Express Pharma February 1-15, 2014

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VOL .9 NO.7 PAGES 68

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Cover Story Blueprint for biotech Management Vision 2025 for Indian bioagri sector

Pharma Life Tracking the right talent

1-15 FEBRUARY 2014,` 40

CONTENTS

TRACKING THE RIGHT

Vol 9 No.7 FEBRUARY 1-15, 2014

Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das

TALENT

Bangalore Neelam M Kachhap Delhi Shalini Gupta

Identifying and grooming the right talent has been an uphill task for the biotechnology industry in India | P60

DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma Photo Editor Sandeep Patil MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal

P34: RESEARCH UPDATE Testosterone therapy not a cure for men's infertility

P62: APPOINTMENTS Semler Research Center US appoints Dr Nuggehally Srinivas as the President of Specialty Pharma

PRODUCTION General Manager B R Tipnis

P64: AWARD

Manager Bhadresh Valia

Abbott receives Golden Peacock Innovation Management Award

Scheduling & Coordination Rohan Thakkar CIRCULATION Circulation Team Mohan Varadkar

P64: CAMPUS BEAT Biocon Academy starts flagship programme in collaboration with KGI

MARKET

8

'THE SWEDISH MARKET IS VERY COMPETITIVE WHEN IT COMES TO BIOTECH AND PHARMA'

10

CADILA PHARMA TIES UP WITH NOVASAID OF SWEDEN

14

IPM CLOCKS ` 6256 CRORES IN DECEMBER 2013

15

4TH ANNUAL VACCINE WORLD SUMMIT INDIA 2014 TO BE HELD IN HYDERABAD

16

SANTA FE JOINS HANDS WITH BIOASIA FOR BILATERAL COLLABORATION

17

ISCR RELEASES CODE FOR CONDUCT FOR CLINICAL RESEARCH AT ANNUAL MEET

MANAGEMENT

24

“CURRENT FINANCING CLIMATE UNABLE TO SUPPORT LARGE VISION MODELS”

25

'WHEN REGULATION BECOMES ILL-DEFINED AND AMBIGUOUS, ALL INDUSTRY PLAYERS SUFFER'

26

'USE OF ENZYMES IN API MANUFACTURE PRODUCES A DIVERSE RANGE OF COST SAVINGS'

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

Light at the end of the biotech tunnel?

A

s we go to press with this spe-

Avesthagen’s founder Villoo Morawala Patel

cial issue focussing on the

agrees. (Page 24: Current financing climate unable

biotechnology sector in India,

to support large vision models)

Biocon's Q3 results seem like

Strand Lifesciences has not just survived but

a light at the end of the tun-

thrived. I met founder Dr Vijay Chandru in 2009

nel. 45 years after its inception, the company is

and his team had already caught the right wave.

now reaping the rewards of dogged perseverance.

(See story: Strand Life Sciences: cutting edge discovery

To list just two recent achievements, its CANMAb is

not

just

the

world’s

first

biosimilar

Trastuzumab, but also the most affordable worldwide. As part of its latest tie up with US-based Advaxis, Biocon will co-develop and deliver cutting edge affordable cervical cancer treatment to women in India and other developing nations.

But it's not smooth sailing for biotech in India.

Our cover story looks at how four CEOs are planning to grow to the next level (Blueprint for biotech,

Abig boost in productivity and revenues will come from global biopharma solution providers who are eager to tap India’s huge market

research informatics, http://bit.ly/1aLNdaE). The success story continues: Strand recently tied up with US based El Camino Hospitals to provide advanced clinical genomics solutions but even Dr Chandru agrees that the ecosystem is not perfect.(See page 25: 'When regulation becomes ill-defined and ambiguous, all industry players suffer').

A big boost in productivity and revenues will come from global biopharma solution providers who are eager to tap India’s huge market. For in-

pages 20-23). While Dr PM Murali, Chief Executive

stance, Novozymes Biopharma has mapped its

Officer and Managing Director, Evolva feels that

strategy for the country (See page 26: 'Use of en-

there will be opportunities for many partnerships

zymes in API manufacture produces a diverse range

and collaborations, Swapan Bhattacharya, Man-

of cost savings')

aging Director, TCG Lifesciences says that the

But besides venture capital, there is another

winning strategies for Indian industry would be to

missing link: the right human capital. (Page

embrace the learnings. Binish Chudgar, Vice

60:Tracking the right talent) Initiatives like the Bio-

Chairman and Managing Director, Intas Pharma-

con KGI Certificate Programme in Biosciences are

ceuticals highlights that biosimilars are a com-

now addressing the skill deficit and will hopefully

pelling opportunity for emerging economies such

help the next generation of bio-entrepreneurs hit

as China, India, and Brazil but KV Subramaniam,

the headlines much faster. After all, no one wants to

President and Chief Executive Officer, Reliance

be stuck in a tunnel.

Life Sciences cautions that there are still formidable challenges in addressing these opportunities.

6

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February 1-15, 2014

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

'The Swedish market is very competitive when it comes to biotech and pharma' Ahmedabad-based Cadila Pharmaceuticals' tie up with NovaSAID of Sweden to develop innovative treatments in inflammation and pain management is yet another affirmation of the perfect fit between the innovative research capabilities of Swedish life sciences companies and the excellent product development capabilities of their counterparts in India, says Fredrika Ornbrant, Consul General, Sweden in an interview with Viveka Roychowdhury How does Sweden want to engage with Indian pharmaceutical and biotechnology companies?

Which ones already have operations in Sweden and of what nature?

There are many small innovative companies in Sweden looking for partners in India and Indian companies are interested in the Swedish life science market – we have expertise, know-how, good infrastructure and are good at manufacturing. How to engage must be decided mutually by the companies themselves, but I can give you a few examples.

Swedish Pergamum and Indian Cadila Pharmaceuticals have a strategic collaboration to develop a novel treatment of infections with a targeting mechanism distinguished from classical antibiotics. By combining Cadila’s advanced product development capabilities with the innovative capacity of Pergamum, both parties benefit from the partnership.

Another type of collaboration is Swedish Bactiguard’s distribution agreement with Cadila Pharmaceuticals. While Cadila Pharmaceuticals get access to Bactiguard’s solution to

8

EXPRESS PHARMA

February 1-15, 2014

prevent health care associated infections, Bactiguard gets access to the Indian market, again a win-win situation.

Kemwell has production and packaging of tablets, capsules and suppositories in Sweden.

The company acquired a facility in 2006, but bought another facility a few years later, which almost doubled its production area in Sweden.

This enables the company to increase its production and to introduce new products. Other Indian companies with operations in Sweden are Dr Reddy’s, Biocon and Ranbaxy.

The Swedish market is very competitive when it comes to biotech and pharma . Our business climate and advanced R&D contribute to this, but I would say that the Nobel award and our traditions in the life science sector also add in.

Are there any incentives for Indian companies to do R&D, manufacture in Sweden?

Sweden believes that a good business climate, with low corporate taxes, equal treatment of foreign companies, easy of business such as establishing companies a R&D initiatives where foreign organisations are welcome, are compelling reasons why

FREDRIKA ORNBRANT, Consul General, Sweden

Sweden attracts business without out-right subsidies.

Add excellence in R&D, a close collaboration between industry, academia and clinical practitioners and a good environment for modern research such as an extensive network of national health registers and databases, and one understands why so many foreign life science companies find Sweden attractive.

Currently there are 800 life science companies in Sweden,

many well-known international brands such as Pfizer, Novartis and Orifarm. Among the Indian biotech and pharma companies established in Sweden are Cadila Pharmaceuticals, Kemwell. Business Sweden, the Swedish entity tasked to attract investments into Sweden and to help Swedish businesses themselves in India, has recorded over 20 investments in life sciences from Indian pharma companies, and the interest levels from India remain strong.

I am actually quite proud that Sweden on a per capita basis consistently is among the top five countries in terms of inbound FDI with few requirements for targeted incentives.

What is the framework in place to facilitate Swedish lifescience companies expanding into India's market and vice versa?

Sweden and India have signed Memorandums of Understanding (MoU) on Science and Technology and on Health. They form a good basis for collaboration for example in the areas of medical equipment and pharma products, health and medical research and R&D. Looking at it from a hands

on perspective, business Sweden has an important role to connect our nations’ companies. Their experts know what kind of collaboration the Swedish companies are looking for and can match-make accordingly, in Sweden or in India.

