Express Pharma September 16-30, 2014

VOL. 9 NO. 22 PAGES 102

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Cover Story Trapping the Ebola virus Management India Pharma Inc rates NaMo govt Research Spill resistant formulations: No crying over spilt syrups!

16-30 SEPTEMBER 2014,` 40

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CONTENTS MARKET Vol.9 No.22 SEPTEMBER 16-30, 2014 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

INDIAPHARMAINC RATES NAMO GOVT

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

The pharma sector gives the Narendra Modi-led Government full marks for good intentions but prefers to reserve judgement till it sees more concrete action | P40

Bangalore Neelam M Kachhap Delhi Shalini Gupta DESIGN National Art Director Bivash Barua

18

HEALTH MINISTERS ADOPT DHAKA DECLARATION ON VECTOR-BORNE DISEASES

19

VENUS TIES UP WITH MYLAN

24

ABLE TO HOST 11TH EDITION OF BIOINVEST

26

OPPI ORGANISES HR SUMMIT

PHARMA ALLY

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West

P33: COVER STORY

Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta

‘We aim to stimulate biotech business in Gujarat’

PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

In choppy waters

P35: INTERVIEW

RESEARCH

46

SPILL RESISTANT FORMULATIONS: NO CRYING OVER SPILT SYRUPS!

48

SANOFI’S DENGUE VACCINE CANDIDATE COMPLETES EFFICACY STUDY

49

FDA LIFTS PARTIAL HOLD ON ONCOMED’S CANCER DRUG TRIALS

P90: CAMPUS BEAT School of Pharmacy, Lloyd Institute of Management & Technology organises seminar

‘OUR PRODUCTS MEET THE STATUTORY AND REGULATORY REQUIREMENTS OF THE EU’

PHARMA LIFE

88

P43: LEGAL EAGLE Analysing reactions to India’s draft pharma patent g’lines

51

LISTENING IS KEY BUT ACTION IS THE REMEDY

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

Rx for NaMo’s next 100 days and beyond

P

rime Minister Modi's first 100 days in office may not have quite met the expectations of India Pharma Inc but the cautious optimism persists, thanks to PM Modi's past performance as a pro-industry Gujarat Chief Minister as well as his successful Japan trip. Read industry’s take on NaMo's performance so far and their advice for the way forward in our story 'India Pharma Inc rates NaMo govt', pages 40-42 , issue dated September 16-30, 2014.

One strong indication that all is not well with India Pharma Inc is the continued run of GMP violations (the latest being the surprise inspections at Sun Pharma's Halol facility, with reports saying that the presence of as many as five inspectors could indicate a serious slip up). The second is the dying of the ‘Discover in India’ dream. Piramal Enterprises’ announcement in end August, that it was re-aligning its R&D to focus on late rather than early stage research could see more of its peers pruning their R&D programmes as well.

Ironically, global agencies are pumping millions into efforts to speed up research and trials on anti-Ebola virus treatments. As the death count mounts, there is a sense of deja vu: we saw the same panic during zoonotic pandemics in the recent past. Sadly, the clamour for a cure fades as the infection subsides, research funds dry up and such projects end up on the back burner. Until the next public health emergency.

In hindsight, epidemiologists have pointed out how the current outbreak of Ebola virus disease did not happen overnight. It is now over eight months from the death of the first known patient: a two-year old child in Gueckedou district, located in the Guinea forest regions, in December last year. The infection grew stronger over the following months but it was only when two infected US health workers were airlifted in early August that Ebola finally got global attention.

Hindsight is always 20/20 but maybe the spread could have been contained if these agencies had

16

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September 16-30, 2014

Modi's mantra of 'Make in India' and his vision of India transforming into a manufacturing powerhouse,has already happened in the pharma industry.

Instead of ‘Make in India’, we need to make ‘Discover in India’our calling card

tracked the infection more closely.

Hopefully, the NaMo government will take a cue from this situation. Modi's mantra of 'Make in India' and his vision of India transforming into a manufacturing powerhouse, has already happened in the pharma industry. Instead of ‘Make in India’, we need to make 'Discover in India' our calling card. We need to re-define our positioning as an innovative, affordable research crucible for diseases which impact our populations, for instance, neglected tropical diseases (NTDs). In fact, with NTDs now surfacing in Western nations (for example Texas, by recent estimates, has more than 800,000 people infected with Chagas disease), there is increased funding for such projects. But challenges continue: read our cover story of this issue ('Trapping the Ebola virus', pages 28-32) as well as other stories in the section which point to low investor sentiment and regulatory hurdles faced by biopharma players ('In choppy waters', pages 33-34).

Fortunately, promising research projects have managed to attract good funding. In November last year, a project from Mumbai’s Institute of Chemical Technology (ICT), Matunga, was chosen from over 2700 applicants for a $100,000 grant from the Bill and Melinda Gates Foundation, to develop what could become the first ever 'green' nanovaccine for nasal immunisation against brucellosis. Like the Ebola virus, this is another zoonotic disease, under control in developed countries but still common in countries with sketchy public health and domestic animal health programmes. Of course, the research at ICT is a long way from fruition but we need to celebrate such sparks (I am sure there are many more such examples across our country) and hopefully fan them on to blazing success. We hope this gets onto the NaMo government’s agenda for the rest of its term.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Health ministers adopt Dhaka Declaration on vector-borne diseases Commit to control and eliminate vector-borne diseases HEALTH MINISTERS from World Health Organization’s (WHO) South-East Asia region adopted the Dhaka Declaration on vector-borne diseases. The Ministers from the Region’s 11 Member States recently met at the Thirtysecond Meeting of Ministers of Health to review health development in the Region, identify challenges and provide policy direction for future action on health issues.

The Dhaka Declaration spells out steps to control and eliminate vector-borne diseases for the Region. Approximately 1.4 billion people are at risk of malaria, 871 million are exposed to lymphatic filariasis and over 147 million are at risk of kala-azar in the region. 52 per cent of those vulnerable to dengue globally, live in the countries of the region.

Sheikh Hasina, Prime Minister, People’s Republic of Bangladesh, inaugurated the Thirty-second Meeting of Ministers of Health and the Sixty-seventh Session of the WHO Regional Committee for South-East Asia. She said, “Health is one of the most important determinants of people’s overall wellbeing. In order to build a healthy nation, our policies have put emphasis to intervene holistic dimensions of social, economic and environmental determinants of health including poverty reduction, education, gender equality, women’s empowerment and family planning. Let us renew our commitment to ‘Universal Health Coverage’ as

18

EXPRESS PHARMA

September 16-30, 2014

an essential precondition to transforming people as human assets and ensuring sustainable growth.”

Hasina made a personal plea to the health delegates from the countries to support Bangladesh’s effort to mobilise global support for the cause of autism. She said, “It is imperative that individuals with autism and other developmental disabilities must find easy access to improved diagnosis and services.”

Dr Margaret Chan, Director-General, World Health Organisation said that despite the many challenges which Bangladesh had faced over decades, “The solid improvements in the country’s health system and the services it provides, together with a stunning rise in overall health status and life expectancy have been internationally documented.”

She added, “The countries of the region have much to learn from the rich experiences and inspiring health leadership of Bangladesh.”

Dr Poonam Khetrapal Singh, Regional Director for South-East Asia, WHO said, “Health in the 21st century requires a 21st century approach. And that the challenges facing the countries are not amenable to technical solutions alone. Singh outlined her vision for health for the people in the region and the four key directions which would achieve that vision. These are “Addressing the persisting and emerging epidemiological and demographic challenges; advancing universal health

coverage and robust health systems; strengthening emergency risk management for sustainable development; and articulating a strong regional voice in the global health agenda.”

Dr Harsh Vardhan, Minister of Health and Family Welfare, the outgoing Chair of the Health Ministers’ Forum, India spoke of the importance of traditional medicine. He said that India would like to further improve on the rich tradition of ayurveda with better research, and quality manufacturing practices. He was happy that India and Bangladesh will be signing a bilateral agreement on cooperation in traditional medicines in Dhaka.

By adopting the Dhaka Declaration on vector-borne diseases the health ministers committed to pursue an intersectoral and multidisciplinary approach in control and elimination of vector-borne diseases. The health ministers recognised the need to strengthen health systems to provide timely treatment and response to vector-borne disease outbreaks, and to strengthen national capacity building by training of vector control teams. The declaration is a commitment to build capacity for efficient surveillance; strengthen national databases and develop mechanisms for data sharing and to encourage research on vectorborne diseases and disease control programmes.

EP News Bureau-Mumbai

Cipla collaborates with S&D Pharma To enter Czech Republic and Slovakia with affordable high quality alternatives CIPLA HAS entered into a commercial collaboration with S&D Pharma in the Czech Republic and Slovakia.

This collaboration will enable Cipla to focus on its core therapy areas, while S&D Pharma will be the key partner for generics.

Under the collaboration, Cipla will be driving its respiratory product portfolio in both Czech Republic and Slovakia through a Cipla-owned sales force team, managed by Cipla Commercial Head. S&D Pharma will physically distribute all products, including

varied product pipeline for the future and very much look forward to contributing to the future success of Cipla's respiratory range."

In the near future, once the necessary regulatory and reimbursement approvals are in place, the SalmeterolFluticasone fixed combination will be launched in both markets under the name Fullhale. With Fullhale, the company will offer in Czech Republic and Slovakia an alternative which is effective and efficient and therefore brings many advantages into

Apart from Croatia, where the combination is already available under the name Duohal, Cipla recently launched the product in Germany and Sweden respiratory products, and this portfolio will increase over the next few years.

Frank Pieters, Head, Cipla Europe said, “We are excited to partner with S&D Pharma and believe that this collaboration will enable us to drive access in the Czech Republic and Slovakia across therapy areas in the coming years.”

Daniel Straus, Chief Executive Officer, S&D Pharma said, "We are delighted to extend our cooperation with such an innovative company as Cipla and to have the opportunity to further develop the Cipla brand and portfolio in our markets. Through this collaboration we have secured a competitive and

a market which suffers from limited resources. Fullhale will be available in a pMDI with HFA propellant in two strengths: 120 doses of 25/125 mcg salmeterol/fluticasone and 120 doses of 25/250 mcg salmeterol/fluticasone.

Apart from Croatia, where the combination is already available under the name Duohal, Cipla recently launched the product in Germany and Sweden. In Germany the product is distributed under the name 'Serroflo', whereas in Sweden the combination is launched as 'Salmeterol/Fluticasone Cipla.'

EP News Bureau-Mumbai

Venus ties up with Mylan To market meropenem in three European countries VENUS PHARMA, Germany, a wholly-owned subsidiary of Venus Remedies has entered into a distribution-cum-outlicensing agreement with Mylan for marketing its generic broad-spectrum antibiotic, meropenem, in three European countries. This deal with Mylan will enable Venus Remedies to market meropenem in Denmark, Sweden and Finland for a period of five years.

“Under this non-exclusive marketing agreement, we will manufacture the drug at our Baddi facility, which recently got a renewed European Union Good Manufacturing Practices (GMP) certification, while the batch release and logistics will be handled by our Germany facility Venus Pharma. The addition of territories on the basis of strategic tie-ups with our existing partners has re-established the faith of our customers in our quality standards and timely deliveries.

This joint venture will further help Venus Pharma and its collaborators in maintaining their market position to figure among the top five players with around 30 per cent share in meropenem markets in countries like Germany, France and UK,” said Ashutosh Jain, Executive Director-cum-Chief Operating Officer, Venus Pharma, Werne, Germany.

“The top line of Venus Pharma, Germany has generated $15.6 million in the last one year, thereby becoming a profit-making unit of Venus Remedies. We are pleased to join hands with Mylan and expect Venus Pharma to achieve a significant increase in turnover in the coming quarters,” said Pawan Chaudhary, Chairman and Managing Director, Venus Remedies.

EP News Bureau-Mumbai

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EXPRESS PHARMA

19

September 16-30, 2014

MARKET

Roche and InterMune reach definitive merger agreement Roche to fully acquire InterMune at a price of $74.00 per share ROCHE AND InterMune have entered into a definitive merger agreement for Roche to fully acquire InterMune at a price of $74.00 per share in an all-cash transaction.

The acquisition of InterMune, a Brisbane, California-based biotech company focused on the research, development and commercialisation of innovative therapies in pulmonology and fibrotic diseases, will allow Roche to broaden and strengthen its respiratory portfolio globally.

InterMune's lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada and under regulatory review in the US. IPF is a progressive, irreversible and ultimately fatal disease characterised by

The acquisition of InterMune, a Brisbane, California-based biotech company,will allow Roche to broaden and strengthen its respiratory portfolio globally progressive loss of lung function due to fibrosis, or scarring, in the lungs. Roche markets Pulmozyme and Xolair in the US and has other novel therapeutic medicines targeting respiratory diseases in clinical development.

Commenting on the transaction, Severin Schwan, Chief Executive Officer, Roche, said,

"Our offer provides significant value to InterMune's shareholders and this acquisition will complement Roche's strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating

disease."

Commenting on the transaction, Dan Welch, Chairman, Chief Executive Officer and President, InterMune's, said, “This merger recognises the significant value created by our team's commitment, hard work and execution for more than a decade to develop and commercialise treatment options for IPF patients and their families.

Roche's global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realise our joint vision to bring additional innovative therapies to patients with respiratory diseases."

EP News Bureau-Mumbai

Wockhardt’s two anti-infective drugs get QIDP status from US FDA WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet WOCKHARDT'S NEW Drug Discovery programme in anti-infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA. A QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are identified by the Centre for Disease Control, US, a top US government health and safety body.

QIDP status allows for fast track review of the drug application by US FDA paving

20 EXPRESS PHARMA September 16-30, 2014

way for an early launch.

Commenting on the achievement, Dr Habil Khorakiwala, Founder Chairman and Group Chief Executive

Officer, Wockhardt, said, “This is indeed a proud moment for us. Not only does the status allow for fast track review of our drug applica-

QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment.

It allows for fast track review of the drug application by US FDA, paving way for an early launch

tion, it also grants a five-year extension to the drug patents in the US which is a major support for the commercial aspect of the drug. These drugs will be entering in their global phase-III clinical trials early next year.”

WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet, which is a significant positive for the drug development scenario as currently there is very little advance drug research in developing solid oral dosages. Most of the research is in developing intravenous drugs.

EP News Bureau-Mumbai

Indian pharma excipients industry sets up IPEC India IPEC India is the fifth member of the IPEC Federation INDIA’S LEADING names in pharma excipients have joined hands to set up its first ever excipients council. The founding members of International Pharmaceutical Excipients Council (IPEC) India are Ajit Singh of ACG Worldwide and Subodh Priolkar of Colorcon Asia. Indchem International, Micro Labs, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma, and Merck Group are the other founder-member companies. IPEC India is the fifth member of the IPEC Federation, the others being the Americas, Europe, Japan and China. Internationally, the IPEC Federation is the leading federation of the pharma excipients industry and has over 250 members across all affiliates. The IPEC Federation provides a unified voice which promotes the proper use of excipients in medicines as a means of improving patient treatment. IPEC India will work actively to promote excipients safety and harmonisation of regulatory standards and pharmacopoeial monographs. It will be a source of advice and expertise on excipients and excipients-related regulations.

The Council will focus its attention on the law, regulations, science and business landscape of the Indian pharma industry for excipient manufacturers and suppliers. It aims to be a proactive colleague of the Indian pharma industry associations and federations.

EP News Bureau-Mumbai

MARKET

Novartis in pact with TB Alliance As per agreement, NITD will fully transfer its TB R&D programme to TB Alliance NOVARTIS HAS signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).

"TB is one of the scourges of the developing world and new medicines are desperately needed to combat its continued spread," said Mark C Fishman, President, Novartis Institutes for BioMedical Research. "TB Alliance is well placed to take our discoveries and compounds through development for the

benefit of patients with TB.” "Our long-standing partnership with Novartis gives us confidence in the scientific underpinnings of the TB portfolio," says Mel Spigelman, President and Chief Executive Officer, TB Alliance. "We look forward to advancing the most promising compounds into the clinic to meet the urgent need for new TB treatments."

Under the terms of agreement, NITD will fully transfer its TB research and development programme to TB Alliance, which will take financial and operational responsibility for continued research, develop-

TB Alliance will take financial and operational responsibility for continued research, development, approval and distribution of compounds in the NITD portfolio ment, approval and distribution of compounds in the portfolio.

Included is a novel class of drugs called indolcarboxamides that are active against drug sensitive and multi-resistant strains of

TB. One of these preclinical compounds NITD304, blocks MmpL3, a protein essential for the TB bacterium's survival.

NITD304 was described last year in a paper published in

Science Translational Medicine.

Novartis has collaborated in the past with TB Alliance and believes it has the best combination of expertise, capacity, and strategic interest to develop new agents and regimens for TB. Novartis’ efforts in discovery of medicines specifically for the developing world continues, specially focused now on new therapies for treating parasitic diseases such as malaria, and human African trypanosomiasis (HAT) - also known as sleeping sickness, as well as viral disease such as dengue fever.

