2013 10 ebsin freeexcerpt

Nº 10 | Volume 12 | 2013 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

ceNTRal eUROpe

Swiss biotech sector presents OECD-compliant numbers NORTHeRN eUROpe

Specialty drugmaker Meda AB swallows Acton for US$200m

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BIO-Europe 2013 – Partnering in Vienna WeSTeRN eUROpe

Ablynx closes Nanobody deals with AbbVie and Merck SOUTHeRN eUROpe

Biotech IPOs: Europe eyes US boom

Menarini Group widens cancer diagnostics portfolio eaSTeRN eUROpe

Esai joins Selvita to map novel tumour kinase targets ScieNce & TecHNOlOgy

European researchers on the trail of universal flu vaccine

Confidence. Inspired by Results.

Alan Alfano Cancer Researcher, University of Maryland School of Medicine, Baltimore, MD

“In cancer research, achieving uniform results with transfection is often a big hurdle. X-tremeGENE is by far the best transfection reagent I’ve ever used. It’s nice to know that with all the potential issues I might encounter in my research, transfection isn’t one of them.”

X-tremeGENE Reagents. Transfect with confidence.

See more of Alan‘s story at www.x-tremegene.roche.com

For life science research only.

Not for use in diagnostic procedures.

X-TREMEGENE is a trademark of Roche.

Roche Diagnostics Corporation Roche Applied Science Indianapolis, Indiana © 2013 Roche Diagnostics.

All rights reserved.

N –º 10 | Volume 12 | 2013

Euro|Biotech|News

Intro

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Editorial

Shifting paradigms in EU biotechnology policies

Peter Schintlmeister, Austrian Federal Ministry of Economics, Family and Youth

T

he start of Europe’s new financial framework and the framework research programme Horizon 2020 seems a good moment to take a step back and look into some recent and not so recent – but even more substantial – changes in (bio-)technology policy paradigms.

From technology-orientation towards justification: In 2002, the European Commission (EC) published its first overarching strategy for Life Sciences and Biotechnology. The focus then was clearly on new technologies and their promise. Meanwhile policy mainstream has changed and all technological efforts are superseded by the need for justifying the posPeter Schintlmeister joined sible contribution to society’s ‘Grand ChalAustria’s Federal Ministry of Economics, Family and Youth lenges’. In practice, even technologies that in 2003 as an expert for life have been politically identified as ‘key techsciences and biotechnology. He nologies’ fall under this regimen, which in has enjoyed chairmanships at turn narrows horizons for possibilities outa number of different entities, including the OECD Task Force side this scope. The good news for cuttingon Industrial Biotechnology, the edge science and technology, however, is that ERA-NET EuroTransBio and the new and more precise instruments (e.g. the European Commission’s Advisory ERC) are easily countermanding the loss of Group on bio-based products for the Lead Market Initiative. focus on technology.

Schintlmeister is a member of The loss of the knowledge-base: the term the European Bioeconomy Panel ‘knowledge-based bio-economy’ first appeared and the Commission’s expert on the radar of technology policy in 2005. group for bio-based products.

He has spent the better part of At that time, it was totally in line with the 2013 in China, where he has been (Lisbon) goals of making Europe competitive contributing to the establishment through enhancing its knowledge-base. When of Austria’s Office of Science and the 2012 strategy ‘Innovation for sustainable Technology in Beijing. growth: A Bio-economy for Europe’ was published, the term ‘knowledge-base’ had interestingly disappeared from the title (although it still appears in places on the website). While this move widens the base of stakeholders significantly by embracing entire traditional industries like agriculture and forestry, it still has to be shown whether Europe can maintain a focus on innovation. This trend can

also be seen in the composition of the new Bioeconomy Panel, which is aimed at providing the European Commission with feedback from the community.

