE technology with Immatics’ expert capabilities to find cancer-specific protein targets (=neoantigens) with its Xpresident platform. Amgen’s approach has been copied

by Roche, who hired staff from Micromet after Amgen had taken over the Munichbased inventor of bispecific T-cell engager (BITE) technology. Roche’s Chugai-unit in Japan is in Phase I testing of a bispe-

cific engager consisting of a CD3 T-cell binding site and an antibody targeting the GPC3 protein. According to the German biotech, Amgen contributed a big share of the now-closed financing round.

Immatics said that it will use the proceeds to progress its pipeline in a series of clinical trials including the candidates IMA101 and IMA201 (both in Phase I since August/September). IMA201 is based on transducing a patient’s own T-cells to express a tumor-specific exogenous T-cell receptor (TCR) and redirecting activated T-cells to the tumour sites. Furthermore, Immatics will invest in the development of its pipeline of bispecific TCR candidates, with the aim to redirect and activate the Tcell response towards cancer cells expressing specific tumour targets.

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News ADC lines its pockets Swiss cancer antibody-drug conjugate (ADC) developer ADC Therapeutics Sarl (Epalinges) has raised US$200m through an oversubscribed private placement. Investors include Auven Therapeutics, Redmile, the Wild Family Office, and development partner AstraZeneca. The proceeds will be used to progress the company’s lymphoma drug candidates ADCT-301 and ADCT-402 into planned registrational trials in 2018.

Since its inception by major shareholder Auven in 2012, ADC Therapeutics has raised US$455m.

Rabbit deal German MAB Discovery GmbH has extended its 2013 collaboration with Biontech AG to produce another set of therapeutic antibodies against a range of undisclosed targets delivered by fellow German biotech Biontech. MAB Discovery will use its rabbit-based antibody discovery platform to generate the novel antibody therapeutics.

Picture: Immatics

So far, 150-strong Immatics raised more than US$230m.

Cancer deal

Not just a shot

Licencing German Bayer AG has acquired ex-US commercialisation rights to US-based Loxo Oncology Inc’s Phase II lead larotrectinib (LOXO101), which targets TRK (tropomyosin receptor kinase) fusions in 17 cancer types, and LOXO-195, a Phase I/II compound designed to prevent acquired resistance against larotrectinib. Bayer paid US$400m upfront and promised as much as US$1.15bn milestone payments. In the US, costs and profits will be shared equally. 

Product development Matched with the publication of the seminal publication (doi: 10.1038/nmeth.4435), biotech company Lexogen GmbH and researchers from the Institute of Molecular Biotechnology (both Vienna, Austria) launched the SLAMseq product family for metabolic RNA sequencing. SLAMseq enables the identification of newly synthesised as well as existing RNA from the same sample in parallel. While previous methods produced snapshots of molecular processes, this one resembles a video. 

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Going global Artificial intelligence specialist Sophia Genetics SA (St. Sulpice, Switzerland) raised US$30m in a Series D round to foster global expansion of its genome sequencing platform-independent cancer diagnostics annotation platform Sophia AI. The Series D round was led by Balderton Capital with new investor 360° Capital Partners, and existing investors Invoke Capital and Alychlo participating. Since 2011, Sophia has interpreted the genome data of more than 125,000 patients.

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Antigens trigger immune system

AMR The Portuguese biotech company Immunethep SA was awarded a US$100,823 grant by the Bill & Melinda Gates Foundation to test its orally administered antibody against the bacterial extracellular virulence factor GAPDH. “The grant is an additional motivation to go forward with our roadmap and it also reinforces our confidence in the scientific platform behind Immunethep’s pipeline,” said Pedro Madureira, CFO of Immunethep.

The spin-off from the University of Porto is developing anti-bacterial immunotherapies based on the discovery of a virulence mechanism shared by different bacteria – including multi-resistant strains – that cause life-threatening infections. After raising a seed round with more than €700,000 from Portugal Ventures in 2015 to execute pre-clinical work, the company is currently raising a Series A round to enter Phase I clinical trials with its PNV1 vaccine candidate. In 2018, they aim to complete a Phase 1b clinical trial in a small patients cohort. The lead indication will be patients undergoing surgical procedures. Investment needs will be around €12m for the next three years, Madureira told EuroBiotech at this year’s Berlin Conference on Life Sciences.

However, the grant will be used for a different project: Immunethep wants to start efficacy and toxicity preclinical trials with the anti-bacterial GAPDH monoclonal antibody immunotherapy to test if orally delivered anti-GAPDH antibodies may prevent group B streptococcus infections.

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enhanced by immune-modulators such as checkpoint inhibitors. Overall, these data indicate a potential way for converting immune-refractory patients into sensitive cases,” explains Bardelli.

Cancer neoantigens are known to stimulate the immune system and be a weak spot in a tumour cell’s defence mechanisms. In lab studies, the researchers observed for the first time that evoking dynamic neoantigen profiles triggered immune-surveillance. “We believe blocking mismatch repair is an attractive therapeutic mechanism, and we are continuing research to further prove the genetics and pharmacology behind this key phenomenon,” states Germano.

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Don Quixote’s biorefineries Bioeconomy Convert the Spanish region Castilla da la Mancha into the headquarter of Southern Europe in biomass exploitation – that was the goal of the Governing Council of Castilla-La Mancha and the Ministry of Economy, Industry and Competitiveness of Spain when they signed a €20m contract at the end of 2013 to push the circular bioeconomy within the region. Four years later, the Clamber (Castilla de La Mancha Bio-Economy Region) biorefinery has opened in Puertollona. The plant consists of two sections: a pilot biorefinery and lab spaces for R&D services to encourage the applied research for regional SMEs. “The main innovation of this plant is the size of the equipment,” states Javier Mena, R&D Director of Clamber. It can treat two tons per day of lignocellulosic biomass in a steam explosion reactor and has a fermentation train reaching from

three liters to 20,000. Already two European projects, Waste2Bio and Urbiofin, both financed by the Horizon 2020 Programme, have started in Clamber. GEACAM, a public company for the environmental management in the region, wants to invest €450,000 between 2017 and 2018.

In November, around 30 members of the EU research initiative Valor Plus visited the biorefinery plant to discuss their final results. They designed new methods for the controlled breakdown, release, and fractionation of the lignocellulosic biomass. “The next challenge will now be the upscaling of the three value chains of hemicellulose, lignin, and glycerol with the microorganisms we identified,” states Klaus Rischka, technical manager of the project. The event was organised

by Spanish biotechindustry association ASEBIO, which was part of the project. L

Pictures: ASEBIO

Funding

Oncology November was a good month for Alberto Bardelli and Giovanni Germano, the two founders of Neophore Ltd., a start-up based in Cambridge, UK, which aims to develop next-generation immuno-oncology therapeutics. They received a £3m funding (€3.4m) from CRT Pioneer Fund; published a paper in Nature (doi:10.1038/nature24673); and announced a collaboration agreement between the company and the University of Torino, where both of them are working. “Our results suggest that inactivation of DNA mismatch repair causes a dynamic hyper-mutation status that increases tumour neoantigens, which in turn, triggers immune surveillance that can be further

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Former flagship for sale Biofuels Beta Renewables, an Italian cellulosic ethanol producer, is in trouble: its parent company Mossi & Ghisolfi (M&G) announced the shut down of its second-generation bioethanol plant in Crescentino, Italy. Due to financial restructuring at US headquartered M&G and the death of Beta Renewables CEO Guido Ghisolfi,

Beta Renewables cellulosic ethanol plant in Crescentino, Italy

the M&G group seems to be no longer interested in saving Crescentino. Crescentino now is for sale, but Beta Renewables is also interested in offering the pilot and demo plants to scale-up other technologies. Starting from 26 October 2017, the company’s management has 60 days to present a restructuring plan to Italian authorities.

Beta Renewables was set up in late 2011 out of a joint venture between M o ssi Ghis olf i’s Bio ch e mt ex and US buyout firm Texas Pacific Group (TPG). In 2012, Danish Enzyme producer Novozymes acquired 10% of the shares of Beta Renewables. The Crescentino plant has the capacity to produce 40,000 tonnes of bioethanol per year, from around 270,000 tonnes of biomass. Crescentino bio-refinery was the world’s first cellulosic ethanol facility in industrial scale, built in 2011.

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Pictures: Beta Renewables

Fast decision lets stocks explode Oryzon Only two days after the referendum on the 1st of October, biotech company Oryzon announced it would move its headquarters from Barcelona to Madrid. The drugmaker became the first listed company to leave the economically unstable region of Catalonia. Meanwhile, two other biotech companies – Pangea Oncology and Inkemia IUCT group – moved their headquarters from Catalonia to other parts of Spain According to Spanish Association of Biotech companies ASEBIO, Catalonia is the Spanish region with the highest number of “user biotechnology companies” (515) and “strictly biotech companies (181).”

“Catalonia has stood out for being able to generate an environment that has allowed the development of a thriving biotechnology industry and we hope that this environment will continue,” states Ion Arocena, General Manager, ASEBIO. For Oryzon the relocation turned out to be a smart move on the part of its

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CEO, Carlos Bueso: After the announcement, Oryzon’s shares rose about 33%.

In a recent interview with Spain’s local newspaper El País Buesa said that the decision “was very thoughtful“ and made “to protect patients and investors.“ Since Roche decided to break the licence agreement they had signed to develop the molecule ORY-1001, Oryzon has had a turbulent year. The announcement in July caused drops of 20% in a single day in their titles. But Buesa remains optimistic. “It would have been serious if Roche returned the molecule because it did not work or because it was dangerous, but that has not happened,” he explained to El País. They will stick to their lead candidate and hope to attract new partners to continue clinical trials in 2018. A recent report by the Spanish financial group Solventis pushed Oryzon’s stock again at the end of November. The biotech company got a market plus from +50.6%.