Swecare Foundation bought a healthcare delegation to India last October. Are there any plans to organise a similar pharma and biotech delegation visit?

For the past years, there have been frequent exchanges between India and Sweden not at least in the area of health.

Last year the Indian Health Minister visited Sweden and the year before that the Swedish Health minister visited India. Swecare has been in India many times in the past years.

The Consulate General plans for a healthcare delegation next fall most probably in connection to the Nobel Memorial activities.

However, we just entered into 2014 so we are still in a planning phase, but I would be delighted to share more information closer to the visit.

Viveka.r@expressindia.com

MARKET COMPANY WATCH

Cadila Pharma ties up with NovaSAID To develop innovative treatments in inflammation and pain management CADILA PHARMACEUTICALS and NovaSAID AB have entered into a strategic partnership to develop new treatments for inflammation and pain in conditions such as rheumatoid arthritis.

NovaSAID is a company in Karolinska Development's portfolio. The companies will collaborate around preclinical and clinical development of drug candidates that have been developed by NovaSAID and the development will be conducted at Cadila Pharmaceuticals' facility in Ahmedabad, India. According to the agreement, all revenue generated from the sale and marketing in India, Middle East and Africa of products covered by the agreement will be retained

by Cadila and net sales in all other countries will be shared by the two companies. Cadila will bear all costs associated with the programme through to phase II.

"This partnership gives the shareholders of NovaSAID the opportunity to take the company forward with great resources and no further costs.

Cadila's drug development expertise matched with NovaSAID's scientific excellence provides a solid platform for the further development of these novel drug candidates. If successfully developed, valuable deals could be signed in major territories such as the US and Europe to the benefit for Karolinska Development's shareholders", said Dr Torbjörn Bjerke, Chief Executive Officer of Karolinska Development.

Speaking on this new initiative, Dr Rajiv I Modi, Chairman and Managing Director, Cadila Pharmaceuticals said, "We have entered into this partnership combining scientific expertise of NovaSAID and our drug development capabilities to work towards novel solu-

tions in treatment of pain and inflammation, which is one of the largest therapy areas. This is in line with the vision of our Founder Chairman, I A Modi, who believed in nurturing innovations and bringing them to Indian patients at an affordable cost. Cadila Pharmaceuticals has a track record of making available, many first-in-theworld innovative products like Polycap (5 in 1 pill for prevention and treatment of cardiovascular diseases), Risorine (Innovative solution for treatment of tuberculosis) and most recently introduced MycidacC, which is the world's first active immunotherapy in lung cancer."

Most of today's medical treatments for inflammation and pain are associated with unwanted side effects such as an increased risk for myocardial infarction and gastric ulcers. NovaSAID's drug candidates targets an enzyme called

microsomal prostaglandin E synthase -1 (mPGES-1), a critically important mediator of inflammation and pain, which theoretically should reduce the risk for side effects. The collaboration with Cadila will provide the resources to take this programme into clinical development and further towards the market. "mPGES-1 constitutes an important target for drug discovery and development of analgetic and anti-inflammatory drugs. In addition, for use in chronic inflammatory diseases, effective enzyme inhibitors may also address a broad range of other diseases with concomitant inflammation such as atherosclerosis, stroke and cancer", says PerJohan Jakobsson, co-Founder and Board Director in NovaSAID and associate professor at Karolinska Institutet.

EP News Bureau – Mumbai

Dr Reddy’s to launch hypertension drug Optidoz Efficacy and safety of Optidoz has been established through the CONTROL-Hypertension clinical study DR REDDY’S Laboratories has received approval for Optidoz - a drug for the treatment of essential hypertension and will be available in the Indian market.

Optidoz is a single pill combination of three anti-hypertensive drugs (Amlodipine 2.5mg, Telmisartan 20mg and Hydrochlorothiazide 6.25mg) with optimal (half of standard) dose of individual drugs.

Efficacy and safety of Optidoz has been established through the CONTROL-Hyper-

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February 1-15, 2014

tension clinical study, approved

by Drug Controller General of India (DCGI). The study (512 patients with mild to moderate Hypertension at 18 centers for a treatment period of eight weeks), was conducted between Nov. 2010 and June 2011, per the Good Clinical Practices (GCP) in accordance with the Helsinki Declaration. The study, demonstrated that Optidoz controls hypertension faster and more effectively with much lesser incidence of adverse events as com-

pared to standard dose double drug combination. Optidoz will also simplify the traditional, complicated step-care treatment approach for hypertension management. The prolonged blood pressure control with minimal adverse effects is expected to improve efficacy response in normalising the blood pressure due to good tolerability with Optidoz and enhanced compliance in patients.

While over 125 anti-hypertensive drugs are available in

the Indian market, 76 per cent cases of blood pressure still remain uncontrolled. Such a paradox is attributed to ineffective drug doses and non-adherence to therapy, which may lead to disease progression of co-morbid conditions like heart disease, heart failure, stroke and kidney diseases. Optidoz is an attempt from Dr Reddy’s to address these concerns and alleviate hypertension related disease burden in India.

EP News Bureau – Mumbai

Ranbaxy and EPIRUS sign licensing agreement for biosimilar product Ranbaxy to market in India and other emerging markets, after approval RANBAXY AND EPIRUS Switzerland, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals, announced the signing of a licensing agreement for BOW015, a biosimilar version of Infliximab. The product will be introduced in India and other emerging markets. Currently, there is no biosimilar of Infliximab approved in India.

Under the terms of the agreement, EPIRUS will develop and supply the product, and upon regulatory approval Ranbaxy will market the same in India and other emerging markets.

Commenting on the partnership, Sanjeev I Dani, Executive Vice President and Head, Global Strategy, Ranbaxy said, “We are pleased to partner with EPIRUS for Biosimilar Infliximab. We will utilise our strong front-end capabilities in making this product available in India and other parts of the world.”

Amit Munshi, President and Chief Executive Officer, EPIRUS commented, “We are pleased to work with Ranbaxy to register and commercialise this important medicine. Ranbaxy has the right focus and infrastructure in these markets to effectively bring this product to the market.”

EP News Bureau – Mumbai

MARKET

Biocon launches CANMAb for breast cancer CANMAb, developed jointly by Biocon and Mylan under a global partnership BIOCON, INTRODUCED CANMAb (150 mg/ 440 mg), a biosimilar trastuzumab for the treatment of HER2-positive metastatic breast cancer in India. CANMAb, developed jointly

by Biocon and Mylan under a global partnership, is the world’s first biosimilar version of Herceptin and is being introduced for the benefit of patients in India.

Breast cancer is the most prevalent cancer among Indian women ahead of cervical cancer and CANMAb will offer a high quality, more affordable option to breast cancer patients in India. Approximately, 1.5 lakh new patients are diagnosed with breast cancer every year in India, of which nearly 25 per cent cases are HER2-positive and el-

igible for treatment with CANMAb. Lack of affordable treatment options has limited the extent of HER2 testing and it is believed that the proportion of HER2-positive patients is probably higher.

Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, “Biocon intends to make a significant difference in the treatment paradigm for HER2-positive breast cancer in India by enhancing access to more affordable treatment with CANMAb (biosimilar trastuzumab), which offers the same level of safety and efficacy as the reference product. The launch of CANMAb in India is an important milestone for our biosimilars programme and demonstrates

our ability to deliver on our promise of affordable innovation with a high quality, world- class product.”

CANMAb is a targeted therapy for the treatment of HER2positive breast cancer and acts by interfering with HER2 protein production and stopping the growth of cancer cells. It is easy to administer and will be given intravenously, once every three weeks or on a weekly basis depending on the patient’s condition. Unlike the product currently available in the market, both 150 and 440 mg formulations of CANMAb can be stored for one month which is an important offering for patients in India, as it will ensure that there is no under dosing or wastage of drug which is quite

common today.

CANMAb is being manufactured at Biocon’s biologics facility in Bangalore and will be available to patients around the first week of February 2014.

CANMAb will be available at about 25 per cent discount to the current list price of the reference product in India, which is already significantly lower than its price in developed markets. In addition, CANMAb’s 150 mg formulation, priced at ` 19,500/vial, will allow extra savings to patients as they can buy smaller quantities as per their requirement.

Developing a quality biosimilar monoclonal antibody requires high technical skills, significant investments in clinical development and

manufacturing and long gestation periods resulting in significantly higher costs of development and manufacturing compared to common chemistry-based pharm drugs. India is witnessing increased usage of targeted therapies like biologics as compared to cytotoxics. This trend is likely to continue given the improved treatment outcomes.