The shift from supply- to demand-side of technology policy: A couple of recent studies concur on the necessity of keeping current austerity measures in place in most EU Member States, and have concluded that investing taxpayer money in technology-based areas might only solve the technological side of the problem. Bringing innovation to the market – an area where Europe has a notoriously bad track record – is a wholly different affair. The Commission’s Lead Market Initiative has sought to balance out issues by emphasising the importance of (low-cost) political measures, such as streamlining the regulatory framework, labeling and certificate schemes (both admittedly tasks worthy of Sisyphus) and enhancing the efficiency of standardisation. The technology­ policy community has recognised that the measures are bringing results, and they have acquired prominent positions in current highlevel strategies like Europe 2020 and the Innovation Union. This will enable them to make a positive difference in the years to come.

European policies are about the larger and broader vision, but most of the impact they have still derives from the national implementation that takes place farther down the road.

The Greek philosopher Heraclitus is attributed to have said that the only constant in life is change – and that aphorism applies to policies as well!

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N –º 10 | Volume 12 | 2013

Euro|Biotech|News

CIRCUL ATION

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European Biotechnology News is published in co-operation with the following organisations: European Biotechnology Net work

Europe: european-biotechnology.net

Germany: biodeutschland.org

Switzerland: swissbiotech.org

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CouncilBlue: of European 100/15/0/35 BioRegions Orange: 0/75/90/0

Belgium: edma-ivd.eu

Europe: cebr.net

Europe: eapb.org

Europe: europabio.org

Europe: ebe-biopharma.org

Ireland: ibec.ie/ibia

Norway: biotekforum.no

Denmark: danskbiotek.dk

Finland: finbio.net

The Netherlands: niaba.nl

Sweden: swedenbio.com

Spain: asebio.com

France: france-biotech.org

Hungary: hungarianbiotech.org

Belgium: bio.be

EuroBiotechNews covers the biotechnology sector of the current 27 EU member states, Norway and Switzerland.

If you would like to subscribe, please refer to Portugal: www.apbio.pt

Italy: assobiotec.it

www.eurobiotechnews.eu

N –º 9 | Volume 12 | 2013

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Euro|Biotech|News

contents

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Insight

Cover Story

Era-Net EuroTransBio kicks-off 9th call, European Parliament lift biofuel cap; Heard in Brussels 10 Contamination alert – European food enzyme makers face severe crisis 12 IP Flash

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European Biotech week

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Regulatory Affairs Update on clinical trials

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Breaking news from the EMA

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IPOs?

Economic Focus on newsflow and dividends

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Stock markets

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Perspectives Interview: Frederico Pollano, Richter-Helm

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Current treatments for metabolic and immune diseases are molecule-based, with available therapies all involving medicines that have been approved for specific conditions.

But what if physicians could instead use targeted electrical current to keep the immune system of a patient who suffers from asthma or diabetes on track? As pacemakers and deep brain stimulation show, electricity can heal. Now big investments on the part of Big Pharma are taking pioneering bioelectronic therapies to the next level.

44 Services

Changing Europe’s Healthcare Strategy is cruccial for Payors, Patients and Producers 46

Special

Regional News

Licensing & Deals: everybody waltz

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Study: Huge growth in Austria’s life science sector

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Interview: Steve Burrill

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Company index

Effects of the new TTBER

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Evolution of an investment strategy

Events What’s on in September-October 2013 49

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Northern Europe

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Central Europe

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Western Europe

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Southern Europe

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Eastern Europe

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Partners & Associations

Bio-Europe 2013

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Biopeople News from Bone Therapeutics; Roche, Theradiag, Nanobiotix, Silence Therapeutics, and the Human Proteome Organization 47

Encore

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Imprint European Biotechnology News is published monthly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, E-Mail: service@eurobiotechnews. eu; Internet: www.eurobiotechnews.eu, Publisher: Andreas Mietzsch, Editorial Team: Thomas Gabrielczyk (Managing Editor), Derrick Williams (Co-editor), Dr. Patrick Dieckhoff, Dr. Bernd Kaltwaßer, Dr. Martin Laqua; Advertising: Oliver Schnell, +49-30-2649-2145, Advertising USA: Avani Media, Inc. , Leslie Hallanan, Tel.: +1-415-331-2150 , Fax: +1-415-289-0402, E-Mail: leslie@avanimedia.com; Distribution: Marcus Laschke, +49-30-2649-2148; Printed at: Druckhaus Humburg, Bremen; Graphic Design: Michaela Reblin. European Biotechnology Science & Industry News is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 100.00, Students € 50.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within 2 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 6 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: ©xxx, Supplement: Forschungszentrum Jülich ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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N –º 10 | Volume 12 | 2013