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News Green cosmetics After four years of project duration, members of the EU-project Optibiocat presented their final results during the green economy fair Ecomondo in Rimini. Optibiocat focuses on the development of novel enzymes for the sustainable and cost-effective production of compounds used in the cosmetic industry. They identified various promising enzymes, and optimised and scaled-up production to 16 L fermenter. Eight compounds have been tested for activity and cytotoxicity for use in cosmetics.

Cannabis growing Slovenia could become a major player in the production of medical cannabis. Europe-based medicinal cannabis company MGC Pharmaceuticals will bring its epilepsy product CannEpil to the Australian market.

MGC’s pharma division plans to manufacture the product at its Slovenian facility, which is currently undergoing GMP certification. According to the company, the 5,000 square meters of cannabis seedlings planted at its open field farm in Slovenia are showing good signs of strength. The harvest is planned for the end of this year.

Skin recovery An international research group headed by Sergio Bondanza and Michele De Luca from Italy has shown for the first time that genetically corrected stem cells can regenerate an entire, fully functional epidermis, reversing damage caused by an incurable genetic skin disease.

(Nature, doi:10.1038/nature24487).

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EASTERN EUROPE

European Biotechnology | Winter Edition | Vol. 16 | 2017

African pioneer Biosimilars Russian bio­ similar producer Biocad has finished transfering its technology to Morocco.

In late November, Biocad announced the first biosimilars produced by Sothema Labs (Bouskoura, south of Casablanca) “will go on sale in the coming days.”

Four years have passed between the start of the collaboration between the Russian and the Moroccan companies and the announcement of the launch.

Besides Morocco, the two biosimilars of rituximab and bevacizumab, respectively, are set to be marketed in Senegal, Gabon, and Côte d’Ivoire.

Investment spree A couple of weeks earlier, Biocad had announced it will also enter the European market with its biologics (including biosimilars) and small molecule portfolio. “As for the EU countries, where the approval of biological product goes under centralised procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorisation for biological products in 2021,” said Dmitry Morozov, general director of the largest Russian biotech company (1,300 employees). To meet this goal, Biocad started to ramp up its manu­facturing capacities. For instance, Biocad plans to built a new plant in Turku (Finland), investing €25m over the next seven years.

In its home town of St. Petersburg, the company will invest €290m until 2022 to boost its drug production unit.

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Dupont Pioneer’s waxy corn could be the first commercial CRISPR/Cas-edited crop.

organisations. According to local news service The Baltic C ourse, US holding company Dow Dupont is one of the investors in Caszyme. The size of the stake and other details were not disclosed.

Dupont Pioneer, a business unit of Dow Dupont’s agriculture division, is the first company to collaborate with Caszyme.

In October, the partners announced that they have entered into a multi-year collaboration to identify and characterise novel CRISPR/Cas nucleases. The joint goal is to provide researchers with additional tools for gene editing across all applications.

Under the terms of the agreement, Pioneer will provide access to its extensive CRISPR/ Cas library and Caszyme will apply its biochemical assays and expertise to characterise the Cas nucleases. Dupont Pioneer is applying CRISPR/Cas as an advanced plant breeding tool to deve­lop seed products for greater environmental resiliency, productivity, and sustainability.

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Trial on hold

Blue and spicy

Oncology Shares of Poland’s largest biotech firm Selvita SA took a dive by more than 17% in early October, when the company announced the placement of a full clinical hold on the Phase I/II clinical trial of its lead candidate SEL24. The trial with patients with relapsed/refractory acute myeloid leukemia (AML) is being conducted in the United States. The decision by the competent US authority FDA followed a patient’s fatal stroke that could possibly be related to the study treatment.

Selvita plans to comply with the requests formulated by the FDA regarding the amendment of the study protocol. “We are currently working on the response we were asked for, which is our priority at the moment,” CSO Krzysztof Brzózka said in mid-November. SEL24 was developed inhouse and out-licensed in March 2017 to Italian Menarini Group. Despite the clinical hold, the shares made up their losses by the end of November.

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Breeding The Czech Potato Research Institute in Havlíčkův Brod registered a new potato variety. Dubbed “Val Blue,” it is characterised by a striking bluepurple colour. According to geneticist and project lead Jaroslava Domkářová, blue potatoes contain higher amounts of anthocyanin pigments: “They have about 20%-30% higher levels of antioxidants than yellow potatoes .”

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Genome Editing The Vilniusbased laboratory of Virginius Šikšnys has been crucial in establishing the genome editing technology CRISPR/Cas. Šikšnys is among the three founders of Caszyme UAB, a Lithuanian company established this autumn. Caszyme focuses on the development of new CRISPR-based molecular tools and provides research services for businesses, other researchers, and

The taste of Val Blue is said to be a bit spicy and therefore quite distinctive.

Pictures: Potato Research Institute Havlíčkův Brod, Ltd. (bottom); Dupont Pioneer (top)

Dupont fosters start-up Caszyme

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Science & Technology

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Plasmodium locked in malaria For decades, researchers have searched without success for a strategy to prevent

malaria. Now, two teams of researchers present a solution that circumvents the problem of surface antigen hypervariability of Plasmodium. Their drug candidate blocks the pathogens’ release from blood cells, resulting in prevention of the life-threatening hot stages.

In 2015, the World Health Organization counted 212 million malaria cases worldwide, resulting in 429,000 deaths. Alternatives to existing drugs are urgently needed as resistant strains of malaria emerge.

Now Armiyaw Nasamu (S cience , doi: 10.1126/science.aan1478) and Paco Pino (S cience, doi: 10.1126/science.aaf8675) have demonstrated that targeting two out of ten Plasmodium falciparum proteins, PMIX and PMX, could be a promising strategy to prevent the parasite from completing its life cycle. The researchers have developed two inhibitors that target the two plasmepsins that regulate the maturation of the enzymes required to disrupt host cell membranes.

Picture Armiyaw Nasamu and Wandy Beatty, Washington University]

Blocking processes crucial for multiplication and spread Nasamu and colleagues from the US and the UK deployed new techniques to conditionally eliminate PMIX and PMX from the parasite during specific stages of its life cycle. The groups revealed that the proteins are essential for two crucial functions. Without PMIX, Plasmodium stages were unable to make intact rhoptries, specialised structures inside the parasite, which help Plasmodium invade red blood cells, where it replicates. The team also discovered that plasmepsin X processes a protein called SUB1. When deprived of plasmepsin X, the parasites couldn’t process SUB1 and were unable to infect red blood cells or exit these cells after multiplying, a process called egress that is necessary for the parasite to spread. The authors had previously identified several compounds that inhibit PMX and PMIX, including CWHM-117, a compound discovered in 2013, which

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An electron micrograph of a malaria parasite inside its host red blood cell, ready to burst out. The small merozoites will each find a new red blood cell to invade and grow within.

was reported to show anti-malarial efficacy in mouse models.

Pino and colleagues from Switzerland, Norway, Finland, and the UK developed an inhibitor that targets both PMIX and PMX called 49c. The new compound achieved 99.9% parasite clearance in culture after 48 hours – comparable to the killing profile of chloroquine, the current standard of care. In mouse models of malaria, parasites were completely undetectable in the blood after two weeks of daily 49c treatment. Importantly, 49c also blocked malaria from

completing the sexual stages of its life cycle in mosquito vectors, highlighting the compound’s potential as a transmission-blocking agent. Treating mice with 49c 30 hours before allowing mosquitoes to bite rodents prevented the parasite from forming structures called oocysts in the insects’ midguts. The scientists demonstrated that 49c both trapped malaria inside red blood cells and prevented the parasite from invading, and that the compound was active against both blood and liver stages. L t.gabrielczyk@biocom.eu

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Synthetic Biology

European Biotechnology | Winter Edition | Vol. 16 | 2017

App design for the cellular processor Genetic Circuitsâ&#x20AC;&#x192; Since the earliest attempts at genetic engineering, scientists have sought to

influence cell behaviour and development through the introduction of foreign genetic material.

Synthetic biologists are now taking the idea to a whole new plane with app-like DNA-based software programs that turn cells into diagnostic sensors, therapeutic entities or tissue generators.

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Synthetic Biology

European Biotechnology | Winter Edition | Vol. 16 | 2017

Pictures: BIOCOM collage, Originals from Ellen11/istockphoto.com (circuit board), luismmolina/istockphoto.com (e. coli) (left); MIT (right)

W

hen Ron Weiss earned his Master’s degree in computer science at the Massachusetts Institute of Technology (MIT) back in 1994, the young researcher had no idea his work would reshape an entire field of scientific endeavour. He probably would have found it even more absurd if you told him back then that the field it would impact so dramatically was biology. At that point, he says, he stayed away from living systems because biology “is so messy.” But working with Tom Knight eventually changed his mind. The computer engineer and MIT professor was one of the first to attempt to control living systems through fundamental principles in engineering and programming. In his approach, DNA is biology’s software while the cells are the hardware – in other words, they should be programmable. Weiss quickly became “fascinated with this notion that we might be able to program cells in the same way that we program computers.” The enthusiasm from those early days has kept Weiss going through the many tough years since, as he struggled to design increasingly complex gene-based programs to alter “messy” biological entities – initially bacteria, then later mammalian cells. Today the researcher is unquestionably one of the world’s most highly respected experts in the field of synthetic biology.

Just as apps can turn smartphones on command into a device for communicating, translating, broadcasting, gaming or banking, the genetic circuits developed by Weiss are able to transform embryo-like cells into liver buds, detect and destroy infected or cancerous cells, or accelerate and improve drug development. “And this is just the beginning,” he says. Synthetic biology is moving past the basic research stage. More and more, pharma­ceutical companies and investors are showing an interest. ‘Synbio’-based companies raised US$500m during the first half of 2017 alone. “It feels like the field is exploding right now,” says Weiss.

‘Programming cells’, ‘genetic circuits’, ‘DNA software’ – after many years of arduous and frustrating experiments, the

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researcher knows that the terms used in synthetic biology are still little more than analogies. “It turns out that it’s not that easy to program cells,” says Weiss. “We have to be humble in the face of bio­ logy, and appreciate how complex the situation is.” Genetic circuits are generally made out of a set of between 3-15 genes, and that package of genetic building blocks is then inserted into a cell.