The relatively higher cost of developing biologics means these drugs remain unaffordable for a large section of the population. The introduction of high quality biosimilars like CANMAb will make access more affordable and thereby expand the patient pool.

EP News Bureau – Mumbai

MARKET

Business Monitor releases report on India’s lifesciences sector

Aurobindo's European arm to acquire Actavis' ops in 7 Euro nations

Report mentions that the government is impeding the development of its pharma sector, mainly due to extensive bureaucracy and poor policy planning

The acquisition will make Aurobindo one of the leading Indian pharmaceutical companies in Europe

DUE TO its large population and substantial unmet medical needs, India represents a market with strong commercial opportunities for pharmaceutical firms. However, Business Monitor highlights in their new report that the government is impeding the development of its pharma sector, mainly due to extensive bureaucracy and poor policy planning. Some of the issues affecting various subsectors in the industry include the regulation of clinical trials, pricing of patented and essential drugs, generally low government involvement in healthcare and foreign direct investments.

Key trends and developments in India’s pharma market has been discussed in the report. In December 2013, the Indian government decided to dissolve an inter-ministerial panel that was created to reduce patented drug prices. The panel was formed in 2007 and involved seven members from the Department of Pharmaceuticals (DoP), the National Pharmaceutical Pricing Authority (NPPA), the National Institute of Pharmaceutical Education and Research, the Pharmaceutical Export Promotion Council of India, and the Drug Controller General (India).

In November 2013, the USbased not-for-profit public service organisation, the Initiative for Medicines, Access & Knowledge (I-MAK), filed a pre-grant opposition aiming to prevent Gilead Sciences/Pharmasset (acquired by Gilead in

12

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February 1-15, 2014

2012) from gaining a patent in India for sofosbuvir, used in the treatment of hepatitis C (HCV), and which is expected to come to market soon. The move has been welcomed by Médecins Sans Frontières (MSF); the organisation claimed that Gilead is expected to charge $80,000 for one treatment course of the drug in the US. Even if offered at a fraction of this price in developing countries, MSF argued, the drug will still be priced out of reach.

In September 2013, the US Food and Drug Administration issued an import alert on products manufactured at Ranbaxy's Mohali plant in India until the company complies with US current GMP standards. The agency had identified 'significant cGMP violations' at the facility during inspections in September and December 2012, including the firm's failure to 'adequately investigate manufacturing problems'. During the inspections, the US FDA found a black fibre in a tablet that could be a human hair. In the same press release, the agency restated that Ranbaxy's facilities at Panota Sahib and Dewas 'have been on FDA import alert since 2008'.

India's economy staged a cyclical bounce in Q2 FY2013/14 (July-September), with real GDP growth accelerating to 4.8 per cent year-onyear (y-o-y) from 4.4 per cent in the previous quarter. Business Monitor state that while it would be tempting to suggest that the economy can now kick

on in the coming quarters, the continued lack of dynamism in investment activity remains a key sticking point. We may have to wait until general elections and monetary easing take place in mid-2014 before seeing a major improvement in investment conditions and, by extension, a sustainable economic recovery.

In terms of India's investment appeal, Business Monitor believe there is a lot riding on the upcoming general elections scheduled for April-May 2014.

However, with nationwide polling only a matter of months away, the outcome remains difficult to predict with much conviction. While India's 60-yearold democracy has withstood the test of poverty, the coming decade will show whether it can stand the test of rising prosperity.

Against a backdrop of economic growth, Indian government will need to work even harder to combat poverty and inequality; invest in education and infrastructure; and clamp down on corruption in order to satisfy an increasingly cognisant electorate. Meanwhile, icy relations with neighbouring Pakistan and growing competition with China will continue to dominate India's international agenda. Failure to address these shortcomings could see social disharmony and pockets of fundamentalism continue to ferment at the grassroots level.

EP News Bureau – Mumbai

AUROBINDO PHARMA and Auro Pharma announced the signing of a binding offer to acquire commercial operations in seven Western European countries from Actavis plc. Closing of the transaction is conditional on certain antitrust approvals and completion of employee consultation processes.

Aurobindo expects to acquire personnel, commercial infrastructure, products, marketing authorisations and dossier license rights in seven European countries. Actavis and Aurobindo will be entering into a long term commercial and supply arrangement in order to support the ongoing growth plans of these businesses. The acquisition expands Aurobindo’s front-end operations into five segments; generics, prescription products, over-the-counter products, hospital products and generics tenders with approximately 1200 products and an additional pipeline of over 200 products.

Management estimates the net sales for the acquired businesses would be around EUR 320 million in 2013 with a growth rate of over 10 per cent year-on-year. Although these businesses are currently lossmaking, Aurobindo expects them to return to profitability in combination with its vertically integrated platform and existing commercial infrastructure. The acquisition will make Aurobindo one of the leading Indian pharma compa-

nies in Europe. The acquisition will enable Aurobindo to achieve critical mass in Western Europe with a top 10 position in several key markets.

V Muralidharan, Senior Vice President of European Operations for Aurobindo said, “The acquisition of these European businesses is a value enhancing and forward-looking initiative for Aurobindo. We have been clear about our intention to focus on growth initiatives in Europe and international markets, which together are expected to be key drivers for future growth. ” Arvind Vasudeva, Chief Executive Officer, Aurobindo’s Formulations Business further stated that, “We have carefully reviewed the Actavis European operations and concluded that with our cost competitiveness and group structure, we could significantly capitalise Actavis’s strong market position in these Western European countries and improve profitability.”

Aurobindo looks forward to the opportunities this transaction provides for us to work even more closely with Actavis, who are one of our existing strategic partners”.

Sigurdur Oli Olafsson, President, Actavis Pharma said, “We believe that the value created by the commercial operations in these seven markets will be better maximised by Aurobindo.”

EP News Bureau – Mumbai

MARKET

Lilly India and Boehringer Ingelheim India launch re-usable insulin pen ELI LILLY and Company India (Lilly) and Boehringer Ingelheim India launched HumaPen Savvio, an insulin delivery pen that meets the diabetics’ individual need. Engineered to resemble a small personal accessory rather than a medical device, this latest innovation was designed following feedback from people with diabetes who shared their aspiration to manage diabetes discreetly. An invention by Lilly, it offers an extended shelf life of up to six years after first use.

It will be co-promoted by the Lilly-Boehringer Ingelheim alliance in India. The device is designed similar to a fashionable, compact pen with durable design and will be available in a range of colours – red, graphite, green and silver. HumaPen Savvio also makes dosing easy and insulin delivery discreet, which helps insulin users feel more at ease when using their medication.

Edgard Olaizola, Managing Director, Eli Lilly and Company India said, “It will help to bring a greater sense of normalcy to using insulin. We will continue to introduce innovative products to address the unmet needs of patients amidst the growing Indian diabetes epidemic.”

Sharad Tyagi, Managing Director, Boehringer Ingelheim India said, “We are constantly working towards pioneering interventions by leveraging scientific know-how and commercial capabilities of both companies and expanding our product portfolio for diabetes in India.”

HumaPen Savvio will be available in India across six metros; Delhi, Mumbai, Kolkata, Chennai, Hyderabad and Bangalore for use with 3 mL insulin cartridges Humalog, Humalog Mix25 and Humalog Mix50 on doctor’s prescription.

® Trademark of The Lubrizol Corporation © 2011 The Lubrizol Corporation

HumaPen Savvio is designed to resemble a small personal accessory rather than a medical device to help manage diabetes discreetly

Carbopol® polymers are highly efficient gel matrix formers for controlling drug release in solid dosage forms. They offer versatility and flexibility… a winning combination.

Processing Versatility n Ability to choose various manufacturing technologies n Available in both powder and granular forms (Carbopol® 71G NF polymer) Flexibility n In modulating drug release n In formulation - Actives with different properties can be formulated to achieve various extended release profiles

n Enables smaller tablet size n Potential formulation cost savings Synergies with other commonly used controlled release excipients

13

February 1-15, 2014

High Performance Pharmaceutical Ingredients

Efficiency (low total polymer level)

EP News Bureau – Mumbai

EXPRESS PHARMA

Carbopol® Polymers

Lubrizol Advanced Materials India Pvt. Ltd., Application & Business Center, Jaswanti Landmark, 6th & 7th Floor, L.B.S. Marg, Vikhroli (West), Mumbai-400079 Phone: +91-22-66027800 Fax: +91-22-66027888 www.pharma.lubrizol.com

MARKET GROWTH TRACKER

IPM clocks ` 6256 crores in December 2013 The IPM market grew for the second consecutive month, clocking a growth of 8.2 per cent THE INDIAN Pharma Market (IPM) grew at 8.2 per cent for the month of December 2013, with the growth driver split between volume and new introductions leading to overall positive growth over December 12.

