Express Pharma (Vol.11, No.1) November 1-15, 2015 by Indian Express

VOL. 11 NO. 1 PAGES 70

www.expresspharmaonline.com

Management A wake up call on NCDs Research ‘Spiolto will allow patients to lead a more normal life’

1-15 NOVEMBER 2015,` 40

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CONTENTS Vol.11 No.1 NOVEMBER 1-15, 2015 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

AWAKE UP CALLON NCDS Changing lifestyles have led to an alarming growth of NCDs in India. Realising the need to tackle this menace and the burden it poses on the economy, the government has prepared a draft policy for NCDs with several amendments to the earlier NPCDCS and intends to legislate it soon | P30

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Harit Mohanty - West & East Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P34: RESEARCH UPDATE J&J’s Stelara succeeds in phase III Crohn's disease trial

Werum IT Solutions and Sarla Technologies sign MoU

‘WE DO NOT ENVISAGE LAUNCH OF FERTIN’S OWN BRAND’

GOVT RESTRICTS PHARMA COS FROM GIVING GIFTS TO DOCS

PRIVATE PLAYERS IN E-PHARMACY SPACE FORM ASSOCIATION

RECIPHARM TO ACQUIRE MAJORITY STAKE IN NITIN LIFESCIENCES

CIPLA MEDPRO, SERUM INSTITUTE INDIA IN AGREEMENT

43 33

'SPIOLTO WILL ALLOW PATIENTS TO LEAD A MORE NORMAL LIFE'

Lupin appoints Fabrice Egros as President of its Asia-Pacific Business

LILLY PILL TRUMPS HUMIRA IN ARTHRITIS STUDY

P64: INITIATIVE

ABBOTT DISSOLVING STENT SUCCEEDS IN PIVOTAL US TRIAL: STUDY

P64: APPOINTMENT

Sanofi celebrates ‘Joy of Giving’ week

PHARMA ALLY

P37: VENDOR NEWS

Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

RESEARCH

MARKET

OVERCOMING A DEVELOPMENT CHALLENGE: CHARACTERISING AGGREGATED MATERIAL IN FORMULATED PRODUCT

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. 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.

EDITOR’S NOTE

Finding the hidden gems

ishal Jajodia could sign up as a poster boy for Prime Minister Narendra Modi's Make In India campaign. Vishal who, do I hear you say? Jajodia heads Mumbai-based Swati Spentose, one of India's numerous API manufacturers. But along with the usual APIs, he chose to focus on generic Pentosan Polysulphate Sodium (PPS), which as Janssen Pharmaceuticals/Johnson & Johnson’s Elmiron, is the only oral medication approved by the US Food and Drug Administration (FDA) for the treatment of interstitial cystitis (IC). The FDA Office of Orphan Products Development designates “orphan products” as those that treat rare diseases affecting fewer than 200,000 Americans and by this definition, PPS qualifies as an orphan drug. So why did Jajodia choose an API that by definition targeted a small patient population and therefore had limited growth potential? And how did he managed to clock eight per cent revenue growth, from a little above ` 5 crores to nearly ` 43 crores in the last five years? Read more about his entrepreneurial story in this issue’s cover story, Small is the next big? (pages 26-29) That headline could probably end up being prophetic. Because it's not coincidence that Jajodia's story has quite a few similarities to Sun Pharma's Dilip Shanghvi’s own story. Both have a Kolkata connection, both started as traders of chemicals and pharma intermediates before moving to Mumbai and becoming manufacturers. Both entrepreneurs decided to make their play in niche areas, a savvy strategy that saw Shanghvi unseat Mukesh Ambani as India's richest person not too long ago.

Swati Spentose’s story is mirrored across India's pharma landscape, with manyAPI manufacturers evolving up the value chain and vying to expand their global footprint

Though Jajodia emphasises that “we are a very small company” at every opportunity, one cannot deny the potential in his strategy, and applaud his determination to “pump in a lot of investment in research.” Perhaps the fact that he sees PPS as not just a business bet but also as a social cause will give him that slight edge in a crowded market. His aim is of course to increase his market base, but is also concerned that there is a lack of awareness about IC both among patients and doctors, as it is a much misunderstood and misdiagnosed diseased condition. Swati Spentose's story is mirrored across India's pharma landscape, with many API manufacturers evolving up the value chain and vying to expand their global footprint. In the coming issues, we hope to feature many more such examples in our attempt to find the hidden gems. Unlike IC, diabetes gets a lot of press through the year and reaches a crescendo around November 14, World Diabetes Day. But despite the awareness campaigns, diabetes continues to add to the NCD disease burden. Pegged to be the ‘Diabetes Capital of the World’, India’s policy to deal with diabetes has seen a few twists and turns. Prevention and control of diabetes is now packaged with cancer, CVD and stroke into one programme under the draft National Health Policy 2015. Our story, 'A wake up call on NCDs' (pages 30-32), reveals that experts are divided on the pros and cons of this U-turn in health policy, but all agree that whatever the policy, execution is the key to sustainable outcomes. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET I N T E R V I E W

‘We do not envisage launch of Fertin’s own brand’ Fertin India, a fully-owned subsidiary of Denmark-based Fertin Pharma, is soon going to start operations at its Goa plant. S Ravi Kumar, Managing Director and CEO, Fertin India, reveals more to Sachin Jagdale

How effective will the nicotine-based chewing gum be as it still has nicotine in it? This is a product invented almost 25 years ago and in use worldwide by many multinational companies as a pharma product with all regulatory approvals.

Bi-layered tablets

Is there any possibility of Fertin Pharma launching its own brand in future? What are the challenges in doing so? We have sold our brands in Europe about 12 years ago and see ourselves as a B2B manufacturer. We do not envisage launch of Fertin’s own brand, but a co-owned brand could be explored and / or as part of a JV with suitable partners.

You have adopted a B2B model. Who are your business partners? Will this model suit the Indian market (as the leaders in this category have their own brands)? If yes, how? Business partners are under discussion and we will let you know when finalised. This model has been found to be effective for us globally for almost 25 years now. In our discussions with potential partners for India also, this model has a very positive response. Are there any chances that your B2B partners from Denmark would shift to an Indian manufacturing plant? Our current MNC partners to whom supplies are being made from Denmark for the European, Australian and the US markets are also evaluating their entry into the Indian and South East Asian markets and supply for these markets will be from Fertin India, Goa. However, supplies to other markets will continue as currently from our Denmark plant.

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Fertin Pharma will soon inaugurate its Goa plant. How much have you invested in the same? What is its capacity? Our current investment is `30 crores and total capacity of the plant is 300 metric tonnes per year.

Fertin has patented compressed technology, bi-layered nutraceutical gums in oral care, energy, weight management, multi vitamins and many other categories which are under development

Which will be the export markets for the Goa plant? South East Asia, Middle East, North Africa, Latin America. As India is the cost sensitive market, have you set any condition for your B2B partners regarding the final price of the product? We aim to provide the market with products developed and manufactured with Fertin’s renowned world-quality at a competitive value pricing.

What percentage of revenue rise is expected for Fertin India with the launch of Goa plant? We aim to reach 95 per cent plant capacity and take market leadership in less than five years. Besides nicotine based chewing gums do you have plans to launch any other medicated chewing gums in India? Yes, nutraceutical bi-layered chewing gums have been of major interest to various partners and discussions are ongoing. Fertin has patented compressed technology, bilayered nutraceutical gums in oral care ( teeth whitening, sensitive teeth etc) , energy, weight management, multi vitamin and many other categories which are under development. Apart from these, in the core pharma segment, we aim for many therapeutic categories where buccal absorption plays a key role and which could be incorporated in a chewing gum format. Many concepts are under development and will be discussed with potential partners for commercialisation. sachin.jagdale@expressindia.com

COMPANY WATCH

Govt restricts pharma cos from giving gifts to docs DoP’s Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) prohibits companies from supplying drugs as samples PHARMA companies may soon be barred from giving any gift, cash or offer hospitality to doctors, as government is considering making it mandatory for them to follow uniform marketing practices code. The Department of Pharmaceuticals (DoP) has prepared the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) and its voluntarily adoption and compilation was started from January 1 this year. The code also prohibits companies from supplying

drugs as samples, which are used to treat depression, inducing sleep such as hypnotic, sedative or tranquilliser. As per the code, the companies should not offer any gift or benefits in kind or offer foreign trips to doctors and if any firm was found following such practices, it could be expelled from the association. “As of now it is voluntary for pharma companies to follow UCPMP, but we are considering to make it compulsory in next few months,” a senior government official said.

As per the code, companies can extend funding for medical research and study through approved institutions

A process has already been started to rework the entire code so that it could be made compulsory and the department will hold discussions for the same with all stakeholders including industry, Medical Council of India and others, the official added. Discussions will also take place with Drug Controller General (India), Ministry of Health and Family Welfare and NGOs, the official said. The marketing code which also cover medical devices sector was initially implemented

from January 1 this year for a period of six months, which was extended for two months till August 31 and now has been extended for four months till December 31 this year. As per the code, companies can extend funding for medical research and study through approved institutions as per law and it should be fully disclosed. The code also have stringent measures for audio video promotional activities and for the supply of free samples of medicines. PTI

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MARKET

Lupin in agreement with BI Lupin to market Linagliptin for Boehringer Ingelheim under the brand name Ondero and Ondero Met in India LUPIN AND Boehringer Ingelheim (BI) have announced a joint strategic alliance for co-marketing linagliptin, a novel Dipeptidylpeptidase-4 (DPP-4) inhibitor in India. BI has a strong presence in the DPP-4 Inhibitors market in India which is growing at 27 per cent. According to the agreement, Lupin will market and sell linagliptin under a separate brand name Ondero (monotherapy) and Ondero Met (fixed-dose combination with metformin) which will be promoted by Lupin’s 400 strong dedicated diabetes speciality field force. BI will continue to sell its linagliptin under the brand names Trajenta (monotherapy) and TrajentaDuo (fixed-dose combination with metformin) through their existing sales force and network. Ondero tablets (monotherapy) are indicated as an ad-

According to the agreement, Lupin will market and sell linagliptin under a separate brand name Ondero (monotherapy) and Ondero Met (fixed-dose combination with metformin) junct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. Ondero Met tablets (fixed-dose combination therapy) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both linagliptin and metformin is appropriate. Shakti Chakraborty, Group President, India Re-

gion Formulations, Lupin said, “I believe our entry into the high growth DPP-4 Inhibitor market with the launch of Ondero and Ondero Met will not only strengthen our diabetes portfolio but also help us consolidate our position as a market leader and the fastest growing player in the TOP 5 in the anti-diabetes segment.” Sharad Tyagi, Managing Director, Boehringer Ingel-

heim India said, “We are pleased to partner with Lupin for the sales and promotion of linagliptin as Lupin has a strong play in the anti-diabetes segment with a robust product portfolio. The partnership is aligned with our commitment towards addressing challenges in treatment of chronic ailments like diabetes by providing broader access to innovative medicines. It is an ideal partnership where BI brings the research and scientific excellence for linagliptin, and Lupin their marketing excellence and brand equity amongst key clinician categories to drive and facilitate product access. Boehringer Ingelheim India will continue to introduce innovative products to address the unmet patients’ needs amidst the growing Indian diabetes epidemic.” EP News Bureau-Mumbai

CCI extends deadline for bids to conduct pharmastudy The anti-trust regulator wants to understand whether there are unfair practices in the sector as part of larger efforts to clamp down on anti-competitive business practices THE COMPETITION Commission of India (CCI) has extended the deadline for submitting bids to carry out a detailed study of pharma and healthcare services sector in the national capital region. The antitrust regulator is planning the study to understand whether there are unfair practices in this sector as part of larger efforts to clamp down on anticompetitive business practices and has also passed many orders in this regard. In recent years, CCI has

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come across various instances within the pharma sector where competition norms seem to have been violated. ‘Entities interested in conducting ‘baseline study/ survey in the pharmaceutical sector and healthcare delivery system/ services in Delhi & NCR region,’ for CCI can now submit their bids till November 5, 2015. The earlier deadline for submission of bids ended on October 17, 2015. Under the proposed study, public and private hospitals, in-

surance companies, pharma firms and their associations, doctors and their associations, among others, would be covered. While inviting Expression of Interest (EOI) in September, the watchdog had said that it came across various issues in pharma sector and healthcare delivery systems/ services. These include ‘non-availability of essential medicines, increasing price of drugs, nexus between pharma companies and pharmacists, nexus

between pharmacists and doctors, nexus between doctors and pathological laboratories, nexus between doctors and pharmaceutical companies, and nexus between hospitals and insurance companies etc,’ it had said. As per CCI, the primary objective of the baseline study/ survey is to collect information and credible evidences on competition issues in the concerned sector and present the same in an analytical manner. PTI

