Express Pharma (Vol.13, No.8) February 16-28, 2018 by Indian Express

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CONTENTS Vol.13 No.8 February 16-28, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas

PHARMA LIFE

Need of the hour Making cancer care affordable is an urgent need in Indian healthcare and ensuring access to easy and costeffective drugs can be pivotal in achieving this objective | Pg 20

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

MANAGEMENT

Senior Artist Rakesh Sharma

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

A SUSTAINABLE FUTURE WITH GREEN CHEMISTRY

CDSS MARKET IN INDIA TO REACH $206.1 M

GLOBAL GLAUCOMA MARKET TO REACH $3.8 BN BY 2026

39 40

NOVARTIS INDIA APPOINTS JAWED ZIA AS VC AND MD

PHARMA ALLY

RESEARCH

Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer)

YLB’S PHASE III CLINICAL TRIAL OF ETANERCEPT BIOSIMILAR MEETS POSITIVE OUTCOME

Automation solutions for PHARMA industry

PFIZER’S XTANDI DELAYS PROSTATE CANCER SPREAD IN EARLY STAGE DISEASE CANCER RISK ELEVATED WITH SEVERE GUM DISEASE

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Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EXPRESS PHARMA

February 16-28, 2018

EDITOR’S NOTE

India Pharma Inc’s place in Modicare

his year’s Union Budget has come and gone with no announcements for the pharmaceutical sector. At best, the sector will reap benefits, and that too in the distant future, once the National Health Protection Scheme (NHPS), is rolled out. In fact, there is some relief that there were no surprises or radical changes on the policy front. The sector is also enthused at the emphasis on the public-private-partnership (PPP) model of the NHPS. But no sector, pharma and healthcare included, is safe from policy changes and whips outside the budget. On February 12, pricing watchdog National Pharmaceutical Pricing Authority (NPPA) reviewed stent prices and fixed the prices of stents till March 31, next year (Bare Metal Stents (BMS) at `7660 ex GST, Drug Eluting Stents at `27890 ex GST). But more importantly, it “decided that there is no case for sub-classification of DES in the light of lack of enough clinical evidence to support superiority of one DES or other.” This was a key demand of certain manufacturers and shows that the NPPA will not budge on this point. A second blow is that another notification analysed the trade margins in cardiac guide wires, balloon catheter and guiding catheters “in recognition of the people’s right to information and also for introspection by the manufacturer/ distributor/hospitals.” Given that the margins range from 234 per cent to 63 per cent, it is only to be expected that these devices are already on the radar and will soon face the axe. This was the first budget after the implementation of the GST and the industry's

Pharma companies will have to come up with strategies to play a meaningful role in the NHPS

revenues are only just recovering from this major tax reform. Today, it is GST Council which wields much power and has the industry on tenterhooks as they wait for clarifications on eWay bills and the like. As a social security net, the NHPS is an idea whose time has most definitely come. But where will India find the finances to roll it out? A complete dependence on PPPs with the private sector, be it hospitals, pharma companies, diagnostics companies as well as medical technologies players will leave the scheme open to abuse. Hence, pharma companies will have to come up with strategies to play a meaningful role in the NHPS. The NHPS cannot not be seen in isolation. The thrust towards digitisation, AI is critical for all sectors but more so for Modicare as it will expand care, monitor fund spends and provide data to improve health systems outcomes. Another key part is the consolidation of the PSU insurance industry. Modicare is most probably going to be covered by the resulting behemoth, and the sheer size of the market, 100 million poor families, with a total of 500 million family members, will allow the government to drive a hard bargain. Thus, `5 lakh per year per family, suddenly seems doable, but there will be unscrupulous players looking to game the system. While NHS of UK, the Medicaid and Medicare of the US are gold standards, their gaps are now well acknowledged. With Modicare looking more like the US rather than the UK model, we have to learn from their experiences and draw our own blueprint. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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EXPRESS PHARMA

February 16-28, 2018

MARKET

Need of the hour Making cancer care affordable is an urgent need in Indian healthcare and ensuring access to easy and cost-effective drugs can be pivotal in achieving this objective. By Usha Sharma

20 EXPRESS PHARMA February 16-28, 2018

hh No! Which stage? Will it be cured? How much will be spent to completely cure the disease? These are some of the questions which plays in one’s mind when diagnosed with cancer. The dreaded disease not only affects the sufferer mentally and physically but also financially. In India, the incidence of cancer is growing and has spread its tentacles. The disease has not restricted itself only to the poor, it has affected the rich as well. There are instances where celebrities like Manisha Koirala (ovarian cancer), Yuvraj Singh (Stage 1 Cancer), Lisa Ray (multiple myeloma), Anurag Basu (blood cancer) and Mumtaz (breast cancer), have successfully conquered the battle against cancer and are now leading a normal life. Most of them opted to go abroad and get cured. However, this is not the case for all. Not everyone can afford these privileges. Having no option, poor patients are sometimes forced to sell off everything to get cured as the treatment is often costly. Often, the patients succumb to the disease despite the family members trying to give their best. Cancer drugs are a major compnent in cancer treatment. The cancer drug market in India is valued at `2500 crores and is growing at 15-18 per cent annually. So, what efforts has the Indian government taken for the cancer drug market?

Need for a revision in the NLEM list Dr YK Gupta, Professor and Head, Department of Pharmacology, President, Indian Society of Nanomedicine, National Scientific Co-ordinator, Pharmacovigilance Programme of India, on being asked about the efforts been taken by the government, informs, “The government is struggling to make expensive anti-cancer medications affordable for patients. Monumental advances in healthcare have been done, yet access to affordable anti-cancer medicines remains a major issue. This requires a multi-pronged

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February 16-28, 2018

approach.” Elaborating on the steps already taken by the government, Gupta briefs, “The National List of Essential Medicine (NLEM) 2015 was prepared under the chairmanship of VM Katoch and myself. The list was drafted after an exten-

sive national wide consultation process. It is a dynamic list and now needs revision after a gap of three years to keep it contemporary.” Bhupinder Singh, Chairman, NPPA, in an address at IDMA's 56th Annual Day in Mumbai, indicated about adding more life

saving drugs to the existing NLEM list. He also informed that in future, the price regime is likely to be more strict and the government intends to bring in more changes to the existing NLEM list. Due to government's intervention, many cancer medicines

are already covered in the NLEM list and cost of treatment has reduced significantly during the last 8-10 years. Dr Sanjit Lamba, MD, Eisai Pharmaceuticals, points out, “In the last few years, the cost of cancer treatment has reduced to a considerable extent. While

MARKET launching products, originator pharma companies evaluates the affordability of the targeted population. Anti-cancer medication in India is five to six times less costly than in the US and other western countries. Cost of basic cancer care treatments has lowered on account of availability of lower priced generic versions and price regulations like the NLEM by the government bodies.” However, Mohandas K Mallath, Senior Consultant, Department of Digestive Diseases, Tata Medical Center offers a counterview and says, “Cost of cancer care has actually increased in the last decade. The reason being patients opting for better treatments such as advanced scans, pathology, surgery, radiotherapy and chemotherapy. The cost of many cancer chemotherapy drugs has reduced but that is the only part of the whole treatment.”

In India, the cost of cancer care appears to be very high. The biggest challenge is delayed diagnosis which leads to requirement of prolonged therapy with multiple modalities Dr YK Gupta, Professor & Head, Department of Pharmacology, National Scientific Co-ordinator, PvPI

Newer treatments like robotic surgery, SBRT and IGRT radiotherapy and many targeted therapies are very costly because they are imported from developed countries Dr Sanjit Lamba, MD, Eisai Pharmaceuticals

Research on newer therapeutic modalities to treat cancer will aid in reducing burden on the existing conventional forms of therapy Dr Pradeep Mahajan, Regenerative Medicine Researcher, Adigos Stem Cells

Cost drivers of cancer treatment Gupta and Bhupinder Singh have already spoken on the price revision in the NLEM list, however, will adding more cancer drugs to this list really help reduce the cost of cancer treatment? What are the other aspects as well which will contribute significantly in increasing the cost of cancer treatments? Lamba informs, “In India, the cost of cancer care appears to be very high. The biggest challenge is delayed diagnosis which leads to requirement of prolonged

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February 16-28, 2018

We need to do more research with old drugs and discover new ones. We need to prevent cancer by tobacco control, vaccinations, improvement of general diet etc. Mohandas K Mallath, Senior Consultant, Dept of Digestive Diseases, Tata Medical Center

therapy with multiple modalities like multiple rounds of chemotherapy or radiotherapy. It also includes the cost of the di-

agnosis tests, biopsies, surgeries, etc., which collectively drives the costs. The later the stage of diagnosis, higher is the cost

of treatment.” Stressing on early diagnosis, Mallath says, “Most cancers in India are diagnosed in locally

advanced or metastatic stages and hence need more diagnostic tests and more than one modality for treatment such as surgery, radiotherapy and chemotherapy or targeted therapy. This multi-modal treatment is expensive.” He continues, “Newer treatments like robotic surgery, SBRT and IGRT radiotherapy and many targeted therapies are very costly because they are imported from developed countries.” Dr Pradeep Mahajan, Regenerative Medicine Researcher, Adigos Stem Cells explains, “Cancer requires immediate attention and unlike other conditions does not have alternative or optional therapies. For e.g., chemotherapy and radiotherapy are mandatory in most cases. Families therefore tend to overlook treatment costs while deciding over life of the affected individual. Having said that, it must also be understood that the availability of generic drugs at government centres have increased thereby bringing down the cost of treatment for patients.” Mahajan rightly pointed out the need for generic drugs at government centres. The government has already taken a step in this direction and has opened several Jan Aushadhi stores across the country and there are plans to start many more in the coming years. However, to accomplish the government's vision successfully, do pharma companies have enough cancer medicines?