EP News Bureau – Mumbai

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EXPRESS PHARMA

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September 16-30, 2014

MARKET DEAL TRACKER

Strengthening product offerings to supplement existing portfolios drive M&A activity Indian pharma sector witnesses no deals during August 2014

FIGURE: M&A (INCLUDING PRIVATE EQUITY) TREND ANALYSIS

M&A ACTIVITY in the pharmaceutical sector was focused on strengthening product portfolio to complement existing products.

In line with the above trend, Roche agreed to acquire InterMune, a US-based biotechnology company, for $8.3 billion.

FIGURE: VENTURE FINANCING TREND ANALYSIS

Source:

Source:

TOP M&A DEALS (AUG 2014) Rank

Date

Target

Acquirer

Deal value ($m)

1

08/24/14

InterMune, Inc. (US)

Roche Holding, Ltd. (CH)

8300

2

08/25/14

Beijing Jialin Pharmaceutical Co., Ltd. (CN)

Shandong Luye Pharmaceutical Co., Ltd..(CN)

597.94

3

08/13/14

TARIS Holdings LLC – LiRIS

Allergan, Inc. (US)

587.5

4

08/04/14

Santaris Pharma A/S (DK)

Roche Holding, Ltd. (CH)

450

5

08/06/14

Dream Pharma Corp. (KR)

Alvogen Pharma US, Inc. (US)

187

6

08/05/14

TheraDoc, Inc. (US)

Premier, Inc. (US)

117

7

08/27/14

Bellicum Pharmaceuticals, Inc. (US)

RA Capital Management, LLC; Perceptive Advisors LLC; Jennison Associates LLC; Sabby Capital; Ridgeback Capital Management LLC; VenBio Select Fund; Redmile Group; AJU IB Investment Co., Ltd.; AVG Ventures, LP; Remeditex Ventures, LLC; Undisclosed Investors

55

8

08/11/14

Alpine Biosciences, Inc. (US)

Oncothyreon, Inc. (US)

27

9

08/19/14

Xenotis Pty., Ltd. (AU)

LeMaitre Vascular, Inc. (US)

7.7

10

08/08/14

ViaCyte, Inc. (US)

Undisclosed Investors

5.4

Source:

TOP VENTURE FINANCING DEALS (AUG 2014) Rank

Date

Target

Investors

Deal value ($m)

1

08/25/14

Civitas Therapeutics, Inc. (US)

Adage Capital Management, L.P.; OrbiMed Advisors, LLC; Rockspring Capital; Sofinnova Ventures, Inc.; Partner Fund Management, L.P.; Alkermes plc; Bay City Capital LLC; Canaan Partners; Fountain Healthcare Partners; Longitude Capital Management Co., LLC; RA Capital Management, LLC; Wellington Management Company, LLP

55

Bay City Capital LLC; New Enterprise Associates, Inc. (NEA); Canaan Partners; UCB S.A.; Apple Tree Partners; Aisling Capital; Rockspring Capital; Sabby Capital; Undisclosed Investors

51

2

08/19/14

Dermira, Inc. (US)

3

08/25/14

ALDEA Pharmaceuticals, Inc. (US)

Canaan Partners; Correlation Ventures; RusnanoMedInvest; WuXi PharmaTech Corporate Venture Fund

24

4

08/07/14

Tolero Pharmaceuticals, Inc. (US)

Fred Alger Management, Inc. (Alger); Undisclosed Investors

14.2

5

08/11/14

Vyome Biosciences Pvt., Ltd. (IN)

Sabre Partners; Aarin Asset Advisors, LLP (formerly Aarin Capital Partners); Kalaari Capital

8

Source:

22 EXPRESS PHARMA September 16-30, 2014

MARKET This acquisition would allow Roche to strengthen its respiratory portfolio globally and complements its strengths in pulmonary therapy.

In addition, Roche would gain access to InterMune’s product Pirfenidone, a therapeutic for the treatment of idiopathic pulmonary fibrosis.

In another key deal, Luye Pharma Group agreed to acquire an aggregate 57.98 per cent equity interest in Beijing Jialin Pharmaceutical, a Chinabased pharmaceutical company, for $597.94 million. The addition of Beijing Jialin’s product ALE (atorvastatin calcium tablets) would supplement Luye Pharma’s existing cardiovascular product portfolio.

This acquisition would also further strengthen Luye Pharma’s market position and would have a competitive advantage in the cardiovascular therapy region, especially in the area of lipid regulators, and thus maximise its size and strengths swiftly.

M&A activity in the pharma sector remain steady in volume and decreased in value terms, when compared to the average of the previous six months’ (February 2014 – July 2014).

According to Datamonitor’s Medtrack database, the pharma sector recorded 29 M&A transactions in Aug 2014, against the previous six months’ average of 28.8 transactions. In value terms, the sector recorded deals worth $10.4 billion, against the previous six months’ average of $25.3 billion.

The Indian pharma sector witnessed no deals during August 2014, against the average of 0.8 deals over the previous six months.

Venture funding Companies in the pharma sector raised $166.5 million during Aug 2014, against the previous six months’ average of $260 million. In terms of volume, the sector recorded 10 venture funded deals, when compared to the previous six months’ average of 14.5 transactions.

Notes Medtrack is a comprehensive, fully integrated, global biomedical database providing information on companies, products,

EXPRESS PHARMA

23

September 16-30, 2014

patents, deals, venture financing, and epidemiology.

It is a live database, constantly updated with news, milestones, trial information, etc.

Medtrack’s unmatched coverage is supported by a userfriendly, highly dynamic set of decision support tools and

analytics.

In-house analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need.

Key uses of the database include competitive intelligence, target identification, screen po-

tential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking.

ues have been disclosed.

2.Trend analysis excludes rumored and terminated deals.

3.Value and volume analysis excludes private equity exits.

Definitions 1.Deal value trend is based on transactions where associate val-

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MARKET PRE EVENTS

ABLE to host 11 edition of BIOINVEST th

The event in Bangalore will discuss about the importance of investing in biotechnology in India THE ASSOCIATION of Biotechnology Led Enterprises (ABLE) will host the 11 th edition of 2014 BIOINVEST on October 17, 2014 in Bangalore.

Dr Goutam Das, Chief Operating Officer, ABLE will give the introductory speech and the key note address will be given by Dr PM Murali, President, ABLE. Panel discussions will be held on ‘The art of a biotechnology deal’, which will be moderated by Utkarsh Palnitkar, Partner, Head of Advisory, Head Life Sciences KPMG, where Dr Rashmi Barbhaiya, Chief Executive Officer and Managing Director, Advinus will share the insights on the Advinus-Takeda deal.

The panel discussion on 'Investing in intellectual capital creation (education and training)' will have Dr PM Murali, President, ABLE, Dr PK Khosla, Vice Chancellor, Shoolini University, Vijayanti Margassery, Associate Director Human Resources, Biocon as the panelists. The panel discussion on 'Investment trends in mature biotech markets - Lessons for India' will have Sanjay Singh, Director Corporate Finance, KPMG, Dr Renu Swarup, Managing Director, BIRAC, Ravi Tyagi, General Manager, SIDBI; Former Head SME Project – NSE, Vikas Dawra, MD-Investment Banking, Yes Bank and Sunny Sharma, Senior Managing Director, Orbimed

The supporting organisations are Biotechnology Industry Organisation, BIRAC, Bangalore India Bio, Shoolini University, Biocon Academy, Venture East, Bio Asia, Nasscom, KBITS Advisors, as the panelists.

Swaminathan Dandapani, Executive Chairman, Manipal Hospitals, Dr Abhay Jere. Associate Vice President & Head - Persistent Labs| Persistent Systems, Dr Anu Acharya, Chief Executive Officer, map-

mygenome, Ati Ranjan Kumar, AVP, Investment Research Aranca will take part in the panel discussion on 'The ‘big data’ healthcare business revolution.’

The panel discussion on ‘Lost in transit - venture capi-

tal for life sciences the missing link in the early journey of indian biotechs’ will have panelists Deepanwita Chattopadhyay, Managing Director and Chief Executive Officer, IKP Knowledge Park, Sohang Chatterjee, Director, Chief Executive Officer, Theramyt, Ravi Jain, Principal - Ventureast Life Fund, Ruchir Sinha, Co-Head, Private Equity Practice, Nishith Desai Associate.

The supporting organisations are Biotechnology Industry Organisation, BIRAC, Bangalore India Bio, Shoolini University, Biocon Academy, Venture East, Bio Asia, Nasscom, KBITS. EP News Bureau-Mumbai

DIAto organise 9 Annual India Conference th

It will be held in Mumbai from October 16-18, 2014; the theme for the event will be ‘The Future of Indian Healthcare: Patients, Access and Innovation' DRUG INFORMATION Association (DIA) will organise 9th Annual India Conference in Mumbai from October 16-18, 2014. The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Access and Innovation.’

The programme committee members are Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals Europe, United Kingdom, Madhur Gupta, Technical Officer - Pharmaceuticals, WHO, India, Prof Ranjit Roy Chaudhury, Chairman, Task Force for Clinical Research, Apollo Hospitals Group.

The programme will include sessions on important topics including patient health safety and compliance for pre-

24 EXPRESS PHARMA September 16-30, 2014

The programme will include sessions on topics including patient health safety and compliance for prescription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing scription medicine, patient participation in clinical trials, universal health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions etc.

Speakers who will take part in the conference are MK Bhan, Former Secretary, De-

partment of Biotechnology (DBT), Government of India, Vikas Mohan Sharma, Senior Director, Medical Ethics & Research Office of CMO, Quintiles Technologies India, Bhasker Iyer, Divisional Vice President, India Commercial Operations, Abbott Healthcare, Urmila Thatte, Director, FERCI, Prof and Head, Dep-

tartment of Clinical Pharmacology, KEM Hospital, Satish Chandra, Senior Specialist and Head Clinical Research, TAWAM Hospital (associate of John Hopkins), United Arab Emirates, YK Gupta, Prof & Head, Department of Pharmacology, All India Institute of Medical Sciences, Pooja Sharma, Patient Advocacy

Groups, CANKIDS, India, Ajoy Roy, Senior Medical Director and Head Medical Affairs, Parexel, Vivek Ahuja, Director, PATH, Adnan Mahmood, Director- Medical Safety & Clinical Development, Global Patient Safety, UK, Mira Shiva Founder, Health Action International Asia Pacific, Mira Shiva, Founder, Health Action International Asia Pacific, Vikas Ahuja, President, The Delhi Network of Positive People, Ketho Angami, Executive Member, HepCoN and Barbara Bierer, Senior Vice President of Research; Professor of Medicine, Harvard Medical School Brigham and Women's Hospital, US. EP News Bureau-Mumbai

MARKET POST EVENTS

FICCI organises ‘HIV/AIDS Health Conclave’ Sets stage for productive deliberations with the industry and government stakeholders from India and African countries FICCI, IN partnership with SHARE-VHS, USAID and NACO, recently organised ‘HIV/AIDS Health Conclave’ under the South to South HIV/AIDS Resource Exchange Project, ‘Partnerships beyond Borders’ in New Delhi. This pivot conclave set the stage for productive deliberations with the industry and government stakeholders from India and the focus African countries, namely Ghana, Nigeria, South Africa, Tanzania and Zambia.

Speaking at the conclave, Meenakshi Datta Ghosh, Senior Consultant, Independent Evaluation, Government of India, commended the private sector for its initiative in the prevention and treatment of AIDS in India and emphasised that the African community could follow India’s lead and successfully curb the spread of the disease.

On the occasion, a knowledge paper, ‘Partnership beyond Borders – Catalysing Solution’ was released. FICCI, in collaboration with Feedback Consulting, has attempted to understand the market potential and assessment of the focus African countries through the report.

The report also emphasises that the market potential of products and services in the area of HIV in the three countries (South Africa, Nigeria and Tanzania) would be over $50 billion in the next 10 years.

EP News Bureau-Mumbai

EXPRESS PHARMA

25

September 16-30, 2014

MARKET

OPPI organises HR Summit

7th Medical Technology Conference held in New Delhi

Discusses talent expectations, aspirations and effective and integrated talent management processes in the pharma industry

Vision Document – 2025, a report on the medical technology sector, unveiled

THE ORGANISATION of Pharmaceutical Producers of India (OPPI) recently organised its annual HR Summit on 'Attracting, Developing and Retaining Talent'. The event witnessed participation of business leaders, academia and HR professionals from the pharma and allied industry. At the event, distinguished speakers discussed the HR challenges of the pharma industry and drew upon experiences from other industries to provide likely solutions to these challenges.

In his inaugural address, Dr Shailesh Ayyangar, President, OPPI and Managing Director, India and Vice President, South Asia, Sanofi said, “Each business leader needs to be a good HR manager. It is important that the pharma industry is cognisant of the current HR challenges.

Innovative talent development programmes alongwith competency and skill development workshops are the need of the hour to harness young talent.”

Ayyangar further stressed that the generation Y has to believe that this industry is indeed a great place to work in. This can happen only when they are empowered with independence along with accountability.

While moderating a CEO’s panel discussion during the summit, Ajay Bhatt, Regional Human Resources Director, Abbott India, said, “It is only when the talent can see a clarity of role, a clear career path and more importantly feels valued that he/she finds fewer reasons to leave. The onus is on business leaders and HR managers to provide this clarity and create a participative environment.”

Moorthy Uppaluri, Vice President, Randstad, mentioned that the Indian

26 EXPRESS PHARMA September 16-30, 2014

Dr Shailesh Ayyangar, President OPPI during the HR summit

THE 7TH Medical Technology Conference was recently organised by the Medical Technology Division of Confederation of Indian Industry in New Delhi. Amitabh Kant, DIPP Secretary, Government of India, along with Union Health Secretary Lov Verma and Dr K Vijay Raghavan from Government of India and leading captains of medical technology industry were present at the event to unveil the ‘Vision Document – 2025’, an extensive report on the Medical Technology sector jointly prepared by CII and Boston Consulting Group (BCG).

Speaking at the conference

promoted if the sector has to realise its true potential and that the Government will have to play a leading, guiding role to ensure that.”

Chandrajit Banerjee, Director General, CII said, “Due to its pleasure and potential CII is happy to acknowledge the medical technology sector as a sunrise sector.”

Expanding on the theme of effective governance, Pavan Choudary, Chairman, Medical Technology Division of the CII and Managing Director, Vygon India said, “Classification of medical devices as drugs burdens the process of investment with fiscal

Distinguished speakers discussed the HR challenges of the pharma industry and drew from experiences of other industries to provide likely solutions to these challenges pharma industry is on the verge of leveraging a large number of talent and we need to maximise this opportunity.

Sudarshan Jain, Managing Director -Healthcare Solutions Abbott stressed on the point that today the critical thing among the pharma senior leadership is talent development.

Ranjit Madan, Chief Executive Officer, Life Sciences Sector Skill Development Council informed about the annual spending of both Indian as well as multinational pharma companies on building up re-skilling programmes. He revealed on the fact that 50 per cent CTCs of individuals are being put on re-skilling by pharma companies.

Alok Sonig, Senior Vice President and India Business Head - Generics, Dr Reddy's Laboratories provided various facts and figures related to the Indian pharma indus-

try's growth. He began his speech with a prediction that the Indian pharma market will touch $25 billion by 2030.

Overall another $20 billion incremental growth would be coming in from the Indian pharma companies in the US, Europe, Russia and China.

He emphasised, “We really need to invest in talent management for India and overseas market for developing and accelerating management skills.” He predicted that one third of Indians will be employed in the overseas markets in next 10 years.

Venkat Changavalli, a leadership mentor and management consultant, and Santosh Babu, an organisation leadership development consultant, spoke on various HR issues and stressed on the importance of mentorship and inclusive leadership.

EP News Bureau-Mumbai

Delegates at the conference during the release of ‘Vision Document – 2025’

Kant said, “The Indian medical technology industry can touch more than $50 billion in the next decade if ample emphasis on local manufacturing is paid by the industry and the Government.

Therefore it is essential that the sector exploits the cost advantage if it wants to compete with China for the global market.”

As per the Vision Document, getting things right could lead to a $30 billion domestic market opportunity as well as setting up the right manufacturing capabilities could spur an additional $20 billion manufacturing opportunity for the Indian medical technology space.

Verma said, “The medical technology sector should also look at CSR initiatives at promoting sanitation like building toilets in schools.” Raghavan accepted that local innovation has to be

policy obstacles and regulatory hurdles. It impacts FDI, technology transfer, local investment, manufacturing, operations, innovation and exports.”

“The Vision Document – 2025 highlights the need for a dedicated, separate and globally harmonised regulation for medical devices,” said Himanshu Baid, Co-Chairman, CII Medical Equipment Division and Managing Director Poly Medicure.

Rahul Guha, Partner and Director, BCG India said that there was lack of investment, lack of regulation, less priority of the Government and this was therefore a vicious circle. BCG also held a set of workshops across Mumbai and Delhi to discuss and debate the right focus areas and develop a roadmap to unlock the true potential of India.