What makes it different from classic genetic engineering is that a circuit is able to compute. “It can sense what is going on inside or outside a cell – the level of a protein, a certain microRNA or mRNA,” says Weiss. “It then takes this information and computes like a miniature PC, which means it actually does something to the cell.”

Cancer? We’ve an App for that One type of program might eventually help fight the HIV retrovirus. The team led by Weiss at MIT have built a circuit able to detect whether a particular cell is HIV positive. “From a computer logic perspective, that’s actually pretty easy,”

Ron Weiss Massachusetts Institute of Technology, Cambridge, US

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I f g enetic circuits are able to differentiate iPS cells into liver tissue and other cell types, could you also add certain features?

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Absolutely. We don’t just want to replicate. We would also like to create better versions of tissues­ – like a super-liver with improved metabolic activity.

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the researcher says. “It’s a single input program.” If the circuit senses a virusspecific protein like gag, it’s programmed to start a certain action – either killing the cell or inducing an immune reaction to it. Weiss says, however, that it’s still not clear whether the circuit is ready at this point to be developed as a therapy in its own right: “We currently use it as a diagnostic tool to understand the dynamics of HIV.” The ultimate goal is to build a circuit able to draw the immune system to tissues in an infected patient that hide latent HIV reservoirs.

Another example of what genetic circuits could theoretically do is much more complex. Will they one day be able to detect whether a cell is cancerous, and act on the diagnosis? “Here we’re moving from a single input to multiple inputs, because this is a complex disease,” Weiss says. “You almost never find a single biomarker for cancer.” Systems that rely on just one biomarker, such as CAR T-cell therapies, often perform poorly.

It’s believed that’s because they work by getting engineered T cells to lock on to a single surface receptor, usually CD19.

But CD19 unfortunately doesn’t just appear on the cell membranes of tumour cells. Healthy cells can display it, too.

CAR T cells can’t tell the difference, and wipes them out along with the diseased cells, which can have severe side effects for a patient. “We need multiple inputs to determine with precision whether it’s a cancer cell or not,” Weiss says. Specificity improves dramatically if a second receptor is added. “We found that we need six inputs to get to a point where we think...it’s safe enough, and hardly ever makes a mistake.“ The first genetic circuit able to distinguish between healthy and cancerous cells and switch on a killer protein garnered the group a publication in Science in 2011 (doi: 10.1126/science.1205527).

But Weiss was aware then that although the data was exciting enough for a publication, it was far from mature enough for therapeutic applications. “The circuit’s error rate was too high,” he says. Genetic circuit outputs still have to be set up to provide one of two solutions – such as

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Synthetic Biology

‘kill’ or ‘don’t kill’. “In this kind of setting, ‘partially kill’ is not really ideal,” Weiss says with a smile. It took his team five years to improve the circuit to the point where the system now makes only about one mistake in a billion cases. “This we are ready to take into the clinic.”

The circuit is ferried into patient cells via a herpes simplex virus (HSV). “When it enters a cell, the first thing the circuit does is perform its computation,” Weiss explains. “And if the computation says ‘yes, this is a breast cancer or a melanoma cell’, then the virus replicates and kills the cell. That sets free new viruses that subsequently infect other cancer cells.” The researcher adds that although results from mice models have yet to be published, they indicate the system works. Initially the virus spreads throughout the entire mouse, Weiss says, but the circuit only acts within the tumour. He isn’t concerned about immune system responses to the therapeutic HSV. To the contrary: “The circuit sends messages to immune cells and recruits them to act on the tumour.”

Bugs in the program A bigger problem is the length of the ‘program’ necessary to make circuits function properly. The first version of the cancer-killing circuit was 5,000 base

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pairs (bp) long, but the final construct topped out at 40,000. More effective programs will certainly be longer – maybe much longer. But many viruses can’t carry that much genetic material. HSV’s limit is 150,000 bp.

As with other genetic technologies aimed at altering human cells, the delivery issue therefore remains a major hurdle. This is especially true for genetic circuits, which are usually much longer than gene therapy cassettes. “The methods synthetic biologists use are no different from the methods developed in gene therapy, cell therapy and genome editing,” says Yaakov (‘Kobi’) Benenson, a synthetic biologist at the ETH Department of Biosystems Science and Engi-

Liver bud organoid tissue generated with a genetic circuit built in the Weiss lab at MIT

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neering in Basel, who collaborated with Weiss for years. “The strengths and limitations of these approaches are carried over to any synthetic biology system intended for biomedical use,” he adds.

One way to ensure that a high percentage of cells in the body receive a desired genetic circuit is to modify cell samples ex vivo and retransplant them – a process that in many cases is already approved for clinical use. “You can deliver relatively large packages of DNA ex vivo if you have time and can select correctly transduced cells,” says Benenson.

But accurate and effective systemic or localised delivery methods are still needed when delivering DNA inside the body, Benenson says: “Large DNA payloads can be delivered by viruses with a lot of capacity – like gutted adeno­v iruses.” But as the size of the DNA package grows, the physical size of the ferry – whether viral or non-viral – becomes more problematic. Larger ferries don’t diffuse as well, reducing delivery efficiency.

To address this issue, Benenson’s team has developed ‘compression’ and ‘decompression’ tools analogous to software programs that reduce (‘zip’) the size of files by transferring repeating elements – like those in promoters – just once. The compressed circuits are only reconstituted inside the cell (Nature Nanotechnology, doi:10.1038/ s41565-017-0004-z). Elegant tools like this could help circumvent the delivery problems inherent in huge circuit therapies, but a lot of groundwork remains to be done. “Treatments that require circuit transduction into patient cells in situ using systemic or local delivery,” says Benenson, “will take longer to develop.”

Another issue is whether delivered circuits should integrate permanently into a patient’s genome. A transient localization in the nucleus, where a genetic circuit persists for just a few cell cycles, might in some cases be sufficient. And it would certainly be easier to get approval for that from medical watchdogs. If transfection is to be transient, DNA doesn’t even have to be the

Pictures: MIT (below); Y. Benenson/R. Weiss ETH/MIT

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basic material used in the circuit. RNA would also be an option. “Because its life is limited, delivering RNA would guarantee the circuit doesn’t become permanent,” Benenson says. “So it’s safer than DNA, which has a chance of permanent integration.” Working with German mRNA-companies Biontech and Curevac, Ron Weiss is already experimenting with RNA-based genetic circuits. “They deliver RNA that translates into a protein or peptide with a certain therapeutic asset,” he says. “The problem there is that RNA is constitutively expressed, and there’s no control.Any cell that the RNA goes into is going to make the protein.” But there’s a way around this problem – by adding a programme that ensures the RNA is only expressed in the correct cell type. “So you deliver to every cell, but it only expresses in particular cells or at a specific time,” says Weiss.

One drawback is that limited RNA lifetime could also pose a problem, e.g. if it decays before the circuit carries out its task. “Excluding DNA from circuit components excludes a large repertoire of building blocks such as transcription regulators,” says Benenson.

“So you must be able to operate with fewer possibilities.” In the long run, he expects both approaches will have uses and proponents.

Picture: ETH Zurich

Growing new organs?

There’s no question that synthetic biology still has to solve a wide range of technical problems, but the possible rewards seem endless. Although they’re even more complex than the senseand-kill designs that are being developed for HIV and cancer, some genetic circuits are able to steer cell differentiation in particular directions. To do that, programs have to react to a sequence of events that occur over time and in changing environments – where spatial, biomechanical and temporal interactions are taking place between different types of cells.

To guide differentiation of iPS or embryonic stem cells into target tissue

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types, developmental biologists currently add growth factors or other developmental triggers to cell cultures. Weiss isn’t doing that from the outside, but the inside: “Implementing a genetic circuit within iPSCs provides a lot of power you just can’t have with external molecules.” The circuits interact with a cell’s own genome, nudging it along particular differentiation pathways.

Starting with a homogenous mixture of iPSCs, the genetic circuit initiates differentiation, causing the cells to begin to self assemble and arrange themselves in patterns. Eventually they transform into the three germ layers – endoderm, mesoderm and ectoderm. “If you are patient and wait seven days,” says Weiss, ”the mesoderm begins to form vascular structures, and the endoderm differentiates hepatocytes that lead to a liver-like tissue.” Other cells develop into hemato­p oetic cells or blood progenitors, while ectodermal cells can form ‘brain buds’ and nerve cell conglomerates similar to forebrain tissue.

What Weiss calls “synthetic morphogenesis” is simple in theory, but difficult to achieve in reality. When his team started trying to coax iPSCs to develop into insulin-producing beta cells, the genetic circuit ‘failed’ – and instead produced liver-bud-like tissue. It was a failure that turned out to be a spectacular success (Nature Communication 2015, doi: 10.1038/ncomms10243). The tissue the team acquired contains not just hepatocytes, but all the known cell types in a natural liver bud. And if the artificial tissue is grown in a 3D culture (as opposed to a flat, two dimensional culture in a petri dish) it develops into a miniature piece of liver that’s far larger than anything anyone else has been able to make so far. Weiss says that’s because the tissue also builds its own network of blood vessels, which allow oxygen and nutrients to penetrate deep into the bud.

Other lab-grown ‘organoids’ lack such vascularisation, which means they stop proliferating when they’re about a millimetre thick. The genetic circuits have created liver organoids that are multiple centimetres in diameter – “30 to

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Yaakov Benenson ETH Department of Biosystems Science and Engineering (Basel, Switzerland)

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Genetic circuits could be transferred transiently into the cytoplasm, but also permanently integrated into cell genomes. Which approach is better when it comes to clinical applications?