Amongst the top 10, Emcurestood at 23.5 per cent followed by Sun Pharma 15.4 per cent and Alkem 14.8 per cent. 34 corporates have crossed the growth of IPM for December 2013 amongst top 50. In the list of top 50 corporates, Corona Remedies has the highest growth of 125.1 per cent followed

by Eris at 33.4 per cent and Ipca at 29.5 per cent. Amongst the 1120 ranked companies Aristo shows high growth at 22.3 per cent followed by Glenmark at 19.7 per cent and Microat 19.3 per cent. 33 pharma companies out of top 50 have grown more than IPM growths. Emcureis the 10th biggest corporate on MAT basis while Alembic entered the ` 1000 crore club. Indian companies have grown at 11.3 per cent versus 0.2 per cent for MNCs in December 2013.

Amongst the top 50 MNCs AstraZeneca grew the highest at 17.6 per cent, followed by MSD at 14.2 per cent and Merck at 12.5 per cent.

The DPCO 2013 containing molecules market was at –8.5 per cent whereas the non DPCO market grew by 10.9 per cent resulting in an overall growth of 8.2 per cent for December 2013.

The DPCO 2013 portfolio for GSK degrew at 27.5 per cent and Ranbaxy degrew by 14.3 per cent, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 9.6 per cent.

The unit market in both the categories grew leading to overall unit growth of 3.1 per cent.

From therapy perspective 10 therapies have outgrown the IPM growth and six therapies have double digit growths. Respiratory market grew up 15.6 per cent, gastrointestinal mar-

14

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February 1-15, 2014

Withbonus units at full value Val in Crs COMPANY

Rank MAT

MAT Dec -13

MTH

IPM Sun Pharma

1

(Val in Crs)

1

Dec-13

Val (Cr)

MS%

GR%

Val (Cr)

MS%

73893

100

6.0

6256

100

GR% 8.2

3920

5.30

17.2

346

5.53

15.4

Cipla

2

2

3721

5.04

6.3

328

5.25

8.4

Zydus Cadila

3

3

2961

4.01

10.8

252

4.02

10.0

Ranbaxy

4

4

2905

3.93

1.6

236

3.77

-1.6

Glaxo

5

5

2851

3.86

-11.7

232

3.70

-12.1

Abbott HC

6

6

2701

3.65

2.1

223

3.56

1.3

Mankind

7

7

2648

3.58

6.5

219

3.50

10.2 14.4

Alkem

8

8

2308

3.12

9.6

192

3.07

Lupin

9

9

2217

3.00

6.3

182

2.91

2.2

Sanofi-Aventis

10

10

1911

2.59

4.6

166

2.66

0.9 8.3

Macleods

11

11

1891

2.56

6.9

164

2.62

Intas

12

12

1872

2.53

12.5

162

2.58

8.7

Aristo

13

13

1759

2.38

9.1

151

2.42

22.3 -3.2

Pfizer

14

17

1623

2.20

-2.3

132

2.11

Dr Reddys

15

15

1621

2.19

8.0

143

2.29

7.0

Glenmark

16

14

1570

2.12

15.9

148

2.36

19.7

Micro Lab

17

18

1490

2.02

7.9

128

2.05

19.5

Abbott

18

16

1437

1.94

4.0

132

2.12

13.8

USV

19

19

1381

1.87

15.0

118

1.88

10.8

Torrent

20

20

1312

1.78

14.7

116

1.85

13.1

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

ket moved up 8.7 per cent whereas anti-infectives grew at 3.4 per cent. Anti-diabetic market grew at 13.8 per cent and cardiac at 6.8 per cent in chronic business. Anti-diabetic

MAT DEC 13 VAL IN CRS Gr% 73893 6.0 12560 1.4 9084 8.5 8320 5.4 6487 4.6 5772 8.4 5316 14.2 5289 4.1 4649 2.9 4626 8.5 3994 9.8 1333 9.3 1236 4.8 1087 -3.8 998 24.2 913 2.2 876 2.4 604 0.3 418 5.8 330 7.5

therapy moves up one rank to be the sixth biggest therapy in the market. Anti-malarials grew up by 23.2 per cent, whereas derma market was at 16.9 per cent.

MTH DEC 13 VAL IN CRS Gr% 6256 8.2 1017 3.4 781 6.8 663 8.7 536 9.1 578 15.6 455 13.8 436 5.5 374 0.4 391 5.1 361 16.9 110 12.2 109 7.1 95 -1.4 91 38.7 79 4.8 71 4.8 43 23.2 37 8.8 28 9.1

From a regional perspective, 12 regions have outgrown the IPM growth. Bihar grew highest at 18.8 per cent whereas Karnataka registered 13.6 per cent. One region had negative

growth in December 2013.

The biggest molecule Amoxycillin + Clavulanic grew by 6.2 per cent, whereas cefixime degrew at 0.3 per cent. paracetamol grew at 10.5 per cent and azithromycin degrew by -1.4 per cent. The markets of vitamin- D grew by 47.8 per cent, glimepiride + metformin grew at 39.1 per cent, levocetirizine + montelukast by 24.8 per cent, rosuvastain by 21.9 per cent and telmisartan by 16.8 per cent.

Mixtard is the top most brand in IPM with 26.8 per cent growth in December 2013.

Amongst the top brands in the IPM, mixtard grew at 26.8 per cent, glycomet – GP grew at 40.7 per cent, skinlite grew at 60 per cent. Over December 2012 brands gaining ranks are Mixtard (+2), Glycomet-GP (+6), Skinlite (+34), Liv-52 (+7), Dexorange (+12), Galvus Met (+20) amongst the top 20 brands in IPM. Corex is the top most brand amongst acute portfolio, whereas mixtard leads amongst chronic brands.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS' research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual TotalMTH – MonthVal (Cr) – Value in CroresMS per cent – Market Share in PercentageGR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

MARKET PRE EVENT th

4 Annual Vaccine World Summit India 2014 to be held in Hyderabad Slated to be held from March 4-6, 2014, it would connect key stakeholders, to facilitate learning, as well as sharing of experiences and knowledge RECOGNISING THAT India plays a crucial role in supplying the world with vaccines, IMAPAC aims to bring together, for the fourth consecutive year, players from the Indian and international vaccine industry at the fourth Annual Vaccine World Summit India 2014. It is being held from March 4-6, 2014 in Hyderabad.

The Indian vaccine industry is expected to grow at 10-13 per cent over the next 10 years. India is the major supplier of basic Expanded Programme on Immunisation vaccine to the United Nations Children’s Fund (UNICEF).

Dr Suresh Jadhav, Executive Director, Serum Institute of India, showed the importance India as a global vaccine supplier, when he said, "Around 75-to-80 per cent of vaccines developed and procured by UN agencies are from the developing world and almost 80 per cent of these are from India�.

The Indian vaccine manufacturers are more involved in the global market than ever. More international collaborations can be seen and the Indian vaccine players are also stepping up their game by acquiring foreign partners around the world. IMAPAC intends to provide a platform to connect key stakeholders, to facilitate learning, as well as sharing of experiences and knowledge through the conference.

Reportedly, this conference features a distinguished panel more than 35 speakers and advisers; each of them playing important roles in their organisations.These key opinion leaders will share their thoughts and discuss key concerns revolving regulations, new technologies, partnerships and clinical trials.

The 4th Annual Vaccine World Summit is supported by international organisations such as Wellcome Trust, Bio Deutschland, the Embassy of Netherlands and more.

EP News Bureau - Mumbai

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MARKET PRE EVENT

Santa Fe joins hands with BioAsia for bilateral collaboration 40 member business delegation from Argentina to participate at BioAsia THE PROVINCE of Santa Fe in Argentina will be leading the biggest-ever foreign government delegation to BioAsia at this year’s edition. The 40-member delegation comprising ministers, senators, bureaucrats, industry and institutions from Santa Fe will be present at BioAsia 2014 to be held from February 17 to 19, 2014.