EP News Bureau-Mumbai

EVENT BRIEF SEPTEMBER -OCTOBER 2014 25

PharmaLytica 2014

PHARMALYTICA 2014 Date: September 25-27, 2014 Venue: BIEC, Bangalore Summary: UBM India will host PharmaLytica 2014 in Bangalore. It will be a combination of a trade fair and conference where participants can pick up on the latest industry trends, techniques and methods. It is a platform connecting the pharmaceutical community with outsourcing solution providers, including clinical trials, contract research, custom manufacturing, biotech, IT and analytical services. PharmaLytica 2014 will spread over 2,000 sq mt featuring over 100 plus exhibitors.

The event will be supported

16

by Karnataka Drugs and Pharmaceuticals Manufacturers' Association (KDPMA). Also, India Pharmaceutical Association (IPA), Confederation of Indian Pharmaceutical Industry (CiPi) and Association of Contract Research Organization (ACRO) will support the event.

Contact details: Rahul Deshpande Sr. Manager - Projects Tel: +91 22 61727165 Mob: +91 98209 02476 Email: rahul.deshpande @ubm.com

9TH ANNUAL CONFERENCE OF DIA Date: October16-18, 2014

To subscribe: bpd.subscription@expressindia.com

9th Annual Conference of DIA

Venue: Mumbai Summary: DIA will organise 9th Annual Conference where national and international speakers are likely to participate. The theme of the meeting is ‘The Future of Indian Healthcare: Patients, Access and Innovation’ chaired by Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research Apollo Hospitals Group and Alexandra Pearce, Senior Vice President and Head Global Regulatory Affairs, Glenmark Pharmaceuticals. The programme will include sessions on topics including patient health safety and compliance for prescription medicine, patient participation in clinical trials, universal

8

health coverage and health insurance, medicine pricing and reimbursement, compulsory licensing, innovations in healthcare solutions etc.

Contact details: Drug Information Association A-303, Wellington Business Park - IMarol, Andheri - Kurla Road Andheri (East) Mumbai - 400 059 Tel: +91.22.67417625 Website: www.diahome.org

ASIA PHARMA EXPO-2015 Date: January 8-10, 2015 Venue: Bangabandhu International Conference Centre, Dhaka, Bangladesh

Asia Pharma Expo-2015

Summary: Bangladesh Association of Pharmaceutical Industries will host international exhibition on South Asian Pharmaceutical industry, Asia Pharma Expo-2015.

The exhibiting companies from more than 26 countries across the world are expected to participate. The expo will be accommodating 400 booths to the exhibitors. Major OEM suppliers from Asia, Europe and the US are likely to participate.

Contact details: Tel: +91 7940008233/ 53 Mob: +91 8000481114 Email: ceo@GPEexpo.com Website: www.asiapharma.org

EXPRESS PHARMA

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cover )

T

hough outbreaks of Ebola virus disease are not uncommon, the recent wave has indeed caused public health officials across the globe to press the panic button. As per World Health Organisation (WHO), as of September 3, more than 3,500 suspected cases have been reported from December from the four affected countries: Guinea, Liberia, Nigeria, Senegal, and Sierra Leone. Of

28 EXPRESS PHARMA September 16-30, 2014

these, recorded deaths cross 1,900.

Clearly, this zoonotic disease is very much on a killing spree. Recent news regarding mutations in the genetic material of the virus has only increased pressure on researchers. However, what has hit healthcare fraternities the most is the inability of the biotech industry to come up with remedies to keep Ebola under check.

Tough task Over the last few years, sporadic incidences of Ebola outbreaks were reported in sub-SaharanAfrica. However, these pale in comparison to the current Ebola epidemic. Today, treatment available for Ebola is more of a supportive type. Though there are some molecules under trial none of them have got final approval from the US FDA. “The current strain of Ebola is the most virulent that has

been reported in early 2014,� points out Dr Babasaheb V Tandale, Scientist D & Group Leader, Epidemiology Group, National Institute of Virology (NIV). Designated to handle Ebola initiatives for the institute, he has been inundated with calls from across the country as NIV serves as the country's foremost national laboratory in providing quick and accurate diagnostic services.

The NIV's brief has been

to research on emerging and re-emerging human viruses of public health concern and it has added Ebola to its already large list which includes HIV, KFD, hepatitis E, chikungunya, and H5N1/swine H1N1 among others.

All these viruses cause considerable morbidity and mortality.

Speaking about Ebola, Tandale says, “Ebola has a more severe disease pattern with high fatality. Biotech companies need to consider the

(

THE MAIN FOCUS

The Ebola outbreak has become a global emergency today. While a few drugs and vaccines are still under trial, the news of possible mutations in the Ebola virus genome poses fresh challenges

BY SACHIN JAGDALE

disease epidemiology, disease burden and impact on human health. It would also depend on risk assessments provided by the international health agencies. Market research and analysis is required prior to deciding priorities for investments. These factors may drive efforts for finding remedies for emerging infections. However, there may be additional challenges in science and technology tools for development of

Over the last few years, sporadic incidences of Ebola outbreaks were reported in sub-Saharan-Africa. However, these pale in comparison to the current Ebola epidemic

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remedies by biotech/pharma companies.”

The task of finding a remedy is made extremely difficult because of the highly virulent nature of the virus. Dr Manju Phadke, Asst. Professor, Dept of Microbiology, SIES College of Arts, Science and Commerce, Mumbai, explains, “Due to the highly virulent nature of the virus, the genetics of the negative single stranded RNA genome of the virus is also

poorly understood, thus making it difficult to design target drugs.” Phadke indicates that the mutations have made Ebola virus more transmissible and difficult to curb with targeted therapy.

Dr Amol Raut, Head, R&D, Chief Wellness Advisor, GeneSupport, talks about the importance of epidemiology in the process of drug development.

He explains, “Epidemiology of any virus is very important from

EXPRESS PHARMA

29

September 16-30, 2014

cover ) a drug discovery point of view.

Epidemiology many times holds the answer for the cure of the disease. Other factors which are making the task difficult are the rate at which the infection spreads in the body. Ebola is a filovirus i.e. from the family Filoviridae. As compared to a retrovirus (like HIV which is the causative agent of AIDS) Ebola causes death in a much shorter time. This virus doesn’t wait for the immune system to get compromised. This deadly virus drives the protein synthesis in hosts which is essential for the haemorrhagic stages of the disease. There are shortcomings in terms of understanding the pathway and inoculation for Ebola, hence discovering a concrete cure is becoming a difficult task for scientists all over.”

Drugs available As mentioned earlier, treatment for Ebola is mostly supportive in nature. It revolves around balancing fluid and electrolyte levels to prevent dehydration.

With no specific drug or vaccine available to treat this disease, drugs are mostly administered to deal with the symptoms as they appear.

Phadke says, “Administration of anti-coagulants early in the infection to prevent or control intravascular coagulation in cases with confirmed diagnosis is critical. Administration of pro-coagulants later in the infection to control internal bleeding is the key factor in treating the disease.

Besides this, maintaining the levels of blood gases, renal function and pain management is also important. Antibiotics can be administered to prevent secondary bacterial infections.” She adds, “The US FDA has allowed two drugs, produced by Mapp Biopharmaceuticals; ZMapp, a combination of three different monoclonal antibodies that bind to the surface protein of the Ebola virus and a drug called TKM Ebola which targets the genetic single strand of negative sense RNA, which is the genome of the virus. The drug acts by interfering with the genetic code of the virus, thus preventing the synthesis of viral proteins which aid in the pathogenesis of the

30 EXPRESS PHARMA September 16-30, 2014

disease. However both these drugs are still in the experimental stages and it is too soon to understand their effectiveness.”

Echoing Phadke’s views, Tandale cautions that it is too early to gauge ZMapp’s effect. According to him, the best way is to conduct a randomised controlled clinical trial to compare outcomes of patients who receive the treatment to untreated patients. Tandale informs, “No such studies have been conducted. At this time, very few courses of this experimental treatment have been manufactured. The manufacturer has indicated that the available doses have been distributed. The efforts to undertake research on evaluation of the product safety and effectiveness are ongoing.”

Several experimental trials on animals are being conducted since early outbreaks to address the treatment issue and target the virus in the most effective way. The evolution of drugs is highly dependent on the responses shown by such drugs after through clinical trials.

Raut informs, “Apart from Zmapp, a drug named Favipiravir has been developed by a subsidiary of Fujifilm Holdings Japan. Although, there are different drugs in development there is no sign of getting a positive response from various people in the medical field.”

On the research front As far as research is concerned, the most promising development till now remains the combination of antibodies that scientists are working upon.

“The outcome of this research is definitely going to be positive as the drug development process has speeded up to get the right cure to the infected popu-

Ebola has a more severe disease pattern with high fatality. Biotech companies need to consider the disease epidemiology, disease burden and impact on human health Dr Babasaheb V Tandale Scientist D & Group Leader, Epidemiology Group, National Institute of Virology

Due to the highly virulent nature of the virus, the genetics of the negative single stranded RNA genome of the virus is also poorly understood, thus making it difficult to design target drugs Dr Manju Phadke, Asst. Professor, Dept. of Microbiology, SIES College of Arts, Science and Commerce, Mumbai

lation and save them,” says an optimistic Raut.

Current research is being conducted mainly at two levels: drug and vaccine development. However, at both the levels scientists have met with limited success. Immune sera is also one of the options that scientists are cautiously hopeful about.

While there is an ongoing effort to develop remedies like antiviral drugs, immune sera and vaccines against Ebola, Tandale also points out that it takes a lot of time to develop, test and get approval of regulatory authorities before a therapy can actually be put to use.

To make matter worse, information about the remedies for Ebola is not available easily and there are lacunae in scientific data and evidence to evaluate them for Ebola, he avers.

Given the emergency, the WHO and other agencies have obviously decided to circumvent the usual procedures to ensure thatwork is carried out on a war footing.

Tandale informs that WHO had arranged a consultation of experts for experimental treatment and vaccines against Ebola on September 4-5. He adds, “Tekmira and Biocryst Pharmaceuticals have therapeutic candidates for Ebola in early development. A company called Newlink is developing an Ebola vaccine candidate.

BioCryst is working to develop an antiviral drug to treat Ebola virus. Other candidate treatments for Ebola include AVI 7537, selective estrogen receptor modulators like clomiphene and toremifene, BCX-4430 and ST-383.”

Despite a lot of hope pinned on vaccines to eradicate Ebola, not much tangible success has been seen. The US FDA has not

yet approved any vaccine. Tandale says, “The US National Institute of Health (NIH’s) National Institute of Allergy and Infectious Diseases is working on developing an Ebola vaccine.

Ebola vaccines were first tested in humans beginning in 2003.

Human safety studies of an experimental Ebola vaccine developed by the NIH and GlaxoSmithKline are being planned.

Another experimental Ebola vaccine, VSV-EBOV, has been developed by the Public Health Agency of Canada.”

Researchers are relying on Favipiravir because it inhibits RNA synthesis in influenza virus and strains of H5N1. This increases its chances of being a promising candidate as both Ebola virus and H5N1 virus have the same kind of negative strand RNA genome.

Future course for biotech companies Like many other outbreaks, the Ebola wave may subside in future, but not before extracting a heavy toll in terms of lives lost.

However, history shows that Ebola has the habit of striking back . The next Ebola outbreak could be even more severe, considering its mutating nature.

Hence the biotech industry should continue efforts towards finding a preventive remedy for Ebola virus and remain alert.

“I think that the research and drug development on Ebola virus should be continued as we all know viruses tend to mutate.

Hence, a mutated strain of the virus can be resistant to a drug which is under development right now. So, continuous observation and study of the virus should be done even after the outbreak subsides. History has proved that there have been sporadic out breaks of this virus and who knows, may be in future a mutated strain may cause a deadly outbreak, lethally damaging the human race. Moreover, the political scenario around the world is not so good; hence a continuous research on drug development front should be the aim as it can be used as a weapon for biological warfare.

History has witnessed the use of anthrax (Bacillus anthracis) as a

( biological warfare weapon in world war and post-world war era. Hope for the best and prepare for the worst,” says Raut.

Though the Ebola outbreak has its origins in the African countries, its effects are evident across the globe. So being a worldwide concern, it is necessary for the world community/ governments to engage themselves in the efforts to control the virus. Especially, biotech experts need to come together to share their expertise.

“Biotech companies could identify the key emerging pathogens based on risk assessments. They could also consider development of partnerships with international health agencies. These would help create international platforms for shar-

current outbreak. Research should be focused on the development of recombinant vaccines

and immunovaccines. Work is already being carried out by companies in this direction. Cost cut-

THE MAIN FOCUS

ting and budget cuts by government agencies as well as biotech and pharma companies should

not be done. It is important to study new Ebola drugs and vaccines.”

Being a worldwide concern, it is necessary for the world community/ governments to engage themselves in the efforts to control the virus ing challenges and issues so that prioritisation could be possible.

The initiatives that need to be considered include development of diagnostic capacities in terms of laboratory and epidemiological expertise including laboratory assays, antivirals, immune sera and vaccines against emerging viruses,” says Tandale.

Phadke opines, “Drugs like Favipir and SERMs are safe drugs as they are used in human beings for the treatment of H5N1 influenza and breast cancer respectively. These drugs should have been put on trials for the treatment of Ebola during the

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EXPRESS PHARMA

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September 16-30, 2014

cover ) Profit matters?

With a few exceptions, Ebola is predominantly confined to particular parts of the world and it goes into a lapse period after every outbreak. Is this the reason why pharma/biotech companies are reluctant to invest into its research, as it offers very limited profit margins? Experts feel so.

Raut says, “Yes, this can be one of the reasons for keeping pharma and biotech companies from investing in research (on Ebola). Ebola outbreaks are sporadic in nature, predominantly affecting low-income countries in the West African continent. Hence, pharma and biotech companies are likely to see very less pay off from these parts of the world and looking at the population it infects, the demand is very less. This

makes the companies to invest less in such research and pharma companies have little incentive to pour their research and development money into curing a disease that surfaces in a sporadic manner. Hence it’s all dependent on the economics of drug development which is very commercial.”

“I agree partially with the limitations and hurdles for investing in development of remedies for emerging viruses by pharma/biotech companies like difficulties in risk assessments, likelihood of emerging virus to have potential impact on human health locally and globally, and relative priorities of companies based on costbenefit scales,” says Tandale.

He adds, “Diseases of the poor receive too little attention from medical researchers and pharma companies. We should

Epidemiology of any virus is very important from a drug discovery point of view.

Epidemiology, many times, holds the answer for the cure of the disease Dr Amol Raut Head, R&D, Chief Wellness Advisor, GeneSupport

be investing more to develop drugs and vaccines to combat diseases like Ebola. It would require a concerted effort with partnerships involving re-

search networks, industry collaborations and initiatives of the international health agencies providing common platform to share difficulties and offer possible solutions so as to minimise the time required for development, testing, approvals and use remedies timely for decreasing impact of emerging infections on global human health.”

Since 1976, when the Ebola virus was first identified, the current Ebola epidemic is the largest and the most persistent. It has shown that an outbreak anywhere can escalate to be a risk everywhere, which wasn’t the case during previous outbreaks. Developing a stronger system to identify and stop future Ebola outbreaks is the moral imperative of governments and researchers across the globe.

Hopefully, this Ebola outbreak

has proved that the entire world is at the risk from such outbreaks, and with the increased focus of WHO and other agencies, we can expect more coordinated and collective efforts from different governments and health agencies.

Global collaborations and funding will hopefully be incentive enough for biotech and pharma firms to continue their research and increase the chances of finding effective drugs and vaccines against Ebola and other such diseases soon. sachin.jagdale@expressindia.com

(The views/opinions provided by Dr Babasaheb Tandale are in his personal scientific capacity and do not represent NIV/ICMR or government departments as the official opinion and stand on any response/replies)

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THE MAIN FOCUS

IN CHOPPY

WATERS Low investor sentiment, regulatory hurdles, drying pipelines are some of the challenges facing the biotech sector. It remains to be seen how will it come out of this scenario

BY SHALINI GUPTA

B

iotech drugs have been slated to become the blockbuster drugs of the future amidst speculations that the bubble is about to burst. A looming question mark hangs as investors fled US biotechnology shares a month ago, turning fund flows negative for the year to date as the Federal Reserve voiced concerns over high valuations in the sector. The sector has always been a risky proposition, but despite enjoying such a status, it has been a boom sector in recent years with smaller companies on the cutting edge of research and development attracting significant sponsorship from investors prepared to bet big on a major drug or medical breakthrough. There are no guarantees though. Out of many who fail, there are success stories which generate huge returns.

Blockbuster on the block?

A record 10 biotech drugs were approved in 2013, with the most prominent one being Sovaldi, that was approved by the FDA in December 2013 for the treatment of hepatitis C infections, putting Gilead Sciences on track for a potential blockbuster several

2014 could be one of the biggest years for biological drug launches, particularly if the PD-1 antibodies make it to market Mahad Narayanamoni, Partner, Advisory Services, Grant Thornton India

times over. The drug has since generated more than $2 billion in sales in its first quarter of full approval alone and has raised enough eyebrows over its cost of $1000 a day, even soliciting congressional inquiries. Another recent blockbuster crossover is from Cubist Pharmaceuticals whose Cubicin, which treats hospital-borne infections, has now crossed over the line of $1 billion in annual sales. As compared to 2013, 2014 looks bleak. There are only three drugs to be launched which include: GlaxoSmithKline's combination COPD therapy, Anoro Ellipta, Lundbeck's Brintellix for major depressive

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cover ) disorder and Celgene's psoriatic athritis drug, Apremilast.