MARKET Availability of cancer medicines The standard drugs required for various forms of cancer (cisplatin, epirubicin, methotrexate, vincristine, chlorambucil etc.) are available in either generic or branded forms. R&D wings of large Indian pharma firms are striving to ensure adequate anticancer drugs in their product pipeline with an aim to meet the ever increasing demands. In the past five years, around 70 new oncology treatments have been launched and are being used to treat over 20 different types of tumour. Many more such drugs are in the pipeline at various stages of clinical trials. In all ~77 companies, inclusive of MNC’s and domestic entities, operate in the market. There are ~140 molecules in the cancer market with ~1337 brands. Most of the MNCs are present in the market with their innovator products while the domestic companies generally are present with the generic versions. Singh informs about Eisai Pharma's product basket and says, “In the oncology space, our in-house research brandHalaven, which is indicated in mBC, was recently approved in India for soft tissue sarcome (STS) as well. Recently, we have launched an in-house innovator research molecule- Lenvatinib (Lenvima) indicated in a niche indication of Differentiated Thyroid Cancer (DTC). Lenvima is currently indicated for DTC. The molecule is also under study for hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC), which will ensure meaningful survival for patients.” Singh further says, “Eisai globally has around six molecules in its pipeline being developed in-house, which are currently at different stages of development. In addition, globally, we have also collaborated with other innovator for development of newer molecules in cancer segment.” Other pharma companies too have been ramping up their portfolio of oncology drugs. Among the newsmakers are Sun Pharma, which has acquired the skin cancer drug Odomzo from Novartis. The cancer drug market in India is a very niche segment as

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February 16-28, 2018

compared to the pharma market consisting of acute and other chronic therapies. Underlining the need for newer class of treatment methods, Mahajan stresses, “Research on newer therapeutic modalities to treat cancer will aid in reducing burden on the existing conventional forms of therapy. Specific cancer targeted therapy, hormone ther-

apy, immunotherapy etc. are now garnering attention owing to utilisation of biological molecules, thus being safe and effective treatment modalities.” The newest category of cancer drugs are immunotherapy agents that act directly on the immune system, by antagonising cancer cells. Some examples are Nivolumab and Pem-

brolizumab, which were launched in India six months back for lung cancer and melanoma. Mallath also recommends that along with research there is a need to prevent people from consuming tobacco because tobacco-related cancers (oral, lung etc.) have been projected to increase by 30 per cent by the

year 2020 amongst the Indian male population. He suggests, “We need to do more research with old drugs as well as discover new ones. We need to prevent cancer by tobacco control, vaccinations, improvement of general diet of the population and creation of places for improving physical activity and fitness. This will help reduce

MARKET deaths from many diseases that are more common than cancer including heart disease and diabetes.”

Learnings from HIV management “If we look back at the start of the millennium, India broke the worldwide stranglehold of high cost anti-retro viral therapy drugs by supplying generic antiretro viral drugs (ARV) at low cost to the HIV-AIDS epidemic stricken African nations. Since then, India has been a major supplier of ARVs across the world. Today, India is at the brink of another such revolution, this time in terms of cancer drug therapy. New alternative therapies that are gradually shifting

THE SIEGE OF CANCER According to the National Cancer Registry and reports from the Indian Council of Medical Research (ICMR), breast cancer accounts for 27 per cent of all cancers while 22.9 per cent women suffer from cervical cancer. Similarly, oral cancer is the most prevalent cancer in Indian males.This type of cancer is primarily attributed to consumption of tobacco and smoking. In case of females, breast, cervix and ovary cancers are more prevalent. Alongwith tobacco,sexually transmitted diseases (syphilis, human papilloma virus etc.), infections and weakened immune status are also causes of the different types of cancers. There has been a significant rise in oral, lung, stomach, prostate and colorectal cancer among male population while the female population is showing increased rates of uterine/ovarian, breast and cervix cancers. These cancers account for almost 50 per cent of all deaths in our country. There are more than 120 types of cancer and related hereditary syndromes and many of these cancer cases are due to lifestyle changes.The prevalence of these cancer cases have been attributed largely to urbanisation.

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OTCdivision@gmail.com 24 EXPRESS PHARMA February 16-28, 2018

focus from chemotherapy to specific cancer targeted therapy, immunotherapy and hormone therapies drive the Indian oncology drug market,” informs Mahajan. What are the other steps needs to be taken to prevent cancer?

Conquering cancer Mahajan suggests, “The first step should always aim towards prevention and creating awareness amongst masses to ensure early diagnosis and prompt treatment. Improving public health education is important, as is introduction of programmes to curb tobacco use and promote healthy living.” Prof Gupta says, “Access to affordable quality medicines is a global challenge and more critical in developing socio-economy country like India.” However, the cost of cancer treatments can be brought down if the disease can be diagnosed at an early stage, since, we have better diagnostic modalities that facilitate early screening, diagnosis and prompt treatment planning of various cancers.” Commenting from a treatment perspective, Singh asserts, “ Availability of biosimilars, MAbs and TKIs along with generics have also helped in driving the costs lower.”

Providing financial assistance Cost of many cancer chemotherapy drugs have reduced but that is the only part of the whole

treatment. What can be done to provide financial assistance to cancer patients? Due to inadequate cancer care system, patients and families have to pay most of the treatment cost from out-of-pocket, which results in drop outs due to bankruptcy and loans. Singh believes that with respect to pharma companies, initiatives should be taken to ensure that the products should be priced in such a way that the common masses can afford it. He remarks, “Alternately, tiered pricing programmes, based on the income group segmentation, should be focussed upon to increase access to medicine. In line with our human health care (hhc) philosophy, Eisai constantly strives to bring in the market the products that address the unmet medical needs.” As the awareness of the disease is increasing among people, many are opting for insurance schemes. From the perspective of pharma companies as well, the companies are proactively introducing differential or tiered pricing programme to ensure that their products are affordable. Mahajan says, “Health insurance plays a key role in healthcare delivery. At present, only one-fifth of the Indian population has healthcare insurance, of which cancer cover is even lower. In most cases, critical illnesses and medications do not fall under the cover of insurance policies. It may be beneficial to

include cancer and other highrisk disease medications under insurance schemes which will enhance accessibility to the otherwise financially compromised sections of the society. India needs strong funding from both public and private sectors to launch cancer care products which address end-to-end cancer treatment expenditure.” He further continues, “Government policies or publicprivate partnership schemes must be announced to ensure that insurance is available to every individual irrespective of social status. There are several schemes/ initiatives run by the government like Rashtriya Swasthya Bima Yojna (RSBY), Vajpayee Arogyashree Scheme, etc. to ensure that people suffering from cancer take the insurance benefits. In addition, the government is setting up hospitals across the states in India to cater to the population who are below the poverty line. Singh feels, “Government should also take initiatives to ensure that cost of cancer care is optimised. Both at the state and central government levels, a structured assessment of existing healthcare policies for delivery of affordable cancer care is needed.” Many public private partnerships have also come up, which help to address the concern of access. Noticeable increase in the number of cancer specialists have helped to diagnosis the disease at a nascent stage, which

MARKET leads to early detection and treatment of cancer. Prof Gupta suggests, “Government needs to ensure that the price of these medicines are within the affordable range, there is subsidy and should be made available from government supply where they are not covered by some insurance policies. These medicines are those which will take care of most cancers in the country. The major thrust should be to bring these medicines under check and ensure their affordability.” “Setting up of cancer institutes in tier II and tier III cities will go a long way in addressing the need of patients. Ensuring compulsory practice by professionals for a pre-determined tenure in these cities, will help to improve the infrastructure in non-metro region of the country. In addition to initiatives like NLEM which keep the price of medicines in check, the government should also take initiatives to ensure that fees of procedures like surgeries and radiation sessions, are kept a close eye on to ensure a more holistic approach towards making a therapy available and affordable.” He further reaffirms, “To bring down the cost, committees have suggested compulsory licensing of cancer drugs. This will allow pharma companies to make generic versions of patented medicines at lower costs. As an example, recently, Natco Pharma acquired the Indian Patent Office rights to manufacture generic version of a drug used to treat certain types of renal and liver cancers. This brought down the manufacturing cost to less than five per cent of the branded version.” Regulatory bodies too need to bring changes in speeding up the regulatory process.

Need faster regulatory process In India, pharma companies are asking the regulatory bodies to speed up the approval process, which will improve accessibility and also affordability. Prof Gupta highlights, “Regulatory approval of such drugs should not be conventional longer phase III trials of thousands of patients. Some time an anticancer drug is developed for one indication but later

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February 16-28, 2018

with bridging studies gets approval for another indication. In such cases simply because of increased market size the price can be reduced voluntarily.” Singh says, “Early detection will in turn help to increase the number of screenings, leading to increased diagnosis and lower cots.” Singh says, “At a preliminary

level, it is assumed that anti-cancer medications are priced very high. However, on a closer look, this doesn’t seem to be the case. Anti-cancer medications are multi-times less costly as compared to the western countries. The government along with private stakeholders need to take proactive steps to ensure that people suffering from can-

cer gets the right treatment and are insured. The government needs to invest more in creating centres like Tata Memorial. A number of initiatives should be taken by each and every stakeholder of the community to ensure that cancer care becomes affordable and accessible. The first and foremost step is to increase awareness of the disease

so that the population in general becomes more aware about the disease, which will help a long way in early detection of the disease. Along with creating awareness, pharma companies too need to analyse about the affordability before launching a product in India. u.sharma@expressindia.com

MARKET DEAL TRACKER

Pharma industry records 73 deals worth $36.7 bn in Jan 18 Sanofi and Celgene reported two deals each which fall into the billion dollar category in January 2018 THE DEAL activity witnessed a significant increase in the pharmaceutical and healthcare industry in January 2018 by recording 73 deals worth $36.7 billion, when compared to five months average of 69 deals worth $8.8 billion. Major pharma companies Sanofi and Celgene reported two deals each which fall into the billion dollar category in January 2018. Sanofi announced two cross-border acquisitions â€” Bioverativ, a US-based biotechnology company focussed on hemophilia and other rare blood disorders, for $11.5 billion and Ablynx, a Belgium-based biopharmaceutical company focussed on the discovery and development of nanobodies, for $4.8 billion. These acquisitions are expected to enhance Sanofiâ€™s specialty care portfolio and its rare blood disorders franchise. Alongside, Celgene announced two acquisitions of Juno Therapeutics, a clinical-stage cell immunotherapy company, and Impact Biomedicines, a developer of treatment for complex cancers, for $9 billion and $7 billion, respectively. The acquisition of Juno will add a novel scientific platform and manufacturing expertise to Celgene's research and operational capabilities; and the acquisition of Impact Biomedicines will enable Celgene to add Fedratinib to its pipeline of novel therapies for haematologic malignancies. The venture capital market recorded 76 deals worth $2 billion in January 2018, when compared to five months average of 83 deals worth $1.3 billion. BioNTech, a biotechnology company focused on the immunotherapies for the treatment of cancer, has raised $270 million in series A financing round and stood ahead of other companies in raising venture funding in January 2018.