Close to 20 biotech companies from the province of Santa Fe, will participate in BioAsia seeking partnership, collaboration and business with Indian companies / institutions on key areas, particularly pharma and bioenergy.

The biotech industry in Santa Fe is focussed on human

health and bio-pharma, Agrobiotechnology and industrial processing. Many of these companies which came up in the last 20 years are SMEs and university spin offs. “India and Santa Fe can work together in the development of new pharma and biopharmaceuticals, biomedical tests, new seeds, new products and processes to improve food industry and agricultural chains value and improvement of biofuel production. As most of our biotech and bio-pharma companies are SMEs, their thrust is on innovation which is why BioAsia as a platform is a perfect fit for us as they too are focussed on innovation in this edition,” said Antonio

BioAsia 2014 will also see UK as the country partner besides Gangwon (South Korea) as another international State Partner

Bonfatti, Governor of the province of Santa Fe. “The official delegation of Santa Fe Government will comprise, Governor of the province of Santa Fe, Minister for Science, Technology and Innovation, Secretary of the Treasury, Director of Industrial Pharmaceutical Laboratory (LIF) and senators among others. The objective of this association is promote businesses, collaborative research and development projects in strategic subjects.

BioAsia will help showcase the full fledged ecosystem of Santa Fe biotech industry to Indian companies looking towards South America to scale up, collaborate or for

mergers and acquisitions,” said Shakthi M Nagappan, Chief Executive Officer, BioAsia.

BioAsia 2014 will also see UK as the country partner besides Gangwon (South Korea) as another international State Partner, KPMG as the knowledge partner ICRISAT as AgBio partner and delegates from about 50 countries. The event is being organised by Federation of Asian Biotech Associations, Government of Andhra Pradesh and Pharmaceuticals Export Promotion Council along with Andhra Pradesh Industrial Infrastructure Corporation.

EP News Bureau- Mumbai

‘Biotech for a Better Tomorrow’key theme at Bangalore India Bio Delegations from various countries are expected, with key participation from the European Union, Scotland and the Czech Republic TH

THE 14 edition of Bangalore INDIA BIO (BIB), the flagship biotech event of India, is scheduled to be held from February 10 - 12, 2014 at The Lalit Ashok, Bangalore with the core theme ‘Biotech for a Better Tomorrow’.

Bangalore INDIA BIO is organised by the Government of Karnataka and the Vision Group on Biotechnology, an apex advisory body consisting of members from both public and pri-

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vate sectors. As per reports, delegations from various countries are expected, with key participation from the European Union, Scotland and the Czech Republic.

Nobel Laureate for 2012 Sir John Bertrand Gurdon, awarded the Nobel Prize for Physiology or Medicine will deliver the distinguished lecture and the World Food Prize Laureate 2013, Em Prof Marc Van Montagu will de-

liver the keynote address.

Bangalore INDIA BIO 2014 will consist of multi-track conferences, international tradeshow, distinguished lecture and keynote talks, interlinxbiopartnering, ceo conclave, bio-excellence awards, poster session, bioquiz and other networking events.

The event will see participation of over 110 speakers from more than 20 countries bringing

together global leaders, scientific minds, regulators and investors to exchange ideas and findings in biotechnology research and development, to share their experiences in advancing biotechnological development and to further research and business cooperation across borders.

The international conference will deliberate on key issues such as biosimilars; drug discovery

and vaccine development through partnerships; stem cells and regenerative medicine; clinical trials; digital health fuelling; pharmacogenomics, biomedical informatics and personalised medicine; investment and entrepreneurial finance for bio business; agribiotech and food security; secondary agriculture; bio energy and energy security.

EP News Bureau- Mumbai

MARKET POST EVENT

ISCR releases Code for Conduct for clinical research at annual meet The 12 point patient-centric code is applicable to all ISCR members

India must become an active centre for ethical clinical research and 'Health India’ which emphasises a collaborative approach by all disciplines of medicine should be our vision,” said distinguished academician and clinical pharmacologist, Prof Ranjit Roy Chaudhury. He was speaking as the guest of honour at 'Research at Crossroads', the 7th Annual Conference held by Indian Society of Clinical Research (ISCR) in Bangalore recently.

Prof Chaudhury shared the fundamental features of his report ‘Professor Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs’.

Underlying the recommendations was the need to ensure a fair, transparent and honest framework that would build credibility for clinical research amongst the public. He also highlighted the need to create awareness about the contribution and value of ethically conducted research to healthcare.

Prof Chaudhury acknowledged the support and contribution of ISCR towards developing the regulatory framework for clinical research. He hoped that in the near future, India would develop a transparent regulatory system for better management and conduct of clinical research in India and that there would be greater interaction between academia and Continued on Page 19

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EVENT BRIEF FEBRUARY-MARCH 2014 10

Bangalore INDIA BIO 2014

BANGALORE INDIA BIO 2014 Date: February 10- 12, 2014 Venue: The Lalit Ashok Bangalore Summary: Bangalore INDIA BIO is organised by the Government of Karnataka and the Vision Group on Biotechnology - an apex advisory body consisting of members from both public and private sectors in association with MM ActivSci-Tech Communications, engaged in creating knowledge and business fora across frontier technologies and emerging sectors. The international conference will deliberate on key issues such as biosimilars; drug discovery and vaccine development through partnerships; stem cells and regenerative medicine; clinical trials; digital health fueling; pharmacogenomics, biomedical informatics and personalised medicine; investment and entrepreneurial finance for bio business; agribiotech and food security; secondary agriculture; bio energy and energy security.

It will consist of multitrack conferences, international trade show, distinguished lecture and keynote talks, interlinXBioPartnering, CEO conclave, bio-excellence awards, poster session, BioQuiz and other Networking Events.

BIOASIA Date: February 17 to 19, 2014 Venue: Hyderabad International Convention Centre Summary: The 11th edition of BioAsia is dedicated to the theme – ‘Innovate. Evolve’.

BioAsia’s focus on ‘Innovation in lifesciences’ will address the increasing disease burden, and the growing need for more efficacious and affordable

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11th edition of BioAsia

healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years.

In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of ‘Harnessing the potential of the global nutraceutical market’ will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA).

Contact details Paridhi Gupta Tel: 040 66446477

CPHI QUALITY BY DESIGN Date: February 24 – 26, 2014 Venue: Kuala Lumpur, Malaysia Summary: CPhI – Quality by Design will focus on the drivers, regulatory framework, risks, principles and approach for QbD, and the benefits for the pharmaceutical industry in Asia to implement QbD to compete in the global arena.

This event is a unique learning platform combining discussions, case studies and best practice to enhance knowledge sharing and networking; coupled with a practical training component to enhance applied and technical implementation know-how.

URL: http://www.qualitybydesign-asia.com/?utm_cam-

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CPHI Quality by Design

paign=EVENTLISTING&utm _medium=MEDIAPARTNERWEBSITE&utm_source=EXPRESSPHARMAONLINE&u tm_content=URL&utm_term = Contact details Marcus Chan UBM Conferences ASEAN Tel: +603 2176 8712 Fax: +603 2176 8786 Email: marcus.chan@ubm.com

4TH ANNUAL VACCINE WORLD SUMMIT INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad, Summary: The fourth Annual Vaccine World Summit India 2014 is the longest running vaccine conference in India which provides an excellent platform for attendees to learn and network with industry front runners. This year, more than 30 industry experts will share their experiences and technical knowledge in this two days conference. On the first day of the conference there will be in-depth discussions on the most pertinent issues in the vaccine market by industry experts while the second day of the conference will feature two streams of topics - ‘Vaccine Manufacturing, Technology and Partnerships’ and ‘Vaccine Clinical Trials’.

Contact details Contact Person: Jen Cheng Contact Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.c om/index.php?page=VaccineWorldSummitIndia2014 Email:

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4th Annual Vaccine World Summit India 2014

jen.cheng@imapac.com

SMART PHARMA MANUFACTURING INDIA 2014 Date: March 4– 6, 2014 Venue: Hyderabad International Convention Centre, Hyderabad, Summary: The Smart Pharma Manufacturing India 2014 is specially tailored for technical directors, heads of operational excellence, plant heads and quality heads looking to transform and optimise its current manufacturing processes to maintain cost advantages and achieve quality assurance at the same time.

This conference serves as a platform for industry stakeholders to meet and discuss the challenges of today and tomorrow.