These are expected to attain blockbuster status by 2018.

While small molecules still dominate new medicines, 2014 could be one of the biggest years for biological drug launches, particularly if the PD1 antibodies make it to market.

The industry's move to 'nichebuster' drugs may explain the switch from blockbuster drug development, but billion-dollar drugs remain an indicator of the sector's productivity, says a report by EvaluatePharma.

It is to be noted that the past two years witnessed a surge of R&D productivity, driving investor confidence and increasing market performance. However, analysts strongly feel that giant new products are needed to restore faith in R&D productivity. It will be worthwhile to see how the lack of blockbuster drug launches will affect investor's views of the biotech sector. When it comes to India, new biological entities remain out of picture even as there is a strong thrust on biosimilars, however, most companies are in early stages. It is felt that although India has gained reputation as the generic capital of the world through reverse engineering, winning the biosimilar battleground is

a formidable challenge.

“Indian companies have biosimilar programmes, however, the guidelines are still evolving, both in the EU and the US as well as India. There is regulatory uncertainity even as investors are looking for an assured return on capital,” says Mahadevan Narayanamoni, Partner, Grant Thornton India LLP. Biosimilar development is all about molecule selection, quality control, right infrastructure and innovation. Many com-

panies have been struggling to keep their biosimilar pipelines in order.

A conducive environment A report published few months back by PwC suggests that India needs an investment of ` 30,000 crores annually in the next five years for the biotech industry to grow to $100 billion by 2025. In his recommendations to the new government, ABLE President, PM Murali has been quoted as saying that,

“Biotechnology and life sciences industries need a road map of growth, opportunity and fiscal responsibility for bio-economy.

We strongly recommend transparent regulatory framework, bio-manufacturing infrastructure, investment in R&D and a very rational tax structure."

This is even more relevant given the fact that chemical product pipelines are drying up, and innovation is the way forward.

But companies are not performing as per investor expectations.

“There are no companies who specialise in biotech products trading at high valuations, if we take out vaccines and biosimilars,” says Narayanamoni. Not only is the investment climate discouraging for the sector, VC funds in India are not genuinely investing in such products.

The future then lies in partnerships with global biotech players to identify products for development and chart out a viable marketing strategy. Partnerships also become critical in the light of the changing R&D environment, as the life sciences industry continues to change into an industry in which collaboration becomes critical for innovative success.

However, it remains to be seen if this would help uplift investor sentiment and recharge pipelines of companies. With few breakthrough ideas that would translate into the medicine of the future and even fewer biotech investors, with little focus on early stage company creation, the challenges of operating in the space are not getting any lesser.

All this makes it even tough for entrepreneurs to navigate through the choppy waters of drug discovery and early development, not to mention the regulatory hurdles. shalini.g@expressindia.com

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34 EXPRESS PHARMA September 16-30, 2014

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I N T E R V I E W

‘We aim to stimulate biotech business in Gujarat’ Gujarat State Biotechnology Mission (GSBTM), a state-level nodal agency, coordinates the activities programme for encouraging and promoting biotechnology in Gujarat. Since its inception, it has added around 154 companies under its aegis.

Akshaykumar Saxena, Mission Director, GSBTM shares details of GSBTM’s mission and vision with Usha Sharma What was the rationale/vision behind the launch of GSBTM in 2004 by the Gujarat Government?

What have been the major milestones so far?

At national level, Department of Biotechnology (DBT) is the department for promoting biotechnology. However, there is no institutional mechanism at the state level. Despite the relevance of biotechnology, the issue remains unaddressed owing to lack of any support system at the state level. The rationale behind creating GSBTM was to establish a state-level nodal agency which could coordinate the activities programme for encouraging and promoting biotechnology in the state. Major milestones have been developing biotechnology policy in state, establishing state-level organisational mechanism for addressing biotechnology development; state supported and funded programmes for holistic development of biotechnology, independent DBT programmes; creating specific research and business related infrastructure; widening base of biotechnology research; popularising and developing modern high-end technologies; as well as stimulating entrepreneurship and biotech (BT) business and investments.

Despite the relevance of biotechnology, the issue remains unaddressed owing to lack of any support system at the state level

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cover ) DBT provides support to all Indian biotech companies.

Are you following DBT's strategies for uplifting the Gujarat-based biotech companies?

We are not duplicating the DBT strategies but are trying to ensure that gap-filling is provided at the state government level. GSBTM programmes and schemes aim to provide support which can enable the companies to become eligible for seeking benefit of DBT schemes.

GSBTM programme aims to dovetail with DBT programmes.

What all policies/schemes have been commissioned for the state-based biotech companies and how accessible are they?

Venture fund is the main scheme which aims to support biotech entrepreneurship and start ups. Till now, six companies have been benefited and other proposals are under scrutiny. GSBTM programme provides indirect support to BT companies. Industrial training programmes, increase in the availability of employable manpower to BT industries, enabling companies to get the Department of Scientific and Industrial Research (DSIR) recognition makes the companies eligible for DBT grants like Biotechnology Ignition Grant (BIG), Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Partnership Programme (BIPP) etc. Tech transfer programme helps in preparing better grant seeking proposal for BT companies. Biotech Park provides a place for BT companies to launch their business.

Do you plan to add more schemes?

Yes, there are plans to develop more schemes which will benefit technology development, technocommercialisation biotech entrepreneurship. However, at this stage the same cannot be shared. These schemes will

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GSBTM does not focus only on industries. It does not treat information about schemes as the only aspect for awareness. Its vision is leveraging biotechnology for building Gujarat as an innovative, socially - responsible and sustainable bio-economy largely address the need of start ups, small and mid-sized companies.

Share the names of biotech companies who have already availed the schemes?

Celestial Biotech, Aura Herbal, Axio-Biotech, Advance Meditech, Century Pharma are few of the companies which have taken the benefit.

How many biotech companies do you have in Gujarat? Do you think it will become a hub for biotech companies?

As per the survey, in 2004, there were around 50 companies engaged in biotechnology operations. As per the survey undertaken in 2013, there are around 154 companies engaged in biotechnology activities. We aim to stimulate biotech business and manufacturing activities. We think Gujarat, with its vast business base in pharma, chemicals and agriculture, will provide a good platform for BT companies to grow in Gujarat.

In the last 10 years, how effective has been the growth of Gujarat-based biotech companies?

In last 10 years, there has been increase in the number of biotechnology education courses, number of post graduates and P.hDs, increase in the number of research projects, research publications, employment created, expansion by existing companies, new start up companies, increase in biotech investment, which are the clear signs of biotechnology

growth in Gujarat.

What strategies have you adopted to create awareness about the schemes being offered by GSBTM to biotech firms and how effective are they?

GSBTM does not focus only on industries. It does not treat information about schemes as the only aspect for awareness.

It treats information about biotechnology sector, its application, potential, its products, state and national level programmes, business, etc. as awareness areas.

GSBTM is addressing the awareness needs of different stakeholders- students (up to higher secondary, undergraduates, post graduates), academicians, industries, public and has taken various steps. Echronicles, seminars, dedicated literature, awareness activities, alerts to state biotech players about key schemes, biotech awareness corners in districts, website etc are key strategies adopted

by GSBTM. How do you plan to raise funds for your initiatives? Is the Centre also contributing?

State-supported activities have been fully financed by the state government. GSBTM would seek financial support for special programmes. This apart, GSBTM is also encouraging, guiding, facilitating and providing handholding to individual project submission under different DBT schemes – SBIRI, BIPP, BIG, research projects, infrastructure strengthening etc. Approximately ` 20-25

crores of central funding has been received in this way for the biotech sector by the state government. GSBTM has also received DBT- BIRAC supported biotech incubator project at Savli for which ` six crores have been approved.

GSBTM, on average, receives ` 10-11 crores of funds from the state government which are used for biotech programmes, infrastructure, research support, venture support, awareness activities etc.

Why are there a handful biotech companies in India and why are they finding it difficult to maintain their growth consistently?

Biotech is a difficult sector, capital intensive, researchdriven and needing highly skilled manpower. Gestation period of new technologies, regulatory aspects, high risk projects, bank ability issues, fund availability etc. are key issues which make biotech business a difficult proposition.

What are the challenges that are hindering the industry's growth? And how to overcome them?

Access to capital, technologies and mechanism for technology, commercialisation of technology-led enterprises/entrepreneurship, market entry for new products/technologies and techno-innovations, bio-safety compliant regulatory and approval systems for GM/GE crops/ products, support system for biotech SMEs, support system for biotech manufacturing and biotech services, system/mechanism

to enable benefits/incentives offered by various state policies, support to new generation technologies and newer technology platforms, appear to be key issues. DBT has been a highly pro-active department which has been monitoring the needs of biotech industry very closely and has provided key inputs from highly active industry association. With every passing year, the Government has been addressing these aspects with new schemes and programmes. DBT has been coordinating with other interfacing departments for regulatory issues.

Tell us about GSBTM's mission and vision?

GSBTM’s vision is leveraging biotechnology for building Gujarat as an innovative, socially responsible and sustainable bio-economy. Its objectives are (i)To utilise biotechnology for rural upliftment and wealth creation (ii)To realise the potentials of inherent resources and strengths of Gujarat using biotechnology (iii) Increase the BT sector’s contribution to state’s economy (iv)To make Gujarat a preferred and globally competitive destination for development of BT products, processes and services; and (v)To create a conducive environment for biotechnology innovation, growth and development.

What plans have you chalked to accelerate the growth of Gujarat-based biotech companies?

GSBTM has developed a long term strategy for growth and development of biotech business. It includes support for research, technology development, techno commercialisation, venture support, etc. At this stage these approaches cannot be shared. u.sharma@expressindia.com

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REPORT

Accelerating growth: Forging India’s bioeconomy Excerpts from a white paper that examines India’s biotech industry from different perspectives, with focus on biopharma and bio-agriculture, and as well policy concerns like taxation, infrastructure, regulation, and technology transfer

T

h e Biotechnology Industry Organization (BIO) and the Association of Biotechnology Led Enterprises (ABLE), have released a white paper: Accelerating Growth: Forging India’s Bioeconomy. It examines India’s emerging biotechnology industry from a variety of angles and perspectives, focusing attention on the various sub-sectors such as biopharmaceuticals and bio-agriculture, and as well various policy concerns such as taxation, infrastructure, regulation, and technology transfer. The recommendations offered in the report reflect a broad set of issues that need to be addressed for the entire ecosystem to flourish, although the authors feel the

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cover ) issues of regulation and intellectual property represent the most pressing issues for India’s bioeconomy. For India to compete globally, attract investment, and enjoy the economic benefits that its strength in biotechnology can bring, it needs to align itself with global standards in these areas.

place in many countries and can serve as a model for professional development in India. ◗ Governments with active technology transfer programmes do not track the performance of the programmes or the outcomes associated with the technologies.

India can take a leadership role in developing an information system for such tracking. Such a system will assist in the monitoring of progress and point to needed changes in policies and practices.

Regulation ◗ The Government of India should consolidate its regulatory agencies and reorganise them so they follow a similar structure to regulatory agencies in the markets into which India sells active pharmaceutical ingredients and finished products. ◗ India should empower an office within the drug review process to act as the single point of contact during a drug review, guide companies through the process, and resolve problems and conflicting instructions from different committees and agencies. ◗ The drug review process coordinator should have the mandate to require standard operating procedures and authority to create and enforce deadlines on a project-by project basis. ◗ The Drugs Controller-General (India) should conduct ongoing quality and process control audits. India should have its own standards for such reviews and related reports, but the process should be crossedchecked annually against foreign reviews of the same products. ◗ Inspections made by off-shore regulators of Indian facilities and clinical studies should be reviewed against reviews made by domestic agencies. Variances should be reported and they should be investigated as appropriate.

efits, and to counteract the spread of misinformation. ◗ The Biotechnology Regulatory Authority of India (BRAI), first proposed in 2008, should be established to bring a more streamlined regulatory approach to agricultural biotechnology. ◗ Authority, transparency, and social and economic accountability of BRAI should be subject to on-going review.

tion of contract research organisations in other countries, and modify them to India’s specific circumstances.

Agricultural biotechnology

Bioservices

Bioinformatics

◗ Leadership from the Government and the biotech industry should find a way of conducting the national debate surrounding agricultural biotechnology based on a thorough social and scientific assessment of an appropriate incorporation of biotechnology into Indian and global food security. ◗ The Government should take an active role in public education about biotechnology and its ben-

◗ India should harmonise its regulatory processes and requirements with those of other countries. ◗ To promote greater use of Indian contract research organisations, India should make accumulated clinical data more useful for regulatory filings in other countries. ◗ In line with harmonisation, India can also adapt the best practices for the oversight and regula-

◗ India can take a global leadership role in formulating and promoting protection of personal data, especially for populations in the emerging markets.

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Intellectual property

Industrial biotechnology ◗ The growth of the industrial biotechnology sector can be promoted at first by mandating use of products for needs that are currently unmet, particularly in energy and environmental remediation.

Technology transfer ◗ India must address gaps in technology transfer quickly. ◗ It should follow developed countries to integrate the subject of translational research into academic coursework and

offer training to faculty members as well. ◗ As is well known throughout India, the technology transfer enterprise in the US was given its big boost with the passage of the Bayh-Dole Act in 1980. While there are imperfections in any mandated system of technology transfer, India should adopt The Protection and Utilisation of Public Funded Intellectual Property legislation first introduced in 2008. The failure to do so has a significant and ongoing cost to the biotechnology industry and the country in terms of lost opportunity and diminished competitive advantage as other countries rapidly develop their own technology transfer systems. ◗ Once mechanisms for technology transfer are in place at academic institutions, developing and maintaining professional staff will be a challenge. National training programmes are in

◗ Using the patent system as a mechanism to control drug pricing forestalls making the difficult decisions about necessary investment in the healthcare system, but does not deal with the underlying issues. As politically challenging as it may be, there should be a reconsideration of the intent and application of Section 3(d) of the Indian Patent Act. The issue of access and affordability are clearly paramount, but as a matter of policy, the Government must consider a broader array of solutions and allow its patent system to encourage needed innovation, particularly among domestic biotechnology companies. Moreover, multinational corporations say the use or threat of compulsory licensing dissuades them from investing in innovation in India.

Human resources development and higher education ◗ Indian universities should develop joint degree programmes in such areas as information technology and biosciences and encourage projects that bring together students in different disciplines for common goals. ◗ The Indian Institutes of Technology and the Indian Institutes of Management should work together to develop joint degree programmes to produce people with both scientific research and management skills. ◗ Programmes should be established to train and encourage entrepreneurial researchers interested in commercialising technology to assist them with understanding issues around such things as intellectual

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property protections, capital formation, market analysis, and regulatory issues. ◗ India should develop programmes and incentives to attract expatriates with deep industry and entrepreneurial experience to return to India as a valuable source of expertise to launch new companies or fill specific skills gaps.

Infrastructure ◗ India could create special zones that provide biotechnology companies with reliable water and power needed for their operations. These zones can have dedicated power plants and water purification, as well as sewage processing. The process of transferring specialised equipment from overseas sources should be expedited.

Taxation ◗ The investment tax credit in equipment that India provides high technology companies should be extended to biotechnol-

pharma companies as a gateway to Asia, provide forums that foster partnering opportunities, and take steps to quell concerns about the protection of intellectual property and other policies, laws, and business practices that impede partnering activity. M&A and partnering have been important mechanisms to access capital, technology, and new markets. ◗ Since access to innovation and markets are two reasons potential partners with Indian companies would seek to enter into a partnership, India will need to address issues that limit its development of innovative products or make its market unattractive to foreign companies despite its large and growing population.

Finance ◗ Angel investing: There are limited interventions for public policy, but providing incentives through tax credits or other measures for angel investors could encourage the availability of capital for

India could create special zones that provide biotechnology companies with reliable water and power needed for their operations ogy companies, as should the ten-year tax holiday afforded companies once they begin producing products. ◗ R&D tax credits extended to biopharmaceutical companies should be extended to contract research organisations and companies in other sectors of biotechnology. ◗ India should introduce accelerated appreciation for research and development expenditures, which could encourage generic drugmakers to invest in biologics and put India in line with China and Singapore, which both offer such incentives. ◗ India should offer tax holidays for R&D related income. In addition, India could incentivise the development of innovation through tax breaks for revenue derived by the sale of patented products. ◗ To incentivise investment in early-stage, privately held biotechnology companies, India should forgo taxes on gains from investments in these companies held for more than 10 years. ◗ India should consider the creation of tax favourable financing vehicles to allow the creation of off-balance sheet financing of R&D projects by private investors.