Source: GlobalData

26 EXPRESS PHARMA February 16-28, 2018

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

22-Jan-18

Sanofi (France)

Bioverativ Inc (US)

11,500.0

21-Jan-18

Celgene Corp (US)

Juno Therapeutics Inc (US)

9,000.0

07-Jan-18

Celgene Corp (US)

Impact Biomedicines Inc (US)

7,000.0

29-Jan-18

Sanofi (France)

Ablynx NV (Belgium)

4,846.6

29-Jan-18

Varian Medical Systems Inc (US)

Sirtex Medical Ltd (Australia)

1,284.8

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

04-Jan-18

The Invus Group, LLC; Redmile Group LLC; Fidelity Management & Research Company; Strungmann Family; Janus Henderson Investors

BioNTech AG (Germany)

270.0

10-Jan-18

RA Capital Management LLC; Rock Springs Braeburn Pharmaceuticals Inc (US) Capital LP; Apple Tree Partners; New Leaf Venture Partners LLC; Deerfield Management Company LP; Avista Capital Partners; Wellington Capital Management LLP

110.0

04-Jan-18

Omega Fund Management, LLC; ARCH Venture Partners LP

Gossamer Bio Inc (US)

100.0

11-Jan-18

C-Bridge Capital; QianHai Equity Investment FOF; FOCUS Media Jiangnanchun Foundation; WTT Investment; Goldman Sachs; Tasly Pharmaceutical

Ascletis BioScience Co Ltd (China)

100.0

23-Jan-18

University of Pennsylvania; Gilead Sciences Tmunity Therapeutics Inc (US) Inc; Lilly Asia ventures; Be The Match Foundation; Ping An Ventures; Parker Institute for Cancer Immunotherapy

Source: GlobalData

100.0

MARKET PRE EVENT

Healthcare Sabha to be held in Pune from March 8-10,2018 Healthcare Sabha 2018 will bring together policy makers, thought leaders, national and international health organisations, social entrepreneurs, and technology and ancillary healthcare service providers INDIAN EXPRESS Group and Express Healthcare will organise the third edition of Healthcare Sabha in Pune from March 8-10, 2018. Healthcare Sabha 2018 will bring together policy makers, thought leaders, national and international health organisations, social entrepreneurs, and technology and ancillary healthcare service providers. Delegate profile includes, Secretary, Addl Secretary, Jt Secretary, DG, DDG etc from Ministry of Health & Family Welfare, Government of India, NHM Mission Directors of various states, NHM policy makers and planning officials, dignitaries from Central Drugs Standard Control Organisation DCG(I), Jt Drugs Controller, Deputy Drugs Controller), Key dignitaries from NHSRC/ SHSRC, NIHFW, dignitaries from state health corporations, state health society and state health mission director, director, deputy director of autonomous institutions like AIIMS, JIPMER, PGIMER, NIMHANS etc. Dignitaries from ESIC (Director General, Medical Commissioners, Deputy Medical Commissioners) DG â€“ AFMS, Addl. DG-AFMS, DG, ED, Director, Deputy Director â€“ Railway Health Services, CMOs of various railway zones, Chief Procurement Officer, Medical Superintendents, Administrative Heads of premier Government and Municipal Hospitals from various states and cities. The first two editions of Healthcare Sabha held in Hyderabad and Vizag provided an excellent platform for researchers, policy makers, healthcare practitioners, public health advocates to share and exchange evidence drawn from research and experiences in health development programmes in India. EP News Bureau

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THE MAIN FOCUS

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he Union Budget 2018-19 was the last full-fledged budget by the Modi government before 2019 elections. Though the pharma industry had a lot of expectations from the budget in terms of reducing the API dependency, increasing R&D investment, support to SMEs etc., it was left disappointed as no major reforms or incentives were announced by Finance Minister, Arun Jaitley. Nevertheless, the government has taken some pivotal decisions in its tenure like Jan Aushadhi Scheme, capping of drug prices, GST and demonetisation etc., which has significantly affected the pharma industry. This issue of Express Pharma analyses the impact of Modi government on the pharma industry and also tries to find out what should be the Modi government's manifesto for the pharma sector, if it is re-elected to power after 2019 election.

The government has been partly successful in increasing the accessibility and affordability by promoting availability of generics by separately creating Jan Aushadhi outlets dispensing exclusively generic medicines Rao VSV Vadlamudi, President, IPA

Modi’s government is successful to a great extent in bringing down the cost of drugs used for life style diseases under DPCO Eshwar Reddy, Executive Director, BDMA (I)

The government has been working on to improve the quality of medicines by having dialogues with international regulators Deepnath Roy Chowdhury, National President, IDMA

How did these initiatives fare? There are quite a few initiatives undertaken by the government for the pharma industry’s growth such as the Jan Aushadhi Scheme, Cluster Development Programme for pharma sector, revamping pharma policy, Pharmaceuticals Promotion and Development Scheme, Make in India initiative and monitoring the price of drugs and medical devices. The Jan Aushadhi Scheme was introduced with an aim to increase the accessibility and affordability of medicine in the country. Under the Jan Aushadhi Scheme, the government intended to open 3,000 stores by March 2017 to provide quality generic medicines at affordable prices, in place of branded medicines. Under the scheme,generic medicines are provided in remote areas. The fund required to open a store is `2.5 lakhs. However, the scheme requires more attention and proper management by the government to make it more successful. Till date, Bureau of Pharma PSU of India (BPPI) has listed 3,111

30 EXPRESS PHARMA February 16-28, 2018

Jan Aushadhi stores on its website. But, due to lack of management and supply of medicines, few stores are on the verge of closing down their shutters. On the other hand, many stores have received government approval but are not functioning. Rao VSV Vadlamudi, President, Indian Pharmaceutical Association (IPA) says, “The government has been partly successful in increasing accessibility and affordability by promoting availability of generics by separately creating Jan Aushadhi outlets dispensing exclusively generic medicines. However, this initiative is yet to gain momentum across the entire country. Some major issues have not been addressed adequately to make sure that the Jan Aushadhi scheme becomes highly effective and successful. Firstly, it is necessary to ensure that a clear understanding of what is a generic and what is a branded drug needs to be created in the minds of all stakeholders. This is very important since in our country several

Hits and misses ◗ Hits ◆ Partial implementation of Jan Aushadhi programme, ◆ Restructuring of pricing of medical devices ◆ Clinical trial regulation amended to provide a balance between need of the industry and interest of the trial subject. ◗ Misses ◆ Slow progress on strengthening of regulatory framework ◆ Lack of immediate measures to reduce dependency on imports of APIs, critical drug intermediates and essential starting materials and solvents from China ◆ Slow progress on skill development initiatives required for pharma industry affecting employability

brands of the same drug molecule are available and in reality, these are all branded generics. Secondly, it is necessary to ensure that generic drugs are not only cheaper but are also |of the same quality as those of branded drugs. It is also necessary to ensure that all generics are manufactured in facilities that have fulfilled all the regulatory requirements specified under Schedule M.” He further opines, “It is necessary to understand that increasing accessibility of quality medicines to public at affordable prices would also tend to increase medication-associated problems such as medication errors, irrational use of medicines, particularly of antibiotics and antimicrobials leading to antimicrobial resistance (AMR) and other adverse events, unless enhanced accessibility is under proper supervision of a technically competent and trained individual i.e. a pharmacist. One more issue that needs to be tackled is the fact that all NLEM drugs are not available in the

generic form in adequate quantities for providing uninterrupted supply to all Jan Aushadhi outlets to make the scheme successful.” Citing another example of government measures to reform the pharma sector, Eshwar Reddy, Executive Director, Bulk Drug Manufacturers Association (India) [BDMA(I)] says, "Modi’s government is successful to a great extent in bringing down the cost of drugs used for life style diseases under Drug Price Control Order (DPCO). There have been a lot of deliberations on the policies to be adopted for the growth of pharma industry. However, no concrete steps have been taken. The Make in India initiative has also not taken off as expected. Even the new proposed pharma policy had failed to address many of the critical issues being faced by the industry. However, offering a different perspective, Vadlamudi believes that National Pharmaceutical Pricing Authority (NPPA) has already taken some proactive measures to improve access to medicines by fixing prices medicines and medical devices such as cardiac stents and prosthetic devices. However, he also presents the flip side of stringent price control of essential drugs. It is the unavailability of those drugs as many manufacturers are opting out of producing them due to poor viability. To ease this situation, a more rational drug pricing policy needs to be developed with greater priority. Deepnath Roy Chowdhury, National President, Indian Drug Manufacturers Associations (IDMA) also appreciates the government’s committment towards ushering growth in the pharma sector and says, "The government has been working to improve the quality of medicines by having dialogues with international regulators. In the domestic market, inspections on pharma plants have been intensified and areas of improvements have been conveyed to the concerned units. As far as lower price is concerned, NPPA has

( been very active."

Challenges unaddressed Vadlamudi lists down the major issues faced by the industry, which are: ◗ Over dependence on China for imports of drug intermediates and APIs and no significant incentives to support manufacturing of intermediates and APIs. ◗ Reforms in clinical trials regulations is moving at a slow pace and the clinical trial industry is slowly diverting to other avenues for sustainability. ◗ Lack of sufficient and effective support for R&D from the government. Chowdhury elaborates on these issues and says, “Critical dependence on Chinese import for APIs still continues. Pharma SMEs are badly in need of technology upgradation funds, which is not forthcoming. There have been frequent changes in drug regulations leading to uncertainty and lack of preparation on the part of the manufacturers. Demonetisation and GST have severely hit the growth of the pharma industry during the current financial year. The industry is now limping back to normal.” Thus, it is a mixed bag of reviews for Modi government's performance when it comes to the pharma sector. When the associations were asked to rate it on a scale of five, BDMA and IPA have rated it three. Thus, the indication is clear. The industry expects a lot more from the government to spur its progress. While there have been discussions on issues like pricing mechanism, generic drugs, ease of doing business etc., and there have been several proposals for strengthening the Indian API sector and technology upgradation fund for pharma SMEs, nothing concrete has emerged yet.

If Modi 2.0 becomes a reality.... If the current government comes back to power in 2019, pharma associations are strongly demanding government support to reduce API dependency on China and

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February 16-28, 2018

revival of API sector. Along with this, IDMA also wants the government to provide enough funding for the SME sector to make them globally competitive. It also highlights that there

should be a stable pricing policy and a consistent regulatory regime. BDMA gives an elaborate list of initiatives that it recommends the government to implement in

THE MAIN FOCUS

the next five years for the growth of the sector:

Fiscal incentives ◗ The government should create large scale pharma clusters

to take the benefit of economy of scale. ◗ Provide common infrastructure like utilities and effluents treatment facilities at par with world class standards through

cover ) government funding; ◗ Revival of sick public sector units HAL and IDPL – Role played by PSUs in establishing manufacturing base in India for APIs and formulations has been totally down played in the draft policy. ◗ Give physical and financial incentives and support to R&D initiatives.

Infrastructure ◗ Dedicated pharma/chemical parks with all supporting infrastructure needs to be created. The clusters will ensure the benefits of shared infrastructure and economy of scale for cost competitiveness. ◗ Provide fiscal incentives for the initial phase of cluster development. ◗ The government should revive PSU manufacturing critical APIs and intermediates that cannot be addressed by the industry due to commercial non-viability and unreasonable prices offered by foreign producers to make local industry unviable.

Environmental measures ◗ Develop flexible and simple environmental laws and policies to help in establishing manufacturing plants without compromising on the environmental standards. ◗ Environmental clearances and other related consents to be on category wise instead of product wise. ◗ Central and State Pollution Control Boards should be made responsible for facilitating environment management systems. ◗Rules and regulations to check the pollution levels and at the same time support the industry to adopt best environmental technologies. In this regard Central Pollution Control Board (CPCB) and National Environmental Engineering Research Institute (NEERI) should provide expert technical guidance and advice which is totally absent at present. Common Effluent Treatment Plants (CETPs) and other central environmental abatement facilities operated by expert agencies should be encouraged. All indus-

32 EXPRESS PHARMA February 16-28, 2018

Picture used for representational purpose only

The Jan Aushadhi Scheme was a major initiative taken by the government to increase the accessibility and affordability of medicine in the country tries irrespective of size and quantity of effluents generated can make use of these facilities rather than having these facilities put up and operated by individual units.