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Most FDA-approved therapies involve ex vivo, stable modification of patient-derived cells (T cells in cancer, hematopoietic stem cells in genetic immune diseases). The safety comes from the fact that the genetic material is confined to these modified cells. For in vivo gene-therapy-like applications, non-integrating viruses have been used, namely Glybera (approved in 2012, but off market since October 2017) and Amgen’s Herpes-simplex-virus-based Imlygic for melanoma. Both are non­ integrating viruses. Many clinical trials are exploring adeno-associated virus (AAV), a non-integrating virus.

However, integrated virus delivered locally is also an option if the delivery is localised to a specific organ.

Locus-specific integration into a safe harbour would be ideal, but it is still a long shot to do this in vivo.

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In theory, you could add safety features to circuits. What ‘safety tools’ do you prefer?

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Many safety tools can be envisioned. I wouldn’t yet speculate about which will be most advantageous for clinical applications.

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synthetic biology

50 times larger than anything else out there,” according to Weiss. And as the artificial tissue can be grown from iPS cells taken from a skin biopsy, it can be made patient-specific, and won’t be attacked by the immune system after retransplantation. “We’re thinking now about transplantation studies in mice to see whether we can replace a liver.”

But there’s more to do before Weiss and his team can publish the results of the 3D culture work: “First, we really want to know how close this is to real bio­logy.” A cell analysis to compare transcriptomes of artificially and natural grown liver tissues is still ongoing.

In parallel, the lab is continuing to build a circuit able to generate beta cells. “We put a genetic circuit into the cells that says: ‘Once you become endoderm and mesoderm, take a right turn and become pancreas.’” Swiss colleagues in Martin Fussenegger’s synthetic biology group at ETH Zurich have already had some success at an endeavour like that. Their glucose sensor and insulin secretion circuit does essentially what a beta cell does, even though Weiss admits it’s still too slow. Naturally occurring beta cells can respond to changes in glucose levels nearly instantaneously. They make insulin and

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store it in vesicles, and if glucose levels rise in the surrounding cellular medium, they almost secrete it almost instantaneously. “Fussenegger’s cells took tens of minutes to hours. Not quite fast enough,” says Weiss. He now hopes to come up with a better beta cell app to either drive cell differentiation or use the circuit as a gene therapy that will re-enable the patient’s own beta cells to do their job.

Although that will take time, there are also more immediate applications for genetic circuits. The artificial human liverbuds, for example, are an ideal milieu for drug candidate testing. “The organoid should be a much better predictor of what a drug candidate would do

than an experiment in a mouse,” Weiss says. “And we can do all kinds of other cool things – like putting sensors in there – that can tell us in real time what’s happening.” Such sensors could quickly sound the alarm if for example a drug candidate changes natural levels of crucial proteins, microRNAs or mRNAs. Weiss says tests with the common pain relief drug acetaminophen (paracetamol), which is toxic to liver cells in high doses, have already been a success: “If we put excess acetaminophen on the liver bud, the sensors embedded in it fluoresced red, which told us that something was wrong.” Benenson also believes circuits have the potential to provide much more information about drug candidates by reporting both intended effects and side effects. His lab developed comparable drug testing ‘devices’ that are based on miRNA-targeting as a proof of concept, and now he intends to expand it to other target families like GPCR. “This could shorten the drug-screening process by reducing the number of assays and counter-assays,” he thinks. The researcher has already patented the methods, and is in talks with companies that want to use the technology.

Placing sensors in tissues shows one direction that synthetic biology will take in the future. Reproducing human tissues is another. But why should the field stop there? “We don’t just want to replicate.

We’d like to do better versions,” Weiss says. “Like a super-liver with even better metabolic activity.” Maybe the next big thing made possible by cellular apps. L

s.karberg@biocom.eu

Possible applications for genetic circuits

Application

Action

› diagnostics

circuit senses levels of disease-related molecules and generates a signal

› drug delivery/gene therapy

circuit ensures cell type/time-specific delivery of drugs or gene expression

› drug discovery

circuit senses and signals efficacy and side effects of drugs

› synthetic morphogenesis

circuit guides development of undifferentiated cells into tissues/organs

› chemical production

circuit controls the production of desired proteins/biomolecules in cells

› therapeutic bacteria

circuit-controlled bacteria secrete drugs in the gut

› plant engineering

circuits react to environmental stress (drought, heat) and react accordingly

Picture: MIT

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Premiere medicines At the end of November, a

sector group of Medicines for Europe organised the first Value Added Medicines conference in Brussels. Around 100 experts discussed and developed solutions for patient-centric innovations and better patient access to value added medicines.

“Pricing, HTA, and market access pathways should be adapted to better assess and recognise the benefits of value added medicines,“ said Umberto Comberiati, Chair of the Value Added Medicines Group at Medicines for Europe. 

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European Biotechnology is published in co-operation with the following organisations: European Biotechnology NET WORK

Europe: european-biotechnology.net

Europe: medtecheurope.org

Europe: europabio.org

Europe: diahome.org

Switzerland: swissbiotech.org

Germany: biodeutschland.org

Medtech wins AWARD In November, the Ministry of Science, Research and Economy honored the four best life sciences projects entered into the international business plan competition, Best of Biotech, at a festival gala in Palais Ferstel. The prize money from sponsors totalled €40,000.

The winner among all 30 applications was BHS Technologies, followed by Macroarray Diagnostics, and Image Biopsy Lab. A special Medtech award was given to Morphomed, a Vienna-based medical technology start-up that specialises in the the development and commercialisation of Class III medical products for regenerating endogenous natural tissue.

BHS Technologies was founded in February 2017 with the goal of developing a new medical device to enhance the performance of microsurgical procedures.

Further details are still under wraps. Macroarray has developed a multiparameter allergy test that can clarify allergic sensitization to all globally relevant allergens in a single laboratory test. The technology of Image Biopsy Lab – third prize winner – addresses X-ray-based prediction and diagnosis of knee osteoarthritis. Best of Biotech is financially supported by Shire, Roche Austria/Roche Diagnostics, Boehringer Ingelheim, the Vienna life science platform LISAvienna, and the Standortagentur Tirol. 

Europe: medicinesforeurope.com

Ireland: ibec.ie/ibia

Denmark: danskbiotek.dk

The Netherlands: hollandbio.nl

Spain: asebio.com

Portugal: www.p-bio.org

Austria: lifescienceaustria.at

France: france-biotech.org

Council of European BioRegions

CMYK

Italy: assobiotec.it

Sweden: swedenbio.com

Hungary: hungarianbiotech.org

Europe: cebr.net

Europe: ebe-biopharma.org

Norway: biotekforum.no

Finland: finbio.net

Belgium: bio.be

Blue: 100/15/0/35 Orange: 0/75/90/0

European Biotechnology covers the biotechnology sector of the current 28 EU member states, Norway and Switzerland. If you would like to subscribe, please refer to european-biotechnology.com

EBE

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Leading chemical companies are exploring the opportunities that have been opened up by modern biotechnology, especially in the field of “white” or industrial biotechnology. And they are also applying these technologies, wherever it makes sense. The SBA takes such initiatives seriously and has formed a working group specifically dedicated to white biotechnology.

The Swiss Industrial Biocatalysis Consortium is an important partner in this effort. The group includes leading multinational companies that support white biotechnology as a pillar of economic growth. The planned activities are in agreement with OECD strategies.

In partnership with the Swiss Biotechnet (see pages 14/15) the SBA develops training programmes and useful support tools for the industry. It is of importance that the industry specifies its training needs so that the academic side can create tailor-made education.

This strategy ensures that the industry gets the right workforce with the right education. The SBA profits from the marketing alliance “Swiss Biotech” (see box) in a multiplied form. Thanks to Swiss Biotech, the

associations

sector is internationally visible. The project-specific participating companies (most of them young and inSWISS BIOTECH... ternationally less savvy) find a comprehensive partner which is helping to put them in the public window. ...is an alliance of four leading Biotech regions of The participating Life Science Regions are important Switzerland (Bio Alps, BioPolo Ticino, Basel Area internal carriers of the dynamics in the Biotech secand Greater Zurich Area). They have combined eftor, thus enhancing the common understanding of the forts to streamline interests the national biotech | WinterofEdition | Vol. European Biotechnology 16 | 2017 industry. This and more knowledge is brought into sector. The SWX Swiss Exchange holds a leading Europa Bio, the European Biotech Association, where position in terms of lifescience listings and offers the SBA is an active member. companies from that industry – be they located in Switzerland or abroad – access to an internationally recognised financial marketplace. The initiative was co-founded by the SBA which also manages the executive office of Swiss Biotech.

Domenico Alexakis is Executive Director of the Swiss Biotech Association.

Switzerland’s activities against AMR Antibiotics In a workshop, the Swiss Biotech Association (SBA)

– together with stakeholders, SMEs, NGOs, academia and public organisations – discussed the current role and activities of Switzerland within AMR research and development.

The Swiss Strategy on Antibiotic Resistance (StAR) addresses the development of new therapeutic and diagnostics tools within two subfields only. Is this sufficient? Does this strategy take full advantage of the innovative life sciences community in academia and industry?

These were the main questions addressed during a stakeholder workshop in October attended by representatives from SMEs, academia, NGOs, and public organisations. The Antibiotic Resistance Platform, run by the National Thematic Network (NTN) Swiss Biotech, unites academia and industry in their efforts to develop solutions to overcome antibiotic resistance.

French Action Plan An insight into the activities in France to tackle antibiotic resistance was given by Florence Séjourné, DaVolterra. The national French strategy coordinated input from nine different ministries and actively invited SMEs with antibiotics in development to participate in the process of the strategy development and execution. In addition, it provides substantial

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funding for the development of innovative antibacterial therapies, diagnostics-based targeted therapies, and novel pricing and reimbursement schemes.

Marie Petit from the BEAM Alliance (Biotech companies in Europe combating AntiMicrobial Resistance) presented an overview on this European industry initiative. The Swiss companies Basilea, BioVersys, Debiopharm and Polyphor play an active role in the BEAM Alliance and contribute significantly to its antibiotics pipeline.