Euro|Biotech|News

INSIGHT EUROPE EurotransBio

Bounty for SMEs

Heard in Brussels M

A Brussels – Era-Net EuroTransBio (ETB), a transnational funding initiative for bio­ tech SMEs put in place by six founding agencies in 2004, published its 9th call on 1 October 2013 (www.eurotransbio.eu). Today made up of 10 funding agencies from eight countries (Austria, Belgium, Finland, France, Germany, Italy, Russia, and Spain) the joint initiative is aimed at encouraging cooperation between bio­tech companies across borders by supporting projects driven by at least two industry partners from different countries. Additionally, academic research partners can participate in the programme. Projects must be crucial for participating companies to position themselves on the market.

In its previous eight calls, the ETB spent a233m on 135 projects. The new call will be open until 31 January 2014.

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European Parliament

Biofuels debate A Strasbourg – The European Parliament is not unconditionally supporting the Euro­pean Commission’s U-turn on bio­ fuels made from feed and food. While the Commission wants to limit admixtures of crop-derived biofuels to 4.5%, MEPs in mid-September voted to set the cap at 6% of the transport fuel burned by 2020. The parliamentarians also decided to delay Commission plans to incorporate an indirect land use change (ILUC) factor by 2020 when evaluating the sustainability of biofuels made from different feedstocks. The vote was good news for companies lobbying to adopt ‘second-generation’ biofuels.

That’s because MEPs increased the target for so-called ‘advanced biofuels’ in transport fuel to 2.5%, promoting production and consumption (see EuroBio­techNews 8/2013). Before it becomes law, the decision still has to be approved by EU Member States.

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Will regulation finally pay off for Europe?

Brussels – A recent interesting look at markets beyond Europe has given some interesting food for thought. You know, sometimes the EU is actually easier to do business in than many other places.

Sounds a bit crazy, but compared with some emerging markets, Europe looks like a safe place to invest in the longer term.

Much is still said about sexy new emerging markets. A few years ago, we were packing up to go to India, and the South American economies were apparently just waiting to take over Europe’s life sciences sector. But as ever with such stories, the reality of these markets makes them much harder to access for R&D than headlines suggest. Europe’s tendency to regulate every­thing is certainly a pain in the backside, but it makes it much easier to know what is going to happen in the longer term. You just have to worry about having enough money to last the week … little things like that.

News from India that clinical trials have been suspended by organisations as big as the NIH tells you that an awful lot of money is suddenly flying out the window and delaying approvals. The reason behind the suspension is the introduction of new liability rules for trial sponsors, which creates uncertainly following a dramatic and poorly defined shift in rules. How many more changes will come – and how long before agencies conduct trials elsewhere?

Brazil is another interesting example; plenty of money and a market comparatively untouched by global competition.

In theory it’s a great new target for innovation and R&D. However, a closer look finds a much stickier situation. South America’s giant demands a 100% transfer of rights for government procurement of technology, and offers an opaque approvals process in return. It’s a tough market to crack for all stages of R&D. Universities

Claire Skentelbery, Secretary General of the European Biotechnology Network

in Europe are already muttering about freedom to use research results, while SMEs don’t have the clout or money to create partnerships or new entities. That leaves only the big global companies to sell products rather than the innovation chain behind them.

Europe has had a painful learning curve in the process of regulation. The challenge of creating legislation for more harmonised operation between countries has ensured that regulation is longterm, and that it has been argued from the perspective of 27 countries. The process might be complicated, but you know it isn’t going to change while you are making your precious investment. Europe also knows the importance of enabling technology development. An enforced loss of rights does nothing to encourage innovation, and frankly, it can’t shovel research out the door of universities fast enough. I used to worry about Europe’s over-zealous regulation – and there’s no doubt we do an awful lot. It might have taken long years of defragmenting regional and national activities, but it seems we’ve finally managed to create a stable European platform.