Approvals and licenses The approval process of central or state drug regulators should be shortened to three months and standardised on one time basis with periodic inspections if required. ◗ The API industry requires almost 20 different licenses from various departments for operating the unit. Government should simplify licensing procedures. The licenses may be provided to the industry on permanent basis with provision of monitoring compliances periodically by regulator. Various government panels have pointed to the corrupt nexus between regulatory agencies and manufacturers while providing marketing

approval for new drugs. In spite of these, there are no concrete mechanisms in place to oversee the approval of new medicines and importantly the weeding out of already approved irrational formulations. The new policy must provide concrete directions regarding how these can be accomplished. ◗ Loan licensing to be allowed up to only 10 per cent of the total production of the company. ◗ Formulations by units manufacturing APIs to be restricted to a maximum of 50 per cent of their production and the balance API quantities to be offered to other pharma formulators similar to what is being practised in pesticides industry. Several interventions by the government earlier led to the development of a robust domestic industry in the pharma sector. During the year 1978 policy introduced ‘ratio parameters’ requiring manufac-

turers to produce APIs (also called ‘bulk drugs’) and finished formulations in certain ratios. Larger manufacturers were required to produce larger quantities of APIs. With the introduction of liberal reforms, ratio parameters were discontinued and Chinese APIs are preferred over locally manufactured APIs due to cheaper price. Our increasing dependence on imported APIs is a matter of grave concern.

Skill development API manufacturing requires highly skilled scientists and technicians to manufacture globally compliant products. This is to be addressed to develop competent and trained manpower pool.

Capital grants ◗ The government should provide capital grants for setting up R&D and testing facilities. There

is an urgent necessity to invest in R&D as there is increased competition from countries like China and Russia and India needs to be proactive in safe guarding its position in generic pharma sector. To retain leading position it has to continuously upgraded its portfolio with drugs and pharmaceuticals that come out of patent protection. ◗ Introduction of new and improved generic drugs is also because they are inexpensive and can directly benefit the common man. Following categories need to be addressed: HIV (AIDS), Hepatitis C drugs, cancer drugs, intermediates and pharma excipients. Thus, the industry expects a lot more from the government if it comes to power in 2019. Will the Modi government get a chance to live up to these expectations? Only time will tell. swati.rana@expressindia.com

MANAGEMENT EXPERT SPEAK

Asustainable future with green chemistry Nitesh H Mehta, Co-Founder Director, Newreka Green-Synth Technologies and Krishna B Padia, Executive Director, Green ChemisTree Foundation, elaborate on the barriers to implementation and industrialisation of Green Chemistry and initiatives to overcome the same

reen Chemistry is now moving in a phase where most people are not asking the question “whether Green Chemistry or not?” but are asking“how can we implement Green Chemistry?” This means that relevance of Green Chemistry is no longer the question. Most stakeholders of chemical industry including industry, academic and research institutions, government and regulatory bodies, teachers and students, investors, etc. are clear that Green Chemistry is a powerful tool that can lead us to a sustainable future. At times when, industry is grappling with shrinking margins and increasing pressure to comply to environment norms, industry has started seeing Green Chemistry as a tool that can enable them to achieve both economical and environmental competitiveness. The academic and research institutions are seeing Green Chemistry as an area for research where they can do meaningful work and contribute towards solving problems which are so relevant in today’s context. Teachers are beginning to see the relevance of teaching Green Chemistry to their students to have them be better prepared and equipped to deliver on the expectations of the industry and the society, after they are graduated. Students are beginning to see Green

Nitesh H Mehta, Co-Founder Director, Newreka Green-Synth Technologies, India

Chemistry as a very promising and growing field with potential to provide great career opportunities. Government and regulatory bodies have realised the role that Green Chemistry can play in improving the quality of air, water and soil for their people and for their country. The next question which each of the above mentioned stakeholders of chemical industry is asking is – “how we can go about it or how we can accelerate the inclusion of Green Chemistry in our domain or in our area of accountability?” As all stakeholders of chemical industry are taking steps towards implementing Green Chemistry, there are various

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barriers being encountered. To accelerate the implementation of Green Chemistry, it’s important to first distinguish and confront these barriers. Once there barriers are distinguished, some new possibilities could be created to breakthrough these barriers/roadblocks. As a Green Chemistry Solution provider, while we engaged with the industry to develop, scale-up and commercialise Green Chemistry-based technologies or solutions, we have had a first-hand experience of some of these barriers. Working for our non-profit organisation, Green ChemisTree Foundation, on various initiatives to expand the awareness of Green Chemistry, we had opportunities to engage with other stakeholders and that’s where we realised some of the other barriers. We are taking this opportunity to share some of the key barriers to implementation and industrialisation of Green Chemistry: ◗ Availability of Green Chemistry-based technologies: The Green Chemistry tool box (set of platform technologies, based on the principles of Green Chemistry and Engineering, alternative to conventional synthetic chemistry based processes/chemistries) is still quite empty. We still don’t have viable Green Chemistry

academic and research institutes can work on.

Krishna B Padia, Executive Director, Green ChemisTree Foundation

based solution for many chemistries/processes like nitration, sulphonation, friedelcraft, etc. In the absence of such solutions, the industry does these chemistries with conventional ways, using huge quantities of acids, alkalies and other reagents. The low conversion, poor selectivity, low yield and huge quantities of effluent generated makes these processes quite undesirable but the industry doesn’t have a viable option. This is one barrier, which academic and research institutes can make significant contribution in overcoming. Creating some fundamental invention/innovation in these areas is a very relevant problem which

◗ Scale-up and Commercialisation of Green Chemistry based technologies: There are many inventions/innovations that have already been developed by various academic and research institutes and these are potential solutions for some of the environmental challenges faced by the industry. However, for whatever reasons, these solutions haven’t been pursued after lab scale development. Scale-up and commercialisation is a barrier because it calls for both academic/research institutes as well as industries to stretch themselves beyond their boundaries. Academic/research institutes need to make extra effort to customise the solutions and demonstrate the technical and commercial viability at a reasonable scale, to gain industry’s confidence. The industry needs to stretch themselves to take the risk that is associated with scale-up and commercialisation of new solutions. ◗ Connecting Green Chemistry Solution Providers to Industry: There are many Green Chemistry solutions that are ready (with some start-up company, scientist/researcher, academic/research institutes, etc) and are proven. These are the most “low hanging fruits.” One of the key barriers is

EXPRESS PHARMA

February 16-28, 2018

MANAGEMENT the communication gap between the industry and such solution providers. This could be because the industry is in one past of the world and the solution provider is in other part of the world. This could also be due to insufficient marketing of the potential solution by the solution provider (usually the case with academic/research institutes who don’t proactively market their solutions to the industry). This could also be due to industry not putting enough efforts to search and look around for solutions. ◗ Understanding of basics of Green Chemistry and Engineering principles amongst chemists and chemical engineers: One of the barriers in implementation of Green Chemistry is that our team of chemists and chemical engineers working on designing new products and processes have limited knowledge about the basic principles of Green Chemistry and Engineering. It’s critical to ensure that our team has a workable knowledge about these principles and it’s also important to introduce Green Chemistry in our curriculum so that the next generation of chemists and chemical engineers are shaped to think from ‘Green.’ ◗ Myths about Green Chemistry: Certain myths about Green Chemistry prevailing around us are also a barrier in implementation of Green Chemistry in the industry. Myths like Green Chemistry is good theory but practically not feasible, Green Chemistry is difficult and complex, it is not viable for small and medium size organisations, it requires huge resources, etc. At Newreka, we have commercialised Green Chemistrybased solutions, ever for small and mid-size pharma and fine chemical companies, involving hardly any capital investment and break-even period of sometimes as low as three months. There could be some solutions that may take longer to develop and may require more resources but that’s not true all the time. At Newreka, we have many case studies

34 EXPRESS PHARMA February 16-28, 2018

which prove that the above myths are ‘Myths.’ ◗ Regulatory barriers: This is a big barrier for the pharma and other industries where any change in process (when a Green Chemistry- based process is replacing a conventional process) has to go through validation trials, change in documentations and filings as well as series of approvals from internal regulatory affairs team, customers and finally from external regulatory agencies like FDA. Besides the time invested for tedious process of making these changes in DMF filings, this also involves significant cost/financial resources. Hence, only when the Green Chemistry- based new solution offers returns that justifies the investment of time and money, it may see the light of the day. Many pharma companies have now started exploring Green Chemistry-based routes of synthesis right during the initial phase of development of the molecule. This is a great initiative however, looking at the vast number of generic drugs that are being manufactured (through conventional synthetic chemistry based processes with high E-Factor), it’s worth

considering the possibility of creating a ‘fast track’ for regulatory approval of process changes involving Green Chemistry and Engineering-based solutions (of-course without compromising on any other aspects of evaluation procedures of FDA). It is also worth considering offering some discount on the costs involved for filing such changes. These would offer encouragement to the pharma and other industries to implement Green Chemistry. ◗ Initiative to overcome barriers: To overcome the above mentioned barriers and to accelerate the implementation of Green Chemistry in the Industry, initiatives need to be taken on multiple fronts simultaneously. Green ChemisTree Foundation, a not-for-profit, organisation based out of India, has created a platform called ‘Industrial Green Chemistry World (IGCW)’ to facilitate addressing some of the above mentioned barriers. IGCW – Convention and Ecosystem, includes the following dimensions to address some of the barriers mentioned above: 1. IGCW- Symposium: To

educate senior decision makers from over 300 pharma, speciality and fine chemical companies about the value of Green Chemistry and empower them to adopt Green Chemistry. 2. IGCW-Expo: An exhibition exclusive for Green Chemistry Solution providers to showcase their products and services. 3. IGCW-Awards: In partnership with SERB (Science and Engineering Research Board, Dept of Science and Tech, Govt of India), Green ChemisTree Foundation acknowledges individuals and organisations doing extraordinary work in the field of Green Chemistry and Engineering. 4. 180o Seminar: Technical seminars to educate chemists and chemical engineers from industry on topics like Green Catalysts, Green Solvents, Green Processes and Green Engineering. 5. Conference for Pollution Control Board Officials: To educate regulatory bodies about Green Chemistry and empower them to be facilitators in implementation of Green Chemistry in the industry. 6. Workshop on Green Solvent and Reagent Selection

Guide: to train chemists and chemical engineering professionals from Industry on tools like ‘Solvent Selection Guide and Reagent Selection Guide,’ which are developed by ACS-Green Chemistry Institute Pharmaceutical Roundtable. This enables them to use this tool to choose safer solvents and reagents while developing a process. 7. Workshop on CSIR – Industry Interaction: A platform for academic/research institutes to proactively market their ‘ready to commercialise’ technologies to the industry. 8. Workshops for students and teachers: Workshop on Green Chemistry to increase awareness and educate teachers and students. Most of the above-mentioned barriers to implementation of Green Chemistry in the industries are common across the world, however, each country might have some specific barriers which are more challenging as compared to other barriers. Based on the identification of these barriers, each country could design its own set of initiatives to overcome the barriers it is facing and thus accelerate the implementation of Green Chemistry and Engineering.