Triple challenge for SMEs Attendees of the workshop discussed the strengths and weaknesses of the StAR program with regards to the development of innovative antibacterial therapies. Drugdeveloping SMEs face a triple challenge: 1) funding their research is difficult, 2) applying “standard” clinical trial procedures to antibacterial clinical development are not convincing, and 3) unconventional business models are urgently needed as national and global antibiotic resistance strategies limit and restrict use of novel and innovative an-

@

Upcoming events For further information please visit www.swissbiotechassociation.ch www.swissbiotech.org

› 3 May 2018, Basel Swiss Biotech Day swissbiotechday.ch

tibacterial drugs that can kill resistant bacterial strains. The insights of the workshop will be further evaluated and developed by NTN Swiss Biotech and the SBA will continue the exchange with relevant funding and regulatory organisations. Attendees of the workshop agree that Switzerland should take an active role in the global discussion on AMR and profit from the excellent positioning and innovation potential of its biotech and life sciences start-ups and SMEs within AMR research and development.

For more information on the current issues, join the “11th Berlin Conference on Life Sciences: Novel Antimicrobials and AMR Diagnostics” on 2 March, 2018. 

SBA abroad Swiss Pavilion The Swiss Biotech Association was present at the BIO-Europe in Berlin and enjoyed the interaction with other associations; SBA members; and interested biotech companies and stakeholders from all over the world.

We are looking forward to our next international presence at BIO in Boston (4–7 June 2018), where the SBA and Switzerland Global Enterprise will organise the Swiss Pavilion. Swissnex Boston will join the pavilion with the 2018 venture leaders. The venture leaders – the members of the Swiss National Startup Team coached

by Venturelab – are attending a business development program co-organised by swissnex Boston and Venturelab, held in Boston and New York, to help budding entrepreneurs achieve their first steps into the US market. If you are in Boston, do visit the Swiss Pavilion! 

Pictures: pixabay, frolicsomepl

“WHITE BIOTECHNOLOGY” WORKING GROUP

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Record attendance Partnering Conference This year’s edition of the European

Upcoming Events

Business Development Conference, organised by the German biotechnology industry association BIO Deutschland, gathered about 150 attendees in the medical science hub of the Rhine-Neckar area.

› 18–19 April, 2018, Berlin 9th German Biotechnology Days www.biotechnologietage.de/en/

New Board Elections The members of BIO Deut-

Pictures: BIO Deutschland BIO Deutschland

European Business Development Conference 2017 in Heidelberg, Germany

In October, experts from the pharma and biotech sector met for the European Business Development Conference (EBDC).

The main topics covered by the program were advances in oncology, the rise of autoimmune disorders, and business development and financing for pharma and biotech companies. In her opening keynote, Paola Casarosa, Corporate Vice President for Business Development & Licensing at Boehringer Ingelheim, stressed the importance of partnering for her corporation.

About 50% of innovations of her company are anchored in external collaborations. Representatives of UCB and Amgen presented similar numbers. Merck’s Chief Innovation Officer, Christoph Hüls, explained in a later keynote the company’s strategy to promote cross-sectoral innovation. “The ‘secret sauce’ of successful innovation,” according to Hüls, “are people, places, processes and products.” To create an optimal environment for innovation, Merck will open a new innovation center in Darmstadt next year.

On the oncology panel, representatives of AbbVie and Merck presented their pipelines and respective partnering activities. Speakers from Menarini and Selvita

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highlighted a recently established cooperation for a drug against acute myeloid leukemia. The experts emphasised that cooperation proposals need to have a strategic fit to the pharma partner. The importance to find new and disruptive therapeutic approaches instead of the development of more “me too” drugs was also a point raised during the discussions. Speakers of the companies MorphoSys, Pfizer and UCB talked about their activities in the indication of immunology and inflammation. MorphoSys presented the recent success story of their antibody Guselkumab for the treatment of psoriasis. In the session on business development and financing, experts from Almirall, Boehringer Ingelheim Venture Fund, BioMed Partners, EMBL Ventures, and Staatz debated the significance of innovation, which indications besides oncology are still attractive, and how collaborations with academia could be improved.

Also in the program were company presentations and start-up pitches, supported by Science4Life. The conference was supported by Technologiepark Heidelberg, Merck, Miltenyi Biotec, Boehringer Ingelheim, CureVac, and Roche. L

schland elected a new board during its 14th ordinary general assembly held in September in Berlin. The ten members of the BIO Deutschland Executive Board represent different areas of innovative biotechnology SMEs and also the pharmaceutical industry. They will serve for the next two years.

The following members were re-elected: Dr Peter Heinrich (Managing Director of Sinfonie Life Science Management GmbH), Norbert Hentschel (Chief Financial Officer of Miltenyi Biotec GmbH), Dr Claus Kremoser (Chief Executive Officer/Management Board Member of Phenex Pharmaceuticals AG), Roland Sackers (Chief Financial Officer and Managing Director of QIAGEN N.V.), Oliver Schacht, PhD (Chief Executive Officer of Curetis N. V.), Dr Jan SchmidtBrand (Managing Director of Heidelberg Pharma Research GmbH and Chief Financial Officer of WILEX AG), Dr Sylvia Wojczewski (Managing Director of BioSpring GmbH), Dr Holger Zimmermann (Chief Executive Officer of AiCuris Anti-infective Cures GmbH).

Newly elected to the board were the following members: Dr med. Peter-Andreas Löschmann (Senior Medical Director Germany/Managing Director of Pfizer Pharma) and Dr Klaus Maleck (Chief Executive Officer of TETEC AG).

Directly after the general meeting, the new board unanimously confirmed the appointment of Peter Heinrich as its chairman. Oliver Schacht was re-appointed as treasurer.

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Brexit talks threaten medtech supply Strategy As talks between the EU and UK enter a critical phase,

there is growing concern that the outcome could undermine the regulatory framework, disrupting the supply of vital diagnostic tests and medical devices. Here is how to make it work.

gical interventions. There is a lot at stake.

The prospect of the UK’s departure from A related source of uncertainty arises from the European single market and customs a lack of clarity on the future of UK Notiunion seriously jeopardises the regulation fied Bodies, which grant CE marks to new of medical technologies in post-Brexit Eumedtech products and renew CE marks rope. The big fear is divergence in the rules for existing products. At present, thanks to governing diagnostics and medical devicthe quality and expertise of the UK’s Noties. The timing is far from ideal. Transition fied Bodies, a sizeable chunk of products periods for the new In Vitro Diagnostics on the market across the (five years) and Medical DevicEuropean continent have es Regulations (three years) are albeen certified there. ready looking tight and are further If these bodies effeccomplicated by the regulatory untively leave the European certainty that comes with Brexit. system, it would repreMedTech Europe has published a sent a sudden loss of exdetailed position paper on the chalpertise and raise question lenges this poses for the industry. marks over whether UKWe also point to solutions that issued CE marks would may mitigate the risk of disrupcomply with the new tion. By fully aligning its post- Serge Bernasconi, EU regulations. The soBrexit medtech regulatory system CEO of MedTech lution might be for both with the EU 27, the UK would fos- Europe sides to continue to recter innovation, competitiveness, ognise existing CE marking certificates isand trade while safeguarding patients. In sued by the UK until their expiry date. practice, this would mean drafting legisWe would also like to see UK Notified lation that mirrors the new EU rules for Bodies remain within the European netdiagnostics and devices. work of oversight mechanisms and continue to be allowed to assess devices for Impact on patients the EU27 and UK markets. This is not a radical idea – the EU and Switzerland alFailure to get this right poses serious ready operate a mutually beneficial sysrisks for patients. EU regulations have altem of this kind. lowed timely access to safe and effective Notified Bodies are not the only piece of technologies for 25 years. If some prodthe regulatory framework facing uncertainucts become unavailable post-Brexit, ty. Legal entities – such as authorised repor if supply is much slower than it is at resentatives, legal manufacturers, and impresent, patients will miss out on highporters – may no longer have a mandate ly valuable products. For example, they from the UK to address EU27 legislations. may wait longer for diagnoses – with poHere, again, the Swiss-EU model tentially worse outcomes as a result – or points the way. Through a Mutual Recogbe unable to benefit from the latest sur-

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Upcoming Event › 23–25 January 2018, Brussels The MedTech Forum 2018

nition Agreement, legal entities based in the UK could be recognised as EU-based legal entities, avoiding the need to relocate to the EU27 jurisdiction.

Seamless trade Not only might it become difficult for companies to trade across the EU-UK border if the conditions are not carefully crafted, production and supply chains could be disrupted in a manner that sets us back several decades.

Modern medtech businesses sometimes avail themselves of “just-in-time” distribution – a lean approach that cuts costs by producing and delivering finished goods only when they are ready to be sold. This system would be severely strained if custom controls caused delays to the flow of goods. It is the same story for the refurbishment and repair of devices.

Financial and administrative costs of doing business across borders are also a huge issue. If devices and diagnostics were subject to tariffs, the costs may impact businesses when considering whether to enter new markets. Our strong view is that customs arrangements should be put in place to minimise the time taken to clear medical products or components across borders. Every effort must be made to avoid unnecessary duplication and disruption.

Predictability and clarity wanted The clock is ticking but it is not enough to hope for clarity by 2019. We urge business leaders on both sides of the negotiating table to prioritise patient safety, public health, and the future competitiveness of a innovative and job creating industry. L

Picture: Medtech Europe

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European Biotechnology | Winter Edition | Vol. 16 | 2017

Celebrating top biotech SMEs Award The 2017 EuropaBio’s Most Innovative European Biotech

SME Awards took place in November in the European Parliament. The winners, NovaBiotics (UK), Carbios (France) and Iden Biotechnology (Spain), received cash prizes and a free EuropaBio membership.