Sphaera Pharma receives USPTO nod SPHAERA PHARMA has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled ‘Substituted methylformyl reagents and method of using same to modify physicochemical and/ or pharmacokinetic properties of compounds’, for its proprietary platform technology. Drug Modification Technology (DMT) platform can help address sub-optimal physicochemical and pharmacokinetic properties of approved drugs and drugs in development. Sphaera’s technology allows for improved delivery of a drug, parenterally or orally, by improving its pH independent solubility and can be easily implemented for almost any drug. Some applications include development of pediatric formulations and alternate dosing forms for approved drugs. Sphaera is advancing multiple drugs using this approach through the various stages of pre-clinical and clinical development and expects the first US FDA approved clinical trial in the US with a NCE developed using this technology by a licensee early next year. Dr Sundeep Dugar, Founder, Sphaera Pharma said, “We are pleased by this development. This not only brings significant credible external validation of the quality of intellectual property developed by Sphaera but also increases the value of drugs developed using this platform for our current and potential partners. Our DMT platform provides an excellent opportunity for existing generic companies to move up the value chain by rescuing, recovering, re-purposing and re-positioning of drugs.” EP News Bureau-Mumbai

MARKET

Private players in e-pharmacy space form association Indian Internet Pharmacy Association wants to make sure that its members adhere to the rules governing pharmacies and the dispensing of prescription medications AMID A nationwide strike of chemists against ‘illegal’ online sale of medicines, private players in the e-pharmacy space have come together to form an association. “The Indian Internet Pharmacy Association (IIPA) officially formed with the mission to promote and protect the public health by ensuring that its members operate in accordance with the existing Drugs & Cosmetics Rules…of Information Technology Act, 2008, and Pharmacy Practice Regulations, 2015,” IIPA said in a statement. With growing penetration and awareness of e-commerce companies enabling retailing of medicines and healthcare products, IIPA wants to make sure that its members adhere to the rules governing pharmacies and the dispensing of prescription medications. IIPA will cater to public’s demand for safe and easily accessible medicines at affordable prices. It also aims to be at the forefront to fulfil the Prime Minister’s vision for a Digital India, it added. The association claimed that it brings together some of the most credible and successful companies from both the pharma and e-commerce industry. The current 11 member list includes Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com (PM Health & Life Care), SaveOnMedicals, Savemymeds and 1mg.com. It would ensure that partners operate in the interests of the public, and would therefore, be extremely selective in its screening process and would only allow ‘the best of the best’ to earn the association’s approval. The main goal of this association is to ensure its members operate in harmony with the requirements of the consumers and the regulator, keep fly-by-night operators out

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of the business and to bring the ‘best of the West’, where online pharmacies are fairly

mature, to India, Prashant Tandon, President, IIPA said. “We welcome and applaud

the regulators’ announcement that they are on a path to draft guidelines to regulate the new

model,” said Kiran Divakaran, General Secretary, IIPA. PTI

MARKET

Recipharm to acquire majority stake in Nitin Lifesciences The former will acquire 74 per cent of the shares for an estimated purchase consideration of ` 6,712 million on a cash and debt free basis SWEDEN-BASED contract development and manufacturing organisation, Recipharm has entered into an agreement whereby it will acquire a majority stake in Nitin Lifesciences, an Indian sterile injectables CMO, currently owned by the Sobti family. Recipharm will acquire 74 per cent of the shares for an estimated purchase consideration of ` 6,712 million on a cash and debt free basis. Recipharm will join forces with the founding and managing owners, the Sobti family, in order to further grow the current business with demanding domestic and multinational customers into a leading position in the Indian sterile CDMO market. Thomas Eldered, Chief Executive Officer, Recipharm said, “I am delighted to be entering into this partnership with the current owners who have successfully expanded and grown the company to

Recipharm will acquire 74 per cent of the shares for an estimated purchase consideration of Rs 6,712 million on a cash and debt free basis. Recipharm will join forces with the founding and managing owners, the Sobti family, in order to further grow the current business what it is today. It is our stated aim to have a more global footprint and participate in the good opportunities that emerging markets bring. The Indian market is particularly attractive showing high growth levels and the transaction firmly establishes Recipharm’s emerging market

strategy. Nitin Lifesciences can also be used as a platform for entry into other regions. We are fortunate to have found such a high quality business and management and we are looking forward to utilising this opportunity to support our current customers’ strategy in the Indian domes-

tic market.” Dr Chetan Sobti, Chief Executive Officer, Nitin Lifesciences said, “I am very much looking forward to this partnership with Recipharm. We have grown tremendously in the domestic market, attracting new multinationalcustomers by offering high quality and service. We believe that with the support and network of Recipharm, we shall be able to further expand and continue to grow both domestically and outside the Indian market.” Nitin Sobti, COO, Nitin said, “We are delighted to be establishing this new partnership with Recipharm. It will significantly add to our service offering for Indian customers by way of new technologies, best in class account management as well as global standards of GMP and regulatory compliance.”

Agreements signed with Kenyan government and NGOs include programmes to distribute medicines, raise disease awareness and strengthen healthcare system capabilities in key NCDs

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launch of the access portfolio and to support effective treatment of chronic diseases in Kenya, Novartis will partner with the Kenyan Ministry of Health, the Kenyan Red Cross, the Kenyan Conference of Catholic Bishops (KCCB), the Christian Health Association of Kenya (CHAK), Management Sciences for Health (MSH) and other key stakeholders. These collaborations are intended to support the healthcare system through measures such

as reinforcing drug distribution channels and training healthcare workers to diagnose and treat chronic illnesses. Novartis is also collaborating with Boston University in the US to measure the impact on health in Kenya and steer ongoing development of Novartis Access. The Novartis Access portfolio includes patented and generic Novartis medicines. The products have been selected based on the World

THE US health regulator, US FDA, has banned imports of human and animal drugs manufactured by Mumbai-based Megafine Pharma at its Lakhamapur plant in Maharashtra over non-compliance of manufacturing norms. The import alert by US FDA on the drugs made at the facility entails ‘detention with-

EP News Bureau-Mumbai

Kenya launches ‘Novartis Access’ NOVARTIS ANNOUNCED the launch of Novartis Access in Kenya, the first country to benefit from a portfolio of 15 affordable medicines to treat cardiovascular diseases, diabetes, respiratory illnesses, and breast cancer. The Novartis portfolio is being offered to the Kenyan government, non-governmental organisations and other public-sector healthcare providers for $1 per treatment, per month. In conjunction with the

US FDA bans import from Megafine Pharma’s M'rashtra facility

Health Organization’s Essential Medicines List and are among the most commonly prescribed medicines. Following Kenya, Novartis Access will be launched in Ethiopia and Vietnam. Over the coming years, Novartis plans to roll out Novartis Access to 30 countries, depending on demand. Novartis expects this new approach to be commercially sustainable over the long term, enabling continuous support in those regions. EP News Bureau-Mumbai

out physical examination of drugs from firms which have not met drug Good Manufacturing Practices (GMPs).’ Under the import alert 6640, the authorities ‘may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert,’ as per the US FDA notice on its site. Megafine manufactures APIs and advanced intermediates for itself but also contract manufactures for global drug discovery and generic companies. The company has presence in more than 40 countries, as per the information on its site. EP News Bureau-Mumbai

MARKET

Cipla Medpro,Serum Institute India in agreement To provide vaccines in South Africa

provals such as product registrations and marketing authorisations. Cipla Medpro has exclusivity and first right of refusal of the SII pipeline within South Africa.

Adar Poonawalla, Chief Executive Officer and Executive Director, SII said, “SII is looking to extend the strong partnership it has with Cipla in Europe and India by working with Cipla Med-

pro in South Africa.” “We are confident that this agreement will support the Department of Health in rolling out its expanded immunisation programme. Cipla Medpro will con-

tinuously look to partner with organisations that are aligned with the company’s ethos of advancing healthcare for all,” concludes Miller. EP News Bureau-Mumbai

CIPLA’S SOUTH African subsidiary Cipla Medpro has entered into an exclusive agreement with Serum Institute of India (SII) in South Africa. The partnership will enable affordable and accessible vaccines for South Africans, and also facilitate a reliable supply stream to the South African Government. Paul Miller, Chief Executive Officer, Cipla Medpro, South Africa said, “This agreement will enable Cipla Medpro to become a significant player in the market. With a presence in 140 countries and 1.3 billion doses manufactured and sold, SII is an ideal ally

The partnership will enable affordable and accessible vaccines for South Africans

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for Cipla Medpro and this partnership will be instrumental in addressing the national vaccine shortage.” SII manufactures a variety of vaccine classes including vaccines for polio, diphtheria, tetanus, BCG (Tuberculosis), Hepatitis B, measles, mumps and rubella. South Africa will be participating in the majority of these portfolios. Michel Baijot, Head of Vaccines, Cipla said, “This Cipla Medpro – SII agreement reflects again the complementarities of our two like-minded companies in bringing high quality, affordable vaccines to more countries.” The agreement stipulates that Cipla Medpro will become the holder of all Medical Control Council (MCC) regulatory ap-

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IPM clocks ` 8626 crores in Sept 2015 12 therapies have outgrown the IPM growth

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MAT

MAT Sept-15 MTH

IPM Sun + Ranbaxy

THE INDIAN Pharmaceutical Market (IPM) clocked ` 8626 crores in September 2015. It has grown at 9.9 per cent in the same month. Amongst the top 10, Zydus grew by 12.6 per cent followed by Lupin at 12.4 per cent and Sun at 11.8 per cent. 20 corporates have crossed the growth of IPM amongst the top 50. Amongst the top 50 corporates, Wockhardt had the highest growth of 42.3 per cent followed by Troikaa at 38.2 per cent and AstraZeneca at 37.8 per cent. 18 corporates have shown growths of more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Intas had the highest growth of 27.4 per cent followed by Micro at 16.7 per cent and Torrent at 16 per cent. Amongst the 21-30 ranked corporates, Wockhardt had the highest growth at 42.3 per cent followed by MSD at 33.1 per cent and Novartis at 9.7 per cent. Amongst the 31-40 ranked corporates, AstraZeneca had the highest growth at 37.8 per cent followed by Bharat Serums at 19.1 per cent and Wallace at 19 per cent. Amongst the 41-50 ranked corporates, Troikaa had the highest growth at 38.2 per cent followed by Fourrts at 9.9 per cent and Allergan at 5.5 per cent. Amongst the 51-60 ranked corporates, Boehringer Ingelheim grew at 43.4 per cent followed by Corona at 21.5 per cent and Hegde and Hegde at 19.5 per cent. Amongst the 61-70 ranked corporates, Fresenius Kabi grew at 63.7 per cent followed by RPG by 19.4 per cent followed by TTK at 16.3 per cent. Troikka had become the 50th biggest corporate on MAT Basis and Wallace 40th Biggest Corporate in IPM. Amongst the top 10, Zydus Cadila grew by 12.9 per cent followed by Abbott HC at 12.5 per cent and Lupin at 12.4 per cent. 20 companies have crossed

Rank

Sep-14

Sep-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

93021

100.00

13.7

7852

8626

100.00

GR% 9.9

8270

8.89

14.6

651

728

8.44

11.8

Abbott + Abbott HC + Novo

5823

6.26

13.5

474

520

6.02

9.6

Cipla

4609

4.96

14.6

411

430

4.98

4.5

Zydus + Biochem

3906

4.20

11.0

318

358

4.14

12.6

Mankind

3255

3.50

12.7

294

308

3.57

4.8

Lupin

3220

3.46

18.0

259

291

3.38

12.4

Alkem + Cachet + Indchemie

3213

3.45

9.8

297

318

3.69

7.1 2.6

Glaxo

3077

3.31

4.3

278

285

3.31

PFIZER

2797

3.01

19.1

230

252

2.92

9.7

Macleods

2689

2.89

18.0

244

258

2.99

6.0

Intas

2575

2.77

22.8

195

248

2.88

27.4

Emcure + Zuventus

2479

2.66

9.5

202

224

2.60

10.6

Sanofi India

2339

2.51

17.4

184

209

2.42

13.5

Aristo

2295

2.47

15.1

220

230

2.66

4.5

Torrent

2194

2.36

23.4

167

193

2.24

16.0 13.1

Glenmark

2165

2.33

23.3

186

210

2.43

Dr. Reddys

2132

2.29

14.7

181

194

2.25

7.5

USV

1845

1.98

19.6

141

155

1.79

9.9

Micro + Bal

1746

1.88

7.5

147

171

1.99

16.7

Alembic

1255

1.35

13.8

117

124

1.44

6.0

Novartis

1218

1.31

6.7

105

116

1.34

9.7

Wockhardt

1213

1.30

23.5

121

1.40

42.3

IPCA

1199

1.29

8.3

122

126

1.46

3.6

MSD + Fulford + Organon

999

1.07

26.3

1.08

33.1

the growth of IPM amongst top 50. Amongst the 21-30 ranked companies, Wockhardt had the highest growth at 42.3 per cent followed by Zuventus 19.9 per cent and Novartis at 9.7 per cent. Indian companies have grown at 9.6 per cent versus 10.7 per cent for MNCs in September 2015. Amongst the top 50 in MNCs, AstraZeneca grew at 37.8 per cent, MSD grew by 33.1 per cent followed by and Merck at 16 per cent. The DPCO containing molecules market grew at 2.8 per cent whereas the non-DPCO market grew by 10.9 per cent and non -Sch Para 19 market at 11.5 per cent resulting in an overall growth of 9.9 per cent for September 2015. The NLEM and Non-NLEM category showed unit growth at 1.2 per cent and 1.1 per cent respectively. The nonSch Para 19 market grew at nine per cent from units perspective.