Key topics that will be dis cussed include: ● Manufacturing leadership and strategy ● Operational excellence and automation ● Handling GMP and regulatory compliance ● Achieving QBD via PAT ● Cold chain management and distribution for bioPharmaceuticals•Future manufacturing Contact details Contact Person: Jen Cheng Contact Number:+65 6493 1871 Fax Number:+65 6722 0649 Website:http://www.imapac.c om/index.php?page=VaccineWorldSummitIndia2014 Email:jen.cheng@imapac.com

EMERGING TRENDS IN DRUG DISCOVERY: AICADD – 2014 Date: July 23-28, 2014 Venue: AMRITA Vishwa Vidyapeetham - Amrita University, Coimbatore Summary: Emerging Trends in Drug Discovery: AICADD –

4

Smart Pharma Manufacturing India 2014

2014 is an international conference organised aims to make a "industry-scientistsacademics" collaboration to meet the major challenges of drug discovery. The emphasis of the conference will be on topics related to the Computer Aided Drug Discovery (CADD). The organisers are expecting more than 500 delegates including Nobel laureates/ scientists/researchers/ students and professionals from academia and industries from all over the country and abroad, will be participating in the conference.

A few identified thrust areas are: clinical pharmacy and pharmacy practice, natural products chemistry, medicinal chemistry, pharmaceutical technology, CADD, pharmacogenomics, pharmacoinformatics, SAR studies and machine learning, drug delivery system, nanomedicine, personalied drug design, bioinformatics and biomedical engineering.

Contact details Dr PK Krishnan Namboori Associate Professor, (Executive Coordinator) AMRITA Insight into Computer Aided Drug DiscoveryAICADD-2014, Computational Chemistry Group (CCG), Computational Engineering and Networking, AMRITA Vishwa Vidyapeetham-Amrita University, Amritanagar, Coimbatore-641 112 Phone:+91 422 2685000 Extn: 5592 Email: aicadd_2014@cb.amrita.edu aicadd2014@gmail.com URL: http://www.amritaccg.in/ Conference URL: http://www.amritaccg.in/aica dd2014

MARKET Continued from Page 17

India should be... industry.

On the occasion, ISCR released the ‘ISCR Code for Conduct of Clinical Research in India’. The 12 point patientcentric code applicable to all ISCR members reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activities.

Earlier, Suneela Thatte, President, ISCR, stressed on the need to develop a clinical research agenda in India given the country's huge disease burden. ‘In-

in the regulatory process to ensure that clinical research in India develops to the potential it showed a few years ago.

Over 200 professionals across the clinical research spectrum came together for engaging and stimulating discussions on topics around ‘Research at Crossroads’, a theme reflective of the increasing challenges being faced by the clinical research fraternity.

ISCR is an association of clinical research professionals that brings to-

dia’s emergence as a knowledge and innovation hub cannot happen without commitment to research and development. Affordable healthcare can only become a reality when patients benefit through local innovation,’ she said.

The inaugural session also had Dr Rebecca Li, Executive Director, MRCT Center at Harvard who spoke about the need to bring together all stakeholders involved

gether all those who are engaged in clinical research activities in India and provides a forum for exchange of information and learning. It aims to build awareness of clinical research as a speciality in India and to facilitate its growth in the country while helping to evolve the highest standards of quality and ethics.

EP News Bureau- Mumbai

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February 1-15, 2014

cover )

20 EXPRESS PHARMA February 1-15, 2014

(

THE MAIN FOCUS

Dr PM MURALI Chief Executive Officer and Managing Director, EVOLVA

BLUEPRINTFOR

BIOTECH Biotechnology players in India can boast of a steady performance but what are they doing to grow to the next level? A glimpse into the minds of four CEOs

BY USHA SHARMA

'There will be a lot of partnerships and collaborations'

T

he key to succeed in this sector is to have adequate capital and sustained capital raise over the years of development which will allow the company's platforms or technology to blossom. It is obvious that any bioteh company can not stop at thinking it is Indian. The business is going to be international and capital will have to flow from outside the country as well. So the key is to build a leadership team which is truly international so that the main requirement of running the company is met.

The second area is to ensure that there are world class people and good infrastructure. We can be thrifty to make ourselves cost competitive but never present ourselves as cheap. While one company builds itself an ecosystem slowly emerges around it which spurs more growth.

So the other area which needs attention is which of the states in India is progressive so that the company will soon have a cluster built around it. These are some of the fundamentals which will allow companies to have the spot light on themselves.

Once the above fundamentals are in place, companies can focus extensively on their global market strategy. A lot here depends on the product and the geography they are focusing on. If it is the traditional US market, then it is obvious that our companies will also have to play by the global rule book. Very high quality and reliable supply chain. It is evident that there will be a lot of partnerships and collaborations as this would be the way for most institutions to share resources and expand quickly.

It is likely that India would work towards leadership in biosimilar and biologics. Cancer would be a focus area and also areas where big pharma companies' have not invested. Management of most companies will be scanning the intellectual property landscape working at the back end to hit the market when they obtain the freedom to operate. Timing is the key to emerge as the leader and like an orchestra conductor, the CEO will have to ensure that all the components of the business play together. Unlike in other countries where there is a well-oiled biotech system, India still does not have one and hence the challenges will be stiffer than most other places on the globe. Companies will still have to figure out ways to tap into public market for funds which is currently not very favourable. Overall management of companies will be trying to complement the missing elements of doing business in India and will look outwards for funds, talent and markets.

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February 1-15, 2014

cover ) SWAPAN BHATTACHARYA

KV SUBRAMANIAM

Managing Director, TCG Lifesciences

President and Chief Executive Officer, Reliance Life Sciences

'The winning strategies for Indian industrywould be to embrace the learning'

‘Formidable challenges in addressing opportunities’

D

ue to the lack of venture funding, biotechnology start-ups are rare in India.

However, Indian clinical research organisations can play a critical role in the innovation of novel drug candidates in collaboration with pharma/biotech companies.

This involves knowledge transfers as well as funding support from the pharma/biotech partners.

While the resulting “asset” may not be a final product, new molecular entities ('NMEs') delivered by such collaborations can offer significant value for high priority drug development candidates. TCG Lifesciences (“TCGLS”) alone has delivered four such assets in the past three years.

The principal value proposition in this domain that TCGLS offers is its ability to combine knowledge, time/cost efficiency and flexibility in performing the iterative process of Structure Activity Relationship (“SAR”).

Some of the essential strengths and expertise TCGLS brings to bear include (i) speed in compound synthesis as a live SAR demands molecules in its loop as quickly possible to make decision making and taking SAR forward; (ii) ability to problem solve as the target molecules are novel and unprecedented; (iii) ability to evolve complementary skills in “route de-

22 EXPRESS PHARMA February 1-15, 2014

sign” to support “compound design” process; (iv) fast decision making with a propensity to “kill” compounds which are likely to fail; and (v) flexibly apply the appropriate scientific domains with multidisciplinary scientists and technology platforms. At TCGLS, we address all these parameters; both in isolation and in a holistic manner wherever they are interconnected. This is a complex process and involves continuous learning of design/problem solving/synthesis aspects, parallel optimisation abilities, continuous improvements in cycle time and productivity specially in the area of purification sciences, optimising procurement and logistics systems, real-time and interactive data sharing and communication system through a web enabled electronic lab notebook system, establishing high throughput biological screening and profiling systems and high end in vivo study platforms.

Development of such expertise has taken time and considerable investment – two of the pre-requisites to play this game. TCGLS was first Indian CRO to set up its biology lab and invested in diverse assay platforms (GPCR, ion channels, kinases etc), and compound handling automation systems. Today TCGLS is considered to be the leader in assay/screening in India.

TCGLS is also the first to set up parallel/library synthesis

through its collaboration with discovery partners, the technology leader in 2002 and has

I

maintained its lead in this domain. Failure is a constant companion of drug researchers; but the ability to learn from its mistakes and to rapidly produce new and improved compounds are vital to success. TCGLS, over the years of working with the best minds and cutting edge technology of its western partners, has established best practices and efficiencies at par with the best global players. The challenge of drug discovery to address unmet medical needs continues to be the need of the hour. India’s contribution in this regard has been limited in terms of “disruptive innovation”. We have played an important role in “incremental innovation” by bringing down cost of medication through generic medicines, but surely the drug industry in India can play a more pivotal role! The winContinued on Page 23

ndia has an opportunity to be a global leader in the world of biotechnology particularly in vaccines and biosimilars. India is already playing a major role as an important source of quality vaccines for life-threatening diseases at a very competitive prices for the developing world. This can be enhanced with a number of other vaccines for life-threatening vaccines as well as for lifestyle diseases.