During a high-profile event at the European Parliament with biotech CEOs, industry leaders and venture capitalists, host MEP Paul Rübig awarded NovaBiotics (healthcare biotech, UK), Carbios (industrial biotech, France), and Iden Biotechnology (agricultural biotech, Spain) with top prizes in the eighth edition of the EuropaBio Most Innovative Biotech SME Awards. Apart from the public recognition, the winners receive 10,000€ each and a two-year free membership of EuropaBio.

Inspiring stories

Picture: EuropaBio

In a statement at the event, Peter Heinrich, Chairman of the EuropaBio SME Platform, noted that “European biotech companies are among the most innovative worldwide and it was inspiring to hear the stories of both the winners and runners-up in this competition. It is also true that biotech SMEs face a difficult

environment in terms of finance, regulatory policy, and legislative rules. This is why it was a privilege to have them showcased in the European Parliament and offer them public recognition demonstrating their outstanding work and benefits to society, and to recognise the importance of sound European policy and business environment for such enterprises to thrive.”

The agony of choice Twenty-seven innovative biotech companies from a dozen European countries applied for this year’s competition. The initiative recognises highly innovative small and medium-sized enterprises in Europe that have developed novel ways of meeting societal, technical, and environmental problems through the application of biotechnology.

More information is available on www. biotechsmeawards.eu.

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John Brennan (EuropaBio), Carlo Incerti (EuropaBio), Philipp Bürling (Numaferm), Teemu Suna (Nightingale Health), Deborah A. O’Neil (NovaBiotics), Martin Stephan (Carbios), Nora Alonso (Iden Biotech), and MEP Paul Rübig (Jury Member).

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Upcoming events › 24–30 September, Europe European Biotech Week www.biotechweek.org › 16–18 October, Toulouse European Forum for Industrial Biotechnology and the Bioeconomy (EFIB) www.efibforum.com

Revised strategy EU Bioeconomy Strategy On the EU Bioeconomy Day, EuropaBio called for a revised strategy that lays down a coherent and holistic policy and financial framework to support access to sustainably produced biomass, foster investments, and further develop the market for bio-based products. Such a revision would help tackle climate change and meet the needs of a growing population while boosting Europe’s resource efficiency, competitiveness, and long-term economic growth. Read more on www. europabio.org/industrial-biotech. 

IP incentives Survey IP rewards and incentives are crucial to healthcare biotechnology innovation in Europe.

Many of the innovative medicines benefitting patients today would never have been developed without the IP rewards and incentives framework.

As stated in the European Commission’s Renewed Industrial Policy Strategy for Europe, the EU needs an IP system that really promotes innovation and creativity.

These are just the top findings of EuropaBio’s recent survey. Read more on europabio.org/healthcare-biotech. 

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European Biotechnology | Winter Edition | Vol. 16 | 2017

Upcoming Events › 27–28 February, Casablanca 1st Regional Conference on Regulatory Harmonisation www.DIAglobal.org/RegionReg

Celebrate our 30th anniversary with us!

› 17–19 April, Basel DIA Europe 2018 www.DIAglobal.org/Europe2018 › 10–12 May, Vienna European Conference on Rare Diseases and Orphan Products www.rare-diseases.eu

Join DIA at the Crossroads of Healthcare DIA Europe 2018

provides the opportunity to learn, engage, and grow as a healthcare professional. The conference will take place in Basel – the heart of Switzerland’s life sciences industry — and present a new platform.

New DIAlogue sessions The 2018 programme strikes a balance between exploring issues from a comprehensive, multi-stakeholder perspective and uniting colleagues to dig deeper on outcome-driven topics within their shared field. Popular DIAmond Sessions probe questions that affect stakeholders throughout the industry such as: “Patient

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Centricity Beyond the Talk” and “Realising the Potential of Future Biomedical Innovation: The Role of Intensified EU Cooperation on HTA.” New DIAlogue sessions are designed to facilitate deeper interactions.

These sessions will delve into specific solutions, such as shaping an aligned training manual for implementing the EMA’s Firstin-Human (FIH) Guideline.

Leader of Tomorrow Challenge While we provide the forum, we are consistently inspired by the actions of our members. DIA participants always bring new ideas to the table and fresh perspectives to the discussion. Drawing on that inspiration, we are excited to announce the launch of the Leader of Tomorrow Challenge. This programme creates a stage for students and young professionals to demonstrate their leadership skills, while simultaneously gaining connections and resources for career development. Encourage rising stars of your organisation to join in the Leader of Tomorrow Challenge!

To learn more about the challenge visit www.DIAglobal.org/LoT. For further de-

Julien Meinrad DIA Marketing Manager and Programme Leader

!

“Bringing together fresh perspectives challenges us all to think outside of our current purview. Incorporating professionals just at the start of their careers is critical in shaping the path forward for healthcare and patient solutions. Leader of Tomorrow provides an inclusive community for young professionals and students. It’s the perfect platform to receive and offer advice, to be inspired, and to inspire others.”

Pictures: DIA

Neutral, global, multidisciplinary, inspirational – these are just a few words that describe DIA Europe 2018.

Next year marks the 30th anniversary of DIA’s annual European flagship conference (formerly called the DIA EuroMeeting). At DIA Europe 2018 we’re bringing together multidisciplinary, collaborative minds in the centre of Europe: Basel, Switzerland.

Joining us at DIA Europe opens doors to a neutral forum to discuss current pressing issues, with the goal of uncovering new ways of working, and new solutions for patients. By incorporating representatives from the full life sciences landscape we ensure that industry, payors, patients and regulators, all have an equal voice.

tails about DIA Europe 2018 and the preliminary programme visit www.DIAglobal.org/Europe2018.

L Cathy Persidis, Senior Conference Manager, DIA Europe

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European Biotechnology | Winter Edition | Vol. 16 | 2017

Science & Technology

Alternative psoriasis target Multiple Myeloma British researchers have identified interleukin 36 as a druggable proinflammatory driver of psoriasis.

The group, headed by Francesca Capon from King’s College in London, believes its findings could pave the way for earlystage clinical trials of IL-36 blockers as targeted therapies for psoriasis. The auto-immune disease, which causes raised, itchy, and often painful skin lesions, affects as many as 3% of people worldwide.

Because IL-17 blockers don’t always give patients the same relief in real-world settings as they do in clinical trials, treatment alternatives are urgently needed. IL–36ag are innate mediators of acute epithelial inflammation. Seeking new treatment options, Satveer Mahil et al. blocked IL-36 with an antibody and a recombinant antagonist in mice and saw substantial reduction of psoriasis lesions. Furthermore, the researchers demonstrated that inhibition of IL-36 alleviated inflammatory signaling in cultured skin from psoriasis patients, and led to significant reductions in

IL-17 expression, keratinocyte activation, and leukocyte infiltration. Adding IL-36 to skin cells growing in culture activated the expression of hundreds of genes known to be associated with psoriasis.

To determine if inhibition of IL-36 signalling is safe in human patients, Mahil and colleagues examined 12 persons carrying inactivating mutations in the gene encoding the cytokine’s receptor. They observed that all individuals were healthy; none had skin abnormalities, cardiovascular disease, cancer, or immune disorders. What’s more, they all mounted adequate protective responses after being exposed to pathogens, and did not have any overt immunodeficiency. The authors conclude their results suggest IL-36 inhibitors could be safe and effective psoriasis treatments in humans.

Last year, Anaptysbio, Inc. and Boehringer Ingelheim published patent applications of IL-36 receptor blockers to treat psoriasis. Researchers at the Trinity College near Dublin filed a patent on inhibitors of IL-36 proteolytic processing.

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News Find the tumour margin In October, Dutch SurgVision BV was taken over by Italian diagnostic imaging major Bracco Imaging Spa. The spin-out's imaging platform builds on the findings of Prof. Dr Vasilis Ntziachristos (from German Helmholtz Centre Munich) and Prof. Dr. Go van Dam (University Hospital Groningen), who pioneered real-time fluorescence imaging of antibody-dye-labelled tumour tissues during surgery. A camera developed by Ntziachristos is able to correct imaging errors caused by light reflection and dispersion in tissues, which had been a major problem in visualising tumour margins. The dyes linked to antibodies, such as Avastin, cause the tumours to glow, helping to guide the physician’s scalpel during an operation. According to Big Pharma researchers who have tested the technology, “the method has the clear potential to reduce the need for follow-up surgery by 50%.”

Blocking glycolysis

IL-6 variant triggers asthma Picture: Asthma and Respiratory Foundation NZ

Asthma The interleukin 6 (IL-6) gene

modifies the effect of smoking on the risk of asthma, researchers at the University of Oulu reported in November.

Taina K. Lajunen and Maritta S. Jaakkola observed that certain IL-6 genotypes increased the susceptibility to the adverse effects of tobacco smoking on the risk of asthma. In 1,453 participants of the Finnish Environment and Asthma Study

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(FEAS) and in 892 military of the Cold, Infections and Asthma in Soldiers study (CIAS) they found smokers with the GG IL-6 polymorphism to show a 1.8 fold increase in the risk of asthma versus carriers of other genotypes. According to experts in the field, the findings must be validated in prospective studies as the correlation is pretty weak. Strong correlations are about ten times higher.

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Pulmonary arterial hypertension (PAH) results from a cancer-like deadly vascular disease that leads to vascular remodeling, block of oxidative phosphorylation, proliferation and apoptosis resistance. British and Canadian researchers applied Dichloroacetate to participants in a first-in-man study on idiopathic pulmonary arterial hypertension (iPAH) to block pyruvate dehydrogenase kinase, an inhibitor of the mitochondrial enzyme pyruvate dehydrogenase (PDH, the gatekeeping enzyme of glucose oxidation). All seven individuals treated responded well in terrms of pulmonary artery pressure and functional capacity.