M&A and partnering ◗ India should promote itself to bio-

early-stage biotech. ◗ Incubator resources: Direct grants of investment capital to incubators may not be the most effective approach. A matching programme to leverage Government investment where the Government provides funds on a 1:3 or 1:4 basis, and the incubator raises the larger portion of capital from private and local public and private sources, might be the best way to engage local communities and align interests. ◗ Government programmes: The Department of Biotechnology programme should preserve a meaningful role in capitalization in order to encourage work towards areas of strategic interest to India.

A mechanism should be created to encourage Indian state governments to participate in funding. ◗ Venture capital: India should create matching programmes similar to China’s Emerging Industry Start-up Investment Scheme. An adaptation of this programme could be a game changer for India. ◗ Public listing: As the Indian government accumulates experience with offshore listings, it could consider expanding the purposes for which Indian companies may list overseas.

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MANAGEMENT

INDIAPHARMAINC RATES NAMO GOVT The pharma sector gives the Narendra Modi-led Government full marks for good intentions but prefers to reserve judgement till it sees more concrete action

BY USHA SHARMA

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iding to victory on massive mandate, Narendra Modi took office on May 26 this year along with 45 ministers and got down to work, aware that it would be under tremendous scrutiny. The Budget presented yet another opportunity for the government to craft policy and announce priority areas 100 days.

There was an air of cautious optimism in the pharmaceutical industry, as well as other sectors.

On September 2, the Government presented its ‘report card’ for its first 100 days. But even though the Indian pharma industry too analysed the Government’s performance, the initial euphoria seemed missing. The general consensus is that on the face of it, nothing had changed much for the sector.

40 EXPRESS PHARMA September 16-30, 2014

Consider the fact that the sector did not get much attention, in terms of funding or ‘big bang’ policy reform, in the NaMo Government’s first budget, despite the BJP’s pre poll manifesto promising a lot of attention to the health sector and improving health indicators. Did the industry expect too much too soon?

Maybe there is a grain of truth in this, when quizzed on this omission, the budget's architect, Union Minister of Finance and Defence, Arun Jaitley replied that there were many more occasions apart from the budget to meet the BJP's manifesto. (Jaitley was fielding queries on the sidelines of an Express Adda held on August 27 little before the 100 days’ milestone).

But the optimism persists as Modi's

message seems to have percolated to the states.

Speaking at a recent conference of media representatives of the health beat, Laxmikant Parsekar, Health Minister, Goa, noted that the current Government is clear with its ideas and streamlining of regulations. He emphasised that with the help of the Central Government, Goa would become the first state to provide health insurance to its entire population, with the launch of this initiative planned for a couple of months down the line. He also raised the point that this idea was on the agenda of the previous government for almost more than a decade but they kept extending it for unknown reasons. He opined that it now seemed close to coming true due

to the sincerity and focused attention from the Central Government.

We asked key industry representatives to rate the NaMo Government’s performance in its first 100 days through the prism of the pharma sector's needs as well as to suggest the way forward.

DAARAB PATEL,Secretary-General, IDMA

100 days are too short to make a definitive assessment Rating: 7/10

T

he Narendra Modi-led Government has completed over 100 days in power and there have been many speedy and sweeping decisions and a few ‘incremental’ ones. The aspirations are many and the confidence level is very high. I would give it a 7, as it is only 100 days since taking charge and implementation on many policies and projects are yet to take off. Modi appears to have understood the importance of the Indian pharma and lifesciences sector with his invitation to global manufacturers to “come and make in India”, in diverse fields including chemicals and pharma. Also his plans and focus in the healthcare sector includes the lifesciences sector implicitly and would boost the sector’s growth. However there are a few issues that are specific to

the Indian pharma and lifesciences sector such as the unhealthy competition from China eroding our active pharmaceutical ingredient (API) industry, concerted moves from some vested interests overseas using TRIPS plus measures to block consignments of our generic drugs from reaching those in need, spurious drugs provisions in D&C Act & Rules, FMRAI issue of fixed working hours, resolving the contentious issue of questions raised on efficacious FDCs that have been prescribed and safely consumed over the last many years, etc.

In view of these and other issues that are hindering the pace of growth of this sector, it is imperative that the industry needs more active involvement of the Government to resolve the issues. However, seeing the support received by the pharma industry in Gujarat under Modi’s

leadership, we are confident of the support and boost the pharma industry will receive on a national level.

Need to tailor schemes The pharma industry faces a few unique problems. For example, the banking industry, without appreciating the factors that differentiate the pharma industry vis-à-vis other manufacturing industries, creates hurdles in generating finance for working capital and growth. Hence the Government needs to urgently set up dedicated pharma /lifesciences teams within banks and also set up site upgradation fund for SMEs, large R&D fund to boost local innovation of affordable medicines etc.

Narendra Modi has been an active Prime Minister, and has imposed a degree of accountability and expectations from his team of Ministers and bureau-

crats with his motto of ‘Minimum Government, Maximum Governance’. While 100 days are too short to make a definitive assessment, Modi appears to have a definite vision of India which he wants to lead us to, glimpses of which have come through in his speeches and decisions over these last few days. This has also been implemented with a clear shift in strategy, relying on social and official media to spread the message. From a revamped PMO website and Twitter updates, the Government appears to have pulled out all stops to adopt a more modern approach and transform India into, in Modi’s words, “digital India with e-governance which is easy governance, economical governance and effective governance”.

Act fast to remove hurdles From tax policy, land acquisition issues, environment approvals,

manufacturing to labour laws, the Government will need to act fast in removing the hurdles in reviving the manufacturing sector and rekindling the entrepreneurial spirit. The new corporate law that is still being amended as it gets implemented requires a serious review as the business community has not been able to comprehend the sweeping changes, the ambiguity in the CSR Rules etc. Similarly the changes made in Service Tax Rules also need to be reviewed. The government appears to have not yet taken the real hard measures like cutting government expenditure on subsidies to boost local production.

The Modi administration will also need to clear the stalled projects and provide the industry with more flexibility to ensure that the bottlenecks are removed swiftly to get the engines of growth roaring again.

SUNEELATHATTE,President, ISCR

We need to encourage innovation, not deter scientific & medical community W

hile a lot has been spoken about access to healthcare, the role of innovation in access to healthcare, especially for unmet medical needs has not got the emphasis it deserves. The rating therefore would be 1/10 from a clinical research perspective.

Given the Government’s commitment to ‘Health for All’, there has been inadequate focus on the life sciences sector in the first 100 days.

Need to create an ecosystem that fosters research and

innovation A lot needs to be done to ensure better and more affordable healthcare for our population. From a clinical research perspective, we need to create an ecosystem that fosters research and innovation. The decision to include Rotavirus vaccine in the Universal Immunisation Programme (UIP) which the Minister of Health has hailed as “one of the most pro-people decisions taken by any Government in recent years because it has the

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potential to drastically reduce infant mortality, particularly among the poorest sections of society,” demonstrates the high calibre of R&D skills available in the country as also how public-private partnership can successfully work together to address cures and treatment for illnesses that affect our country.

We need to encourage innovation and not deter the scientific and medical community from continuing in the quest to find safer and more effective

treatment for our disease burden. It is only through clinical research that we will be able to find newer and better medicines to treat our population and reduce mortality rates for various diseases, including those unique to our part of the world. We need a quick turnaround in some of the amendments to contentious guidelines as well as quicker and more streamlined approvals.

The Government can play a major role in using its channels to create better awareness and

Rating: 1/5

education about clinical research so that patients are aware of their rights and responsibilities and the public misconceptions are addressed.

The way forward There needs to be an investment in infrastructure and capacity building within the regulatory department.

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MANAGEMENT

RAJESH DESAI,Executive Director – Finance, Glenmark

If single-minded focus on development agenda continues, success will follow Rating: 4/5

I

t has been an impressive start by the Prime Minister. What is important to note is that he is very much focused on the country and its development. His intentions of building strong relations with Japan and some other nations is also a step in the positive direction. There is a lot to benefit if India aligns with Japan.

The impact of his economic policy will be known in a few quarters from now. But definitely the overall sentiment for business has improved in the country.

The Prime Minister needs to be lauded for his focus on Governance and efforts to streamline the bureaucracy. It is also evident that the Government is working aggressively on making India an attractive investment destination to provide jobs to

millions and grow the economy.

In the first 100 days, the government had taken many small steps to prepare the stage for economic repair and a highgrowth trajectory.

The Government’s focus on ‘Health for All’ was visible in its maiden Union Budget with announcement of measures like providing free drug and diagnostic services to needy patients and creating AIIMS in

every state of the country. It important to address the critical challenge of providing access to high quality medicines and medical treatment to our 1.2 billion-plus population and at least the intent can be seen in the 100 odds days of the Modi government.

The Government should take steps to introduce the Goods and Services Tax (GST) soon; which will help in simplifying and

streamlining the indirect tax regime and will benefit all industries. Similarly, a lot of other policy decisions needs to be taken and most importantly these policies need to be implemented and its progress monitored over a substantial time frame. For now, all we can say is that the PM is on the right course and if this single-minded focus on the development agenda continues, success will follow.

Biocon

Lupin

Steps in the right direction; a lot still needs to be done

We have to give time to set the wheels in motion

Rating: 3.5-4 /5

T

hough the life sciences sector is yet to see ‘radical reforms’, the Narendra Modi Government’s efforts to improve the overall business environment in India are likely to have ripple effects on the life sciences sector too. The life sciences sector has propelled India into global prominence and leadership without significant government support. However, it has far greater potential. To help achieve this, there needs to be greater stakeholder engagement in the healthcare and life sciences sectors for meaningful reforms and policy making.

Already, the maiden Budget of the Modi government has proposed to scale up the Bangalore and Faridabad biotech clusters and also expressed its intent to bring global leadership status to the International Centre for Genetic Engineering and Biotechnology. While these are steps in the right direction a lot still needs to be done.

42 EXPRESS PHARMA September 16-30, 2014

Policies needed for three strategic areas The life sciences sector in India is over-regulated, over-taxed, under-incentivised and under-invested. To make the industry globally competitive and to prime it for sustained high growth, policies are needed to address three strategic areas: manufacturing, innovation and entrepreneurship.

Suggestions for roadmap The Government is serious about improving the ease of doing business in India through the simplification of laws and policies and introduction of self-certification and automatic approvals. I believe these measures will go a long way in boosting the life sciences industry. In addition, the Government needs to take the following steps: ◗ Support manufacturing The Government should make low-interest loans available to the life sciences sector to support capital investment for upgrading and expanding manufacturing infrastructure. ◗ Incentivise R&D The weighted tax deduction on

R&D costs allowed to companies does not permit the inclusion of international patenting and overseas drug development expenses. This tax exemption should be allowed urgently. ◗ Take a rational approach to drug price controls Drug price ceilings should be calculated based on an equitable formula which ensures like-to-like comparison and takes into account the quantum of investments. ◗ Boost exports Pharma and Biotech SEZs should be allowed to choose the starting year of the five-year tax holiday based on obtaining required regulatory approvals. The Minimum Alternate Tax (MAT) on SEZs should be abolished. ◗ Revive clinical trials The Government should intervene to revive the clinical trials industry. It should re-look at some of the recent changes brought in to strengthen the monitoring of clinical trials as irrational guidelines will scare away innovators from India and irretrievably hurt the country’s ability to partake in new drug development.

Rating : 2.5/5

I

t is too early to be measure the impact that the new Government has had on the economy and markets. The Prime Minister and his Government’s affirmative and positive stand on important issues like economic policy, reforms with the emphasis on e-governance, the manufacturing sector, affordable housing, easing of FDI norms and improving relations with the international countries has reaffirmed confidence in India’s growth story- the prime reason behind what has moved the markets upward. A lot needs to be done in terms of true policy

reform and we have to give the government some time to set the wheels in motion.

Having said that, similar sentiments cannot be shared about the pharma sector. The new Government hasn’t made any new provisions for tax incentives to encourage innovation in R&D and assist in developing and honing Indian IP. The Government spoke about formulating a clear roadmap for GST which is still unclear and something the industry is eagerly awaiting. Further, the inclusion of additional key drugs under the ambit of drug pricing will have an undesirable and adverse impact on the pharma industry. u.sharma@expressindia.com

MANAGEMENT LEGAL EAGLE

Analysing reactions to India’s draft pharma patent g’lines

SANKAR SUNDARAM, Pharmaceutical sciences professor at JSS University, Mysore and a patent agent with India’s intellectual property office

Sankar Sundaram, pharmaceutical sciences professor at JSS University, Mysore and a patent agent with India's intellectual property office, counters comments on the Indian patent office's proposed draft patent guidelines for pharmaceuticals and analyses the possible impact once these guidelines are adopted ON FEBRUARY 28, 2014, the office of the Controller General of Patents, Design and Trade Marks (CGPDTM), Department of Industrial Policy and Promotion, Ministry of Commerce & Industry, Government of India had issued a set of draft guidelines for examination of patent applications in the field of pharmaceuticals and had invited comments from the various stakeholders who would be affected by the implementation of these draft guidelines into their finalised version.

Consequently agencies like the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Commission’s Director-General for Trade, the International Federation of Intellectual Property Attorneys (FICPI), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japan Pharmaceutical Manufacturers Association (JPMA), the Lawyers Collective, Mylan Laboratories, the Organisation of Pharmaceutical Producers of India (OPPI), South Centre (Innovation and Access to Knowledge Programme), the US –India Business Council (USIBC) and many other advocacy groups and individuals had commented.

On June 12, 2014 the CGPDTM had customarily published these comments in their website before vetting them.

Then a discussion meeting of the various stake holders were held in New Delhi and those proceed-

ings were published online by the CGPDTM on August 1. Subsequently a second set of draft guidelines for Examination of Patent Applications in the Field of Pharmaceuticals was issued by the CGPDTM on the August 12, after vetting the stakeholder’s comments. These findings are a cursory analysis of those comments concluding with their logical implications and the message the Indian pharma majors should heed to.

Silence on 'working' of pharma inventions One salient feature about the stakeholder’s comments in general is their stark silence in respect to the draft guidelines’ connection, to the import and working of pharmaceutical inventions into our country. It is understandable that most of the comments represent interests who along with securing patent protection for their pharmaceutical-related intellectual property in highly regulated markets also-want it protected in our country. While it is a good indication that more the patents filed in a country more is its development in the field of science and technology, this growth should be self-attained and not be thrust or solicited. Naturally, most of these comments don’t mention about the need for accessibility of the pharma inventions by the patients whose interest too, these guidelines are intended to promote.

Bias against pharma sector?

Some comments air the view

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that these guidelines show a bias against the pharma sector and also that there is no need to warrant a special treatment for the pharma sector. It has been further pointed out by some agencies that the guidelines regarding bad patents are exemplifying only pharmaceutical sector’s applications.

Interestingly, there exists a precedent where an US court (the US district Court for Columbia) had on May 30, 2014 ruled that the US Federal Trade Commission (FTC) has statutory authority to issue pharma industry-specific rules under a certain Hart-Scott-Rodino Antitrust Improvements Act, provided that there is a rational basis for the rules and the FTC observes the procedural requirements of the Administrative Provisional Act of the USA. As a result of this Court’s decision, the US FTC’s all commercially significant rights test could be ap-

plied to the transfer of patent rights in the US pharma industry. Could this be construed as a discriminatory and biased treatment against the pharma sector of the US? Further, if pharma patents are run-of-the-mill stuff with no need for a distinction between other type of patents, then why has the Generating Antibiotic Incentives Now (GAIN) Act enacted by the US Congress in 2012 been providing extended marketing exclusivities to the pharma manufacturers of antiinfective drugs in the US for Qualified Infectious Disease Product-NDA Approved drugs?

Pharma patent claims unduly broad It has been pointed out that there are no evidences in the draft guidelines to support a statement that pharma patent claims are unduly broad. But, a casual look at any of the patent

applications, almost anywhere in the world, would exude the fencing, hedging, or thicketing measures undertaken by a patent-applicant. There are quite a few patentees who would permit a third party to make a commercial advantage out of their patent teachings. The playing fields need to be level, whether in India or elsewhere. Certainly, it would be a welcome scenario to see, in the draft guidelines, the examples of allowed claims in the actual patent applications, which have been issued over the last 20 years and which relate to the discovery of drugs used to treat tropical-afflicting diseases.

These examples, for our country would be like a motivational tonic. Only internationally, these patent applications for the antibiotic-related Active Pharmaceutical Ingredients (APIs) are becoming rarer and rarer, over the last 40 years.

Section 3(i) broader than permitted by TRIPS Article 27.3 It has been expressed that Section 3(i) of the India Patents Act which excludes from patentability “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is broader than the narrow exception to patentability permitted

by Trade Related Aspects of Intellectual Property Rights (TRIPS) Article 27.3. As any

EXPRESS PHARMA

43

September 16-30, 2014

MANAGEMENT physician would vouch, prophylaxis and cure are the therapies for any patient foreseeing to undergo medicinal treatment and these are the fundamental rights of any life anywhere in the world, period. These are not negotiable and cannot constitute any TRIPS Article 27.3 violation.