VAL IN CRS Super Group IPM ANTI-INFECTIVES CARDIAC GASTRO INTESTINAL VITAMINS / MINERALS / NUTRIENTS ANTI DIABETIC RESPIRATORY PAIN / ANALGESICS NEURO / CNS DERMA GYNAECOLOGICAL VACCINES HORMONES ANTI-NEOPLASTICS OPHTHAL BLOOD RELATED UROLOGY OTHERS ANTI MALARIALS SEX STIMULANTS / REJUVENATORS STOMATOLOGICALS OPHTHAL / OTOLOGICALS OTOLOGICALS

MAT AUG 15 MATAug 15 93021 14197 11649 10842 8378 7481 7212 6426 5711 5548 4623 1599 1566 1548 1365 1084 1015 1007 546 503 387 226 109

Gr% 13.7 7.4 15.1 16.0 12.4 26.0 11.6 11.3 14.0 18.3 10.9 10.4 10.5 14.2 16.7 12.1 22.9 22.8 1.3 11.6 9.2 3.9 9.0

MONTH AUG-15 Month Aug-15 8626 1438 1016 996 759 671 663 612 515 507 424 148 146 127 119 103 93 105 80 41 34 19 12

Gr% 9.9 3.2 11.8 12.8 5.9 18.1 4.1 9.0 15.2 12.9 13.4 15.4 11.2 2.2 9.5 18.9 12.1 42.4 7.5 10.2 0.8 -11.6 -6.9

MARKET From therapy perspective, 12 therapies have outgrown the IPM growth. The gynaecological market grew at 13.4 per cent, respiratory market grew at 4.1 per cent, gastrointestinal market grew at 12.8 per cent, pain and analgesics market grew at nine per cent whereas anti-infectives grew at 3.2 per cent. The anti-diabetic market grew at 18.1 per cent and cardiac at 11.8 per cent in chronic business. The derma market grew by 12.9 per cent and the urology market at 12.1 per cent. From regional perspective, 13 regions have outgrown the IPM growth. The UP East market grew the highest at 20.7 per cent followed by Haryana market at 20.6 per cent and Uttarakhand + UP West market at 18.7 per cent. Four regions had a negative growth in September 2015. Amoxycillin + Clavulanic acid market grew at 0.6 per cent whereas Glimepiride + Metformin grew at 11.3 per cent at number two. The markets of paracetamol grew at 20.3 per cent, Atorvastatin 2.9 per cent, probiotic microbes at 19.7 per cent, cefixime -3.6 per cent, pantoprazole 7.5 per cent, montelukast + levocetrizine at 5.5 per cent, glimepiride + metformin + pioglitazone at 13.7 per cent, Vitamin-D at 22.3 per cent, hydroquinone + mometasone + tretinoin at 12.3 per cent, voglibose + metformin + glimepiride at 42.9 per cent, rosuvastatin at 22 per cent, protein supplements at -2.6 per cent, azithromycin at minus seven per cent, calcium carbonate + Vit D3 market at 18.1 per cent. Carica papaya became ` 6-crore market on MAT basis. Monocef leads the pack with ` 34 crores followed by Mixtard, Spasmoproxyvon Plus, Augmentin and Corex for September 15. Spasmoproxyvon Plus grew at 127.3 per cent followed by Janumet at 104 per cent, Corex 44 per cent amongst top 10 brands. Few Brands who have gained ranks include Rotarix (+133), Mifegest Kit (+110), Meronem (+86), Chymoral Forte (+73), Omez (+50), Trajenta (+44), Betnovate C (+41), Vertin (+40), Janumet (+39), Rantac (+32), Panderm Plus, Istamet (+31), Betnesol (+29), levipil (+28), Spasmoproxyvon Plus (+25), Rosuvas (+24), Shelcal (+16), Dolo

EXPRESS PHARMA

November 1-15, 2015

(+12), Orofer XT (+11), amongst top 100 Brands over September 14. Caripill moved into Top 500 Brands in September 2015. The 300th biggest brand is Gestofit from Alembic. A total of 253 brands and 437 SKUs were launched in September 2015. The top new brands in September 2015 were Vilazine,

Lupiheme and Vilano. The biggest new launch by an MNC are Amicolon SB, Stugeron Plus and BHRF in September 2015.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All

Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage. For more information, visit http:// www.aiocd.net

MARKET PRE EVENTS

CPhI India to be held in Mumbai from Dec 1-3,2015 CPhI India will be co-located with P-Mec CPHI INDIA and its co-located events are the largest and most comprehensive pharmaceutical industry events in South Asia. CPhI India will be held along with P-MEC, which will take place at Bombay Convention and Exhibition Centre, Mumbai, from December 1-3, 2015. Visitors will be able to meet with key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France, Italy. They will be able to find all major suppliers of pharma ingredients, outsourcing, equipment and bio-

solutions in one location, source high-quality ingredients and services at competitive prices, learn about the latest innovations, technologies, trends and developments in India's pharma industry. Technical seminars will be held during the event. CPhI India Pharma Awards will be given out to recognise and appreciate the contribution and efforts of the Indian pharma industry. Exhibitor profile includes, active pharma ingredients, alkaloids, amino acids, antibiotics, antibodies, antimicrobial

Visitors will be able to meet with key decision makers in the pharma industry from 92 countries

preservatives, antioxidants, biocatalysts, biotechnology, capsules/ encapsulation, chemical synthesis/ analysis, chira intermediates, coating agents, colour and dispersions, custom manufacturing, cytokines, emulsifying/solubilising agents, enzymes, excipients and drug formulation, fine chemicals, flavours and perfumes, glidants, herbal teas, hormones and synthetic substances, immunochemistry, intermediates, medicinal plants, microencapsulation, ointments bases, peptides, phos-

pholipids, plant/animal extracts, prostaglandins, publisher, purification and separation techniques, regulatory affairs, sera and vaccines, solvents, stiffening agents, stiffening bases, suppository bases, suspending/viscosity, increasing agents, sweetening agents, synthetic organic chemistry, tablet binders, tablet disintegrants, tablet filler-binders, tablet lubricants, tissue culture medias, wetting/ solubilising agents. EP News Bureau-Mumbai

India Pharma 2016 to be held from January 7-9, 2016 India Pharma 2016 will cover all the sectors of the pharma industry such as finished formulations, APIs, Bio-pharma, fine chemicals and intermediates, natural extracts, excipients etc INDIA PHARMA 2016, an international exhibition and conference on pharmaceutical industry, is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). The conference, to be held in Bangalore International Exhibition Centre, Bengaluru, from January 7-9, 2016, will pro-

20 EXPRESS PHARMA November 1-15, 2015

vide a common platform to all the participants to get an opportunity in order to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event. India Pharma 2016 will cover all the sectors of the pharma industry starting from finished formulations, APIs,

Bio-pharma, fine chemicals and intermediates, natural extracts, excipients and many more. Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will be displayed. Visitors will have direct access to highly targeted senior pharma executives, buyers, procurement managers, contract manufacturers. They can

also meet managers and business development managers who are looking for new supplies, building strategic partnerships or entering into new ventures. CEOs, technocrats and scientists from drug manufacturing companies, decision makers, pharmacists, engineers, R&D professionals, biotechnology specialists, doctors, policy

makers, diplomats and foreign commercial corporations, regulatory officers, purchase officers of pharma companies, hospital administrators, academicians, teachers and students, equipment suppliers and distributors and medical representatives are likely to visit the conference. EP News Bureau-Mumbai

MARKET

67th IPC to be held in Mysuru More than 10,000 delegates from across the country and abroad are expected to participate in the three-day conference from December 19-21, 2015 THE 67TH Indian Pharmaceutical Congress (IPC) will be held at JSS University, Mysuru from December 19-21, 2015. It will be hosted by Indian Hospital Pharmacists Association (IHPA), which is one of the federating organisations of Indian Pharmaceutical Congress Association (IPCA). Pharma industry leaders, regulators, practitioners, researchers and academics from all across the world will participate to deliberate on the future actions which the pharma professionals should take. The conference theme will be â&#x20AC;&#x2DC;Pharmacist for a Healthy India (Swasth Bharat).â&#x20AC;&#x2122; More than 10,000 delegates from across the country and also abroad are expected to participate in the three-day conference. The scientific programme includes plenary lectures, symposia, panel discussions, poster presentations and placement opportunities on a wide range of topics. The Pharma Expo which attracts pharma manufacturers and pharma machine manufacturers to showcase their products is likely to be a star attraction for industry leaders, regulators and scientists to witness and experience at this mega event. The scientific services committee will be led by Dr TKRavi, Convener;

More than 10,000 delegates from across the country and also abroad are expected to participate in the three-day conference Dr A Ramkishan, Co-Convener and Dr KPR Chowdary, Co-Convener. The other members are Kaushik Desai, Dr B Jayakar, Dr H G Shivakumar, Dr GK Rao, Dr M Sreenivasa Reddy, Dr M Ramanathan, Dr Atmaram Pawar, Dr Raman Dang, Dr Swarnlata Saraf, Dr SP Dhanabal, Dr S Krishnan and Dr B Rajalingam. Abstracts will be accepted on or before October 31, 2015, which can be submitted through online mode only. The list of accepted papers will be displayed on November 7, 2015. EP News Bureau-Mumbai

Annamalai University to host conference on DDT-2016 The focus of the conference will be on the interdisciplinary fields related to drug discovery and therapy DEPARTMENT OF Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016) on January 7 and 8, 2015. The conference will provide an excellent forum for sharing research results and interaction/ discussion for the scientists and students working in the area of drug discovery research. It will be the platform for the discussion and presentation of new advances in the fields of drug discovery, biotherapeutics, phar-

macology, medicinal chemistry, bioinformatics and drug trials. The conference will address the critical challenges and emerging paradigms in drug discovery, high-throughput drug screening, drug designing, molecular targets, drug resistance and drug delivery systems. The focus of the conference will be on the interdisciplinary fields related to drug discovery and therapy.

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EP News Bureau-Mumbai

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November 1-15, 2015

MARKET POST EVENTS

‘Longitude Prize’aims to conserve antibiotics for future generations The event at IIT Bombay discussed methods to tackle antimicrobial resistance Sachin Jagdale Mumbai A PANEL DISCUSSION on Longitude Prize to tackle antimicrobial resistance was recently held at IIT Bombay. Longitude Prize is a £10-million challenge aiming to conserve antibiotics for future generations. Longitude Prize is the largest UK challenge prize and the first of its kind in the world, to be determined through a public vote, where one winner will be selected. It is being developed and delivered by Nesta with funding partner Innovate UK. This is linked to one of the objectives of Longitude, to attract innovators, start-ups and entrants from a range of unexpected disciplines.

Some of the most acclaimed names from the healthcare field like Dr Rohini Kelkar, Tata Memorial Hospital, Dr BR Das, SRL Mumbai, Dr Nerges Mistry, The Foundation for Medical Research, Dr Mugdha Lele, Venture Centre Pune, Dr Abdul Ghafur, Apollo Hospital, Chennai and Tamar Ghosh, Lead – Longitude Prize, took part in the discussion. The panelists gave their views on the possible reasons behind antimicrobial resistance. According to Kelkar, there is hardly any hospitals in India that can give authenticate data regarding antimicrobial drug resistance. Ghafur insisted, “Antimicrobial policy should be implemented in India, but it is extremely difficult.