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Events

BIO-Europe Spring 12–14 March, ­Amsterdam BIOEurope Spring is an essential event for anyone serious about partnering in the biotech and pharma industry. As the springtime counterpart to BIO-Europe, the conference encourages delegates to continue establishing and maintaining partnerships using EBD Group’s industry-acclaimed approach. www.ebdgroup.com/bes

European Biotechnology | Winter Edition | Vol. 16 | 2017

26.–27.2.18

6.–8.3.18

26.–27.2.18

13.–14.3.18

4. EUCROF Conference, Vienna (AT) Info: EuropeanCRO Federation, www.eucrof-conference.eu

11th Annual European Life Sciences CEO Forum & Exhibition, Zurich (CH) Info: Sachs Associates, www.sachsforum.com

BIOKET 2018, Strasbourg (F) Info: IAR – The French Bioeconomy Cluster, www.bioket.eu

Nano and Micro Formulations Conference, Berlin (GER) Info: Concept Heidelberg, www.gmp-compliance.org

26.–28.2.18

Soil as a Sustainable Resource, Berlin (GER) Info: Susanne Lange, F&U confirm, www.bonares2018.de

6th Conference on CO2 15–16 March, Cologne The 6th

2.3.18

11th Berlin Conference on Life Sciences: Novel Antimicrobials and AMR Diagnostics, Berlin (GER) Info: Uta Holmer, BIOCOM AG, http://berlin-conferences.com/home/

4.–7.3.18

Eco-Bio 2018, Dublin (IRL) Info: Elsevier B.V., https://www.elsevier.com

Conference on Carbon Dioxide as Feedstock for Fuels, Chemistry and Polymers invites leading international experts in CO2 utilization. More than 200 participants are expected to attend the conference.

http://co2-chemistry.eu

5.–6.3.18

17.–18.1.18

Biostimulants Europe, Valencia (ES) Info: Rohan Baryah, ACI, www.wplgroup.com

19.-21.1.18

BIOSTEC 2018 – 11th International Joint Conference on Biomedical Engineering Systems and Technologies, Funchal (PT) Info: Institute for Systems and Technologies of Information, Control and Communication (INSTICC), www.biostec.org

23.1.18

The MedTech Forum, Brussels (B) Info: MedTech Europe, http://www.medtecheurope.org

1.2.18

Innovation for Health, Rotterdam (NL) Info: Manon de Jong, Hyphen Projects, www.innovationforhealth.nl

1.2.18

Zurich Life Science Day, Zurich (CH) Info: Life Science Zurich Young Scientist Network, http://zlsd18.lszysn.ch/

3rd International Conference on Enzymology & Molecular Biology, London UK) Info: Conferenceseries Ltd, https://enzymology.conferenceseries.com

5.–6.3.18

EuroPLX 66 – European Pharma License Exchange, Cascais/Lisbon (PT) Info: Dr. Norbert Rau, RauCon, www.europlx.com

14.–15.3.18

IBF Conference 13–14 March, Munich The In-

dustrial Biotechnology Forum (IBF) presents new developments, recent scientific results and future trends in industrial biotechnology. It intends to open the doors to scientists from academia and industry worldwide for an intense interdisciplinary exchange on this innovative field.

http://ibf-conference.org

European Food & Beverage Plastic Packaging, Amsterdam (NL) Info: Mado Lampropoulou, ACI, www.wplgroup.com

19.–20.3.18

Immuno-Oncology Summit Europe, London (UK) Info: Nicole Lyscom, CHI – Cambridge Healthtech Institute, www.immuno-oncologyeurope.com/

20.–22.3.18

World Bio Markets, Amsterdam (NL) Info: Robert Wilson, Green Power Conferences, http://worldbiomarkets.com

Pharmapack 2018, Paris (F) Info: UBM, www.pharmapackeurope.com

19.–21.2.18

Biotech World 2018, Moscow (RUS) Info: Vladimir Aleshnikov, Academician of RAS, http://eng.biomos.ru/

80_EB_Winter_2017_Events_mak.indd 80

11th Edition of International Conference on Proteomics – Exploring Novel Drug in the Field of Proteomics, London (UK) Info: EuroSciCon Ltd, http://proteomics.euroscicon.com/

9.4.18

Genome Editing 2018, Oxford (UK) Info: LPMHealthcare, http://lpmhealthcare.com/genome-editing-2018/

Pictures: Ludwig Schedl/IBF/pixabay

22.–23.3.18

7.–8.2.18

06.12.2017 16:16:55 Uhr

Picture: Candor Bioscience

European Biotechnology | Winter Edition | Vol. 16 | 2017

360 Capital Partners (LU). . . . . . . . . . . . . . . . . . . . . . . . . 63 4SC AG (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 5AM Ventures (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Ability Pharmaceuticals SL (ES). . . . . . . . . . . . . . . . . . . . . 20 Abingworth LLP (UK). . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Ablynx NV (B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 ADC Therapeutics Sarl (CH). . . . . . . . . . . . . . . . . . . . . . . 63 Advanced Accelerator Applications SA (F) . . . . . . . . . . . . 61 Advicenne SA (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Aescap Venture (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 AGiLebiotics (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 AiCuris GmbH & Co KG (GER). . . . . . . . . . . . . . . . . . . . . . 6 ALK-Abello A/S (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 ALS Investment Fund (NL) . . . . . . . . . . . . . . . . . . . . . . . . 58 Alychlo N.V. (B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Amgen Inc. (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Antabio (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 AntibioTX (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Apitope NV (UK/B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Arctic Fund Management AS (N). . . . . . . . . . . . . . . . . . . . 22 arGEN-X B.V. (NL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Argenx BV (B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 AstraZeneca (UK/S). . . . . . . . . . . . . . . . . . . . . . . . . . . 23, 63 AT Impf (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Attero (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Auven Therapeutics (UK) . . . . . . . . . . . . . . . . . . . . . . . . . 63 Avacta Group plc (UK). . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Avantium NV (NL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Balderton Capital (UK). . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Basilea Pharmaceutica (CH). . . . . . . . . . . . . . . . . . . . . . . . 6 Bayer AG (GER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Bejing Zhongyuan Ltd. (CN). . . . . . . . . . . . . . . . . . . . . . . 59 Beta Renawables S.p.A. (IT) . . . . . . . . . . . . . . . . . . . . . . . 65 BHS Technologies GmbH (AT) . . . . . . . . . . . . . . . . . . . . . 73 Bio-On S.p.a. (IT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Biocad (RU). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 BIOCOM AG (GER) . . . . . . . . . . . . . . . . . . . . . . . 13, 35, 45 Biogen Idec Inc. (USA). . . . . . . . . . . . . . . . . . . . . . . . 19, 27 BioGeneration Ventures (NL) . . . . . . . . . . . . . . . . . . . 22, 61 Biolipox AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Biontech AG (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 BioVersys AG (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Boehringer Ingelheim (GER). . . . . . . . . . . . . . . . . . . . 59, 73 Bracco Imaging S.p.A. (IT) . . . . . . . . . . . . . . . . . . . . . . . . 79 Bristol Myers Squibb (USA). . . . . . . . . . . . . . . . . . 22, 25, 61 Calliditas Therapeutics AB (SE). . . . . . . . . . . . . . . . . . . . . 59 Candor Bioscience GmbH (GER) . . . . . . . . . . . . . . . . . . . 81 Carbios SA (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . 55, 56, 57 Caszyme UAB (LT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Catalym (GER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Celgene Europe Ltd. (UK). . . . . . . . . . . . . . . . . . . . . . 23, 27 Celltrion (KR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Celonic AG (CH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Chemspec Europe 2018 (UK). . . . . . . . . . . . . . . . . . . . . . 53 Chugai (JP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Concept Heidelberg (GER) . . . . . . . . . . . . . . . . . . . . . . . . 49 CureVac AG (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Cyxone AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Da Volterra (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Datwyler Group (CH). . . . . . . . . . . . . . . . . . . . . . . . . 31, 36 DBV Technologies (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Debiopharm S.A. (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Dievini Hopp Biotech Holding GmbH (GER). . . . . . . . . . 63 Dow Agrosciences LLC (USA). . . . . . . . . . . . . . . . . . . . . . 66 EBD Group (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Eli Lilli & Co. (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Eppendorf AG - Bioprocess Center Europe (GER) . . . . . . CP3 Ergomed plc (UK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Eurogentec S.A. (B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 EuropaBio / European Biotech Week (B). . . . . . . Supplement Excalier Biosciences (NL). . . . . . . . . . . . . . . . . . . . . . . . . 61 Exilixis Inc. (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 FGK Clinical Research GmbH (GER) . . . . . . . . . . . . . . . . 19 FIT Biotech Oyi Plc (FI). . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Galapagos NV (B). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Genmab A/S (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . 27, 58 Genovis AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Genzyme (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Gesynta Pharma AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . 59 Gilead Ltd. (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Herantis Pharma (FI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Hercules Technology Growth Capital (USA). . . . . . . . . . . . 6 Holodiag (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 IDInvest Partners (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Idorsia Ltd. (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Ignyta Inc. (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 IKEA Group (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Image Biopsy Lab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 immatics biotechnologies GmbH (GER). . . . . . . . . . . . . . 63 Immunethep SA (PT). . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 64 Inflarx AG (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Inkemia IUCT Group (ES). . . . . . . . . . . . . . . . . . . . . . . . . 65 Invoke Capital (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Ipsen S.A. (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Janssen Biotech Inc. (USA). . . . . . . . . . . . . . . . . . . . . 58, 62 Johnson & Johnson (USA). . . . . . . . . . . . . . . . 22, 23, 58, 61 Kurma Partners (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 L'Oréal (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 56 LEGO AS (DK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