Purpose of granting 'selection' inventions self defeating It has been commented that the draft guidelines need to clarify that 'selection' inventions could be novel and therefore patentable, including over the prior art that might have disclosed a broader genus. The very purpose of granting selection patents is self defeating and is likely to lead to the abuse of the patent system of a country, especially with respect to APIs. This is because not only is non-obviousness one of the criteria for the grant of a patent protection, but the chemical art is inherently unpredictable.

Now, assuming that a genus patent has been granted to a research company and another research company too comes out independently with a better species- API and after applying for a patent gets one on a species subset. Would the former innovator be so magnanimous to accept the later granted species patent or would it appeal against the grant of the patent on obviousness grounds? You cannot have the cake and eat it too. Of course any research team would like to reap the patent protection conferred by a state.

Opposition to obviousness consideration In the paragraph of the Draft Guidelines regarding a reasonable expectation of success in the obviousness consideration, opposition has been raised for the statement “In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious tests”. To negate this opposition, instead of totally deleting that statement, if it can be amended suitably, as for example - In other words enhanced effects cannot be adduced as evidence of inventive step if they emerge from obvious to try alternatives- then it would make the ground of the the

44 EXPRESS PHARMA September 16-30, 2014

CGPDTM even clearer to all the stakeholders.

A relevant example could be a recent rejection of non obviousness in the US of the superiority of the SSSSS isomer of an angiotensin-converting enzyme inhibitor over the RRSSS isomer of the same stereoisomer. This is in fact the result of the dicta in the US Supreme Court’s ruling for a recent obviousness/non-obviousness case wherein it has been ruled that when the effects in the inventions are enhanced, as compared to the prior-art and this enhancement has been got by the application of a finite number of identified predictable solutions within the grasp of the person having ordinary skill in the art, then, the invention is more likely to be obvious.

Prohibition against plants and animals overbroad Many agencies point out that the draft guideline’s prohibition, under Section 3(j) of the Patents Act, 1970, against plants and animals is overbroad. But then, after the recent cases at the Supreme Court of the US, it could be inferred that natural products are not patentable in the US unless they are significantly different to the product as it occurs in nature. On a different note, the United States Patent and Trademarks Office’s (USPTO) draft guidance excludes from patenting, chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria,

plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature unless there is a markedly different change in their structures as compared to the naturally occurring substance.

Preventing biopiracy of traditional knowledge Many agencies express the view that Section 3(p) of the Patent Act, 1970 which excludes from patentability “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” would affect the patentability of a claim in a patent application. Unlike many countries, in India more than 100 languages and dialects are being spoken. Hence, it has not been possible for the exhaustive and complete codification of the concepts, in any one particular language, to this day. This is despite the availability of the Traditional Knowledge Digital Library (TKDL) database, made available by India. If the traditional knowledge is treated as prior art, then it would generate the complexity of diverting the pursuit of novelty/anticipation of an invention into a hunt for a written description, enablement etc in a common language, which in many instances is difficult to unearth, despite the prevalence of the word of mouth. This would divert our country’s resources needed for ascertaining patentability into a witch-hunt for archives in one of the 13 official languages of the World Intellectual Property Organization (WIPO).

There are reservations from

certain agencies regarding the requirement in the draft guidelines stating that if biological materials are used in an invention, an identification of the country of source and geographical origin is required to be disclosed in the specification. They call this as an additional requirement which they say introduces ‘significant uncertainty’ as the country of source and/or geographical origin may or may not be discoverable by a patent applicant. There are numerous instances of misuse of traditional knowledge for the purpose of securing patent protection. A cursory Internet-search using the term 'biopiracy' would tell a plethora of stories about the use of traditional knowledge in medical therapies being appropriated and then patent-issued unilaterally by one entity, without having served the interests of the total community from whom the knowledge was got in the first place.

So, while these draft guidelines are intended to strengthen the Intellectual Property (IP) protection cover to the actual holders of this knowledge, additional milieu has been covered by the second draft Guidelines of CGPDTM in the August 2014 amendments enhancing the discoverability of the source and geographical origin of the invention.

Markush claim applications Many agencies object to the first draft guidelines’ requirement to provide in a Markush claim application the disclosure of all the possible embodiments covered under the claimed Markush formula, to provide physical and chemical properties of claimed compounds, and to include a test conducted for each embodiment to overcome the objection on the claims to prevent the Indian Intellectual Property Offices’ action as “lacking unity of invention, as well as for insufficiency of disclosure” as unreasonable.

Now, the amended draft guideline states that test conducted for the representatives of such embodiments be included in the patent application, as opposed to all the possible embodiments. Thus the objection regarding the old draft guideline has been overcome.

If too many (a quantity outnumbering the working realm of the patent applicant) Markush claims are patent-issued and the patentee does not work all of those Markush products and causes these Markush product patents to be amenable for a section 83 action under the Patents Act 1970 by the Indian Patent Office, was it worthwhile in the first place to get a patent issued for those Markush formulae compounds?

Also, an unduly broad Markush claim, could lead to a situation where a subset of the originally claimed invention, suddenly turns out to show “surprising activity”. As can be seen in draft guidelines’ example 1 of section 8.10 and once again in Draft Guidelines’ example 1 of section 12.10 there are pointers in the draft guidelines wherein Markush products have been quoted as being patent-eligible.

Further, the Scope part of the second draft guidelines of CGPDTM in the August 2014 amendments includes a disclaimer regarding the non-limiting nature of the proffered examples in the draft guidelines.

In defense of additional patentability criteria Some comments tend to out howl the patentability criteria expressed in these draft guidelines as imposing additional requirements of patentability for pharmaceuticals. It is well known that oftentimes ‘new’ in the patent law has been interpreted to mean a previously known, but not recited in the claims process for the preparation of an already known compound or to mean a new method of use or to mean a new homologue etc. Similarly non-obvious in the patent law has been interpreted to mean subject matter which could have been arrived at anyway using the knowledge of a person skilled in the art.

Similarly industrial applicability or utility has been interpreted to mean contribution of a certain technique in the academic-enhancement of further knowledge or to point out to an intermediate whose uses is not known now and which could be put into a future use. This is equivalent to requesting that a weed be conferred patent protection because it is a plant out

MANAGEMENT of place and on a fine day there would be a technology, which would find a good use for the weed, though there is no current use for that weed. There is no discrimination against pharmaceuticals in the draft guidelines with respect to TRIPS Article 27. But the draft guidelines imply that the intellectual property rights (IPR) protection should be earned by a deserving applicant in exchange for the subject matter disclosed.

With respect to a clarification requesting better discussions for a product-by-process patent application, concerning the three situations relating to i) a novel product alone or ii) a novel process alone or iii) a novel product which is a result of a novel process, it could be interpreted by the use of the legend 'alone' in the dicta of the case law cited, that it is dependent on the combination of considerations quoted in the Research Foundation Of State University Of New York Vs Assistant Controller Of Patents [OA/11/2009/PT/DEL (ORDER No. 200/2012)]; “Accordingly the product by process claim must define a novel and un-obvious product and the patentability in such claim cannot depend on the novelty and un-obviousness of the process limitation alone”.

Excluding patentability for new uses of known substances It has been commented that India diverges from other jurisdictions by excluding patentability for new uses of known substances. In India the method of treatment is not a patentable invention under sec 3(i) whereas in the US and Australia the use of a compound for the method of treatment of a disease has been conferred patent protection on the grounds of definiteness. All the same, many of the Latin American countries have excluded the patentability for new uses of known drugs and France is currently considering offering permission for the off-label uses of an API. So, to expect other states to follow the same set of rules for intellectual property protection is rather primitive.

For our country which adopts the common law principles, there needs to be ample legal space for the evolution of standards commensurate with the technical advancements in any field. As IPRs are territory-based, a comparison of the different states’ advancement requirements in scientific and technological arena are also different. Again, the scope and breadth and interpretation of IP laws may be different in different jurisdictions, depending on the medical needs of the citizens of the country in question and the need of the country to protect its public health, as per TRIPS Article No 27.2. A situation where the

The draft guidelines when adopted would surely open the flood-gates of litigation in the IPR sector

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applicant may seek “the second use/indication in the form of a product claim of an already known pharma compound/new form of a known substance or compound” has been dealt with deftly in the second draft Guidelines of CGPDTM in the August 2014 amendments.

Keeping room for evolution of IP laws What is being understood as ‘big’ or ‘small’ or ‘significant’ today may not be the same in the near future. There needs to be breadth for the evolution of techno-legal glossary. It is a bedrock principle in patent law that the meaning of a word turns on its context. Thus, no Patent Act and Rules of any country anywhere in the world would clarify the numerical value of the terms 'finite' and 'infinite' in quantifying the solutions for a technical problem. This would have to be decided on a case by case basis. Also the relevant prior art searching is by itself an art. Like any art, it cannot be rigidly bound within the four corners of any guidelines. It would be best left to the imagination and the talent of the Examining Corps, to do the search, a total justice.

A pragmatic approach The fact that so many comments have been expressed shows the strength of the Indian pharma sector and is a tribute by the national and international agencies to the 'pharmacy of the world'.

But, this strength needs to be sustained by the way of drug discovery in those therapeutic segments where there exists a dearth of treatment. This drug discovery is easier when our country’s manpower and the monetary backup from abroad are pooled together.

Secondly, these draft guidelines when adopted would surely open the flood-gates of litigation in the IPR sector.

The concerned departments of our country need to be ready for this and if necessary, a special patent court similar to the Court of Appeals for the Federal Circuit of the US needs to be established.

EXPRESS PHARMA

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September 16-30, 2014

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RESEARCH INSIGHT

Spill resistant formulations: No crying over spilt syrups!

ADHITHI RAGHAVAN, Final Year B Pharm Student, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, NMIMS University, Mumbai

Adhithi Raghavan,Final Year B.Pharm.Student,Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management,NMIMS University,Mumbai,gives an outlook about the benefits of spill resistant formulations FEW WOULD argue that administering liquid medication to an unruly child is often challenging and typically results in as much medicine on the floor as in the patient.

A survey conducted by Taro Pharmaceuticals and the National Association of Child Care Professionals (NACCP), carried out by Kelton Research, a US-based market research firm, found that 61 per cent of parents spill liquid medicines when administering them to their children, and more than half reported that their children resist taking medication.

And the problem is not restricted to children alone.

The elderly and the infirm often have problems in filling liquid in a spoon and bringing it to the mouth without spilling the contents.

The consequence: Inadequate dosing, and possibly improper treatment. Often, the patient compensates by pouring out another spoonful – further compounding the problem of incorrect dosage.

Now, pharma formulation science has come to the rescue, with scientists at Taro Pharmaceuticals (Hawthorne, NY) developing a ‘NonSpil’ semi-liquid drug delivery system that prevents spillage and ensures more accurate dosage. ‘NonSpil’ medication is packaged in a squeezable container and pours onto a spoon as a semi-liquid. Once on the spoon, the formulation thickens and turns into a gel – that will not spill even if the spoon is turned upside down

46 EXPRESS PHARMA September 16-30, 2014

for the typical time durations encountered between filling a spoon and putting the medicine in the mouth. Then, when the pressure- and temperature-sensitive medication enters the mouth, the forces of the tongue and cheeks on the spoon cause the gel to instantly liquify.

In September 2003, Taro Pharmaceuticals introduced ElixSure in the US market, a line of spill-resistant singlesymptom children's medications for fever/pain, cough and congestion, containing acetaminophen, pseudoephedrine HCl, and dextromethorphan HBr. Another benefit of the formulation is that it is a solution, as opposed to a suspension, with the active ingredients uniformly distributed in the medication. Therefore, it doesn’t need to be shaken before use, and a consistent amount of medication is ensured.

Comprehensive solution

NonSpil prevents spillage and ensures more accurate dosage.

On the spoon, the formulation thickens and turns into a gel - that will not spill even if the spoon is turned upside down

Taro has addressed and solved the problem in a comprehensive manner: innovating a unique and patented drug delivery system for a semi-solid pharma formulation; combined with an appropriately designed squeezable container and dispenser.

Each of these elements of the drug delivery system has certain characteristics so that the combination (a) allows easy administration (b) of a measured amount of the drug, (c) from a convenient, preferably tamper-resistant and child-proof container, (d) with

predetermined resistance to spilling, (e) while providing a suitable storage stable pharma composition with compatible components.

The science behind For most formulations, spill resistance means the formulation does not spill from a teaspoon for a definite period: at least about 30 or 60 seconds on spoon inversion; about 30 or 60 seconds on spoon vibration; and about 10, 20, or 30 seconds on spoon tilting. Spill resistant properties correlate with viscosity, but are not necessarily directly linked, so that a composition within the target viscosity range may still lack spill resistance.

Typically, a spill-resistant pharma formulation for oral administration from a squeezable container comprises a pharma agent in a suitable vehicle consisting of a liquid base and a thickening agent. It has the following properties: ◗ A viscosity within the range of about 7,500 to about 12,500 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 20 rpm and 20-25°C; ◗ A consistency permitting the composition to be squeezed by light manual pressure through a channel, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling on spoon inversion, tilting at 90 degrees and vibration; ◗ Homogeneity such that the components do not

separate under conditions of use; and ◗ Storage stability such that the above properties are retained for at least two years shelf-life.

Table 1 Ibuprofen spill-resistant suspension berry flavour suspension (with preservative)

Patent study Spill resistant pharma formulations for oral administration are described in US Patent 6071523 issued to Mehta et al., and US Patent 6102254 issued to Ross et al. Spill resistant suspension formulations are described in another patent (WO2003105804 A1) issued to Moros et al.

In their patent, Mehta et al. describe a formulation that preferably comprises about 0.25 per cent to about one per cent water-soluble carboxyvinyl polymer and is preferably essentially free of sodium. The liquid base preferably comprises glycerin and sorbitol, and the thickening agent preferably comprises sodium carboxymethylcellulose in an amount of less than about 2.5 per cent and microcrystalline cellulose in an amount of about 0.9 per cent. The formulation preferably comprises glycerin and sorbitol as a solution of about 70 per cent in water, the concentration of glycerin and sorbitol solution being about 40 per cent, and microcrystalline cellulose in an amount of about 0.9 per cent, and carboxymethylcellulose in an amount of about 0.9 per cent to about 2.4 per cent.

The pharma agent is preferably selected from the group consisting of an analgesic, non-steroidal antiinflammatory, antihistamine, cough suppressant, expectorant, bronchodilator, antiinfective, CNS active drug, cardiovascular drug, antineoplastic, cholesterol-lowering drug, anti-emetic, vitamin, mineral supplement and faecal softener. The pharma agent may be selected from the group consisting of acetaminophen, aspirin, ibuprofen, diphenhydramine, dextromethorphan, guafenesin, pseudoephedrine, carbidopa, levodopa, terfenadine, ranitidine, ciprofloxacin, triazolam, fluconazole, propra-

Ingredients

%

Quantity [gm]

Ibuprofen

1.79

895

Purified water

43

21313.5

Glycerin

39

19500

Sorbitol (Crystalline)

5

2500

Propylene Glycol

10

5000

Carbomer 934P (Carbopol® 974P)

0.5

250

Poloxamer 188

0.05

25

FD&C Yellow #6

0.005

2.5

Sodium hydroxide

0.08

40

Sucralose liquid concentrate

0.4

200

Masking Agent #141.18074

0.2

100

Berry flavour

0.83

415

Butylparaben

0.018

9

Source: Ibuprofen suspension, Shen Gao, Daniel Moros, Maxine Moldenhauer, WO2003105804 A1

For most formulations, spill resistance means the formulation does not spill from a teaspoon for a definite period: at least about 30 or 60 seconds on spoon inversion; about 30 or 60 seconds on spoon vibration; and about 10, 20, or 30 seconds on spoon tilting

until a clear solution was formed. The stirrer was adjusted to yield a vortex in the stainless steel pot. 0.880 grams of loratadine was slowly added to the centre of the vortex. One gram of peach flavour and three grams of masking agent were then added. 20 grams of glycerin was used to rinse. The ingredients were then mixed until a smooth slurry was formed.

Step 3: In another stainless steel pot 294.6 grams of purified water and 3.0 grams of sucralose concentrate were added. 3.2 grams of Carbomer 934 P (Carbopol 974P) was then slowly added. The solution was mixed with a Caframo mixer until a smooth solution was formed. 50 grams of crystalline sorbitol was added until completely dissolved. 380 grams of Glycerin was added and mixed at 300±200 rpm for 10 minutes. 5.94 grams of purified water and 0.66 grams of sodium hydroxide were added and mixed for approximately 10 minutes to a final pH of 6.4 to 7.3.

Step 4: The loratadine phase was added to the stainless steel pot and mixing continued for approximately 30 minutes.

References 1.Pharmaceutical Technology, February 2004, p. 15-16.

nolol, acyclovir, fluoxetine, enalapril, diltiazem, lovastatin and a pharmaceutically acceptable salt or ester thereof.