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MANAGEMENT REPORTS

CDSS market in India to reach $206.1 m According to the new BIS Research report, the spread of this technology to other markets and geographies in India will be driven by its success in Tier I cities, cost-benefit comparisons, and clinical benefits in reducing re-admission rates and medication errors GLOBAL MARKET intelligence, research, and advisory company BIS Research released its latest report, ‘Clinical Decision Support Systems (CDSS) Market – Analysis and Forecast, 2017-2025,’ projecting that this sector would reach a global market size of $10.83 billion by 2025. The rate of medication errors and the harms they cause — both in terms of increasing healthcare costs and preventable fatalities — are expected to drive this growth. The adoption of these systems is, for the 2018-2025 period, projected to be limited to Tier I cities, and hospitals like AIIMS, Apollo Hospitals, and Max Health. The spread of this technology to

other markets and geographies in India will be driven by its success in Tier I cities, cost-benefit comparisons, and clinical benefits in reducing re-admission rates and medication errors. The report provides a multidimensional view of the global clinical decision support systems market in terms of market size and growth potential. Drawing upon meticulous research from a variety of primary and secondary sources, the report aims to identify and delve deeply into the key factors driving the market. It also underlines the threats that can inhibit its growth, and the current opportunities that will shape the future growth trajectory of

this market. In its analysis of India, it finds that the changing IT technology landscape, improved healthcare access and standards, as well as the increased life expectancy and the increasing incidence of lifestyle/chronic diseases will drive the sector’s growth. The report finds that Indian hospitals are quickly adapting information systems for the automation of their departments, enabling a digitalisation of records for both hospitals and patients. It further indicates that the increase in adoption of electronic health records, mHealth, telemedicine, and web-based services has made electronic patient data expand.

This has necessitated the implementation of robust clinical decision support systems in Indian hospitals. The report pegs the value of the CDSS market in India at $43.8 million, and expects the sector to grow to $206.1 million by 2025, by which time the total healthcare IT market of India will reach a $ 2530.3 million valuation. Commenting on the release of the new report, Abdul Wahid, Lead Analyst, BIS Research, said, “The clinical decision support systems market is, to a large extent, going to be driven by the urgent need to reduce healthcare costs and the rising number of deaths due to preventable medical errors. While

the sector is still at a nascent stage in India, most large hospitals in Tier I cities already have modular information systems, while some have fully integrated systems. In the future, we expect the full integration of systems, more shareable information platforms, and the standardisation that could lead to user-friendliness and greater usability. We also believe that in the near future, these systems will use tablets and other mobile devices to enhance the uptake of advanced tools like telemedicine and virtual meeting systems for knowledge sharing.” EP News Bureau

Melanoma sales projected to rise to $5.5 bn in 2026 According to GlobalData, there will be nearly 207,000 cases of melanoma in 2026, rising from nearly 166,000 in 2016 THE VALUE of the melanoma market was estimated to be $3.3 bn across the seven major markets (7MM) in 2016. This is expected to grow to $5.5 bn in 2026, at a Compound Annual Growth Rate (CAGR) of 5.3 per cent, according to GlobalData, a leading data and analytics company. GlobalData expects that there will be nearly 207,000 cases of melanoma in 2026, rising from nearly 166,000 in 2016. The company’s latest report: ‘PharmaPoint: Melanoma’ states that this increase, coupled with an anticipated increase in prescriptions for branded agents, will drive growth of the global melanoma market over the forecast period.

36 EXPRESS PHARMA February 16-28, 2018

The 2011 launch of Yervoy propelled Bristol-Myers Squibb (BMS) onto the melanoma market and positioned the company as the premier immuno-oncology player. Yervoy has rapidly become the best-selling brand in melanoma, achieving blockbuster status in 2014, with growth fuelled by recent label extension in the first-line (1L) setting in Europe. The 2014 launch of its second melanoma asset, the anti-PD-1 antibody Opdivo, allowed BMS to further strengthen its position in the checkpoint immunotherapy and melanoma markets. Louis Perdios, Healthcare Analyst, GlobalData, comments, “GlobalData expects Opdivo/Yervoy to continue

driving the robust growth of Yervoy’s sales. However, it is anticipated that Yervoy will be eclipsed by Opdivo, which will become the market leader at the end of the forecast period. We expect the checkpoint immunotherapy drug class to dominate the melanoma market for both BRAF wild-type (WT) and BRAF V600 mutation-positive patients, with an overall 72 per cent share of the melanoma market in 2026.” As the melanoma market becomes increasingly saturated with the development of anti-PD-1 immunotherapies across the various lines of treatment, GlobalData expects developers of this drug class to increasingly focus on PD-1 combinations with other

targeted agents. This strategy is expected to improve response rates and treatment outcomes, and may help differentiate from competitors. Perdios continues, “GlobalData expects the development of safe and effective drug combinations involving anti-PD-1 immunotherapy to remain a significant R&D strategy for developers looking to compete with BMS during and beyond the forecast period.” Key Opinion Leaders (KOLs) interviewed by GlobalData report disappointment with the efficacy of current adjuvant interferon treatments for high-risk Stage II and III melanoma patients. GlobalData’s primary research confirms that a large proportion of

these patients receive surgery with no drug treatment and without entering clinical trials. KOLs reported that despite the availability of interferon adjuvant therapy, a significant portion of these patients will ultimately recur or progress to metastatic disease. Perdios adds, “As a result of this unmet need and the large patient pool, the melanoma adjuvant setting represents a lucrative opportunity for drug developers. We expect there to remain high commercial reward for developers of efficacious and well-tolerated drugs that can improve the cure rate and cater to this large population of patients.” EP News Bureau

MANAGEMENT

Global glaucoma market to reach $3.8 bn by 2026 The growth will be driven by the launch of pipeline products THE TOTAL glaucoma market was estimated to be $2.6 billion across the seven major markets (7MM-US, France, Germany, Italy, Spain, UK and Japan.) in 2016. This is expected to grow to $3.8 bn in 2026, at a Compound Annual Growth Rate (CAGR) of 4.1 per cent, according to GlobalData. The company’s latest report: ‘PharmaPoint: Glaucoma’ revealed that this growth will be driven by the launch of pipeline products. GlobalData anticipates that five products in the late-stage pipeline will enter the glaucoma market during the forecast period. These products include a first-in-class drug Santen’s DE-117 as well as one drug with an undisclosed MOA. Aerie’s fixed-dose combination

therapy, Roclatan, and two sustained-release (SR) implants are also set to launch during the forecast period. Thomas Moore, Healthcare Analyst, GlobalData, comments, “The late-stage pipeline drugs are set to have a significant impact on the glaucoma market, and be a key driver of growth throughout the forecast period. GlobalData forecasts that two pipeline products, Aerie’s Roclatan and Allergan’s Bimatoprost SR, will become the most successful drugs in the glaucoma market, with sales of $631.9 million and $609.5 million, respectively. Overall, GlobalData predicts that drugs that launch during the forecast period will account for 41 per cent of the global glaucoma market

in 2026.” Since 2014, the focus of pharmaceutical companies has begun to shift towards the development of new classes of glaucoma drugs, and this trend is expected to continue throughout the forecast period. Kowa’s Glanatec (ripasudil), launched in Japan in 2014, was the first Rho kinase inhibitor in the 7MM, and the first new class of glaucoma drug since Pfizer’s Xalatan launched in 1996. The glaucoma pipeline is set to continue this trend, with the recent approval of Valeant’s Vyzulta (latanoprostene bunod) and Aerie Pharmaceuticals’ Rhopressa (netarsudil) providing new classes of glaucoma drugs to ophthalmologists in the US.

Moore continues, “Some pharma companies have opted to continue the established strategy of reformulating existing drugs for glaucoma to provide added value. In particular, there are two late-stage pipeline products, Ocular Therapeutix’s OTX-TP and Allergan’s Bimatoprost SR, which contain established prostaglandin analogues reformulated into an SR implant. These products are set to address poor patient adherence in glaucoma patients, and are expected to have a significant impact on the glaucoma market.” Glaucoma is an established indication with a large number of treatment options available, and as a result the disease is generally associated with low

levels of unmet need. However, some unmet need does remain in this disease area, with the most significant generally considered to be a need for greater patient compliance. Moore adds, “The importance of the unmet need for greater compliance is reflected in the late-stage pipeline, which contains several products poised to help meet this unmet need. Specifically, there are two SR implants, Ocular Therapeutix’s OTX-TP and Allergan’s Bimatoprost SR, which will deliver drugs directly into the eye over several months, and thus avoid potential issues of noncompliance associated with topical medicines.” EP News Bureau

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RESEARCH UPDATES

YLB’s phase III clinical trial of Etanercept biosimilar meets positive outcome The study was a multinational randomised double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis in 11 countries

L Biologics (YLB) has announced that a global phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. YLB is the joint venture of Lupin and Yoshindo in Japan. The phase III study of YLB113 was a multinational randomised double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis (RA) in 11 countries. It compared YLB113’s efficacy and safety directly against Enbrel (of Amgen/ Pfizer) which has a global market of US $11 billion (IQVIA MAT Q3 2017), and is a widely successful biologic agent globally used for the treatment of multiple autoimmune disorders including RA. The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global RA trial in Japan.