81_EB_Winter_2017_INDEX_PI_MAK.indd 81

company index / Product

Life Science Partners (GER). . . . . . . . . . . . . . . . . . . . . 58, 62 LISA Vienna Region, Clustermanagement (AT) . . . . . . . . . 73 Lumobiotics (GER). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 MAB Discovery GmbH (GER). . . . . . . . . . . . . . . . . . . . . . 63 Macroarray Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . 73 MAN Pension Trust. . . . . . . . . . . . . . . . . . . . . . . . . . . 22, 61 Medicine for Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Medicxi (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Medivir AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 MedTech Europe (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Mellon Medical (NL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Menarini Biotech S.r.l. (IT) . . . . . . . . . . . . . . . . . . . . . . . . 66 Merck KGaA (GER). . . . . . . . . . . . . . . . . . . . . 19, 20, 23, 60 MetaLinear (UK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Micromet AG (GER/USA). . . . . . . . . . . . . . . . . . . . . . . . . 63 Mobidiag Oy (FI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Moderna Therapeutics Inc. (USA). . . . . . . . . . . . . . . . . . . 59 Morgan Sindall Professional Services AG (CH). . . . . . . . . . 7 Morphomed (AT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Mossi & Ghisolfi Group (IT). . . . . . . . . . . . . . . . . . . . . . . 65 Motif Bio plc (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 24 MSD Sharp & Dohme (USA). . . . . . . . . . . . . . . . . . . . 10, 11 Mylan (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Nanobiotix S.A. (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Neophore Ltd. (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Nerviano Medical Sciences Spa (IT). . . . . . . . . . . . . . . . . 23 Nogra Pharma Ltd. (IRL). . . . . . . . . . . . . . . . . . . . . . . . . . 23 Northern Antibiotics AB(FI). . . . . . . . . . . . . . . . . . . . . . . . 24 Nouscom GmbH (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . 62 nova-Institut GmbH // Biobased-Materials 2018 (GER). . . 11 Novartis AG (CH). . . . . . . . . . . . . . . . . . . . . . . . . . . . 61, 20 Novo A/S (DK) . . . . . . . . . . . . . . . . . . . . . . . . . . . 27, 58, 59 Novozymes (DK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55, 65 Örsted (DK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Onxeo S.A. (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 OPIS s.r.l. (IT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Orexo AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Orphazyme AS (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Oryzon Genetics S.A. (ES) . . . . . . . . . . . . . . . . . . . . . . . . 65 Otsuka Pharmaceutical Co. Ltd. (JP). . . . . . . . . . . . . . . . . 30 Pangea Oncology (ES). . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Pelago Bioscience (SE) . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Pfizer CentreOne (USA). . . . . . . . . . . . . . . . . . . . . . . . . CP4 Pfizer Inc. (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Phagomed (AT). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Pharmalink AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Polpharma Biologics (PL) . . . . . . . . . . . . . . . . . . . . . CP2, 26 Poxel SA (F) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Procter & Gamble (USA). . . . . . . . . . . . . . . . . . . . . . . . . . 57 Recipharm AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Redmile Group (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Regemat3D (ES). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Rentschler Biopharma SE (GER) . . . . . . . . . . . . . . . . . . . . 26 Roche Group (CH). . . . . . . . . . . . . . . . . . . . . 19, 63, 65, 73 Sanofi SA (F) . . . . . . . . . . . . . . . . . . . . . . . . . 10, 11, 19, 27 Scenic Biotech (NL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Schröder Adveq Management AG (CH). . . . . . . . . . . . 22, 61 Selvita S.A. (PL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Shanghai Titan Scientific Ltd. (CN). . . . . . . . . . . . . . . . . . 59 Shire plc (IRL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Sobi AB (SE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Sofinnova Partners (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Solventis (ES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Sophia Genetics SA (CH) . . . . . . . . . . . . . . . . . . . . . . . . . 63 Sothema Laboratories (MA). . . . . . . . . . . . . . . . . . . . . . . . 66 Spero Therapeutics LLC (USA) . . . . . . . . . . . . . . . . . . . . . 24 Spiral Therapeutics (ES). . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Standortagentur Tirol (AT). . . . . . . . . . . . . . . . . . . . . . . . . 73 STAT Diagnostica & Innovation (ES). . . . . . . . . . . . . . . . . . 6 Sumitomo Dainippon Pharma (JP) . . . . . . . . . . . . . . . . . . 61 Sunstone Capital (DK). . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Surgvision BV (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Swiss Biotech Association (CH). . . . . . . . . . . . . . . . . . . . . 51 Synvina (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Targovax ASA (N). . . . . . . . . . . . . . . . . . . . . . . . . . . . 24, 58 TerraCycle Germany GmbH. . . . . . . . . . . . . . . . . . . . . . . 57 Tetraneuron (ES). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Teva Pharma (IL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Texas Pacific Group (USA) . . . . . . . . . . . . . . . . . . . . . . . . 65 Transgene SA (F). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Trianni, Inc. (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 UBM (UK) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 UBMi BV – Pharmapack Europe 2018 (NL) . . . . . . . . . . . 43 Valneva (F/A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Varmx (NL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Vaxdyn (ES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 20 Vectron Biosolutions AS (N). . . . . . . . . . . . . . . . . . . . . . . 21 Verona Pharma plc (UK). . . . . . . . . . . . . . . . . . . . . . . . . . 22 Versant Ventures (USA). . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Vertex Pharmaceuticals (Europe) Ltd. (UK). . . . . . . . . . . . 27 Vetter Pharma-Fertigung GmbH & Co.KG (GER). . . . . . . . 25 Wellington Partners (GER). . . . . . . . . . . . . . . . . . . . . . . . . 63 Wild Family Office (CH). . . . . . . . . . . . . . . . . . . . . . . . . . 63 Wilhelm Bähren GmbH & Co. KG (GER). . . . . . . . . . . . . 32 Wilhelm Haselmeier GmbH & Co. KG (CH). . . . . 30, 34, 33 Wyeth (USA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Xelia Pharmaceuticals ApS (DK). . . . . . . . . . . . . . . . . . . . 59 Ysios Capital Partners (ES). . . . . . . . . . . . . . . . . . . . . . . . . 20 Zealand Pharmaceuticals A/S (DK). . . . . . . . . . . . . . . 22, 27

81

Antibody Stabilizer

CANDOR Bioscience Antibody Stabilizer is a stabilizer for long-term storage of proteins or antibodies at 2–8°C. Antibody Stabilizer conserves the structure of proteins and antibodies preventing them from losing functionality due to storage.

Just dissolve proteins or antibodies with Antibody Stabilizer and store in the refrigerator. Therefore freezing and thawing cycles which can decrease the activity of antibodies are not necessary.

Antibody Stabilizer is used for storage of assay antibodies and for storage of proteins, which are used as calibration standards or controls in immunoassays.

The stabilizer is ready-to-use and available based on TRIS or based on PBS in bottle sizes of 50 ml, 125 ml and 500 ml. 

CANDOR Bioscience GmbH Phone: +49 7522 795270 Fax: +49 7522 7952729 info@candor-bioscience.com www.candor-bioscience.com

08.12.2017 11:19:05 Uhr

Encore

I’m in biotechnology because …

US Support A US life

sciences investment fund plans to invest up to US$1bn to create a large biotech company in the UK. Supported by the UK government as part of a “sector deal,” the investor – still unnamed in early December – will move some operations to develop a major presence in the UK.

paper T he T elegraph , US life sciences company Johnson & Johnson put its plans on hold to build a new JLabs incubator in the UK due to concerns about the economy. Typically, these centres house ­between 30 and 50 small biotech companies. 

Marijana Golubovic Business Management & Strategic Projects, Sanofi-Aventis Deutschland GmbH

“… cutting-edge science enables us to develop and bring life-saving medicines to the patients and thereby create tremendous positive impact on their lives, families, and communities.”

MRSA still a challenge Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of antibiotic-resistant healthcare-associated infections worldwide. Increasing levels of community-associated MRSA are being reported from many parts of the world, including Europe. Across the continent as a whole, the MRSA percentage has decreased significantly between 2013 and 2016, but there are large inter-country variations. MRSA remains a public health priority in Europe.

//

50%

2013 2016

25%

Top SMEs @solazyme #EMA Taking the #EMA from London is a massive economic win for Amsterdam, and more. It brings experts, companies, and services through your city. Couldn't have happened to a nicer city. @bengoldacre Ablynx prices upsized $200m US IPO buff.ly/2yRKXlA Congratulations Edwin! #smallcap @AblynxABLX @demycolton Top EU biotech SMEs named! Three innovative #biotech companies have received

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Diagnostics A Danish team made a big stride towards successfully controlling single enzyme activity. Employing DNA nanotechnology, a team led by Ebbe Sloth Andersen at Aarhus University designed a DNA-based container with programmable structural and dynamic properties – and locked up an enzyme in there (Nature Communications, doi: 10.1038/s41467-01701072-8). The container can be opened and closed – by adding sequence-specific DNA keys – to regulate the enzyme’s access to its substrate. As the locking system employed can be modified in order to respond to the presence of proteins, RNA, and small molecules, as well as environmental variations in pH, temperature and ion concentration, the so-called DNA vault might emerge as a basis for new biosensors. 

AUT BEL BGR HRV CYP CZE DNK EST FIN FRA DEU GRC HUN ISL IRL ITA LVA LTU LUX MLT NLD NOR POL PRT ROU SVK SVN ESP SWE GBR

US Pull-Out According to British news-

DNA as a locker

the prestigious @EuropaBio #SME Awards: http://bit.ly/2AZoNzk @EuroBiotechNews

Please follow us @EuroBiotechNews Netherlands: @CORBION complete @terravia (former @solazyme) acquisition bioint.io/DDq9o #algae #biochemicals #bioproducts #biofuels @BioenergyIntl

Next issue spring edition A topic of perpetual importance for the life sciences industry will be covered by the spring edition of European ­Biotechnology: “Bioprocessing + GMP.” The issue will be published on 8 March 2018. If you’d like to place an advertisement, please contact us by 19 February. Questions will be answered

by Christian Böhm (+49-30-264921-49), Andreas Macht (+49-30-264921-54) and Oliver Schnell (+49-30-264921-45). Or just hit the keyboard: marketing@biocom.de. 

Picture: Europabio/Veldemanphoto; FARBAI/fotolia.com (bacteria icons)

Winners & losers

European Biotechnology | Winter Edition | Vol. 16 | 2017

Source: www.nesta.org.uk/ European Centre for Disease Prevention and Control

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