The liquid base is preferably in an amount of about 45 weight-per cent to about 95 weight-per cent, comprising a palatable solvent, selected from the group consisting of water, propylene glycol, polyethylene glycol, glycerin, and mixtures thereof, and the thickening agent is preferably in an amount of about one weight-per cent to about 55 weight-per cent, and is selected from the group consisting of starch, modified starch, sodium carboxymethyl cellulose in an amount of less than about two per cent,

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microcrystalline cellulose, hydroxypropyl cellulose, other cellulose derivatives, acacia, tragacanth, pectin, gelatin, polyethylene glycol, and water-soluble carboxyvinyl polymers in a concentration of less than one per cent and in the absence of a sodium component. The thickening agent is preferably a cellulose derivative in an amount of about 0.9 to 2.5 weight per cent by volume.

Asotra et al., have described (USP 7758877) that loratadine in a spill resistant pharma suspension is resistant to oxidative degradation and has increased rheological storage stability as compared to solutions of loratadine.

The loratadine spill resistant suspension was prepared in the following manner: Step 1: Butylparaben (0.18 grams) was dissolved in 50 grams of propylene glycol.

20 grams purified water and 1.0 gram Poloxamer 188 were mixed in a stainless steel pot until a clear solution is formed and then added to the propylene glycol mixture.

Step 2: 120 grams of glycerin was placed in a stainless steel pot and the Poloxamer solution of step I was added. A Caframo mixer (Ontario, Canada) was used to mix for approximately five minutes

2.Spill resistant pharmaceutical compositions in semi-solid form, Mehta Rakesh, Dan Moros, United States Patent: 6071523; 6399079 B1 3.Pharmaceutical compositions in semisolid form and a device for administration thereof, Frank Ross, Malcolm Stewart, US Patent 6102254 A. 4.Ibuprofen suspension, Shen Gao, Daniel Moros, Maxine Moldenhauer, WO2003105804 A1.

5.Stable loratadine spill resistant formulation, Asotra, Satish, Gao, Shen, Wang, Xiaoli, 2010, US Patent 7758877.

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September 16-30, 2014

RESEARCH CLINICAL UPDATES

Sanofi’s dengue vaccine candidate completes efficacy study Second large-scale phase III study successfully meets primary endpoint with overall vaccine efficacy of 60.8 per cent and shows efficacy against each of the four dengue serotypes SANOFI PASTEUR, the vaccines division of Sanofi, announced that the final landmark phase III efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8 per cent of dengue disease cases in children and adolescents nine to 16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes.

Additional observations of the results showed a clinically important reduction by 80.3

per cent in the risk of hospitalisation due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever (DHF), the severe form of dengue 1, which is consistent with the results released from Sanofi’s phase III dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.

Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events SAEs) during the study showed similar reporting rates between the vaccine and control groups and are consis-

tent with the favourable safety profile documented in previous studies (phase I, II, III).

A full analysis of the effi-

cacy and safety data from the phase III study will be completed and reviewed by external experts before publication in a peer-reviewed scientific journal and presentation at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting, to be held from November 2 to 6, 2014, in New Orleans, Louisiana, US. “For the first time ever, after 20 years of research and industrial commitment, dengue is set to become a vaccine preventable disease,” said Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur. “The data gen-

erated from our comprehensive research and clinical programme involving 40,000 children, adolescents and adults from 15 countries, will be submitted to the health authorities in countries where dengue is a public health priority.”

References 1. World Health Organization (WHO). Dengue guidelines for diagnosis, treatment, prevention and control. Available at: http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf. Published 2009. Accessed March 24, 2013.

EP News Bureau-Mumbai

Novartis’Ultibro Breezhaler reduces COPD flare ups Once-daily Ultibro Breezhaler reduces exacerbations (flare ups) by 31 per cent compared to twice-daily Seretide Accuhaler in moderate-to-severe COPD patients NOVARTIS’ ULTIBRO Breezhaler (indacaterol/glycopyrronium bromide) was superior in reducing exacerbations (flare ups) and improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone (SFC)), in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). These findings from the head-to-head LANTERN study were presented for the first time at the European Respiratory Society (ERS) International Congress in Munich, Germany.

The LANTERN study showed Ultibro Breezhaler

48 EXPRESS PHARMA September 16-30, 2014

significantly reduced the rate of moderate-to-severe exacerbations by 31 per cent compared to SFC[1], in moderateto-severe COPD patients with a history of one exacerbation or none in the previous year. In addition, Ultibro Breezhaler patients had significantly increased lung function, as compared to SFC after 26 weeks of treatment. The safety profile of Ultibro Breezhaler was comparable to SFC[1].

“These new results from LANTERN provide further evidence of the potential of Ultibro Breezhaler to deliver better exacerbation reduction and improvements in lung

function, compared to the current standard of care," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals[1],[2].

The new findings from LANTERN support the use of Ultibro Breezhaler as an alternative steroid-free treatment to SFC in moderate-to-severe COPD patients[1]. This approach is consistent with the Global Initiative for Chronic Obstructive Lung Disease 2014 guidelines[3].

COPD symptoms can have a major negative impact on a patient's ability to breathe and function, reducing their quality of life[3],[4].

References [1] Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281; Date: September 8 2014 Time: 12:50-14:40].

[2] Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013.

Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC50015125 5.pdf [Accessed 23 July 2014].

[3] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease.

Updated 2014. http://www. goldcopd.org/uploads/users/files/ GOLD_Report2014_Feb07.pdf [Accessed 23 July 2014].

[4] Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.

EP News Bureau-Mumbai

RESEARCH RESEARCH UPDATES

FDAlifts partial hold on OncoMed’s cancer drug trials OncoMed had voluntarily halted enrolments as a ‘precautionary measure’, after reports that two of its drugs, were causing mild-to-moderate bone-related side effects ONCOMED Pharmaceuticals said the US Food and Drug Administration lifted a partial hold on patient enrolments for three trials testing its experimental cancer drug, vantictumab. Enrolment of new patients is expected to resume in the next few weeks after the revised trial protocol are approved, the company said.

OncoMed had voluntarily halted enrolments on June 13 as a ‘precautionary measure’, after reports that two of its drugs, vantictumab and ipafricept, were causing mild-to-moderate bonerelated side effects.

The FDA formally placed a partial hold on vantictumab, which is being tested in combination with standard-of-care chemotherapy in three studies in patients with forms of advanced lung, breast and pancreatic cancer.

Vantictumab and ipafricept are being developed in collaboration with Germany’s Bayer and are in early-stage tests.

OncoMed recently said the amendments to the trials include modified dosing regimens, risk mitigation measures, and modified enrolment criteria.

The company has various anti-cancer drugs in its pipeline and is developing antibodies and other agents that target biological pathways critical to tumourinitiating cells, also known as ‘cancer stem cells’.

Reuters

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RESEARCH

Ebola vaccine from GSK fast-tracked into clinical trials GSK’s candidate vaccine,being co-developed with the US National Institutes of Health,is expected to be given to healthy volunteers in Britain and the US from about mid-September AN EXPERIMENTAL Ebola vaccine from GlaxoSmithKline is being fast-tracked into human studies and the company plans to build a stockpile of up to 10,000 doses for emergency deployment, if results are good.

The research work is being accelerated with funding from an international consortium, reflecting mounting concern over the worst outbreak of the disease that has killed more than 1,500 people in West Africa.

GSK’s candidate vaccine, being co-developed with the US National Institutes of Health (NIH), is expected to be given to healthy volunteers in Britain and the US from about midSeptember, with the programme then being extended to Gambia and Mali. The phase I trials would start as soon as they received ethical and regulatory approvals.

The NIH’s National Institute of Allergy and Infectious Diseases is also working on a wider programme of clinical trials, including tests of a version of the GSK vaccine that may fight a second strain of Ebola, as well as the West African one.

In addition, US researchers plan human tests of a vaccine developed by Canadian government scientists, which has been licensed to NewLink Genetics.

The trials being announced will enrol healthy volunteers with the goal of determining whether the vaccine is safe and whether it provokes a protective immune response.

The aim is to complete these tests by the end of 2014, after which vaccines could be de-

50 EXPRESS PHARMA September 16-30, 2014

ployed on an emergency basis.

Jeremy Farrar, Director of the Wellcome Trust medical charity, which is helping to fund the vaccine trials, said the effectiveness of vaccines and drugs could only be assessed during epidemics, so it was vital to test products now.

GSK plans to begin making up to about 10,000 additional doses of its vaccine at the same time as the initial clinical trials, so if they are successful vaccine could be made available immediately for an emergency immunisation programme. NewLink has also contracted for the manufacture of increased supplies of its vaccine.

A steering committee made up of senior officials from NIH and the US Department of Defense also approved last week the first step toward using three advanced laboratories to manufacture Ebola vaccines and treatments. The three labs, in Texas, Maryland and North Carolina, were set up in 2012 by the US Department of Health and Human Services (HHS) in partnership with private industry to respond to pandemics or chemical, biological, radiological or nuclear threats.

The GSK vaccine consists of a common cold virus, called an adenovirus, that has been engineered to carry two genes of the Ebola virus. Animal testing has shown that when the adenovirus infects cells the Ebola genes produce harmless proteins that stimulate the immune system to produce antibodies to Ebola.

Reuters

GENE STUDIES OF EBOLA SHOWVIRUS IS MUTATING FAST GENETIC STUDIES of some of the earliest Ebola cases in Sierra Leone reveal more than 300 genetic changes in the virus as it leapt from person to person, changes that could blunt the effectiveness of diagnostic tests and experimental treatments now in development, researchers said.

“We found the virus is doing what viruses do. It is mutating,”said Pardis Sabeti of Harvard University and the Broad Institute, who led the massive study of samples from 78 people in Sierra Leone, all of whose infections could be traced to a faith healer whose claims of a cure attracted Ebola patients from Guinea, where the virus first took hold.

The findings, published in Science, suggest the virus is mutating quickly and in ways that could affect current diagnostics and future vaccines and treatments, such as GlaxoSmithKline’s Ebola vaccine, which was just fasttracked to begin clinical trials, or the antibody drug ZMapp, being developed by California biotech Mapp Biopharmaceutical.

The findings come as the World Health Organization said that the epidemic could infect more than 20,000 people and spread to more countries.AWHO representative could not immediately be reached for comment on the latest genetic study.

Study coauthor Robert Garry of Tulane University said the virus is mutating at twice the rate in people as it was in animal hosts, such as fruit

bats.

Garry said the study has shown changes in the glycoprotein, the surface protein that binds the virus to human cells, allowing it to start replicating in its human host.“It’s also what your immune system will recognise,”he said.

In an unusual step, the researchers posted the sequences online as soon as they became available, giving other researchers early access to the data.

Erica Ollmann Saphire of the Scripps Research Institute in La Jolla, California, has already checked the data to see if it impacts the three antibodies in ZMapp, a drug in short supply that has been tried on several individuals, including the two US missionaries who contracted Ebola in Sierra Leone and who have since recovered.

“It appears that they do not (affect ZMapp),”said Saphire.

Saphire said the speed with which Sabeti and colleagues mapped genetic changes in the virus gives researchers information that “will also be critical”to companies developing RNAbased therapeutics.

That could impact treatments under way from Vancouver-based Tekmira Pharmaceuticals Corp and privately held Profectus BioSciences of Tarrytown, New York.

Part of what makes the data useful is the precise picture it paints as the epidemic unfolded. Sabeti credits years of work by her lab, colleagues at Tulane and the Sierra Leone Ministry of Health and Sanitation in developing a response network for Lassa fever, a virus similar to Ebola that is endemic in West Africa.

Several of the study authors gave their lives to the work, including Dr Sheik Humarr Khan, the doctor from the Kenema Government Hospital, who died from Ebola.

The team used a technique called deep sequencing in which sequences are done repeatedly to generate highly specific results, allowing them to see not only how the virus is mutating from person to person, but how it is mutating in cells within the same person.

Reuters

PHARMA ALLY I N T E R V I E W

‘Our products meet the statutory and regulatory requirements of the EU’ More than five decades old, Mumbai-based manufacturer of laboratory/magnetic stirrers and centrifuges, and blood bank refrigerators/freezers, Remi Elektrotechnik has crossed several milestones since inception. With a small manufacturing unit in Vasai, today it claims to cater to over 50 per cent of the total Indian demand. Sunil Saraf, Director, Remi Elektrotechnik share more insights about the company, with Usha Sharma What are Remi’s major milestones?

Remi is a well-known brand with the scientific and healthcare professionals in India for more than 50 years.

REMI is a pioneer in supplying innovative products that are import substitutes thereby helping the nation save precious foreign exchange. We were the first in India to manufacture table top centrifuges, laboratory and magnetic stirrers, high speed (20000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuge for component separation, CE marking for table top centrifuges, mixers and shakers and biggest top entry agitator in India for fluid mixing.

The company is a global manufacturer and exporter of laboratory and blood bank instruments. How far has the company been able to spread its business?

Remi has been exporting its products to more than 50 countries globally. Our products are used extensively in our neighbouring countries and in African sub-continent.

We have around 50 per cent market share in Italy for bench top centrifuges and are now looking at other countries in Europe to increase our penetration. Our products meet the statutory and regulatory requirements of the European Union. We

also participate in international exhibitions and trade shows to increase our presence and keep ourselves abreast with the changing technology and customer requirements, new product introductions etc.

Tell us about your certifications obtained from global authorities?

Being a global exporter of laboratory and blood bank instruments, it is imperative for REMI to get its products and processes certified by international bodies. All REMI products have certifications recognised by international organisations such as ISO-13485 : 2003: Quality management system for medical devices, ISO9001-2008: certification for design, manufacturing and supply of laboratory and blood banking instruments, CE Marking: important conformity standards in EU, all REMI products carry a CE mark as adhering to conformity. WHO-GMP certificate: manufacturing facilities adhere to WHO – GMP guidelines as laid down

by World Health organisation time to time.

Has the company conducted any research work recently? How rewarding and successful was it?

Research forms an integral part for survival of a company.

Though we don’t have to involve in path breaking

To subscribe: bpd.subscription@expressindia.com

Being a global exporter of laboratory and blood bank instruments, it is imperative for REMI to get its products and processes certified by international bodies

research like the pharma majors and CRMS, but often focus on incorporating products with new versions.

Our research is based on developing user-interface and integrating maximum functions on microprocessors to eliminate human errors.

Since all the products are manufactured in-house it offers us maximum flexibility to validate the products along with testing prior to launch.

Lately, we launched a new product for our healthcare division ‘PRP Centrifuge’ the evolution of product was need-based to harvest platelet-rich-plasma (PRP).

Been a leader in blood bank instrument industry, our sales and service team felt need to develop specific product to address this issue faced by physicians and surgeons (Used to harvest platelet-richplasma in pain, wound and cosmetic treatments).

Presently Remi PRP Centrifuge is the only product specially focused for harvesting PRP in India.

Indian pharma companies are facing a lot of flak from global regulators like the US FDA. Does your products meet all these regulatory compliances? Do you think your products will help Indian pharma companies resolve issues faced on the regulatory front?

Our products meet the requirements of global

regulators like US FDA. Instruments like incubators, stability chambers, freezers, walk in stability chambers, cold rooms etc. are supplied with proprietary “REMI Datasoft” software which comply with the requirements of 21 CFR Part 11.

Where are your manufacturing facilities located?

Starting way back in 1960 in a small shed, today our manufacturing facility is located at Vasai. The facility is spread across an area of 65,000 sq ft which houses all different departments’ like design and development, fabrication, pre-treatment, powder coating, assembly lines, quality assurance, packaging and dispatch. The installed capacity is more than 5000 units per month.

We also have a dedicated test room to simulate different environment conditions to do type testing of our products internally. The manufactured products include FHP motors, laboratory and magnetic stirrers, bench top and floor standing centrifuges in refrigerated and non refrigerated versions, shakers and mixers, incubators, stability chambers, cold cabinets, deep freezers, etc.

We also manufacture blood bank instruments like blood bank refrigerators, blood collection monitors, plasma freezers, platelet incubators/agitators and ultra

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Q A &

PHARMA ALLY

Q

Harish Kapoor, General Manager - International Business Development, ACG Worldwide: What is a Type I glass?

A

Schott Glass India: Type I is a special designation used in the ISO standards and pharmacopeia to describe the quality of glass used for pharmaceutical primary packaging. Type I describes the highest quality and is generally recommended to be used for parenteral packaging whereas Type III describes the lower quality and is recommended to be used rather for orally applied and solid drugs (except for lyophilisation products).

According to the definition in the current Pharmacopeia Type I glasses are borosilicate glasses containing significant amounts of boric oxide, aluminum oxide and alkali and/or alkaline earth oxides. With this composition they offer a high hydrolytic resistance and a high thermal shock resistance.

Whether glasses belong to the group of Type I glasses is determined with both the glass grain test and the container surface test. Both tests evaluate the resistance of the glass against water attack at 121°C. The higher the resistance of the glass is the higher is its quality and the more it is a preferable packaging material.

Q

Abhay Bagesar, Manager Regulatory Affairs, USV: What are extractables and leachables (E & L)?