If the profits of pharma companies are coming by selling antibiotics then it is very difficult to implement such policies.” Sticking to the purpose of Longitude Prize there was a common consensus over having a diagnostic machine that can detect infection with drop

of blood, drop of urine etc. “We will encourage such applications. It is important to have a technology that will give result in lesser time,” stated Ghafur. There was a thoughtful debate among panelists and the attendees over the possible social causes of antimicrobial re-

sistance as well. Food adulteration, random use of antibiotics at the places like poultry farms were also termed as culprits. One view was to have indicators to decide where to stop the usage of antibiotics. Longitude Prize is very specific about diagnostic applications with rapid, cost-effective and accurate as some of the few essential requirements. As per Tamar Ghosh, Lead, Longitude Prize, a winner can be decided at any time up to until the end of 2019. The prize was opened to the world in November 2014 and teams can now register at any time. They can then apply at any time to win, at one of the submission dates, which takes place every four months. sachin.jagdale@expressindia.com

SELECTBIO organises tri-conference in Hyderabad 150-plus participants took part in the event SELECTBIO RECENTLY organised a tri-conference on 'Drug Discovery & Development India 2015', 'MedChem India 2015' and 'NanoPharmaceuticals' in Hyderabad. The conferences witnessed over 50 talks including four plenary talks, 11 keynote talks, 35 invited lectures and two technology spotlights. There were 150-plus participants who took part in the event. Thermo Fisher Scientific participated as corporate sponsor. The 'Drug Discovery & Development India 2015' conference had the theme 'Chemical

22 EXPRESS PHARMA November 1-15, 2015

Biology Approaches and Innovative Translational Research. Dignitaries present were Dr Noel de Souza, Consultant from Independent Pharma Drug Discovery & Development; Dr Manu Jaggi, CSO, Dabur Research Foundation; Dr Dipak Ramji, Reader from Cardiff University; Dr Anu Singh, Vice President, Dabur Research Foundation and Dr Sanjay Bajaj, Managing Director, Select Biosciences India amongst others. In the opening session dedicated to Drug Discovery Success Stories from India, the

MARKET first talk was given by de Souza followed by the keynote presentation by Singh. Discussions were held on drug discovery success stories with several case studies in discovery and development. Dr Ahmed Kamal from CSIR-IICT and Dr Amitabha Chattopadhyay from CSIRCCMB addressed the audience. While Kamal’s presentation laid emphasis on the use of natural products for the development of anticancer compounds, Chattopadhyay’s talk stressed upon the use of chemical biology approaches for drug discovery. The event also witnessed a panel discussion on the topic 'Driving Medicinal Chemistry towards Drug Discovery & Development.' The experts in this discussion were Prof Anamik Shah, Vice-Chancellor, Gujarat Vidyapith University, Dr Sergei Makarov, President and Chief Executive Officer, Attagene and Dr Subhrahmanyam Vangala, Vice President, Advinus Therapeutics. The key point that came out of this discussion was that there is a strong need to go ahead with structured drug discovery programmes and for developing collaborations between the different scientists working in different reputed institutions and industries within India. Talks were also held to initiate work in this direction. The two-day conference on 'NanoPharmaceuticals' were attended by Dr Ahmed Faheem, Senior Lecturer from University of Sunderland; Dr Mandip Sachdeva, Professor, Florida A&M University; Dr Indu Pal Kaur, Professor, Panjab University and Dr Sanjay Bajaj, Managing Director, Select Biosciences India. The conference witnessed six keynote talks by Sachdeva; Dr Jagat kanwar, Professor, Deakin University; Dr Kamalinder Singh, Professor, University of Central Lancashire; Dr Kewal Jain, Chief Executive Officer, Jain PharmaBiotech and Dr Manika Pal Bhadra, Principal Scientist, CSIR-IICT. In the poster sessions, poster by Subhradip Kar-

makar was adjudged the best for Drug Discovery & Development India Conference, Kalam Sirisha for MedChem India 2015 and Priyanka Prabhu for NanoPharmaceuticals conference. They were awarded with a memento sponsored by ePoster.net. EP News Bureau-Mumbai

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EXPRESS PHARMA

November 1-15, 2015

Glatt. Integrated Process Solutions.

MARKET

IDMAconcludes 18 PAC in Mumbai th

The two-day long IDMA -APA PAC 2015 conference on ‘Quality and Compliance – Global Expectations’ in Mumbai sought to enlighten the attendees with detailed information on the regulatory requirements for marketing pharmaceutical products Usha Sharma Mumbai INDIAN DRUG Manufacturers' Association (IDMA) recently organised the 18th edition of the Pharmaceutical Analysts' Convention in Mumbai. The two-day long IDMA -APA PAC 2015 conference on ‘Quality and Compliance – Global Expectations’ in Mumbai sought to enlighten the attendees with detailed information on the regulatory requirements for marketing pharmaceutical products in the global pharma market and the parameters to meet compliance issues. Dr K Bangarurajan, Deputy Drugs Controller (India), CDSCO, West Zone Mumbai shared insights on the initiatives taken by the CDSCO. He informed about the last assessment process conducted by the WHO -Geneva which took place in 2012, spoke about the challenges faced by the Indian regulatory authority and recommended steps to overcome them. He also informed that the next assessment is going to take place in early 2016 by the WHO team. The CDSCO has tied up with the WHO and many other agencies to initiate different regulatory programmes which would help in meeting the global standards. Bangarurajan also spoke on equipping the Indian regulators as well as technologies to meet global standards. He also mentioned that under the five year plan, the government has sanctioned ` 1000 crores for setting up state and central laboratories as well as strengthening manpower across India. Commenting on the regulatory parameters being followed by the Indian pharma companies, he said that out of the total exports, nearly 48 per cent medicines are exported to the regulated market which shows

24 EXPRESS PHARMA November 1-15, 2015

that our regulations are at par with the global standards. He also added that the CDSCO has already started online initiatives and now companies can apply online for export application. Subhanu Saxena, Managing Director and Global Chief Executive Officer, Cipla was the chief guest of the conference and he delivered a speech which was inspiring and well appreciated by the audience. While delivering the speech he mentioned, “Our mission is to deliver high quality medicines

at affordable prices to both Indians as well as global patients. He also added that hence we should set our own standards for safety measures. Further, highlighting the importance of investing in existing resources, he said that our people are the biggest assets of an organisation because they are well disciplined, organised and committed than anybody else in the globe, so we should invest in them.” He further said, “We want to equip them to handle critical challenges and help them in striking better per-

spectives.” Saxena also stressed that partnerships help organisations to grow much faster. He suggested that we should have active partnerships with regulators, which will help in exchanging and broadening ours as well as their perspectives. Signing off, Saxena said that we should work with compassion, passion and commitment. Dr PL Sahu, Principal Scientific Officer, Indian Pharmacopoeia Commission shared details of the initiatives introduced by Indian Pharma-

copoeia, for e.g. SMS alert facility. Dr KV Surendranath, Senior Vice President, International Site Operations, United States Pharmacopoeia revealed USP's strategies for the next five years. He also mentioned that USP's strategies were introduced last year and over the next one and a half years, they would be evaluated continuously. Surendranath informed that they are investing largely in research and development to support the mission of creating food for the database. He also revealed that they were going to work on modernising of monographs. “USP's new way of working is reinforcing the criticality of science and quality,” he said. SM Mudda, Chairman, Regulatory Affairs Subcommittee, IDMA presented the US FDA draft guidance on how FDA intends to use quality-metric parameters. He also mentioned about the effects of non-reporting and its impact on a pharma company's performance. SG Belapure, President, Manufacturing Formulations, Zydus Cadila talked about validations in the pharma industry. He pointed out that in the earlier days, validation used to be a one time exercise, whereas these days it is more like a lifecycle approach. He also informed the audience that the new Annexure 15 EMA qualification and validation guidance is becoming effective from midOctober, this year. The organiser also presented 'Young Analyst of the Year' and 'Outstanding Analyst' awards to Dr Manesh Jagtap, Manager, Regulatory Affairs, JB Chemicals and Pharmaceuticals and Dr Premnath Shenoy, Chief Technical Officer, Dossier Solutions & Services respectively. u.sharma@expressindia.com

EVENT BRIEF NOVEMBER 2015 - JANUARY 2016 19

Advanced Techniques & Applications of Mass Spectrometry

OTC Pe Charcha

CPhI India

National Conference on Drug Discovery & Therapy

ADVANCED TECHNIQUES & APPLICATIONS OF MASS SPECTROMETRY Date: November 19-20, 2015 Venue: Ramada Powai Hotel & Convention Centre, Mumbai, Summary: SELECTBIO will organise its 2 nd international conference ‘Advanced Techniques & Applications of Mass Spectrometry.’ Experts will cover various advanced techniques followed by novel applications of mass spectrometry in analysis of pharmaceutical and forced degradation products, metabolites, food, environment, forensic, clinical and biological samples. In addition, a workshop entitled ‘Mass Spectrometry for Clinical Analysis’ is scheduled to be conducted by Dr Nigel Brown, Consultant Clinical Scientist, Wansbeck General Hospital on the second day. Contact details Sakshi Modgil Customer Services Manager, SELECTBIO India, Tel: +91 172 5025050 Mob: +91 7696 125050 Email: s.modgil@ selectbio.com

OTC PE CHARCHA Date: November 27, 2015 Venue: Sofitel, Mumbai Summary: Cube X, a division of Sorento, will organise ‘OTC Pe Charcha.’ Visitors at this year’s OTC conference will come face-to-face with firsthand consumer insights, expert views and successfully executed strategies in the OTC arena. Contact details Prashansa Bora email: pbora@cubex.co.in, Tel (D): +91 022 4036 2037 (B): +91 022 4036 2000

India Pharma 2016

pharma manufacturing technologies, will be beneficial to all participants from local business associates to international machinery manufacturers and API / bulk active manufacturers. through participation at the exhibition. During APE 2015, 492 exhibiting companies from 28 countries along with 8,500 square metres of floor space and 9,000 trade professionals visited the show. Contact details Email: mail@AsiaPharma.org Website: www.AsiaPharma.org

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharma industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors will be able meet all major suppliers of pharma ingredients, outsourcing, equipment and biosolutions in one location. PMEC, ICSE and BioPh will be co-located with CPhI event. Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol, Andheri (East) Mumbai – 400 059 Tel: +91 22 61727272 Fax: +91 22 61727273

NATIONAL CONFERENCE ON DRUG DISCOVERY & THERAPY Date: January 7-8, 2016 Venue: Department of Biochemistry and Biotechnology, Annamalai University

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Summary: Department of Biochemistry and Biotechnology, Annamalai University will organise National Conference on Drug Discovery & Therapy (DDT-2016). The conference will provide an excellent forum for sharing research results and interaction/ discussion for the scientists and students working in the area of drug discovery research. Contact details Dr N Rajendra Prasad, Assistant Professor, Dept of Biochemistry & Biotechnology,Annamalai University, Annamalainagar 608 002 Tamil Nadu Tel: + 91 4144 – 238343 Fax: +91 4144 – 239141 Mob: + 91 9842305384 Email: drprasadnr@ gmail.com

INDIA PHARMA 2016 Date: January 7-9, 2016 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: Department of Pharmaceuticals, Ministry of

Chemicals and Fertilisers, Government of India with FICCI will provide a platform to global investment community to connect with stakeholders in the pharmaceutical sector in India, central and state governments, leading business leaders and top executives from the industry, academics and experts from the world. The event will cover the whole process of pharma manufacturing, from various kind of manufacturing/processing machineries to lab equipment, analytical instruments, APIs and other total solutions. Contact details BK Nayak, Senior Assistant Director, FICCIT/ F: 080 22861949 Mob: 91 9945790735 Email:nayak.bk@ficci.com

ASIA PHARMA EXPO 2016 Date: January 28 to 30, 2016 Venue: Dhaka, Bangladesh Summary: Asia Pharma Expo 2016 (APE 2016), the 8th international exhibition on complete

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectable, ointment, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key contractors. Contact details PHARMA Pro&Pack Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square B/h Divya Bhaskar, SG Highway Ahmedabad 380 051 T: +91-79-40008233 / 40008253 E: mail@PharmaProPack.com W: www.PharmaProPack.com

EXPRESS PHARMA

November 1-15, 2015

cover )

26 EXPRESS PHARMA November 1-15, 2015

(

THE MAIN FOCUS

After successfully launching the worldâ&#x20AC;&#x2122;s first ever generic Pentosan Polysulfate Sodium (PPS) for interstitial cystitis, and now on track to hit the ` 50 crore milestone, Swati Spentose founder Vishal Jajodia believes that niche APIs are both a social need as well as sound business strategy BY SACHIN JAGDALE

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EXPRESS PHARMA

November 1-15, 2015

cover )

hen talk turns to quality APIs and formulations, Mumbai-based Swati Spentose Pvt Ltd (SSPL) figures as one of the most sought after manufacturers, thanks to its primary focus on neglected diseases. SSPL is part of the 45-yearold V group, with clients in over 60 countries worldwide. Besides manufacturing, the company also specialises in marketing of APIs and formulations and is also investing in R&D and clinical studies on niche molecules for the nglected diseases sector, both in India and for global markets.

The beginning It all started in the 1970s when the late Chairman, Narayan Jajodia, arrived in Mumbai from Kolkata to specialise in the trade of APIs. He set up a distribution business within India and across 30 countries thanks to his skills and network, and he soon represented some of well known pharmaceutical manufacturers in Europe. SSPL was incorporated much later in December 2005 as a manufacturer of APIs for regulated markets, focused on polysaccharide chemistry as well as more established speciality ingredients. The same year saw the commissioning of the manufacturing facility for Pentosan Polysulfate Sodium (PPS) in compliance with guidelines of international regulatory agencies like the US FDA, UK's Medicines and Healthcare products Regulatory Agency (MHRA), European Directorate for the Quality of Medicines (EDQM), Therapeutic Goods Administration (TGA) of Australia, Medicine Control Council (MCC) of South Africa. Under the helm of the second generation, the

28 EXPRESS PHARMA November 1-15, 2015

company’s current Chief Executive Officer, Vishal Jajodia, Swati Spentose developed the orphan molecule of PPS and successfully launched the world’s first ever generic PPS for interstitial cystitis, a condition manifested as painful and frequent urination. The company is the only other commercially established manufacturer of PPS in the world apart from the originator, Janssen Pharmaceuticals/ Johnson & Johnson. He has been on the boards of councils like Chemical Export Promotion Council (Chemexil), Pharmaceuticals Export Promotion Council of India (Pharmexcil), Indian Drug Manufacturers' Association (IDMA) and Federation of Indian Export Organisation (FIEO) at various positions since the last 16 years including vice chairman, under the Ministry of Commerce and Industry, Government of India, and is also active in on policy formation initiatives as part of these associations.