As regards biosimilars, large sections of society in the developing world are not able to afford high-priced biopharmaceuticals, most of which meet critical health care needs. Even if some sections of society are able to afford to an extent, health care practitioners have to resort to sub-optimal dosages.

However, there are several formidable challenges in addressing these opportunities.

These are primarily in significant investments involved, long gestation periods, high-end competencies required, increasingly demanding regulatory environment, and in

being able to meet highquality standards.

Reliance Life Sciences (RLS) has been addressing the biosimilars opportunity by developing an array of biosimilar products.

RLS has invested significantly in creating the infrastructure, having competencies across the value chain, investing significant capital in product development, pre-clinical and clinical studies and in quality management.

RLS believes that a strong emphasis on quality and cost-competitiveness, through in-house research, process development, manufacturing, pre-clinical and clinical research, and strong quality management systems and processes, will help it address the larger global opportunity.

(

THE MAIN FOCUS

BINISH CHUDGAR Vice Chairman and Managing Director, Intas Pharmaceuticals

'Biosimilars is a compelling opportunityfor emerging economies such as China,India,Brazil'

I

ndia’s pharma industry is one of the most mature and thriving industries in the country. Having started under the protectionist era, the industry has thrived in the post liberalisation phase. From a mere ` 10 crores industry at the time of independence in 1947, the Indian pharma sector has grown to an estimated $17 billion in 2012. It is expected that the industry will reach about $36 billion in 2016. Upto now, factors such as changing demographics, globalisation of our economy, cost competitiveness, favorable patent regime (in the past) and pricing policy were the key drivers of this growth.

However, as we look into the crystal ball many new and emerging factors will influence the Indian and global pharma market. Key among these is the growing prominence of the biopharmaceutical (biologics) sector.

In the year 2010, as per IMS estimates, the global spend on biologics was $138 billion or about 16 per cent of the total spend. Of this, biosimilars spending was only $0.3 billion (a mere 0.2 per cent). However it is estimated that the biosimilars opportunity will grow to about $2.0 billion by 2015 and could be anywhere between $11.0 billion to $25 billion by

2020. The EU is currently in the driver seat due to early adoption of regulatory pathway for biosimilars. It is expected that the EU growth of biosimilars would continue with key drivers being further clarity of regulations, patent cliff and countries that were slow adapters following the leading adapters of biosimilars. The opportunity becomes more compelling due to the currently prevalent economic conditions.

As we all know, the world is going through a recessionary phase currently.

Most economies are struggling to meet their healthcare bills and there is immense pressure building up to stem the rising healthcare costs. This becomes even more relevant for the future as people are living longer and hence will require healthcare coverage for more number of years. There are 18 biosimilars approved in EU (as of November 2013) including the first mAb infliximab. From India, Intas is the only Indian company currently to have a product approved in the EU (through a partner). The US represents the highest potential latent demand for Biosimilars. It is the biggest market for biologics (over 50 per cent of the global sales) but has been slow in the adoption of biosimilars. With the Patient Protec-

tion and Affordable Care Act (Obamacare) coming into effect and the adoption of biosimilar regulatory pathway similar to EU, coupled with the patent cliff for most blockbuster biologics, the US is forecasted to be the single biggest opportunity for biosimilars by 2020.

Biosimilars is also a compelling opportunity for emerging economies such as China, India, Brazil etc. With vast populations and a need to expand the healthcare coverage while balancing the limited resources, the availability of biosimilars at lower costs would play a major role in these markets. In cases such as India, this is also coupled with the need to attract foreign investment and creating manufacturing and R&D centers. Most countries in this third category already have developed their own regulatory pathway for biosimilars. Coming to novel biologics, we are seeing some emerging trends in R&D and particularly Biopharmaceutical R&D. We find that more and more companies are rationalising their R&D costs through better utilisation of resources, recognising drug candidate failures at earlier stages, greater focus on discovery of biologics and thereby improvements in the protein design and characterisation tech-

The four CEOs have presented their take on industry trends as well as a glimpse into the strategies being followed at their companies. CEOs aiming to better access global opportunities should also attempt to create a confidence among

niques, migration of drug discovery to the Asian countries, as well as through industry consolidation especially acquisition of biotech companies by the larger pharma companies.

Globally, higher focus is on the R&D of biopharmaceuticals and it is estimated that already >40 per cent of all pharma industry research is in novel biologics rather than chemical drugs. Many large pharma companies invest greater than half to almost all of their R&D expenditures on biopharmaceuticals with a large concentration on monoclonal antibodies and cancer drugs. Biologics have evolved so rapidly over the past several years that 5 of the top 10 prescription drugs in the year 2012 were biologics with combined sales of ~$36 billion of the total sales of $ ~73 billion for top 10 drugs.

Continued from Page 22

'The winning strategies ... ning strategies for Indian industry would be to embrace the learning that has happened through engagement with innovation leaders in the West and to apply the knowledge and best practices to focus on new drug development.

Our scientific and engineering talents play a leading role in driving innovation outside India. China has propelled itself forward in the drug R&D field as recently as the past decade through startup biotechs, local pharma/CRO partnerships and leveraging domestic academic and traditional medicine strengths. India can apply some of the same measures and strategies for bringing in first-in-class remedies for diseases endemic to India, particularly those that are not the focus of the innovators in the West. The science and business of drug discovery and development is constantly evolving due to its intrinsic complexity and challenges. TCGLS is continuously focusing on its strategy of investing in new technology platforms and domain expertise in diverse therapeutic segments. It is already collaborating with a few of the pharma/biotech players in India and also reaching out to other Indian companies to develop win-win collaborations for the future.

multinational players to do business in India. In the long term this blueprint will spur growth and help the industry to win the race.

u.sharma@expressindia.com

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MANAGEMENT I N T E R V I E W

“Current financing climate unable to support large vision models�

A promising biotechnology start up that attracted investors in the initial stages, Avesthagen today finds itself in a funding crunch. Villoo Morawala Patel, Founder and Chief Managing Director, Avesthagen rues the fact that innovation is not encouraged in India, and companies riding through a tough time do not get adequate support. Shalini Gupta finds out more How has the business model of the company changed since inception?

Avesthagen began with a model based on R&D and innovation and focussed at the convergence of food, pharma and population genetics leading to predictive, preventive, personalised healthcare and food security. We were ahead of our time and would have still continued to break path as a disruptive model if the markets had not let us down in 2008.

The current financing climate is unable to support large vision models and now that we are product ready we have decided to just move the products out into three companies, dedicated to pharma, nutrition and agriculture. Avesthagen will continue to move forward as an R&D focussed on preventive and personalised healthcare, The Avestagenome Project and Environment Adjusted Crops. So it is not really a demerger so much as a spin-off opportunity.

Will all the entities be incorporated outside India?

With regards to our spin offs, there is no hard and fast rule. At the moment we will have to wait and watch for the best situation for our company.

We will go where we get the best quality and quantity of

24 EXPRESS PHARMA February 1-15, 2014

funds, operate where we get the best human resource and sell where we get the best price.

While over 50 IPOs have raised about $ 7.5 billion in the US in 2013 why have Indian investment firms not been able to match up?

50 IPOs across all kinds of sectors in the world's biggest economy - India is nowhere. In fact we have a lot of hard work to do before we even think of a comparison. For example, India did not even get a mention by Jamie Dimon in the recently held JP Morgan Healthcare Conference. We do not encourage innovation in India, we do not support companies that are riding through a tough time. In the US, there is a respect for entrepreneurship and risk taking and even for failure. Not so in India. It is by just determination (that) we hang on. Yes, some of us are diehard entrepreneurs and we don’t give up even in adversity because we are committed to the nation and to its people.

The company raised money through PE and VC funding, was planning to have an IPO in 2008, the recent demerger move is also to raise capital.

Do you think that Indian biotech, particularly start ups, are struggling to raise

VILLOO MORAWALA PATEL, Founder and Chief Managing Director, Avesthagen

funds in India? What reasons do you see for this?

Yes it is to raise capital. This industry cannot be built in a Rs 5-15 crores. To be really globally competitive we need larger financing rounds of 20-30 million Euros to have any significant impact. The Indian banks and PE and VC is nowhere near that. The Indian IPO market is perceived by the bankers to be non-receptive to the mid stage biotech IPOs. I have more faith in the Indian public so if we could find a brave banker willing to take a mid - stage biotech with good products to the market, we are ready to list.