The primary endpoint was an equivalent improvement in the RA, as measured by American College of Rheumatology 20 (ACR20) response rate. The ACR20 response rate of YLB113 has been found to be within a

pre-defined equivalence margin that is expected by most advanced regulatory agencies for marketing authorisation. In addition, safety and immunogenicity (antibody formation) of YLB113 was also found to be sim-

ilar to Enbrel indicating therapeutic equivalence. “We are excited by the positive results from the phase III trial. This helps us put together a robust regulatory dossier intended for global regulatory fil-

Takeda’s Zika vaccine gets US FDA’s ‘fast track’status The drug, TAK-426, is currently being tested on 240 patients between the ages of 18 and 49 and is in early stages of development JAPAN’S TAKEDA Pharmaceutical said that the US Food and Drug Administration had granted ‘fast track’ status to its vaccine for the mosquito-borne Zika virus, which erupted as a major public hazard in Brazil three years ago. The drug, TAK-426, is currently being tested on 240 patients between the ages of 18 and 49 and is in early stages

38 EXPRESS PHARMA February 16-28, 2018

of development. The virus might be responsible for an increase in birth defects in the US and its territories, the US Centers for Disease Control and Prevention said in a report last week. The Zika outbreak was declared an international public health emergency by the World Health Organization in

2016 due to linkages found between the virus and severe birth defects. The FDA’s ‘fast track’ designation aims to facilitate the development and expedite the review process for certain drugs and vaccines for serious conditions with unmet medical need. Reuters

ings for YLB113. We currently have multiple high value biosimilar candidates in our late-stage global development pipeline. We remain committed to advancing our biotech R&D capabilities so that more patients across the world can access affordable, high-quality biosimilars” said Nilesh Gupta, MD Lupin Limited. Dr Toshihiko Hibino, President of YLB expressed his satisfaction in achieving this important milestone that will recognise YLBs efforts in commercialising its first biosimilar for a crippling disease like Rheumatoid Arthritis in Japan. “We believe that it is our joint responsibility with our parent companies to subsidise the cost of RA treatment by offering a clinically equivalent biosimilar Etanercept to the Japanese patients”, he said. YLB is in the process of compiling a regulatory dossier for submission to PMDA for its marketing authorisation. EP News Bureau

Pfizer’s Xtandi delays prostate cancer spread in early stage disease Data shows that it took 36.6 months for the disease to spread to other parts of the body in patients who received Xtandi plus ADT USE OF Xtandi in early stage prostate cancer on top of standard hormone therapy reduced the risk of disease spreading or death by 71 per cent compared with hormone therapy alone, study results that could lead to significantly increased sales of the Pfizer and Astellas Pharma medicine. The data from a highly anticipated study released recently showed that it

took 36.6 months for the disease to spread to other parts of the body in patients who received Xtandi plus androgen deprivation therapy (ADT), a measure known as median metastasisfree survival. That compared with 14.7 months for ADT alone, a highly statistically significant difference of nearly two years. Subjects in the 1,400-patient study were deemed at elevated risk of developing metastases in the bones or elsewhere. “The findings from the trial are quite impressive in terms of delaying the visibility of the cancer,” said Dr Maha Hussain, the study’s lead investigator who will present the data at a cancer meeting in San Francisco later this week.

She noted that current treatments for this patient population are not life prolonging or significantly impactful, so there is a high unmet need for delaying development of metastases and progression to advanced cancer. “The data is very likely practice changing,” added Hussain, from the Robert H Lurie Comprehensive Cancer Center of Northwestern University. That would be good news for Pfizer and Astellas, providing a lucrative new outlet for Xtandi. The data has been submitted for review to US and European regulators, the companies said. Xtandi and rival drug Zytiga from Johnson & Johnson are currently approved for advanced cancer that has spread beyond the prostate. “The treatment opportunities are almost double than the current indication,” said Albert Bourla, COO, Pfizer. “And the financial interest is larger because the duration of treatment is longer.” Prostate cancer is the second most common cancer in men worldwide. More than 164,000 men in the US are estimated to be newly diagnosed with it this year. Adverse side effects were similar to those reported in previous Xtandi trials of more advanced cancer patients, the companies said. About nine per cent of patients in the Xtandi arm discontinued treatment due to side effects compared with 6 per cent of those on ADT alone. Major adverse cardiovascular events, such as heart attack, were reported in five per cent of Xtandi plus ADT patients versus three per cent with ADT. Xtandi also significantly delayed median time to prostate-specific antigen (PSA) progression, a biomarker tied to disease worsening - 33.3 months versus 3.9 months.

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Reuters

EXPRESS PHARMA

February 16-28, 2018

RESEARCH

Cancer risk elevated with severe gum disease Odds of developing colorectal cancer were increased particularly for non-smokers with severe gum disease, the researchers found PEOPLE WITH severe gum disease may be at greater risk for cancer, a US study suggests. “What this report does is continue the support of the idea that gum disease is not just a matter of what happens to our teeth,” said Dr Leonard Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society. Researchers performed dental exams on 7,466 individuals from Mississippi, Maryland, Minnesota and North Carolina and then monitored them for an average of 15 years. None of the participants had cancer at the start of the study. 15 years later, individuals with severe gum disease on the dental exam had a 24 per cent higher risk of developing any kind of cancer, and more than double the risk of lung cancer, compared to those with no or mild gum disease. Odds of developing colorectal cancer were increased particularly for non-smokers with severe gum disease, the

researchers found. These findings, based on actual dental exams, are consistent with prior studies that have used self-reports of gum disease, lead study author Dominique Michaud, professor of public health and community medicine at the Tuft’s School of Medicine, told Reuters Health. The researchers took cancer risk factors into account, including age, gender, weight status, smoking, race and socioeconomic status. In the study, being

older, male, black, less educated, obese or a smoker was more common with advancing periodontitis severity. Overall, researchers did not see links between periodontal disease and breast cancer, prostate cancer or blood or lymphatic-related cancers. Nearly half all Americans over age 30 suffer from some form of gum disease, according to the Centers for Disease Control and Prevention (CDC). Also known as periodontal disease,

the condition develops when bacteria in the mouth infect tissue surrounding the tooth, causing inflammation - which has long been associated with cancer risk. Unchecked, gum disease can progress to tooth loss. In the study, associations between gum disease and cancer were generally weaker, or not apparent among black participants, except for lung and colorectal cancers, the authors report in the Journal of the National Cancer Institute. Lichtenfeld, who was not involved in the study, said this could be due to additional barriers black Americans might face compared to their white counterparts. “There are issues for black Americans such as access to care, education and socioeconomic status. Although some of those factors were controlled (in the study), others were not, and that may make a sufficient difference such that periodontal disease may not be a

distinguishing characteristic among black Americans the same way it is among white Americans.” The study can’t prove that gum disease actually causes cancer. Furthermore, given that the dental exam predated the diagnosis of cancer, any faulty measurement of periodontal disease could produce an underor over-estimation of the correlation. Despite adjusting for smoking dose and duration in participants, the authors also said they could not rule out confounding by smoking, especially for lung cancer. The American Dental Association highlighted some factors that may have also influenced the findings; “Both income and health insurance are very influential predictors of whether someone can access timely and high quality dental or health care, and both income and health insurance patterns relate to race in the US.” Reuters

Sanofi and partner seek EMA review for sleep sickness product Fexinidazole is being developed in collaboration with the DNDi, a not-for-profit research organisation FRENCH HEALTHCARE group Sanofi, along with its business partner, has asked the European Medicines Agency (EMA) to review the fexinidazole product for the treatment of sleeping sickness, the company said. Fexinidazole is being developed in collaboration with the Drugs for Neglected Disease initiative (DNDi), a not-for-profit research organisation. It would be the first all-oral treatment under examination for Trypanosoma brucei gambiense human African trypanosomiasis (g-HAT), commonly known as sleeping sickness which affects many in Africa, added

40 EXPRESS PHARMA February 16-28, 2018

Sanofi. The EMA has accepted the application under a special procedure called 'Article 58' which allows the EMA to give a scientific opinion, in cooperation with the World Health Organization, for the evaluation of medicinal products intended exclusively for markets outside of the European Union. Human African Trypanosomiasis (HAT) or 'sleeping sickness' is a tropical disease affecting sub-Saharan African countries. Reuters

RESEARCH

Living kidney donors have low but elevated risk of renal failure Compared with non-donors,living kidney donors were almost nine times more likely to develop ESRD KIDNEY DONORS may be no more likely than other people to develop chronic health problems like diabetes or high blood pressure but they may still have an increased risk of renal failure, a research review suggests. “This study highlights the low but real risks of living kidney donation and emphasises the importance of careful assessment and counseling for all living donors,” senior study author Dr Emanuele Di Angelantonio, director of the NIHR Biomedical Research Unit in Donor Health and Genomics at the University of Cambridge in the UK, said. Compared with non-donors, living kidney donors were almost nine times more likely to develop end-stage renal disease (ESRD), severe kidney failure that requires people to receive a transplant or go on dialysis. Each year, the absolute risk of ESRD was 0.5 cases for every 1,000 living donors, compared with 0.1 cases for every 1,000 non-donors. Even though living kidney donation is the gold standard treatment for patients with ESRD, much of the research on the health effects for donors has offered an inconclusive picture of the long-term consequences of giving away a kidney, researchers note in the Annals of Internal Medicine. To get a clearer picture of the lasting health effects of donation, researchers examined data from 52 previously published studies that, combined, included a total of 118,426 living kidney donors and 117,576 otherwise similar individuals who weren’t donors. These smaller studies followed participants for an average of 1 to 24 years. Overall, there was no increased risk of death from all causes associated with being a living kidney donor, the research review found. Living kidney donors also didn’t appear to have an increased risk of developing cardiovascular disease, diabetes, high blood pressure or mental health problems. Women did have a higher risk of preeclampsia, a serious form of high blood pressure that can develop during pregnancy and endanger the lives of both women and their babies when it isn’t properly treated.

Among living donors, there were 5.9 cases of preeclampsia for every 100 pregnancies, compared with 3.1 cases for every 100 pregnancies among nondonors. One limitation of the study is that the control groups of non-donors in the analysis may not have been as healthy overall as the donors because of the stringent medical evaluations people must undergo to qualify to become living donors, the authors note. Another drawback is that some health problems related to donation might take decades to develop, making them impossible to detect in this study. “It’s safe to say that we now know a lot about what happens to kidney donors in the first 10 years after donation, but much less about what happens later,” said Dr Peter Reese, author of an accompanying editorial and a researcher at the University of Pennsylvania Perelman School of Medicine in Philadelphia. Donors younger than 25 should be particularly cautious about the potential long-term unknown risks of donation, since they might have many decades of life with only one kidney, Reese said by email. Patricia Sheiner, transplant surgeon and Director of Transplant at Hartford Hospital in Connecticut, who wasn’t involved in the study, told Reuters Health, “Even though the risk of kidney failure is higher in kidney donors than in the general population, the absolute incidence is still very low. However, it’s important that people considering donation understand the short-term and long-term risks. It’s also important that transplant programmes continue to carefully select suitable donors, excluding those who are at risk for developing conditions that could contribute to kidney problems.” “We must keep in mind that the results might be different if donors were followed up for 30 years,” Reese added. “It is possible that there are small increased risks of death or cardiovascular disease from kidney donation that were not recognised because many living kidney donors may be selected because of their overall good health.” Reuters

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EXPRESS PHARMA

February 16-28, 2018

RESEARCH

US FDAapproves Gilead triple HIVdrug The new Gilead drug’s label includes a boxed warning that use could worsen hepatitis B infection in certain patients THE US Food and Drug Administration has approved Biktarvy, Gilead Sciences' oncedaily, triple-combination tablet for treatment of HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market. Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide. Rival ViiV Healthcare, a joint venture majority-owned by GlaxoSmithKline with Pfizer and Shionogi, quickly

filed a lawsuit alleging that Gilead was infringing patents on ViiV’s dolutegravir, a component of the venture’s tripledrug HIV treatment Triumeq. Viiv is seeking 'financial redress', but is not asking for an injunction against sales of Biktarvy, according to Glaxo spokeswoman Sarah Spencer. Dolutegravir, sold under the brand name Tivicay and as a component of Triumeq, is a key growth driver for Glaxo, posting fiscal 2017 sales of nearly 4 billion pounds ($5.6 billion). The Gilead drug’s wholesale price, about $36,000 a year, is in line with current therapies, according to Guggenheim