Venturing into challenging territory

The challenge today is to sustain the ever-growing need of the regulatory bodies and government norms such as environment and Swati Spentose has made sure that it will be able to cater to all the needs for years to come Vishal Jajodia Chief Executive Officer SSPL

The company started with the basic pharmaceutical supplies of bulk drug but since the past 15 years, evolved to complex polysaccharide chemistry. “Very few people are able understand polysaccharide chemistry and to take it successfully to the market. The challenge today is to sustain the ever-growing need of the regulatory bodies and government norms such as environment and Swati Spentose has made sure that it will be able to cater to all the needs for years to come,” says Jajodia. The pharma sector is a chemical-based industry and happens to be one of the leading polluting industries in the world. However, this is where Swati Spentose has proved itself different from its peers. With zero discharge achievement even after manufacturing products like phenytoin sodium, SSPL has become a success story for such bulk

drugs and other manufacturing plants in the highly polluted area of Vapi, an industrial township in Gujarat, dominated by chemical manufacturing units. Jajodia opines, “As we say, change is the only constant. We also have to change with the times, as the markets are getting very stringent with new regulation from all over the world. We have seen an array of changes with respect to the products made in the early era and now.” He also mentions that while many companies face challenges due to the chemistry, analytical and stability of the products like Dextran, ES, PPS to name a few, SSPL is one of the handful of players in the hormones and steroids sector, since these entail challenging and complicated manufacturing processes. The company’s manufacturing units are located in Vapi, Gujarat. Swati Spentose Unit I is housed in a 6,000 sq mt facility (64,560 sq ft) with 3,978 sq mt (42,800 sq ft) manufacturing and storage area having world class utilities. They have high efficiency and environment-friendly op-

(

THE MAIN FOCUS

`42.93 Cr 2014-15

erations consisting of multipurpose and dedicated polysaccharide blocks. Ultra filtration block has an annual capacity of 18 MT to manufacture polysaccharide and multipurpose block has a capacity of 300 MT capacity. SSPL seems well placed in terms of positioning as bulk drug manufacturing has become the most critical but unfortunately the weakest link in today's pharmaceutical supply chain. Jajodia's claims seem to be borne out by the eight per cent growth rate over the past five years and with India billed as the best option ahead of China when it comes to reliability and consistency in quality, SSPL seems set to continue on track. Listing the infrastruture put in placed over the past decade, Jajodia points to facility consisting of a world class line reactors, stainless steel reactors, high purifying water system etc, non-polluting captive effluent treatment facility, fully compliant with environment, health and safety guidelines as per global and industrial standard. He projects that the facility and product mix has a potential of generating revenues around $150 million per annum at 100 per cent capacity in the next five years.

`41.73 Cr

THE REVENUE OF SSPL FOR LAST FIVE YEARS

smile,” informs Jajodia. Jajodia is confident about the company’s ability to take healthcare to every needy person in the country and across the globe. He explains, “Inspite of being a small company (in terms of profits/turnover), if we can work for the better (health) of needy patients by fighting against all the odds (huge investment, less profit generation, research), we are sure that it will create an awareness so that it will reach out to the masses/ patients.” He points out that most patients end up suffering silently, as they are unaware about the disease, and in most cases it is misunderstood as a urinary infection. SSPL's Jajodia believes that bulk drug manufacturing compa-

SOURCE: SSPL

APPROX.

`25 Cr `25.92 Cr 2012-13

Small is the next big Interstitial Cystitis (IC) is a neglected disease condition in India and indeed across most parts of the world, due to lack of awareness among affected patients. The medical fraternity is still struggling to find the right diagnosis for this disease. There are almost 40,000 prescriptions in the US alone for this drug. SSPL thinks that a lot can be done in this disease category. “India being a huge country, we believe that we have only touched the tip of the iceberg. Also, pentosan is available in very few countries around the world. We plan to expand our market to reach patients suffering with the disease. Also, we wish to bring new delivery solutions for this disease, even though we have to pump in a lot of investment in research, but we are committed to bring in new solutions in this area. We want to see patients

2013-14

`17.67 Cr 2011-12

`5.36 Cr 2010-11

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Apr to Sep 2015

Interstitial Cystitis (IC) is a neglected disease condition in India and indeed across most parts of the world

nies will play a major role in the growth of the pharma sector since India will overtake China in product quality and pricing. Products like biosimilars, polysaccharides, i.e. products with low volume - high price, will be the way forward for pharma companies. “We believe niche molecules and polysaccharide chemistry are the growth model in future for the company. Looking at the scenario, the companies have plans for expansion in the area of biosimilars and orphan drugs such as mucopolysacchridosis,” says Jajodia signing off on a positive note. sachin.jagdale@expressindia.com

EXPRESS PHARMA

November 1-15, 2015

MANAGEMENT

remature deaths caused by non-communicable diseases (NCDs) such as cardiovascular diseases, cancer, chronic respiratory diseases and diabetes have risen drastically and each year nearly 5.8 million Indians die from these ailments. In other words, one in four Indians risks dying from NCDs before the age of 70. According to the World Health Organisation (WHO), more than 80 per cent of all NCD deaths are attributed to four diseases namely, cardiovascular, cancers, chronic respiratory and diabetes. These diseases occur due to multiple factors like demographic change in population, nutritional change with high calorie food consumption, low physical activity levels, etc. An AIOCD/AWACS report for MAT June 2015 states that cardiac segment at `11,204 crores is growing at 14.2 per cent while anti-diabetics at `7,092 crores is growing at 26.3 per cent. Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting says, “Although the situation looks grim, this burden can be significantly reduced by concerted actions as several effective options exist.”

will be launched soon, Dr Damodar Bachani, Deputy Commissioner (NCD), Ministry of Health & Family Welfare Government of India says, “The Ministry of Health and Family Welfare has received numerous suggestions and comments on the draft policy. An expert group is examining them for its inclusion and hence is taking more time to get finalised.” From the industry side, Varma, says, “Policies and guidelines developed in the draft National Health Policy 2015 regarding financial allocations, framework for various programme implementation, etc. are now clearly defined. Moreover, the government has received suggestions from various stakeholders to be included in the draft policy.”

Action plan

Growing significantly Nilaya Varma, Partner and Head, Government & Healthcare, KPMG in India, while quoting a report from the International Diabetes Federation, states that India is expected to see an increase in diabetic population to 101.1 million contributed by 8.4 per cent of India's adult population by 2030. Referring to the report, Chronic diseases in India: Burden and implications,” on the Swiss Re Centre for Global Dialogue website, he mentions that along with diabetes, cases of hypertension are also expected to increase up to 213 million by 2025. Both diabetes and hypertension are attributable to higher risk factor burden for increased cardiovascular disease cases. Going forward, NCDs are expected to increase death burden by up to 68 per cent by 2030 wherein cardiovascular diseases

30 EXPRESS PHARMA November 1-15, 2015

Changing lifestyles have led to an alarming growth of NCDs in India. Realising the need to tackle this menace and the burden it poses on the economy, the government has prepared a draft policy for NCDs with several amendments to the earlier NPCDCS and intends to legislate it soon BY USHA SHARMA

are projected to be the major contributors, attributing to 54 per cent of NCD associated deaths. These projections look scary and indicate that NCDs are going to be responsible for more deaths in India than injuries, maternal, communicable and nutritional conditions.

This is in addition to many health related issues which impact quality of life. So the question arises, is the government of India geared up to handle the situation?

A key role Well, atleast attempts to bring

the situation under control are underway. The Ministry of Health and Family Welfare (MoHFW), Government of India, has formulated a draft policy on NCDs. It was scheduled to be introduced in February 2015, but got delayed due to several reasons. Revealing that the policy

The government’s action plan and framework for prevention and control of NCDs in India has also gone through some changes. As per the National Action Plan and Monitoring Framework for Prevention and Control of NCDs in India, NCDs have surpassed communicable disease as the most common causes of morbidity and premature mortality in the country. Hence, the Ministry has launched the National Programme for Preventive and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke (NPCDCS) in 2010 by merging the National Cancer Control Programme and the National Programme for Prevention and Control of Diabetes and Stroke. The programme is being implemented in 100 districts and is due to be expanded to cover all districts of the country in a phased manner during the 12th Five Year Plan. The government later felt the urge to reduce the risk associated with NCDs and drafted guidelines around this intent. Varma shares the insight of the draft and presents, “The draft National Health Policy 2015 supports the development of an integrated approach to screen NCDs at an early stage in primary care centres to reduce the morbidity and mortality rates. It is also expected that specialist

The situation looks grim, this burden can be significantly reduced by concerted actions as several effective options exist Dr Ajit Dangi President and Chief Executive Officer, Danssen Consulting

Preventing and managing chronic non-communicable diseases have significant bearing on economy Dr Damodar Bachani Deputy Commissioner (NCD), Ministry of Health & Family Welfare Government of India

consultations would be provided to patients at primary level itself, together with regular follow ups. Suitable access to medication for chronic illness on a long-term basis is also on the primacy list for the government. A national programme on NCDs has also been visualised that can provide necessary resources and capacity building support to be functional at the district level. Since NCDs require lifelong management, the draft National Health Policy suggests that mainstreaming AYUSH could effectively prevent and provide cost effective treatment options to patients.” Dr Dangi says, “The draft plan includes interventions like wellness awareness campaigns for lifestyle modifications, early and better diagnostic and screening facilities, emergency medical services, rehabilitation and palliative care, human resource and capacity building etc. As in any action plan of such magnitude, financial funding will remain a crucial factor.” The suggestions from industry on the draft National Health Policy 2015 are well defined but the questions remains on how to execute it? Dangi adds, “With the government healthcare budget of just over one per cent of gross domestic product (GDP), its implementation will remain a challenge. Several other avenues such as public private partnership (PPP) model, assistance from NGOs, national and international, funding from international bodies such as WHO, World Bank, UN etc. should also be explored. While burden of NCDs in a developing country like India cannot be eliminated, it can be reduced significantly by appropriate interventions.” Planning policy is made more difficult when the data itself is questionable. As Dangi opines, “The first step is to collect reasonably accurate data on the incidence and prevalence of each of the NCD and then devise focused and dedicated strategies to

manage and control these diseases. While the one-size-fits-all approach is unlikely to be effective, integrated and co-ordinated efforts are necessary as there is a common link between many NCDs. Identifying the key risk factors is the next step. The risk factors include alcohol and tobacco abuse, environmental pollution, sedentary lifestyle, nutritional deficiency, increasing life expectancy, urbanisation, burgeoning population and often genetics. Each of these risk factors need appropriate intervention. In a country like India, socio-economic inequalities add to the complexity.” Several suggestions have been made to the draft policy. For example, Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI) informs, “In our suggestions on non-communicable diseases in the draft National Health Policy 2015, the OPPI has suggested that it is important to develop and implement an integrated approach to urban health through behavioural change, supplemented by modern technological and social approaches to public services.” Also on OPPI's list is the establishment of a ‘complimentary research network’ of private healthcare companies to focus on disease awareness of NCDs and vaccines for preventable diseases as well as collaboration with industry partners to create disease awareness, early diagnosis and best in class treatment. As an example, she mentions AstraZeneca's Youth Health Programme in Brazil, China, India and Zambia in collaboration with government authorities to focus on awareness and prevention of NCDs amongst adolescents in marginalised communities. She further says, “Utilisation of CSR budget of pharma companies on healthcare related initiatives is the need besides capacity building, particularly of existing government facilities, to create trust among the masses, which could be achieved

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EXPRESS PHARMA

November 1-15, 2015

MANAGEMENT through paigns.”

awareness

cam-

Measuring the disease burden

It is high time now that the government finalises and releases the policies and programmes mentioned in the draft National Health Policy 2015 with appropriate budget allocations Nilaya Varma Partner and Head, Government & Healthcare, KPMG in India

It is important to develop and implement an integrated approach to urban health through behavioural change, supplemented by modern technological and social approaches to public services Ranjana Smetacek Director General, OPPI

32 EXPRESS PHARMA November 1-15, 2015

Speaking at a recent the industry event in Mumbai CM Reddy, Chief Scientific Officer, Innovertus Nutrition Technologies delivered a speech on the role of nutraceuticals and highlighted the fact that in the last four decades, lifestyles in India have changed drastically. Recalling the first census programme, which was started one year after the independence in 1948 and completed in 1952, it was recorded that only six per cent of the total population were on medication whereas, last census report reflects that 69 per cent of today's population relies on some form of medication. This shows that over a period of time as lifestyles change, associated chronic diseases have increased. The approaching disease burden, looks challenging, particularly for a country like India, where most of the health spend is out of pocket. In such a scenario, should the government consider handling each disease portfolio individually and prepare separate policies or club them into one policy? The latter approach seems to be favoured by one section. As Varma opines, “The treatment journey needs a separate policy for individual diseases as the treatments are long term, expensive and require a different plan of care for each disease. A comprehensive policy framework would be required for capacity building and establishing an effective healthcare network for rehabilitative and palliative care. Altogether, the economic disparity amongst the population, cultural diversity and different treatment journey makes it imperative to invest in separate programmes for management of NCDs.” He emphasises, “Though cardiovascular disease is the major segment contributing to increased NCD burden, the risk factors which act as precursor for all leading NCDs are typically common. Most of the premature deaths from NCDs are related to high tobacco and alcohol usage, unhealthy diet and

physical inactivity due to changing life styles. Policy makers now need to streamline their efforts to create public policies for healthy living while strengthening focus on prevention, screening and monitoring of diseases. Specific emphasis should be on awareness and health promotion while accentuating on improving dietary and lifestyle habits. NCDs like cancer, diabetes, cardiovascular diseases and chronic respiratory diseases are chronic in nature where effective lifestyle changes can just boost the health status of individuals.” The PPP model has had mixed success in India so could PPPs be an option to handle NCDs? Bachani says, “Every stakeholder has a role to play. While healthy public policies and population-based public health interventions are within the domain of the government (Central/State), provision of affordable, accessible and quality healthcare is the responsibility of healthcare providers, be it government, NGOs or the private healthcare sector.”