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N –º 10 | Volume 12 | 2013

Euro|Biotech|News

regul atory Affair s

News M

Tag team against craving

Uppsala – Swedish Orexo AB kicked off a Phase II trial in August to assess safety and efficacy of Zubsolv® (buprenorphine and naloxone) sublingual tablets. The combination will be compared to conventional buprenorphine/naloxone for maintenance treatment of opioid dependence.

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Skin study

Canterbury – Creabilis Ltd. has begun a Phase IIb Trial with its TrkA kinase inhibitor CT327 in 210 atopic dermatitis patients. Primary endpoints will assess pruritus, control of disease, and quality of life measures.

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Europe

Update of ongoing clinical trials A Monthly injections of Roche’s complement factor D blocker lampalizumab reduced geographic atrophy in patients with dry AMD, the most common form of agerelated blindness. However, bimonthly shots of the antibody into the eye didn’t reach the primary endpoint of the Phase II study. At the end of September, Roche re-

Suppressing metastases

Breda – arGEN-X will be kicking off a Phase IB dose escalation trial with ARGX-111 in cancer patients overexpressing c-met, a receptor crucial for metastasis formation. It will measure classic ADMET features of the human monoclonal antibody, and monitor bio­markers critical to understanding the effect of ARGX-111 on c-Met biology, the company announced in mid-September.

Vaccine booster

Lyon – French firm Imaxio S.A. has started dosing in a Phase I dose escalation trial comparing immuno­ genicity of the experimental TB vaccine MVA85A with a viral vector vaccine encoding the bacterial antigen 85A fused to Imaxio’s IMX313 chicken protein adjuvant. The trial aims to demonstrate that IMX313 boosts immuno­genicity of the vaccine.

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are expected to be complete by the first quarter of 2014.

British-Belgian Apitope NV (Bristol/ Diepenbeek) has announced positive Phase I results in MS patients treated with its peptide ATX-MS-1467. Intradermal injection of the derivative of the MS auto­ antigen myelin basic protein led to a significant decrease in the number of contrastenhancing brain lesions (CEL) in patients with relapsing multiple sclerosis, the company reported in September.

Swiss Anergis S.A.’s (Epalinges) allergy vaccine AllerT has reached the endpoint in a Phase II proof-of-concept study. In 230 subjects who suffer from birch pollen allergy, five shots over two months reduced the symptom score by approximately 30%.

mained undecided on whether to progress the treatment – which Genentech licensed from Tanox in 2006 – to Phase III trials.

Patients overexpressing zink­-finger protein 64 (ZFP-64) respond better to German 4SC AG’s (Planegg-Martinsried) histone deacetylase (HDAC) inhibitor Resminostat than the general population of liver cancer patients.

Obtained in the course of the Phase II SHELTER study, the results are good news for the nearly 70% of patients that overexpress the biomarker: They lived twice as long as cancer patients without ZFP-64. Resminostat blocks ZFP-64 expression, which co­activates the NOTCH signalling that induces tumour proliferation and progression.

British-based Acacia Pharma (Cambridge) began two pivotal Phase III studies in midSeptember for its substance APD421, a treatment for the prevention of post-operative nausea & vomiting (PONV). Up to 680 patients undergoing major surgery will be enrolled. The studies involving the intravenous formulation of the marketed dopamine D2/D3 antagonist amisulpride

Dutch Kiadis Pharma NV (Amsterdam) has reported significant progress with a new approach called ATIR™, which aims at reducing life-threatening graft-versus-host disease (GVHD) in blood cancer patients undergoing stem-cell transplantation. By eliminating T-cells in a haplo­identical graft that would cause life-threatening GVHD, Kiadis achieved an overall survival rate of 67% in a five-year follow-up of its Phase I/ II programme. Additionally, no transplantrelated mortalities occurred in the 19 patients. The company expects results from a Phase II trail to verify the results in a larger population of AML, ALL and MDS patients in H1/2014.

Virttu Biologics Ltd has begun treatment of a first cohort of cancer patients with its oncolytic virus formulation Seprehvir® (HSV1716). Safety and tolerability will be tested when given both as single and repeat intrapleural doses in patients with inoperable, malignant pleural mesothelioma, which is caused by occupational exposure to asbestos. Seprehvir is a Herpes Simplex Virus 1 that has been engineered to kill cancer cells while leaving normal cells unharmed. B

European Biotechnology Net work

Join the European Biotechnology Network!