A

Schott Glass India : Extractables are compo-

Remi Elektrotechnik’s upcoming new manufacturing facility

low temperature freezers. Recently, we have introduced Clevofuge and PRP centrifuges in the Indian market. The manufacturing facility is ISO-9001:2008 certified and ISO-13485 certified for medical devices and possesses a documentary quality management system in place. All products prior to dispatch are calibrated internally with the use of calibrators which are tested in NABL accredited test laboratories. We provide all documents and test reports as per customer requirements.

Do you plan to set up new facilities or expand the existing ones?

Our existing facility has sufficient space to fulfil our expansion plans in the coming years. Up-gradation of facility and investment in new technologies, machinery etc. would be done in keeping with our expansion plans to cater to our customers, both in India and abroad.

Who are your major clients?

Our major clients include leading hospitals, path labs and diagnostic centres, medical colleges, educational and research institutions, pharma/biotech/chemical/cement/paint industries and CSIR labs etc. We take pride in the fact that every twenty minutes; someone in India is buying a Remi laboratory/blood banking product for their use.

How much revenue did the company generate during the last fiscal? What are your expectations from the current year?

Due to a wide customer base using our basket of products, we have not been affected by any slowdown. In fact, Remi has been significantly growing year-on-year.

Last year we grew by more than 15 per cent.

Considering the feel good factor that is slowly creeping in the Indian economy, we expect to increase our growth rate substantially and double our existing turnover in a short span.

52 EXPRESS PHARMA September 16-30, 2014

Our major clients include leading hospitals, path labs and diagnostic centres, medical colleges, educational and research institutions, pharma/biotech/ chemical/cement/ paint industries and CSIR labs Tell us about the company’s plans for the next 25 years’?

Our historic and successful past has helped to gather profound insights on customer needs in the segments that we operate in. We introduce new products or upgrade our existing products based on our customers’ feedback. We see a lot of business opportunities in healthcare and medical devices market. In future, we will launch new products for this segment. We have already chalked out exciting plans to venture into this segment with the launch of ‘Remi Healthcare Division’ this year.

You will hear more about this division in the coming years.

At the moment, Remi is also helping blood banks in upgrading themselves from a storage centre to a component preparation blood bank. We see ourselves in facilitating this changeover in a big way, in the years to come. We will also look at consultancy opportunities in the field of upgrading or establishing new blood banks, path labs and diagnostic centres. u.sharma@expressindia.com

WITH SCHOTT GLASS INDIA

nents of the container closure system (all packaging materials) that are released during a certain stress test procedure (e.g. aggressive solvents, exaggerated conditions of time and temperature).

Leachables are components of the container closure system that migrate into the drug formulation during usual production process and storage.

The amount of E & L coming from the material is dependant on many different factors like the material itself (glass or plastic; Type I or Type III glass), the converting process, pH value of the drug formulation, ionic strength of the formulation, closure system, sterilisation methods, temperatures during processing and storage, secondary packaging, and many more. Due to this high amount of diverse parameters only the owner of the finished product (the pharma company) is able and obliged to perform E & L studies on their products. These studies are done as stability studies (extractables studies, accelerated aging studies, durability studies) to evaluate the quality and the compatibility of the packaging material.

(To feature in this column, email your queries to Dr Bettine Boltres ,SCHOTT AG: bettine.boltres@schott.com)

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PHARMA ALLY PRODUCTS

IKAlaunches immersion and circulating thermostats IKA HAS expanded its product portfolio to include immersion and circulating thermostats.

The IC immersion circulator is a classic bridge thermostat. The HBC 5 and HBC 10 are heating bath circulators with a maximum capacity of five and ten litres, respectively. The detachable wireless controller (WiCo– an innovation never before seen in such temperature control systems – enables users to control all key parameters from a distance of up to 40 metres.

The IC and HBC models are both available in 'basic' and 'control' versions. The

basic versions of these thermostats already offer more features than most

circulating baths of this type.

For example, the infinitely adjustable pressure and

suction pump or the option to connect an external temperature sensor are features of these basic 'basic' models that are not found in the marketplace. In addition to all the features supported by the basic versions, the control models also have space for ten programmes, allowing individual procedures to be performed.

In addition, these units have increased temperature stability, more powerful pumps and a higher maximum temperature. Also, connection to a PC network is possible in these models, which enables control through a software

package (IKA labworldsoft) and the evaluation of all relevant data.

As accessories, IKA supplies a wide range of high quality stainless steel and plastic bath vessels with capacities from 12 to 20 litres.

Contact details Shripad Borgaonkar Marketing Manager IKA India 814/475, Survey No.129/1 Mysore Road | Kengeri | 560060, Bangalore | Karnataka Phone: +91 (080) 26253 960 Fax: +91 (080) 26253 901 E-mail: Shripad.B@ika.in

BD introduces microbiological testing system THE FACSMICROCOUNT System is a popular microbiology enumeration platform from BD which uses liquid flow cytometry to count live, dead and total biomass from a given sample. It can address quality testing requirements for manufacturers of pharmaceutical products, personal care products, beverages and probiotics, as well as home cleaning products.

The BD FACSMicroCount System is a versatile, fully automated platform that can do the following: ◗ Finished product and raw material screening for bioburden ◗ Stock culture enumeration ◗ Monitoring microbial

54 EXPRESS PHARMA September 16-30, 2014

fermentation ◗ Purified and process water total viable organism screening ◗ Microbial enumeration for probiotic manufacturing The system detects a wide range of microbes, making it the platform of choice worldwide for rapid microbiological testing: ◗ Gram-positive bacteria ◗ Gram-negative bacteria ◗ Mycoplasma ◗ Spirochetes ◗ Anaerobes ◗ Spores - bacterial and mold ◗ Filamentous bacteria, yeasts and molds Designed for ease of use and automation, the BD FACSMicroCount System runs various sample types, with correlation to traditional

methods. It can provide results in minutes instead of days for most samples, compared to two to five days for a regular count with traditional

methods. As an example of how fast BD FACSMicroCount is, consider the following: ◗ Microbial enumeration in just four minutes

◗ Pass / Fail results for presence / absence of microbial contamination in 24 to 48 hours ◗ Yeast, bacteria and mold detection in a single run ◗ Up to 20 samples per hour for qualitative analysis (presence / absence) ◗ Up to 15 samples per hour for quantitative analysis (enumeration) ◗ Several reagents for enumeration of live cells, dead cells or total biomass ◗ Graphical displays include intensity, fluorescence, side scatter and counts vs. time ◗ Data analysis possible while the system processes other samples Contact details http://bd.com/ds/im/microCou nt/index.asp

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PHARMA LIFE INSIGHT

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IS THE REMEDY Tarun Gupta, Professor Emeritus at the School of Business at NMIMS University (deemed-tobe) and Chairman, MBA, Pharmaceutical Management at NMIMS, examines some of the interesting points highlighted by Dr Savita Chari in her recent paper; Listening is the key, recently published in Express Pharma

T

he point that top management hardly even listens to what the field-force has to say is not incorrect. It is largely because for the CEO in a pharmaceutical company, there are too many problems to be taken care of within a short period of time.

Too many problems, too little time In managing day-to-day activities in a pharma company, regulatory and other issues must be attended on an urgent basis.

There are too many urgent problems that have to be solved which get priority over listening to the field-force. So the field force problems are delegated to other senior management. It is humanly impossible to attend to all problems.

Consider two companies where the field force is 6000 strong. Mankind Pharma and multinational Abbott (earlier Piramal Pharmaceuticals). In

88 EXPRESS PHARMA September 16-30, 2014

these two companies, top management does listen to their field force much more than in other companies. In fact, Mankind Pharma is known to manage their field force extremely competently. One member of the field force, mentioned to this writer that field staff can contact Ramesh Juneja, the Chairman of the company anytime they want to talk to him directly about any field issues. Whether they do so or not is a moot point but the fact that any field issue can be taken up with the senior most people in the company, provides a tremendous boost to field force morale in a company.

Perception is reality If this statement is even half true, how many would deny that this is a major strength for a company which has a large field force spread over the entire country? Mankind Pharma manages their field force far more effectively than many others. Today, Sun Pharma and even Cipla, apart from Abbott would have fairly large field

forces. Can other companies claim to be as responsive as Mankind? What members of the field force believe to be true is a powerful source of differentiation. This enduring belief that any member of the field force can directly contact the chairman of the company and other top management members and they are willing to listen and solve problems. This is a strong morale booster as well as a differentiator that few companies can claim to possess. For a large field force, spread all over the country, this advantage can make a palpable difference to field force morale. No other pharma company generates as many prescriptions as Mankind Pharma as reported by market research companies in recent times.

A matter of management mindset It is obvious that if top management wants to stay in touch, it can set up a system of listening to their own field force and solve problems. Mankind Pharma has

done this from their early days and continues to do so as the Company has become one of the country’s largest employers.

This is an excellent example of “field force connectivity” which is a major strength of Mankind.

The point to be noted is that few companies are in that “close a touch” with their own field force. Those who have made it a practice understandably enjoy superior growth.

A satisfier too The net gain of such connectivity with your own field force is not just awareness of problems that plague the field force, but it is also a powerful for satisfier for the field force. Most pharma companies do not have the time or inclination to really bother about such “connectivity”. And it calls for a great deal of efforts from top management.

A major competitive advantage Listening to your own field force can become a major competitive advantage leading to positive

feelings about the company among field staff. This has an input on the attrition rate. And being heard is as strong morale builder. Particularly, when field staff members know that few companies are willing to do this.

Just listening is not enough Listening is no doubt a critical first step. But just listening is not enough. Remedial action is clearly more important. This is where Mankind pharma excels.

Remedial action is possible because the Chairman is aware of the problems and also willing to sort out problems quickly.

Quick remedial action, from top management is the key here.

Ritualistic listening is unproductive Field force is smart enough to realise that top management sometimes pretends to listen in silence and forgets the issues raised, once they come back to head office. Hundreds of other urgent problems are waiting to be resolved and competing for

problems. Do not listen to problems for more than half an hour.

It should not lapse into a grievance airing meeting. Ask clearly and get to the bottom of what you are hearing. But learn for the field force directly, not from what first line managers say. Once you begin to listen to problems, you mindset undergoes change. You realise that problems are not insurmountable.

Build a listening culture

the CEO’s attention. So how can anyone address, the issues that emanate from the field force?

Action essential Listening is fine, but unless action is taken fairly quickly, and the fieldforce is made aware of what action is being taken, it can sometimes affect management credibility. Pretending to listen is not good enough; listening and the willingness to solve problems go together and this is where most management’s don’t stand up to close scrutiny.

Management action matters Consider the case of a fully owned Ranbaxy subsidiary, where during the first six months of its start-up, field force was not receiving salaries on time. Ranbaxy had no cash problems those days, and one can guess what will happen to the morale of a young field force, if monthly salaries don’t reach young recruits on time The Managing Director was present at a meeting where rather reluctantly one Trainee brought this problem up. If the problem had not surfaced at the meeting and if no remedial action was taken urgently, it could have led to more dissatisfaction as well as attrition.

It was taken care of in three days once the Managing Director returned to headquarters.

The Chairman of the Company was surprised to learn that such a problem had raised its

ugly head. Never again did the field force have any problem of not receiving salaries on time.

Recurring problems are known to erode field force confidence.

So while awareness of a problem is critical, so is management! Willingness to solve the problem as rapidly as possible, important. How many CEO’s are aware of the problem that promotional inputs often do not reach the fieldforce on time? A problem that can and must be solved quite easily by holding individuals responsible for ensuring that promotional material reach field force well ahead of time.

The willingness to take corrective action, leads to top management being viewed as credible. When action does not emanate from head office top management has a problem!

Its credibility starts to erode and this lack of credibility cannot be built again all that easily. Listening and pretending to listen are not the same and unless remedial action does not follow rapidly, fieldforce one can even misunderstand the process of management

listening mere posturing.

Many issues cannot be solved in one stroke To expect all problems to be solved in one simple stroke is unrealistic. Problems,must be understood first, then there are many ramifications of a problem taken quickly. If top management is resourceful enough and willing to take some risks, the lines of regular communication must be kept open.

Sometimes remedial action is not possible as promised, but one has to be in communication with one’s field staff on a regular basis. So periodic listening is essential. Listening at annual conferences can get rather complex, and defeat the key purpose. Once a year listening sessions are not as productive as periodic listening at regional meetings.

Is a system in place in your company?

Listening once a quarter to field force problems can be a reasonable beginning. Periodic visits by the CEO can help make a good start. It is difficult

to emerge as a Listening Company overnight. But small beginning can be made. My suggestion is that it is good to visit an area that is performing extremely well first. There would be some problems that need attention there too. Then go to an area where results are not encouraging and then to an area where results are far from satisfactory. In all these places, problems will surface with varying devises of seriousness.

How much to listen and from whom Listening is a critical task that cannot be delegated to others. Listening periodically, eg. once a quarter is useful. Start from a market, near your headquarters. Many interesting issues will emerge. Every market would have problems that need to be sorted out. If you listen well, you may discover that problems all over, India fall into 3 or 4 categories.

Going to regional meetings is useful Yes, it is useful only if the field force is primed up to highlight

Listening is fine, but unless action is taken fairly quickly, and the fieldforce is made aware of what action is being taken, it can sometimes affect management credibility

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It is very productive to build a listening culture in a company. If you are not afraid to confront problems, you need not be unduly worried. Avoid promising instant solutions. As you listen, these sessions would become learning sessions. And if you are willing to listen and learn about what is happening in your company, you would get many new ideas about how to solve them.

Welcome problems Most of the time, top management does not want to learn about problems and want to receive good news. This does not work. Don’t spend too much time listening. Half an hour at a time, is enough but listen to real problems. Some are just aired, but some could be critical that need to be attended to. It is a change in management mindset that helps here. It is better to seek out problems and hear about them early rather than running away from problems because they are difficult to sort out.

If you welcome problems, somehow not many problems will not overwhelm you. It is important to choose important problems before they become substantial and not push them under the carpet and pretend that don’t exist.

A powerful management mindset is to be willing to listen, learn and lead the team confidently and not by wishing problems away. Alternately, management action is the key and willingness to take some risks is what makes management effective.

EXPRESS PHARMA

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PHARMA LIFE CAMPUS BEAT

School of Pharmacy,Lloyd Institute of Management & Technology organises seminar th

Orientation day programme for the 11 batch of B Pharmacy students was held LLOYD INSTITUTE of Management & Technology recently organised a national seminar on 'Pharma Regulatory Affairs: Current Trends & Career Opportunities' along with an orientation day programme for the 11th batch of B Pharmacy students. The Chief Guest of the seminar Archna Mudgal, Registrar cum Secretary, Pharmacy Council of India (PCI) was felicitated by Manohar Thairani, President, Lloyd Group. Thairani, in his welcome address, thanked all the dignitaries for sparing their valuable time for the seminar at Lloyd.

Mudgal congratulated the 11th batch of B. Pharmacy students for opting to study Pharmacy at Lloyd Institute. She emphasised on the need for a quality education system with more of practical orientation and informed the audiences about the various initiatives taken by PCI. Vijay Bhalla, Director of School of Pharmacy, welcomed the guests, students and parents and explained to students about the growth and potential of pharma industry in India.

Atul K Nasa, Licencing Authority, President IPGA, Managing Trustee- IPGA Welfare Trust, Drugs Control Department, NCT Delhi, in his key note address, informed students about the various career opportunities available in pharma regulatory affairs and also briefed the students about the importance of joining professional associations and participation in mega events like Indian Pharmaceutical Congress.

SL Nasa, Registrar, Delhi State Pharmacy Council, President- IHPA also congratulated the institute and the management for maintaining such high standards of teaching in the

90 EXPRESS PHARMA September 16-30, 2014

The critical issues in pharma regulatory affairs were deliberated on in the scientific sessions

Atul Kumar Nasa, lightening the lamp during inaugural ceremony of national seminar

Manohar Thairani, President - Lloyd Group of Institutions, presenting memento and participation certificate to Atul K Nasa- Licencing Auhtority, Drugs Control Department, NCT Delhi

Department of Pharmacy at Lloyd. He told the audience about the various initiatives that he, as the registrar of the Delhi Pharmacy Council, had undertaken for the upliftment of the pharmacy profession.

Lab-coats were given to all the new entrants in a formal ceremony by SL Nasa, wherein 375 students took the pharmacistâ&#x20AC;&#x2122;s oath. More than 40 abstracts were received from 14 different colleges and a CD comprising these scientific abstracts was released on the occasion. Kirti Soni of Jamia Hamdard received the best poster award. Garima Mishra received the second prize while Harsharan and Renuka shared the third prize.

The speakers at the scientific session included PK Jaggi (Ex Head of office and LA), Dr A Ramakrishnan (DDC-FDA), Dr MK Chourasia (Scientist-CDRI, Lucknow), Dr Nitin Jain (Scientist-DBT, New Delhi) and Rajeev Karwayun (Lead Auditor-TUV).

The critical issues in pharma regulatory affairs were deliberated on in the scientific sessions.

Vandana Arora thanked the guests and the entire team of Lloyd for making the event successful.

EP News Bureau-Mumbai

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