Impact on economy The projected disease burden of NCDs are huge. If we do not control the growing incidence of NCDs it will have significant adverse impact on the Indian economy as well. Mindful of this reality, the government has included the NCDs in the National Health Policy 2015. Commenting on the ways to reduce NCDs in the long term, Bachani highlights, “Preventing and managing chronic NCDs have a significant bearing on the economy. Firstly, by reducing incidence of (new) cases through risk reduction, you are improving life expectancy and better quality of life (thus improved productivity) and thus better economic development. Secondly, by identifying NCDs at early stages (through screening, periodic check-up), you are reducing costs of treatment. Treatment at early stage is cheaper (e.g. many cancers in stage I and II can be treated and even cured by surgery but advanced stages require very costly treatment (radiotherapy or chemotherapy) and even then survival is short. Diabetes without complications can be

managed at low expenses but diabetes with kidney failure may require frequent dialysis, which is costly. Investment in prevention and control of NCDs has therefore been cost-effective in long run. As of now NCDs are creeping even in poor and rural populations, economic implications could be disastrous.” Highlighting projections from the World Economic Forum and the Harvard School of Public Health, Varma refers to the report on 'Economics of Non-Communicable Diseases in India, World Economic Forum, November 2014, p23) (based on 2010 dollars' mentions, “NCDs are expected to lead to as much as $4.58 trillion loss of output between 2012-30. CVDs are major contributors to the economic burden in NCDs.” Varma also refers to the November 2014 World Economic Forum Report titled 'Economics of Non-Communicable Diseases in India' which states that NCDs were responsible for more disability-adjusted life years (DALYs) in 2010 (~235 million) than communicable diseases (~222 million) in India. Diabetes is one of the major concerns in India, as number of DALYs due to the disease nearly doubled from approximately 4.1 to 8 million, from 1990 to 2010. Hence, NCDs are going to impact India on various aspects such as productivity, wellness, economic loss and burden on healthcare infrastructure. Bachani has rightly mentioned that early stage diagnosis and treatment will ease the cost of treatment and will not affect the economy as badly as targeted.

Way forward The paradigm shift from communicable diseases to NCDs needs to be addressed with a focused approach from all stakeholders involved, feels Varma. He says, “India’s healthcare sector needs pressing attention from the government to address the gap present in the current system. Policies and guidelines developed in the draft National Health Policy 2015 regarding financial allocations, framework for various programme implementation,

etc. are now clearly defined. NCDs have been included in the draft National Health Policy 2015 for the first time and it is a welcome step towards the vision for healthy India.” He also feels , “It is crucial for the government and private sector to work in close coordination to identify effective solutions to reduce NCDs burden. A cohesive action plan that incorporates effective public as well as private healthcare interventions to minimise risk factor exposure is necessary. The combined efforts of government and the private sector should focus on capacity building of super-speciality hospitals, strengthening primary care, creating awareness on healthy lifestyle and coordinated movement of all public and private healthcare centres.” While referring to WHO Action Plan 2013-2020, Dangi says, “The WHO Global Action Plan 2013-2020 for the prevention and control of NCDs outlines nine global targets. India must commit to achieving these targets in a time bound manner to ensure that public health and its impact on our economy is not compromised.” Varma says, “India also needs to develop a national database on NCDs which can help in making informed decisions regarding allocation of resources and can also help in sharing best practices among medical professionals. Different states have also started taking initiatives to cater to NCD challenges, however, there is a need to follow a more collaborative approach to address growing concerns. It is high time now that the government finalises and releases the policies and programmes mentioned in the draft National Health Policy 2015 with appropriate budget allocations.” NCDs have already taken firm root in India and shows no sign of decreasing. It is a no brainer that the impact of NCDs on our lives, not to mention the Indian economy will be drastic. Thus, it is the right time for both the public and private players to come together and form sound policies and strategies to control the growth of NCDs for a better tomorrow! u.sharma@expressindia.com

RESEARCH I N T E R V I E W

'Spiolto will allow patients to lead a more normal life' Boehringer Ingelheim has recently published a clinical trial data on Spiolto Respimat at ERS Congress in Amsterdam. Prof Dave Singh, Clinical Pharmacology and Respiratory Medicine, University of Manchester, informs Usha Sharma about the benefits and effectiveness of Spiolto Respimat Recently, Spiolto Respimatâ&#x20AC;&#x2122;s data was presented at ERS Congress in Amsterdam. Can you reveal more about the findings of the study? The OTEMTO study shows a greater impact on the quality of life for Spiolto compared to tiotropium. Tiotropium is a good medicine that has successfully treated chronic obstructive pulmonary disease (COPD) patients for many years. OTEMTO shows that lung function and health status are better with spiolto. How severe is the COPD problem globally? COPD is projected to be the third biggest cause of death worldwide. The burden of disability is enormous. Spiolto has the potential to significantly improve the lives of many COPD patients in many countries. The study claims that it works effectively against placebo. Throw some light on the same. OTEMTO shows that Spiolto has a greater impact on lung function and quality of life compared to tiotropium and compared to placebo. The study also indicates that it will work effectively and significantly in improving breathless issues and how? Improving lung function allows

patients to breathe more easily, and also to perform their routine daily activities. Spiolto will allow patients to lead a more normal life. What are the side effects of Spiolto and what precautions do you recommend? Spiolto many cause mild sde effects such as dry mouth, or urine retention. These resolve on stopping the medicine. How will these products enhance patientsâ&#x20AC;&#x2122; quality of life? Improving lung function allows patients to breathe more easily and also to perform their routine daily activities. Spiolto will allow patients to lead a more normal life. u.sharma@expressindia.com

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EXPRESS PHARMA

November 1-15, 2015

RESEARCH

Genocea to not develop pneumonia vaccine

RESEARCH UPDATES

J&J’s Stelara succeeds in phase III Crohn's disease trial Stelara is approved to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis JOHNSON & Johnson’s (J&J) Stelara was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. J&J reported $613 million in third-quarter Stelara sales. The company said it was on track for global approval filings for Crohn’s this year. Subjects in the 628-patient trial presented recently received either a single infusion of 130 milligrams of Stelara, a Stelara infusion of 6 mg per kilogram of weight or a placebo. After six weeks, 52 per cent of those in the 130 mg group and 56 per cent in the 6mg/kg

group experienced a clinical response, defined as a reduction from baseline of at least 100 points in the Crohn's Disease Activity Index score. That compared with 29 per cent in the placebo group. In addition, 31 per cent of the Stelara 130 mg group and 40 per cent in the other dosing arm achieved clinical remission by week eight of the study, versus 20 per cent for placebo. The results were deemed to be statistically significant.

"I think this is an approvable drug," said Dr Brian Feagan, co-lead investigator of the study presented at the American College of Gastroenterology meeting in Honolulu. "We need drugs that are alternatives to TNF blockers," he said of widely used biologic medicines such as AbbVie's Humira. "This drug can be a first-line biologic therapy." Patients in the study had previously failed to be helped by steroids or immunomodula-

tor drugs, such as methotrexate. Another study is testing Stelara in those who failed antiTNF therapy. Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects about 700,000 Americans and 250,000 Europeans. Symptoms can include frequent diarrheoa, abdominal pain and rectal bleeding. In addition to reductions in signs and symptoms of disease, Stelara patients reported significant improvements in the Inflammatory Bowel Disease Questionnaire, a health-related quality of life measure, researchers said. The rate of serious side effects, including infections, was similar for Stelara and placebo. "Serious infection is really the thing that clinicians worry about and there was not a signal here, which is surprisingly great news," Feagan said. Reuters

DRUG DEVELOPER Genocea Biosciences said it was suspending the development of a vaccine for pneumoniacausing bacteria after it failed to significantly reduce infection in a mid-stage study. Genocea said it was dropping the development of the vaccine, GEN-004, from its near-term plans to focus on its lead drug, a treatment for genital herpes. GEN-004 was being developed to fight streptococcus pneumoniae, a type of bacteria that causes a number of infectious diseases including bronchitis, conjunctivitis and brain abscess. The World Health Organization estimates that up to 1.6 million people, including 800,000 children, die annually from infections caused by the bacteria. During the trial, which included 98 adults, the vaccine showed consistent reductions in bacterial infection when compared with a placebo, but was not able to achieve statistical significance, the company said. Reuters

US FDA approves BI’s blood thinner reversal agent Praxbind, an intravenous injection, works by binding to the drug compound to neutralise it US HEALTH regulators have approved Praxbind, a reversal agent made by Germany's privately held Boehringer Ingelheim (BI), for use in emergency situations by patients taking the company's widely used Pradaxa blood thinner. The Food and Drug Administration said it granted accelerated approval for Praxbind "for managing patients taking

34 EXPRESS PHARMA November 1-15, 2015

Pradaxa, in emergency or lifethreatening situations when bleeding can’t be controlled.” The FDA in 2010 approved Pradaxa, a pill, to prevent stroke in patients with a common heart rhythm irregularity called atrial fibrillation. Although Pradaxa is highly effective at preventing blood clots that can cause strokes in such patients, until now there has

been no way to reverse the drug's effects. Praxbind, an intravenous injection, is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralise it, the FDA said. Another company is working on a reversal agent for two other leading oral blood thinner drugs.

Portola Pharmaceuticals plans before the end of 2015 to seek FDA approval for its agent that has proven highly able to reverse the effects of Johnson & Johnson's Xarelto and Eliquis from Bristol-Myers Squibb and Pfizer. As blood thinners, Pradaxa, Xarelto and Eliquis are all meant to be more convenient alternatives to war-

farin, an oral anti-coagulant that has been sold for more than 60 years but which comes with serious bleeding risks, difficult dietary restrictions and the need for routine blood monitoring. Vitamin K is often used to reverse the effects of warfarin, when bleeding emergencies occur. Reuters

RESEARCH

Lilly pill trumps Humira in arthritis study Lilly plans to release full data at a November scientific meeting ELI LILLY and Co's experimental pill for rheumatoid arthritis proved superior to Abbvie's leading injectable Humira treatment in a large study, which analysts said could prod them to raise sales forecasts for the medicine. Lilly said it was the first study to show that a once-daily oral treatment was superior to $13 billion-a-year Humira, the world’s best-selling drug, in improving signs and symptoms of rheumatoid arthritis. It was the fourth successful latestage trial for Lilly’s medicine, called

Lilly said that a once-daily oral treatment was superior to $13 billion-a-year Humira, the world's bestselling drug, in improving signs of rheumatoid arthritis

baricitinib, which it is developing in partnership with Incyte Corp. “What is disclosed is quite impressive - about as good an outcome as Lilly could hope for,” Sanford Bernstein analyst Tim Anderson said in a research note. Baricitinib works through a similar mechanism as Pfizer Inc's approved twice-daily Xeljanz pill for rheumatoid arthritis, by blocking proteins called Janus kinases that cause inflammation. Xeljanz, with annual sales of $500 million, has not yet become the blockbuster product Wall Street had hoped, when it was approved in 2012. If approved, baricitinib could achieve annual sales of $831 million by 2020, Anderson said, adding he may raise his forecast as more data is made public. Incyte would collect a royalty of about 20 per cent on sales, he added. Baricitinib met its primary goal in the latest study by proving superior to placebo after 12 weeks, as judged by its ability to produce at least a 20 per cent improvement in disease severity. In another arm of the trial, baricitinib at 12 weeks was superior to Humira on key secondary objectives related to the number of patients achieving at least 20 per cent improvement, as well as in improvement based upon another standard arthritis measure called a DAS28-hsCRP score. Moreover, after 24 weeks of treatment, baricitinib was shown to be better than placebo at preventing further structural joint damage, Lilly said. Treatment benefits on all measures continued through a full year of therapy, Lilly said. Lilly plans to release full data at a November scientific meeting. Analysts said more data is needed, including how many patients achieved 50 per cent or 70 per cent reductions in disease severity. The number of serious side effects seen with baricitinib were similar to placebo, while those taking Humira had fewer side effects than placebo. Serious infection rates were similar in all patient groups, Lilly said.