Securities. The global market for HIV

drugs could reach as high as $40 billion a year by 2021, ac-

cording to pharmaceutical data company Quintiles IMS Institute, now known as IQVIA. The new Gilead drug’s label includes a boxed warning that use could worsen hepatitis B infection in certain patients. ViiV said it would seek to prove that Biktarvy infringed ViiV’s US and Canadian patents covering dolutegravir and many other compounds that include dolutegravir’s unique chemical scaffold. The US case was filed in the US District Court for the District of Delaware and the Canadian case in the Canadian Federal Court in Toronto. Reuters

Biogen stops testing Tysabri to Roche wins US FDA's treat stroke after study fails breakthrough therapy The company also has other drugs in mid-stage trials including treatments for Alzheimer’s disease and stroke BIOGEN WILL stop testing established drug Tysabri for the treatment of acute ischemic stroke after it failed a mid-stage study, the US drugmaker said recently. Tysabri, which made nearly $2 billion in 2017 sales, belongs to Biogen’s franchise of multiple sclerosis (MS) drugs that has driven much of the Cambridge, Massachusetts-based company’s explosive growth in recent years. Tysabri’s stroke trial comes as Biogen’s MS portfolio, which is led by top-selling drug Tecfidera, faces mounting competition from Roche’s Ocrevus and Sanofi's Aubagio. Analysts, who have viewed Biogen’s plans to develop Tysabri for stroke as risky, were unsurprised by the trial’s failure. “Tysabri’s failure in stroke this morning is likely to have limited impact, as our sense had

42 EXPRESS PHARMA February 16-28, 2018

In the midstage trial, Biogen’s treatment failed to improve patients’ selfdependence and their ability to perform daily activities been that expectations were quite low,” said RBC Capital Markets analyst Brian Abrahams. Ischemic strokes require

immediate medical attention and occur when blood supply is cut off to part of the brain. In the mid-stage trial, Biogen’s treatment failed to improve patients’ self-dependence and their ability to perform daily activities when compared with a placebo. Biogen also has other drugs in mid-stage trials including treatments for Alzheimer’s disease and stroke. Its closely watched Alzheimer’s drug candidate aducanumab is in late-stage testing, while another Alzheimer’s treatment failed a mid-stage study in December. “We continue to believe Biogen’s mid-stage neuro pipeline is scientifically sound and should generate more interest as programmes reach later stages,” RBC’s Abrahams said.

label for autism drug SWISS DRUG MAKER Roche said the US Food and Drug Administration granted its breakthrough therapy designation for Balovaptan to treat autism spectrum disorder (ASD), potentially accelerating its development and approval. Balovaptan, which may improve social interaction and communication in people with ASD, is being developed by Roche’s Swiss-based pRED research unit and has an expected filing date of after 2020, according to the company’s website. Autism spectrum disorder has no standard FDA-approved drugs for its core symptoms such as social interaction difficulties, communication challenges and a tendency to engage in repetitive behaviours. Roche said Balovaptan has shown the potential to improve social interaction and communication in people with ASD. “We look forward to working closely with the FDA in the hope that we can bring this medicine to these individuals as quickly as possible,” said Sandra Horning, Chief Medical Officer, Roche. Roche’s pRED research and development unit has historically lagged the output of its California-based Genentech unit, the source of nearly all its biggest sellers. Still, the Basel-based company has begun highlighting several pRED medicines, including Balovaptan, as among its top drug prospects. Reuters

Reuters

RESEARCH

Overactive bladder treatment may also lead to better sleep Childbirth is a common reason for weak pelvic muscles and obesity worsens the problem WOMEN WITH overactive bladder who take medication to address the problem may feel the urge to urinate less often and also sleep better at night as a result, a US study suggests. For the study, researchers examined data on 645 women with overactive bladder who were randomly assigned to take one of two doses of fesoterodine (Toviaz) to treat the condition or received a placebo, or dummy pill. After 12 weeks, women taking medication experienced greater decrease in so-called urge urinary incontinence than women on the placebo, and medication was also associated with less voiding at night and greater improvements in sleep duration, researchers report in Obstetrics & Gynecology. “Overactive bladder and urgency incontinence can disrupt sleep by causing overnight urgency, incontinence, bed wetting and getting up to urinate,” said senior study author Dr Leslee Subak, a researcher at Stanford University School of Medicine in California. “If we can treat the underlying problem, a woman (or man, but we only included women in this study) may experience less frequent symptoms and have less disruptions of sleep,” Subak said by email. Women are particularly prone to stress urinary incontinence, when the pelvic floor muscles are too weak to support the bladder. As a result, urine leaks during coughing, sneezing or exercise. Childbirth is a common reason for weak pelvic muscles and obesity worsens the problem. Urge incontinence, in contrast, doesn’t have a clear cause, although it can sometimes happen as a result of neurological problems, the au-

44 EXPRESS PHARMA February 16-28, 2018

thors note. Some women may get both types of incontinence at once or develop bladder problems from a urinary tract infection. In the current study, all of the women had urge incontinence and more than half of them reported poor quality sleep, defined as a score above 5 on a sleep-quality questionnaire. The participants were 56 years old on average and the majority were white. At the start of the study, women were having an average 4.6 episodes per day of all types of urinary incontinence, and 3.9 daily episodes of urge urinary incontinence in particular. After 12 weeks, women on the drug and in the placebo group experienced fewer episodes of incontinence, but for women on the drug the decrease was greater - they had

about one less episode per day of urge urinary incontinence than the women receiving a placebo, the study found. With medication, women also reported greater improvements in overall sleep quality, sleep duration and what’s known as sleep efficiency, or how much time people spend in bed asleep instead of awake. One limitation of the study is that it included generally healthy women, and results might be different for people who were elderly, frail or suffering from a variety of chronic medical problems. Even so, the findings offer fresh evidence of the potential for medications for urinary incontinence to help improve sleep, said Donald Bliwise, Director of the Program in Sleep, Aging and Chronobiology, Emory University School of Medicine in Atlanta.

“Any drug that decreases bladder activity or decreases the production of night time urine might improve sleep quality,” Bliwise, who wasn’t involved in the study, said by email. Beyond making people tired during the day, waking frequently during the night can lead to a variety of health problems, noted Dr Karel Everaert of Ghent University Hospital in Belgium. When treating overactive bladder improves sleep, other benefits may follow. “Sleep is extremely important to our health,” Everaert, who wasn’t involved in the study, said by email. “Lacking it kills people through cardiovascular disease and diabetes, and it is bothersome, sometimes also for our partners.” Reuters

GSK's shingles vaccine gets green light from EMApanel GLAXOSMITHKLINE’S (GSK) shingles vaccine moved one step closer to market after an European Medicines Agency (EMA) panel gave a positive opinion on the drug, which is a key product for the British drugmaker’s pipeline. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing approval for Shingrix, citing the drug’s ability to significantly decrease the incidence of herpes zoster and post-herpetic neuralgia compared with placebo. CHMP’s opinions are normally endorsed by the European Commission after a review. In October, the US Food and Drug Administration approved the vaccine for adults 50 and over. Shingrix is seen as an improvement over Zostavax, the only shingles prevention vaccine available, and sold by Merck & Co. GSK’s vaccine is considered a key product in its pipeline, with annual sales forecast to reach 1.03 billion pounds ($1.36 billion) by 2023, Thomson Reuters data shows. Shingrix has shown greater protection against shingles among the elderly than Zostavax. Four years after injection, the Glaxo vaccine remained about 90 per cent effective in people over age 70, while the efficacy of Zostavax declines noticeably over time. Older adults are most at risk for an outbreak of shingles, a painful, often debilitating blistering rash that results from reactivation of the varicella-zoster virus, which causes chickenpox and remains latent in those who have had that disease. Reuters

PHARMA ALLY VENDOR NEWS

Clariant launches EQius brand for humidity-control packaging solutions The new brand will be used as an umbrella brand for products currently marketed as EQ-Pak packets, EQ-Can canisters, EQ-Stopper closures and EQ-Bag bags

lariant, a world leader in specialty chemicals, and its healthcare packaging business unit, is introducing a new brand name to encompass all of the products and technology related to equilibrium relative humidity (ERH) stabilisation. The announcement was made at Pharmapack Europe 2018 (Paris, February 7 and 8). The new brand, Eqius, will be used as an umbrella brand for products currently marketed as EQ-Pak packets, EQCan canisters, EQ-Stopper closures, and EQ-Bag bags, along with the raw material that goes in them. The differ-

ent forms make it possible to customise humidity control throughout the drug-product development cycle, from bulk ingredients to finished pharmaceuticals. “When Clariant first introduced the ‘EQ’ concept, we

offered only two forms – packets and canisters,” recalls Elisa Le Floch, Business Development Manager, Clariant Healthcare Packaging. The EQius products are made using specially engineered sorbents that can act

as humectants (desorbers) and desiccants (adsorbers) simultaneously, maintaining a particular equilibrium relative humidity inside product packaging. This line of standard equilibrium-stabilizer products can maintain ERH levels of 10 per cent, 20 per cent, or 30 per cent to help protect finished drug products in bottles or tubes, or to help protect bulk ingredients (powders, capsules) in boxes or bags before, during, or after tableting or filling operations. “Specific drug properties may require that a specific range of humidity be maintain throughout the shelf life of a drug product or

ingredient.” Typical examples include micronized drug powders used in inhalers or gelatin capsules. In these and other applications both too much humidity and too little can cause unacceptable damage. The existing Clariant humidity-equilibrium products themselves will not change. Once fully in place, the EQius brandname – which will be clearly printed on each unit -can be expected to make things simpler for customers. This new single and strong brand will likely offer increased protection against counterfeiting. EP News Bureau

Waters newACQUITYArc Bio System brings advanced method transfer capabilities to routine bioseparations WATERS CORPORATION introduced the Waters ACQUITY Arc Bio System, a versatile, iron-free, bio-inert, quaternary liquid chromatograph specifically engineered to enable the efficient transfer and improvement of bioseparation analytical methods regardless of the LC platform on which the original method was developed. The ACQUITY Arc Bio System is ideally suited to run reversed-phase, ion exchange, size exclusion and hydrophobic interaction LC methods with minimal carryover and maximum recovery of biomolecules. The ACQUITY Arc Bio

System’s flow paths are made of non-stainless steel and ironfree bio-inert materials designed to minimise undesirable protein interactions and maximise system robustness under salt and pH extremes. What also sets the instrument apart is the unique Arc Multi-flow path technology which delivers plug-and-play compatibility with HPLC or UHPLC methods through a selectable dwell volume, emulating the dwell volume of the original instrument. This minimises the time it takes laboratories to redevelop methods from internal and external partners. In addition to replicating