The European Biotechnology Network is dedicated to facilitating co-operation between professionals in biotechnology and the life sciences all over Europe. This non-profit organisation brings research groups, universities, SMEs, large companies and indeed all actors in biotechnology together to build and deliver partnerships.

Do you want to know more about the advantages of a (free) membership?

Just have a look at our website: www.european-biotechnology.net

European Biotechnology Network Avenue de Tervueren 13 1040 Brusseles, Belgium Tel: +32 2 733 72 37 Fax +32 2 64 92 989 info@european-biotechnology.net www.european-biotechnology.net

N –º 10 | Volume 12 | 2013

Company And Advertiser Inde x 4SC AG (GER)… ………………………………… 16 AB Sciex GmbH (GER)… ………………………… 46 AbbVie Inc. (USA)… ……………………………… 26 Ablynx (B)… ……………………………………… 26 Acacia Pharma Ltd. (UK)… ……………………… 16 Actelion AG (CH)… ……………………………… 24 Activaris Biotech GmbH (A)……………………… 28 Anergis SA (CH)…………………………………… 16 Antisense Pharma GmbH (GER)… ……………… 50 Apitope NV (UK/B)… …………………………… 16 Araim Pharma Europe Ltd. (UK)… ……………… 18 arGEN-X B.V. (NL)… ……………………………… 16 Arsanis Inc. (A)… ………………………………… 50 Arts et Techniques du Progres (F)… …………… 30 Astellas Pharma Europe B.V. (NL)……………… 46 Astra Zeneca (GB/S)……………………………… 22 austria wirtschaftsservice | erp-fonds (A)… … 34, 35 BASF SE (GER)… ………………………………… 24 Bayer AG (GER)…………………………………… 34 Bayer Pharma AG (GER)… ……………………… 18 Berlin Partner GmbH (GER)……………………… 19 BIOCOM (GER)………………………………… 24, 34 BioFire Diagnostics Inc. (USA)…………………… 26 Biogen Idec (USA)………………………………… 34 BioGeneriX AG (GER)… ………………………… 44 BioM Biotech Cluster Development (GER)………… 7 Biomerieux (F)… ………………………………… 26 Biotechnology Value Fund (USA)………………… 25 BioWin – The Health Cluster of Wallonia (B)…… 27 BlueSens gas sensor GmbH (GER)……………… 13 Boehringer Ingelheim (GER)……………………… 26 Bone Therapeutics (B)…………………………… 46 Bruker SA (USA)…………………………………… 13 Burrill & Company (USA)… ………………… 6, 33, 38 CATS Consultants GmbH… ……………………… 18 Celgene Europe Ltd. (UK)……………………… 25, 34 Celltrion (KR)……………………………………… 26 Ceptaris Therapeutics (USA)…………………… 24 Chiesi Farmaceutici S.p.A. (I)… ………………… 28 Chiesi Group (I)…………………………………… 28 Cloetta (S)………………………………………… 12 Congenia S.r.l.……………………………………… 28 Cornerstone Therapeutics Inc. (USA)… ………… 28 CREABILIS Therapeutics S.p.A. (UK)… ………… 16 CSL Behring GmbH (GER)… …………………… 18 Debiopharm S.A. (CH)…………………………… 33 Definiens AG (GER)… …………………………… 46 Deutsche Bahn AG (GER)………………………… 46 Devgen (B)………………………………………… 46 ecoplus GmbH (A)………………………………… 29 Egis Pharmaceuticals PLC (HUN)………………… 30 Eli Lilly (USA)…………………………………… 33, 43 EuroTransBio – ETB (B)…………………………… 41 European Biotechnology Network (B)…………… 48 EvaluatePharma (UK)… ………………………… 33 Evotec AG (GER)… …………………………… 25, 33 Fleet Laboratories (USA)… ……………………… 28 Forbion Capital Partners (NL)… ………………… 34 Forschungszentrum Jülich GmbH (GER)……… Suppl.