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Reuters

EXPRESS PHARMA

November 1-15, 2015

DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

RESEARCH

Abbott dissolving stent succeeds in pivotal US trial: Study The bioabsorbable Absorb stent succeeded in demonstrating non-inferiority to Xience up to one year after implantation in the 2,008-patient study called Absorb III A NOVEL dissolving heart stent developed by Abbott Laboratories proved comparably safe and effective as its market-leading Xience stent in a large, late-stage trial that will be used to seek US approval of the device, according to data presented at a medical meeting recently. The bioabsorbable Absorb stent succeeded in demonstrating non-inferiority to Xience up to one year after implantation in the 2,008-patient study called Absorb III, researchers at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco reported. The primary data point measuring target lesion failure, a combination of heart diseaserelated death, heart attacks associated with the treated blood vessel and need for repeat pro-

cedures in the treated area, occurred in 7.8 per cent of Absorb patients versus 6.1 per cent for Xience. The difference

was not deemed statistically significant, researchers said. On a variety of secondary measures, Xience also ap-

peared to be numerically better at one year, but with no statistically significant differences. Researchers believe advantages of Absorb will reveal themselves over time once it has fully dissolved. Patients in the trial will be followed for at least five years. "We've got good reason to be very hopeful that the longterm outcomes for patients will be improved with this device compared with a normal metallic drug-eluting stent," Stone said. Stents are tiny tubes used to prop open arteries cleared of blockages. They are coated with drugs that help prevent reclogging. Absorb, which is made of a plastic similar to that used in dissolving sutures, is designed to fully disappear by three

years after implantation, returning the treated blood vessel to its natural, flexible state. That is in contrast to the justapproved Synergy stent from Boston Scientific, in which the polymer coating used to deliver the drug disappears over time, leaving a bare metal stent in place. Stone said it will take some time for doctors to learn how to use the new device, which is a bit larger and softer than traditional metal stents. "A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition," he said. "It will be very good for young patients who will live 30 or 40 years with this decision." EP News Bureau-Mumbai

Ironwoodâ&#x20AC;&#x2122;s constipation drug meets main goal in late-stage study Ironwood along with its partner Allergan said they plan to submit a supplemental new drug application (sNDA) for the 72 mcg dose of the drug in the first half of 2016 IRONWOOD Pharmaceuticals said a lower dose of its constipation drug met the main goal of improving bowel movements of patients in a late-stage study. The drug developer said a 72 micrograms (mcg) dose of the drug, linaclotide, fared better than a placebo when tested in adults with chronic idiopathic constipation (CIC), a type of gastrointestinal disorder. Two higher doses of linaclotide are already on the mar-

36 EXPRESS PHARMA November 1-15, 2015

CIC, a type of gastrointestinal disorder where individuals have infrequent bowel movements, affects about 15 per cent of the US population, according to the National Institutes of Health ket: a 145 mcg capsule for patients with CIC and a 290 mcg capsule for adults who have irritable bowel syndrome with

constipation. Ironwood along with its partner Allergan said they plan to submit a supplemental new

drug application (sNDA) for the 72 mcg dose of the drug in the first half of 2016. An sNDA is required to

make any changes the packaging, labeling, dosages, ingredients or new indications for a drug that is already approved by the FDA. CIC, a type of gastrointestinal disorder where individuals have infrequent bowel movements, affects about 15 per cent of the US population, according to the National Institutes of Health. It is called idiopathic because the cause is unknown. Reuters

PHARMA ALLY VENDOR NEWS

Werum IT Solutions and Sarla Technologies sign MoU Partnership will help in delivering MES projects in India WERUM IT Solutions, a leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries and Sarla Technologies jointly announced a memorandum of understanding to partner for delivering MES projects in India. Sarla Technologies will become an official partner for Werum’s PAS-X

the number one global MES solution up and running in a very short. “We are pleased that Sarla Technologies will join us as a partner to expand our presence in India and to leverage their great experience and track record in the Indian pharma industry and also in automation and process control for projects requiring complete integration with machines and equipment,” says Lars Hornung,

Sarla Technologies will become an official partner for Werum’s PAS-X MES throughout India providing project control and Werum’s PAS-X MES enables pharma facilities to run manufacturing processes completely paperless at the highest level MES throughout India providing project control and Werum’s PAS-X MES enables pharmaceutical facilities to run manufacturing processes completely paperless at the highest level and to be compliant with international GMP guidelines and FDA regulations. The requirements of the pharma industry are directly addressed by Werum’s out-of-the-box solution without any need for expensive and time-consuming customisation. Based on standard functionality and best practice content, pharma manufacturers will be able to have

Senior Director Global Sales, Werum IT Solutions. Anil Mehta, Chief Executive Officer, Sarla Technologies adds, “Our partnership with Werum enables multinationals and leading local pharma companies in India to gain full advantage of MES. PAS-X and Werum’s expertise along with Sarla’s Level 2 integration and automation know-how will tremendously help them to increase productivity and meet global regulatory requirements.” EP News Bureau-Mumbai

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November 1-15, 2015

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Merck Millipore introduces enhancements to its EMPROVE programme The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission MERCK MILLIPORE has introduced enhancements to its industry-leading EMPROVE portfolio of pharmaceutical raw materials. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. This was the first regulatory body to formalise risk assessment requirements for pharma excipients, despite the practice being common in industry. The EMPROVE portfolio includes approximately 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharma ingredients.

The EMPROVE portfolio includes approximately 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharma ingredients The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment. The essential products target moderate risk level applications, expert products are specified for higher risk applications where low microbiological and endotoxin levels are critical. API products provide the quality and regulatory documentation required for active pharma ingredients.

GMP requirements are fulfilled, as all products are produced in Europe, according to the ICH Q7 guideline. In addition to the currently-available material qualification dossier (formerly referred to as the basic dossier) drug manufacturers can obtain two new dossiers for regulatory information. These new dossiers help streamline and accelerate the costly and time consuming information collection and risk assessment

Corbion Purac in agreement with MSL The transaction includes the sales and delivery of lactic acid and lactic acid-based derivatives in India CORBION PURAC and Malladi Specialties Limited (MSL) have recently signed an acquisition agreement. The transaction includes the sales and delivery of lactic acid and lactic acid-based derivatives in India. No production facilities will be acquired. Production will remain with Malladi Drugs and Pharmaceuticals Limited (MDPL), also part of the Malladi Group, which will produce derivatives on behalf of Corbion Purac. MDPL is one of India’s leading pharma manufacturing company with a global presence. This transaction al-

lows for a local production base through the partnership, while maintaining control on quality supplied to our customers. Corbion Purac has acquired the lactic acid business for an undisclosed amount. MSL is a leading manufacturer in India of lactic acid and lactic acid-based derivatives such as calcium lactate, sodium lactate and buffered lactic acid and supplies the pharmaceutical, home and personal care, chemical and food industries in India. MSL is a Malladi Group Company, one of India's leading

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pharmaceutical companies. Frank Goovaerts, Regional Vice President, Corbion Purac Asia Pacific said, “For over 80 years Corbion Purac has been an established name and superior service provider in the food and pharmaceutical industry with lactic acid and its derivatives. MSL has a very strong customer base and distribution network in India. This acquisition will enable Corbion to grow its distribution network and customer service in India even further.” EP News Bureau-Mumbai

Thermo Fisher Scientific receives IVDD CE Mark

process. The quality management dossier is structured according to the new EU guideline 2015/C 95/02 and supports risk assessment and supplier qualification for excipients. With greater detail on raw material properties, the new operational excellence dossier helps drug manufacturers design more consistent and predictable processes and quality. This dossier includes elemental impurity profiles that address the ICH Q3D guideline requirements published in December 2014. Drug manufacturers have an option to use the new online EMPROVE Suite Web site. This platform provides product information and dossiers for the entire EMPROVE portfolio and enables direct, 24/7 access to the comprehensive regulatory information.

THERMO FISHER Scientific, a leader in serving science, has received the in vitro diagnostics device (IVDD) CE mark for its Thermo Scientific Prelude MD HPLC, Endura MD mass spectrometer and ClinQuan MD software. Available for general in vitro diagnostic use in Europe, clinical laboratories now have access to a high performance liquid chromatograph, mass spectrometer and LC-MS software designed and manufactured for in vitro diagnostic use in analysing patient samples as components of laboratory-developed tests. "We're strongly committed to bringing the advantages of LC-MS to the clinical market," said Bradley Hart, Strategic Director, life sciences mass spectrometry, clinical markets, Thermo Fisher. “These three products are part of a larger initiative to make mass spectrometry more useful and accessible to clinicians.”

EP News Bureau-Mumbai

Aesica launches new brand identity FOLLOWING ITS recent acquisition by Consort Medical, Aesica Pharmaceuticals, the global pharmaceutical contract development and manufacturing organisation (CDMO), has launched its new brand identity. This reflects the new alignment and consolidation of the full Consort Medical group. The combination of Aesica and Bespak enables Consort Medical to provide customers with a single source for drug and device development, formulation,

manufacturing and packaging. The group’s unrivalled global offering comprises advanced delivery technologies, formulation development and manufacturing solutions for drugs. The new logo and branding will be adopted across all Consort Medical businesses, creating a consistent identity for all group companies. The official launch to the market has been planned to coincide with CPhI 2015. EP News Bureau-Mumbai

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November 1-15, 2015

PHARMA ALLY PRODUCTS

Gandhi Automations launches Porto and MaxVista GANDHI AUTOMATIONS, India’s entrance automation and loading bay equipment company, has launched Porto and Max Vista —automatic sectional overhead doors — the ideal solution for all industrial and commercial needs. Porto: Porto sectional overhead doors are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door to be aesthetically pleasing and perfectly suited to any architectural environment from modern and traditional industrial buildings to fine commercial buildings. As these doors slide vertically, stopping in the proximity of the ceiling, they blend in with the architectural features of the building. Porto doors are built to ensure the highest ease and flexibility of use which, in turn ensures a quick, hassle free and accurate replacement of old doors. Their compact size ensures more available space both inside and outside the premises. Depending on the structure of the building and the requirement a choice can be made from a standard lift, vertical lift, horizontal lift, low headroom or inclined lift. Porto range consists of a wide series of track systems, panel options and safety features. Special glazed doors provide excellent lighting and vision into the building where required. Max Vista: Max Vista sectional overhead doors are ideal for industrial and commercial buildings. The doors are made with a combination of aluminium panels and

40 EXPRESS PHARMA November 1-15, 2015

◗ Extreme robustness. ◗ Safe operation in compliance with safety requirements. ◗ Design-oriented surfaces and optimum light solutions. ◗ Minimal bulk for more space indoors and outdoors ◗ Easy and practical to open and operate ◗ Energy savings and more comfort ◗ Bright indoor environment and attractive design ◗ Pre-painted, galvanised steel, sandwich panel, thickness 40 mm, 80 mm and 100 mm ◗ The gaskets, made of a special non ageing rubber, seal the perimeter of the door opening. ◗ They produce a perfect seal, preventing water, air and dust infiltration ◗ Minimal bulk for more space indoors and outdoors ◗ Easy and practical to open and operate ◗ Energy savings and more comfort ◗ Bright indoor environment and attractive design ◗ Sectional Overhead Doors can be customised as Gas Tight Ripening Room Doors. ◗ Opening - Closing speed = 0.2 - 0.4 m/s. ◗ Sizes available : Width (max) = 15000 mm ◗ Height (max) =10000 mm

Sectional overhead door porto

Max Vista

transparent acrylic, grilled or meshed windows giving it a distinctive look and enhancing the look of a building. Max Vista Doors make the environment bright and pleasant to work in as it allows natural

Porto

light to pass through the large clear areas. Gandhi sectional overhead doors provide heat insulation and sound proofing thus improving the working conditions on the premises and sav-

ing energy. The products are affixed with a CE mark making them reliable and safe.

Key features ◗ Reliable and low- noise operation.

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

Q A &

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Sanner to introduce Atmo Guard System at CPhI India AT CPHI India (booth V87), Sanner, the manufacturer of high-quality plastic packaging, will introduce its Atmo Guard System. This comprehensive service is offered to all customers purchasing a desiccant plastic packaging from Sanner, and ensures a safe, timely and cost-efficient market launch of new pharmaceutical and healthcare products. The Sanner Atmo Guard System relies on real, product-specific data and takes all relevant factors into account, thus delivering reliable measuring results backed by safe, tried and tested processes. As true primary packaging experts, Sanner has an extensive know-how regarding moisture input. The holistic approach of the Atmo Guard

The Sanner Atmo Guard System is designed according to the motto ‘as much desiccant as needed, as little as possible’ System makes sure that all steps and aspects are incorporated in the process – be it

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for drop-in, integrated or individual desiccant packaging solutions. The Sanner Atmo Guard System is designed according to the motto “as much desiccant as needed, as little as possible”. Sanner engineers put their focus on the ideal interaction of product, desiccant and packaging. By taking into account the right parameters, they define the most economic packaging solution. Contact details Communication Harmonists GmbH & Co. KG Annette Crowther Poststraße 48 69115 Heidelberg Germany Tel. +49 (0)6221 58609-18 Fax +49 (0)6221 58609-11 sanner@commha.de

WITH SCHOTT GLASS INDIA

What is the shelf-life of glass?

Schott Glass India: Glass is in use for centuries already. The earliest finding of a glass recipe comes from Syria (700 BC) stating to take 60 parts of sand, 180 of ash from seaweed and five parts of chalk, mix it together and you receive glass. Since that time glass vessels are in use and the oldest existing glass vessel is a cup from the Egyptian king from 1450 BC. Clearly from that glass is not decomposing or degrading with UV light. It keeps its properties over the time. As this is also known from church windows such studies to prove this were never really made. The shelf life of glass is generally considered to be infinite.

What is the chemical resistance of glass?