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established HPLC assays, the ACQUITY Arc Bio System can improve the sensitivity, resolution and speed of chromatography methods by leveraging

more modern, more efficient 2.5 - 2.7 micron particle column technologies. These include the new Waters BioResolve RP mAb Polyphenyl solid core Columns for the reproducible analysis of intact or sub units of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). The system also supports previously developed ‘legacy methods on traditional 3 - 5 micron HPLC columns. The ACQUITY Arc Bio System is compatible with numerous detectors from Waters, including photodiode array, UV/Vis, fluorescence, refractive index, evaporative

light scattering and the ACQUITY QDa mass detector. In addition, the ACQUITY Arc Bio System features novel Auto Blend Plus Technology that automatically blends up to four solvents in any combination or proportion and allows the operator to programme in pH and ionic strength for ionexchange or size exclusionbased methods, or program in the organic solvent concentration and pH for reversed-phase gradient separations. This significantly reduces human error and the task of preparing buffered mobile phases manually. EP News Bureau

EXPRESS PHARMA

February 16-28, 2018

PHARMA ALLY PRODUCTS

Gandhi Automations' clean room doors a necessity DOES YOUR business plan include the development of an area in your plant for clean manufacturing? Better quality or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which the amount of dust and dirt in the area of the manufacturing needs to be limited. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One should know about the requirement for a specific product or process. Clean rooms have become an integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the door choosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where controlled environment is needed. The opening and closing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi Automations are engineered carefully with feature below:◗ Concept of low air permeability in pressurized rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h ? 50 PA . ◗ Control device enclosure in Stainless Steel SS 316

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off : +91 22 66720200 / 66720300(200 Lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

46 EXPRESS PHARMA February 16-28, 2018

PHARMA ALLY

Ziath showcases low-profile 2D barcode scanner for liquid handling systems at SLAS2018 ZIATH SHOWCASED its new, cost-effective 2D barcode rack scanner, the DataPaq Mirage, at SLAS2018 at San Diego, CA. This innovative camera-based scanner has a low-profile design enabling it to be easily integrated with robotic liquid handling systems, as well as other laboratory automation solutions. As a result, the DataPaq Mirage allows the benefits of a more sophisticated camera-based 2D barcode rack scanner to be brought to automation workflows for the same price as an old flatbed scanner. Researchers working in biotechs, academia, and pharma frequently manage a large number of samples and, as a result, require automated solutions to assist with routine techniques, such as liquid dispensing. Most

camera-based scanners are too tall for use on liquid handling workstations; however, the patent-pending technology of Ziathâ€™s DataPaq Mirage utilises a mirror to give the scanner a more compact design. The low-profile DataPaq Mirage enables easy integration with liquid handling systems, as well as other laboratory automation solutions, allowing samples in SBS format racks to be efficiently scanned and recorded at the point of processing. Despite the compact nature of the DataPaq Mirage, its powerful camera system means the depth of image focussing is not compromised, ensuring that a variety of 2D-barcoded tubes can be quickly and reliably scanned. Contact details info@ziath.com

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EXPRESS PHARMA

February 16-28, 2018

PHARMA ALLY VALUE ADD

Evolution of temperature and humidity monitoring in pharma From psychrometers, to chart recorders and finally highly automated smart data loggers, pharma monitoring has come a long way. An insight by Ishan Dave, Enterprise Sales Manager, Inventrom TEMPERATURE and humidity are critical parameters for several pharmaceutical manufacturing and storage processes. Over the past few decades, several guidelines dictated by WHO and FDA have come to place, and have been adopted by pharma companies across the globe.

Golden days of chart recorders and hygrometers In the old days, wet and dry bulb hygrometers were the last word in temperature/humidity logging and in-fact, are still in use in a few pharma companies. While these are reasonably accurate and dependable, it is incredibly hard to maintain them over a long period. Firstly, it should be ensured that sufficient purified water is present in the cistern and that the wick is clean and wet at all times. Secondly, the wick has to be kept clean and often needs replacement as well. Even logging data requires extensive human intervention, which ends up taking a lot of time and resources. In the past, another device used extensively in pharma companies for monitoring temperature and humidity was the traditional chart recorder. Chart recorders use bi-metallic coil technology. A pointer, or stylus, is attached to the end of a bi-metallic coil, and that moving pointer can record temperatures on a strip of moving chart paper beneath the stylus. While these recorders make it easier to retrieve historical data and observe large excursions in temperature/humidity, they are often not accurate enough to meet stringent pharma monitoring guidelines.

48 EXPRESS PHARMA February 16-28, 2018

Circular Chart Recorder

BTHM Dashboard

Wet and Dry Bulb Hygrometer

Also, mechanical equipment with coils and moving parts are susceptible to mechanical wear and tear. Furthermore, newer WHO GMP guidelines dictate that not only should temperature/humidity values be logged, but the monitoring equipment must alert the right personnel remotely if there is any unwanted excursion. Enter - Data Loggers. Data loggers are digital instruments that use sensors to log and document parameters. Temperature and humidity log-

gers have already replaced the traditional chart recorders and hygrometers due to several reasons.

The benefits of going digital Temperature and humidity data loggers are a large departure from traditional chart recorders. Not only do they log data in real time, but make data download + logging tamper proof and automatic. This means that pharma companies no longer need to keep a human

resource who manually logs data from recorders every two hours, and can also rest assured that the data recorded does not have any scope for human error. Going digital also makes remote monitoring easy. For example, Inventromâ€™s BTHM Bolt temperature and humidity monitors allow environmental conditions to be monitored so that any out-of-range condition triggers an SMS, email message or desktop alert on a computer or the company network. BTHMâ€™s dedicated online dashboard also lets you analyse data in real time and allows you to download temperature/humid-

ity data for audit reports.

The future IoT devices like the BTHM are cutting edge in temperature/humidity monitoring for Pharma. More and more companies are shifting to IoT solutions, as the modern solution for temperature and humidity recording. Does this spell the end for chart recorders in the industry? Not necessarily. What it does mean is that products like the BTHM, which boast a wide sensor range, higher accuracy and real time visibility into pharma operations are slowly becoming the norm for critical process monitoring.

PHARMA TECHNOLOGY REVIEW

Saama in partnership with Informa Pharma Intelligence’s Citeline The partnership will bridge clinical trial information to real world evidence for unprecedented customer experience

aama Technologies, a leading clinical analytics company, and Citeline, part of Informa Pharma Intelligence’s suite of pharmaceutical and biomedical research and analysis solutions, unveiled a strategic partnership that will disrupt and advance the existing clinical trial landscape. The alliance integrates Saama’s cutting-edge artificial intelligence, machine learning and deep learning solutions with Citeline’s new application programming interfaces (APIs) to link global clinical data with real world data. Customers will benefit from unmatched analytic insight for planning and conducting clinical trials. “Saama is excited to partner with Citeline and apply our award-winning AI-enabled technologies to their outstanding clinical trial registry data to realise trial planning and conduct solutions that accelerate clinical outcomes for improved patient care,” said Luke Stewart, Director of Product Management, Saama. “This is a new level of innovation in the clinical trial space. Structured and unstructured real world data can be intelligently leveraged to accelerate a proposed clinical trial based on the performance of related trials, sites, and investigators, all through an integrated user experience.” “Through partnering with Saama, we’re able to collectively provide next-level solutions that enable our joint customers to overcome clinical development challenges, gain industry insights, and optimise trial success,” said Jason Tse, Head of Strategic Partnerships, Informa Pharma Intelligence. “This partnership will expand the boundaries of clinical trial planning through the incorporation of real world data and the ability to bridge multiple data points in one platform.”

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PHARMA TECHNOLOGY REVIEW

F-Star collaborates with Takeda to fight Alzheimer’s Changes that occur to neurons in the brain as Alzheimer’s disease progresses F-STAR’S BISPECIFIC antibody technology has received validation in the form of two pharma companies using it for the development of new drugs for neurodegenerative diseases. San Franciscobased Denali Therapeutics and Japanese company

Takeda will collaborate on up to three candidates that originate from F-star’s development pipeline. Each drug has been developed for a specific genetically validated target and uses Denali’s Antibody Transport Vehicle (ATV) to help therapeutics across the

blood-brain barrier. Although F-Star will not receive any money from the latest deal, it does provide strong support for the biotech’s technology. Takeda will pay an initial $150 million (€122M) in the form of cash and the purchasing of equity in Denali, as well

as milestone payments of up to $90 million (€73M). In return, Denali will take care of the development and costs until the filing of Investigational New Drug (IND) applications. At this point, Takeda can decide whether or not it would like the support of Denali during

clinical development. The two pharma companies will form a powerful force in the neurodegenerative diseases field, which TauRx COO/CBO, Tim Earle, described to us as “the last unclaimed therapeutic space.” EP News Bureau

APPOINTMENT

ACG appoints Steven Facer as Vice President – Europe Facer will be responsible for supporting ambitious growth plans for the company’s capsules business across the region ACG HAS appointed Steven Facer as Vice President – Europe. In his role, he will be responsible for supporting the ambitious growth plans for the company’s capsules business across the region and continue to develop the sales and customer support teams to provide real proximity for European customers. Facer brings with him more than 25 years of pharmaceutical and healthcare experience

50 EXPRESS PHARMA February 16-28, 2018

spread across global markets. Facer headed Colorcon as the Managing Director EMEA before being appointed as Senior Vice President at Capsugel, where he was responsible for the EMEA region. He has also served as Vice President at Catalent Pharma. Facer takes over from Keith Nazareth, who will be retiring following a 27-year career with ACG, where he was responsible for setting up and growing the

company’s established European business. Commenting on the appointment, Selwyn Noronha, CEO, Capsules at ACG, said, “We’d like to welcome Facer to the team. The roles that Facer has previously worked in provide him with operational plant and commercial experience, which gives him a holistic view of the sector and will help us achieve our regional development plans.”

Facer added, “ACG has ambitious growth plans and I am looking forward to undertaking this challenge and being part of this exciting journey. “ACG is an exciting brand, with the capsules business already having created a strong foothold in the European market, but there is still a lot of opportunity available and we have some exciting announcements to make in the coming months.” EP News Bureau

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PHARMA LIFE APPOINTMENT

Novartis India appoints Jawed Zia as VC and MD His appointment is effective March 1, 2018

t a recently held meeting in Mumbai , the Board of Directors of Novartis India announced the appointment of Jawed Zia as VC and MD effective March 1, 2018. Jawed Zia is currently Head Pharmaceuticals, Novartis India. He has a wealth of experience gained in various geographies and functions in the healthcare sector across the globe. Having joined Ciba-Geigy in 1987, he has had a successful career history working across pharmaceuticals, consumer health and devices in positions of increasing responsibility in various functions of market research, brand management, marketing management,

66 EXPRESS PHARMA February 16-28, 2018

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