Fujifilm Diosynth Biotechnologies (UK)… ……… 32 Gedeon Richter Ltd. (HUN)… …………………… 45 Genentech Inc. (USA)… ……………………… 16, 33 Genextra S.p.A.… ………………………………… 28 Gilead Ltd. (USA)… …………………………… 18, 34 GlaxoSmithKline (UK)… ……………………… 44, 50

Göteborg Kex (S)… ……………………………… 12 Grünecker Patent- und Rechtsanwälte (GER)…… 14 Gubra ApS (DK)…………………………………… 23 Helvea Baader Bank Group (CH)………………… 19 High-Tech Gründerfonds Management (GER)… 43 Hospira (UK/USA)………………………………… 26 Hospira One 2 One Global Pharmac. (USA)… … CP4 Hungaropharma (HUN)… ……………………… 30 Imaxio S.A. (F)… ………………………………… 16 Ixchelsis Ltd. (UK)… ……………………………… 43 Johnson & Johnson (USA)… …………………… 47 Kaneq Biosciences Ltd. (CDN)…………………… 43 Kiadis Pharma BV (NL)…………………………… 16 Laboratories Casen Fleet SLU (E)………………… 28 Leukocare AG (GER)……………………………… 25 Life Science Austria LISA (A)…………………… 17, 36 Lonza AG (CH)… ……………………………… 19, 45 Lufthansa AG (GER)… …………………………… 46 Medimmune Ltd (UK)… ………………………… 18 Medtronic Inc. (USA)……………………………… 47 Menarini Biotech S.r.l. (I)… ……………………… 28 Merck & Co. (USA)……………………………… 22, 43 Merck KGaA (GER)………………………………… 26 Mettler Toledo AG (CH)… ……………………… 46 MorphoSys AG (GER)… ………………………… 25 Nanobiotix S.A. (F)……………………………… 46 Nestle Health Science SA (CH)… ……………… 24 Novartis AG (CH)… ……………………………… 26 Novo Nordisk A/S (DK)…………………………… 18 OLBRICHT Patentanwälte (GER)………………… 11 Orexo AB (S)… …………………………………… 16 Ortoma AB (S)… ………………………………… 30 Otsuka Pharmaceutical (J)… ………………… 18, 34 Patrys GmbH (GER)… …………………………… 18 Pfizer Inc. (USA)………………………………… 34, 43 Philips Healthcare (GER)… ……………………… 46 Poly Implant Prothése (F)………………………… 14 Prestizia (F)… …………………………………… 46 ProBioSanus UAB (LIT)…………………………… 30 ProQR Therapeutics BV (NL)… ………………… 18 Prosensa BV (NL)… ……………………………… 50 Recordati S.p.A. (I)………………………………… 28 Reed Exhibitions Japan Ltd (J)……………………… 9 Richter-Helm BioLogics GmbH & Co. KG (GER)… 44 Richter-Helm BioTec (GER)… …………………… 35 Roche AG (CH)… …………… 16, 25, 26, 34, 46, 50 Roche Diagnostics GmbH (GER)…………… CP2, 24 Roche Registration Ltd. (UK)…………………… 18 Salans FMC SNR Denton Europe LLP (GER)… 37, 40 Sanofi SA (F)…………………………………… 19, 23 SBA (CH)… ……………………………………… 15 Schering Plough (USA)…………………………… 47 Selvita S.A. (PL)…………………………………… 30 Servier (F)… ……………………………………… 30 Silicon Biosystems S.p.A. (I)……………………… 28 SIRION Biotech GmbH (GER)… ………………… 45 Smartfish AS (N)… ……………………………… 22 Tanox (USA)… …………………………………… 16 Teva Pharmaceutical Industries Ltd. (IL)………… 19 Theradiag SA (F)… ……………………………… 46 Theravance Inc. (USA)… ………………………… 50 TVM Capital (GER)………………………………… 25 Verenium Corp. (USA)… ………………………… 24 Virttu Biologics Ltd. (UK)… ……………………… 16 WIL Research (USA)… …………………………… CP3 Xcellerex (USA)… ………………………………… 39

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