Schott Glass India: The chemical resistance describes the resistance against chemical attack by defined agents. As glass does not react with organic solutions this can be neglected. The reaction of glass with an aqueous and acidic solution is basically the same. A hydrogen ion from the solution exchanges with a sodium ion from the glass. So in the end there is an accumulation of Sodium in the solution which can be measured by titration or flame spectroscopy. This reaction is provoked in the test for hydrolytic resistance according to USP and Ph. Eur. The lower the accumulation of Sodium in the solution the better is the quality of the glass. The reaction with alkaline solutions is completely different. Here the hydroxide ions directly attack the silicon in the glass structure and erode the surface. This happens more intense at higher pH values, around pH 10 and higher.

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Aptar Stelmi to feature PremiumCoat at CPhI India APTAR STELMI, which provides premium elastomeric closure systems for injectables, have announced a new addition to its broad portfolio of products with the introduction of a novel range of coated stoppers called PremiumCoat, designed for the protection of sensitive and high-value drugs, including biopharmaceuticals. Sensitive and high-value injectables encompass complex and potent drugs manufactured by chemical synthesis and biological agents engineered in a living system such as a microorganism, plant or animal cell. They include cytotoxic drugs used in cancer therapies, novel vaccines, blood derivatives, hormones and many compounds used to treat auto-immune diseases, including monoclonal an-

jectables are fragile by nature. Therefore maintaining the integrity of the container closure

tibodies. The market for biologics represents 20 per cent of the global drug market with growth

at a CAGR of 10 per cent in 2010-2015, twice that of the global drug market. Sensitive and high-value in-

while minimising interaction between the drug compound(s) and the component constituents is a challenge. Conven-

tional elastomeric closure systems may not be an optimal solution for these fragile drugs. PremiumCoat is a novel range of elastomeric stoppers developed by Aptar Stelmi. The surface of the elastomer is coated during manufacturing with a thin fluoropolymer film. This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug. As a result, compatibility of the drug and the closure is significantly superior with PremiumCoat stoppers. Contact details Anne Bailly, Product Communication Manager Tel.: + 33 (0)1 48 63 56 71 email: anne.bailly@aptar.com

Thermo Fisher Scientific launches spectrophotometers THERMO FISHER Scientific has launched Thermo Scientific NanoDrop One and NanoDrop OneC UV-Vis microvolume spectrophotometers, which are designed to help life science researchers gain a more complete understanding of sample quality and avoid costly delays due to troubleshooting and repeating experiments. These new spectrophotometers introduce the Thermo Scientific Acclaro Sample Intelligence technology, which enables researchers

42 EXPRESS PHARMA November 1-15, 2015

to identify sample contaminants and obtain corrected concentration results, receive instant feedback about sample quality with on-demand technical support and guided troubleshooting; and confidently measure samples with embedded sensor and digital image analysis. The NanoDrop One instrument with its high-resolution, touchscreen interface makes it simple to use as a compact, ergonomic instrument, while the powerful auto-range pathlength tech-

nology facilitates accurate measurements for concentrated samples with no need for dilutions. The patented NanoDrop sample-retention system measures 1-2 ÎźL of sample in seconds without the need for cuvettes, making it a cost- and time-effective solution for busy labs. Workflows can be streamlined on the NanoDrop One instrument with the Auto-Measure functionality, while modern connectivity allows results to be shared and archived via Wi-Fi, Ethernet or USB. The Nan-

oDrop OneC instrument contains both pedestal and cuvette measuring positions, increasing dynamic range and assay flexibility.

Contact details Maria Perr Madison, WI, USA +1 608-276-6319 maria.perr@thermofisher.com

PHARMA ALLY VALUE ADD

Overcoming a development challenge: Characterising aggregated material in formulated product Dr Michael Caves, India Business Development Manager, Malvern Instruments and Dr Namrata Jain, Product Technical Specialist â&#x20AC;&#x201D; Nanometrics Bioscience, Malvern Instruments in this article give an insight on the use of two novel instruments for subvisible particle characterisation and viscosity screening of bioformulations THERAPEUTIC antibodies represent one of the fastest growing sectors for novel biopharmaceuticals, necessitating development of new analytical platforms for faster and better antibody selection and characterisation. Early quality control and risk assessment of biophysical parameters such as aggregation, viscosity and stability can help prevent failure in the later stages of development, and thus can reduce costs and save time. Malvern Instruments provides a growing range of solutions focused specifically on critical path of testing and manufacturing requirements, which take into account the pressures of time and cost, to speed you through characterisation studies, formulation development and process development, through to commercial manufacture. We report on the use of two novel instruments from Malvern biotherapeutic development initiative for subvisible particle characterisation and viscosity screening of bioformulations.

The solution Characterisation of subvisible particles in biotherapeutics has been the subject of intense interest due to concerns regarding immunogenic responses that compromise drug safety and efficacy. It is therefore essential to monitor aggregation in the development, manufacture and storage of

Dr Michael Caves, India Business Development Manager, Malvern Instruments

Figure 1. Archimedes harnesses the technique of resonant mass measurement for detection, quantification and identification of protein aggregates in the subvisible range.

Dr Namrata Jain, Product Technical Specialist â&#x20AC;&#x201D; Nanometrics Bioscience, Malvern Instruments

therapeutic proteins. Subvisible aggregates are coming under increasing regulatory scrutiny, but are often inaccessible to optical methods due to limits on resolution. Protein formulations are also often complicated by the presence of leachables such as silicone oil droplets and other foreign particulate matter introduced

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during product manufacture, handling and storage. An ideal analysis method for biopharma formulations would therefore clearly distinguish contaminating matter from the aggregate content. Archimedes is an innovative, high-performance system which harnesses the technique of resonant mass measure-

ment in order to count particles in the size range 50nm 5Îźm and to measure particle mass and size. The system is also capable of providing information on sample concentration, density and volume, and distinguishing between negatively buoyant proteinaceous particles and positively buoyant contaminant such as sili-

cone oil (Figure 1), fulfilling the regulatory demand for differentiation of protein and nonprotein particles. The system is based on a MEMS (Micro Electro-Mechanical Systems) technology sensor, allowing sensitive, reliable and reproducible measurement of aggregates one by one. Even with the current reg-

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Figure 2. Viscosizer TD is an automated biophysical characterisation tool utilizing Taylor Dispersion Analysis providing unique solutionbased molecular size and stability measurement capabilities, combined with Poiseuilleâ&#x20AC;&#x2122;s flow for relative viscosity assessment

ulatory concern over sub-visible particles we must maintain our focus on smaller aggregates also. Many current aggregate sizing techniques (such as those that rely on light scattering) are not selective enough to fully characterise complex formulations. Commonly used biopharma excipients such as arginine, sucrose and PEG can all interfere with light scattering measurements. The early stages of biopharma formulation development also require work with small amounts of expensive sample. Malvernâ&#x20AC;&#x2122;s Viscosizer TD uses an absorbance-based, selective sizing method (Taylor Dispersion Analysis) to characterise aggregates without interference from formulation components or bias towards larger particulates. Taylor Dispersion Analysis with UV absorbance area imaging of microcapillary flow enables ultra-low volume analysis, each measurement typically consuming only 40 nl of sample. Viscosizer TD uses fully automated methodology to analyse the stability of peptides and proteins in formulation, and is selective enough even for analysis of small molecule drug size. Screening for stability allows selection of the most stable formulations for further studies (such as clinical trials), and the Viscosizer also affords another means of formulation screening. By measuring the speed at which sample flows

44 EXPRESS PHARMA November 1-15, 2015

through the microcapillary (using exactly the same hardware as for the sizing measurement) relative viscosity can be calculated according to Poiseuilleâ&#x20AC;&#x2122;s law. Viscosity issues often accompany parenteral administration. High viscosities can be unsuitable for injection and its discovery at later stage of bioformulation development have significant cost implications. Viscosizer TD can accurately and reproducibly discern differences between the relative viscosities of different protein formulations at low concentrations during the early stage of their production and therefore identify abnormal viscosity concentration profiles (Figure 2).

Figure 3. Quantification of protein aggregates in response to shear stress

Proof of concept This article further describes monoclonal antibodies formulation study using the two technologies. Figure 3 shows quantification of sub-visible particles using RMM pre and post syringe-induced shear stress. Prior to syringe stress, the number of particles detected by the Archimedes system is very low, demonstrating the sample is reasonably pure, with very few large protein aggregates. This is to be expected, as the sample had been filtered. However, this does demonstrate the low noise baseline of the technique, enabling accurate analysis of pure samples. Following shearstress the number of particles detected increases significantly, with particle sizes rang-

Figure 4. Hydrodynamic radius of insulin measured by TDA in a range of buffer conditions

ing from 500 nm up to 1700 nm. The particle size distribution provides important data regarding the response to the type of stress induced. Such data can be used to compare different stress conditions to provide an overall picture of the degradation profile for the biopharma of interest. Figure 4 shows the variation in self-association and oligomeric state of Insulin in a selection of different formulation buffers as measured by TDA. These data follow the same trends that are well char-

acterised within the literature. Monomeric and Dimeric Insulin are accurately characterised, as is mixture of insulin oligomeric states, without bias towards larger aggregates or interference from formulation components. Such mass-based sizing can be used to fully characterise the different oligomeric states of important hormone and antibody drugs.

The malvern orthogonal approach The complexities involved in biotherapeutic development

(aggregation for instance) make an orthogonal approach to characterisation essential. This article outlines two of the many solutions Malvern offers for the challenge of biopharma development, focussing on both large and small aggregates. Together with our customers, we have created a suite of instruments which provide access to a raft of biophysical information on your product, to speed you through characterisation studies, formulation development, quality control and beyond.

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PHARMA PLANT AVAILABLE FOR SALE (ON “AS IS WHERE IS BASIS”) A fully integrated formulation plant, suitable for production of tablets, capsules and oral liquids, is available for sale near Village Kachivani Singaram, Ghatkesar Mandal, Ranga Reddy District, Hyderabad. Spread over 1½ acres land, the built up area of the plant is around 28,500 sq. ft. The plant can produce up to 10 crores of tablet/capsules per annum and 75 lakhs bottles of oral liquids per annum. We are ready to sell the land & building and plant & machinery separately. If Interested,

Please Contact: Mr. V. Narendra Rao at +91-95819 92861 50

November 1-15, 2015

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

November 1-15, 2015

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

November 1-15, 2015

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ABS

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Manufacturers Of: Pharma, Cosmetic, Food Process & Allied Equipments Semi Drier

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November 1-15, 2015

Mr. Anup K. Nath Cell: 9890204833

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PHARMA LIFE APPOINTMENT

Lupin appoints Fabrice Egros as President of its Asia-Pacific Business Egros has over 25 years of experience within the global pharmaceutical industry LUPIN HAS appointed Fabrice Egros as the President, Asia Pacific and Japan. He will be based in Tokyo, Japan. Egros has over 25 years of experience within the global pharmaceutical industry, having worked in leadership roles encompassing P&L management for new markets, mergers and acquisitions, marketing and commercial, global strategy and business development as well as global clinical development, regulatory and manu-

facturing. Egros will be responsible for Lupin’s growth and development across key markets such as Japan, Australia, the Philippines, South East Asia and new markets in the rest of the ASEAN region. Prior to joining Lupin, Fabrice was with NovaMedica where he was the Deputy CEO/ COO and instrumental in setting up an integrated new pharma business. Before NovaMedica, he has worked with global majors

such as UCB, Sanofi and Parke Davis in various global and regional capacities. Egros holds a Degree in Pharmacy, a MS in clinical pharmacology and a Doctorate in Pharmaceutical Sciences from the University of Paris (School of Medicine and Pharmacy) as well as a MBA from Schiller University. He has also completed Advanced Management Program from Harvard University. Nilesh Gupta, Managing Di-

rector, Lupin said, “We are delighted to have Egros join the Lupin family. His deep knowledge of the Asia-Pacific markets will be invaluable as we consolidate and grow our business in the region. This region is the third largest revenue contributor for us globally and I believe that Egros’ experience will help Lupin achieve its growth plans for the Asia Pacific region, and help us scale the business to new heights.” EP News Bureau-Mumbai

INITIATIVE

Sanofi celebrates ‘Joy of Giving’week Also known as ‘Daan Utsav’, the week witnessed a line of line-up of philanthropic activities SANOFI INDIA recently celebrated the Joy of Giving week, also known as 'Daan Utsav'. The eventful week had an interesting line-up of philanthropic activities that the employees and management at Sanofi India undertook. Each day had a special theme that aimed at contributing to different areas of the society along with tie-ups with the leading NGO working in each of these areas. The employees enthusiastically joined in to fulfil the wishes of little ambitious hearts at the Child Help Foundation through the Wish Tree initiative. The second day focused on fulfilling the nourishment needs of the children at Jeevan Asha through the ‘Anna Daan’ initiative. Team Sanofi contributed essential

64 EXPRESS PHARMA November 1-15, 2015

groceries like for ensuring their daily need of a balanced meal. As a part of the ‘Vidya Daan’ Initiative, Team Sanofi extended educational support by providing essential stationery and utilities that would contribute to educational growth of children through an NGO – Community Outreach Program. The initiative also constituted a unique activity in which the master chefs at Sanofi prepared delectable savouries and sold them to raise funds to the differently-abled at the Muskaan foundation. A grand NGO mela was also organised to help and support an array of causes that each of the participating NGOs stand for. EP News Bureau-Mumbai

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.

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