APAG has eight biosimilars in the pipeline worth $40 million. Apart from Avdesp (Darbapoetin) and Avent (Enbrel), what are some of the other classes of biosimilars?

How have the guidelines released last year in India helped companies?

Avesthagen has eight biosimilar cell lines that address a $ 40 billion opportunity post patents, that will be moving into a new company. Besides Avdesp and Avent, the other molecules address monoclonal antibodies targeting cancers. Yes the guidelines are clear and favourable provided we get funded for the clinical trials.

Most guidelines are arriving at a sweet spot and that is good analytics to prove biosimilarity and ability to scale up. We do not have any products in the market however we are seeing early licensing deals for distribution rights. There will be a few challenges on the way ahead and this will need to be overcome.

Avesthagen has stressed on a strong focus on innovative R&D. You have been unequivocal about MNCs misusing India's patent system, what then are your views on the Indian Patent Act and decisions which have

come under sharp attack by the US? Yes we have a strong focus on R&D and innovation. With regards to the patent system I have nothing to say pro or against MNCs or Indian companies. In this extremely cut throat game of pharma, I have seen Indian companies do much worse than the MNCs so its about the pot calling the kettle black. To some extent I have lost faith in our system where there is jungle raj and people make claims and counter claims. And there is no decision making and sitting on a fence all the time. Its boring and detrimental. I am not interested and I just want to be allowed to do good work.

With Environment Minister M Veerappa Moily considering approval for GM crops, how do you see the move for the bioagri sector?

We have to get good science based products to the market.

So I am all for the release of "environment adjusted crops" to the market as we have so much to do with our marginal land. Care and control of course needs to be put in place. But let's get a good system in place with the NGOs also respected for their opinions and suggestions. shalini.g@expressindia.com

I N T E R V I E W

'When regulation becomes ill-defined and ambiguous, all industry players suffer' With an established clinical genomics practice in India.Covering over 20 hospitals around the country, Strand Life Sciences recently signed an MoU with California-based El Camino Hospital. Dr Vijay Chandru, Chairman and Chief Executive Officer, Strand Life Sciences reveals more details of this MoU and gives his suggestions regarding the current regulatory framework and changes required in Indian biotech sector to Usha Sharma

Recently, Strand Life Sciences has signed an MoU with El Camino Hospital. Tell us more about the agreement? ?

Strand is well known in the genomics community for building the “gold standard” informatics tools for secondary and tertiary analysis of molecular data.

We serve well over 2000 labs worldwide which amounts to about 30 per cent global market share. The El Camino Hospital is both a community hospital and a research savvy hospital. Being located in the technology hub of Silicon Valley in Mountain View also means that the community is very open to new breakthrough technologies like genomics. This made El Camino Hospital an ideal partner for Strand’s entry into the US healthcare establishment.

When we entered the emerging domain of “clinical genomics” or the use of genomics for personalisation of medical treatment of patients, we were soon seen to be a front runner because of the history of being a strong informatics player for

over a decade. We have rapidly established a clinical genomics practice in India with over 20 hospitals around the country. This includes next generation sequencing of DNA samples from patients at these hospitals, analysis of the data and clinical interpretation of the patterns found and related clinical advice to the attending physicians. We only work with physicians and not directly with patients because of the sensitivity of the medical advice. We also provide genetic counselling appropriate to the tests and follow closely the best practices and guidelines of the American College of Medical Genetics in our reporting.

The leadership of El Camino Hospital had been evaluating several candidate partners for providing clinical genomics services to their community through their centre for medical genomics. Over the last six months of interaction with Strand, they were convinced of the quality of our services and have entered into an understanding with Strand

DR VIJAY CHANDRU, Chairman and Chief Executive Officer, Strand Life Sciences

to establish a Strand Centre for Genomics and Personalised medicine at their hospital.

How much would you like to invest in setting up a new lab at El Camino Hospital and how do you plan to raise the fund?

Strand has raised a series B round of $10 million in February 2013 from Biomark Capital Partners of San Francisco. We are adequately funded to implement this project.

What research work have you planned through this

partnership and how it will be beneficial to the Indian patients?

El Camino Hospital runs a famous programme known as the “The South Asian Heart Study” which currently has around 4,500 volunteers from South Asia who are residents of Silicon Valley.

We plan to extend the heart study by also testing a large fraction of the volunteers for their genomic profiles that may indicate predispositions to certain types of cardiac ailments. A large fraction of the study subjects have consented to such profiling and their DNA samples have been collected. The learning from such an exercise would be enormous for South Asians everywhere including India of course. The pharmacogenomics research programme would also eventually benefit patients in India.

As per the agreement, research will be carried out in areas of advanced genomic tests in cardiology, oncology, pharmacogenomics and personalised medicine to the community

served by the El Camino Hospital. By when will the tests be launched in the market?

The initial focus of the services would be in profiling of genomic risk for cardiac diseases, diagnostic tests in oncology for both somatic profiling of tumour DNA and for germline cancer risk, whole exome personal genome profiling of community members and a novel pharmacogenomic test.

The first three tests are already on offer to Strand customers in India while the fourth (pharmacogenomics) is being developed with researchers at El Camino Hospital as a collaborative project.

What are the other focus areas identified under the partnership?

Other areas would evolve and are under discussion. We have talked about running an annual clinical genomics conference along with El Camino Hospital to bring about awareness of these tests to the community.

Continued on Page 27

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MANAGEMENT I N T E R V I E W

'Use of enzymes in API manufacture produces a diverse range of cost savings' Incorporating biocatalysis within the API manufacturing process can aid Indian manufacturers increase global market share by reducing costs further, improving API/intermediate quality and simultaneously remaining aligned to the latest regulatory demands. Rose Lance, Senior Marketing Manager, Novozymes Biopharma briefs Sachin Jagdale on the company's strategy and commitment for India and to work with companies to develop biocatalytic pathways

How does biocatalysis work?

Biocatalysis involves the implementation of natural catalysts, such as enzymes, in place of chemical catalysts in synthetic processes. This change can enable new, more sustainable routes for the production of intermediates and APIs. One of the biggest advantages of enzymes in organic synthesis is their remarkable selective properties, which gives a number of commercial benefits including better production of single stereoisomers, fewer side reactions, less reprocessing or purification steps, easier product separation and less pollution. The combination of all of these means lower costs. Biocatalysis has become an increasingly important tool for medicinal chemists, process chemists and polymer chemists, allowing the development of efficient and highly attractive organic synthetic processes on an industrial scale.

In what way does it reduce the cost of API

26 EXPRESS PHARMA February 1-15, 2014

manufacturing?

Changes in manufacturing procedures are a major contributor in improving operating margins. By pursuing a new manufacturing process, the original innovator of a pharmaceutical can compete with generic manufacturers using a different, more effective manufacturing process. Traditionally, production cost reductions have taken place in the later stages of clinical development, as innovators have been reluctant to make process changes after a product has been launched.

However, pressures reduce costs have increased alongside regulatory demands and generic competition. As a result, innovators have increasingly been pursuing cost reductions earlier in product development.

Biocatalysis is one recognised technique that can be employed to reduce costs, providing a sustainable process and improving the quality of the API. By pursuing this type of manufacture earlier, the

ROSE LANCE, Senior Marketing Manager, Novozymes Biopharma

pharma innovator can protect themselves much better against future generic manufacturers and remain aligned to the latest regulatory demands.

The use of enzymes in the manufacture of APIs produces a diverse range of cost savings, particularly in terms of reductions in raw material inputs and overhead costs of equipment, labour, and energy usage by approximately 10-15 per cent.

Costs of manufacture are reduced through various channels using this

enzymatic method.

Biocatalysis provides an opportunity for formulators and manufacturers to use enzymes to efficiently resolve an existing racemic mixture, creating new chiral centres or delivering a chirally pure compound through asymmetric reactions. This improves the production of single stereoisomers, creates fewer side reactions, allows easier separation of products, and reduces waste. Due to the efficiency of the technique, the total cost of implementing biocatalysis in drug manufacture is relatively low.

To use an example, the synthesis of the molecule, Duloxetine, through biocatalysis is vastly more cost-efficient due to the reduction in raw material input and raw material consumption. Raw materials no longer required include isopropyl alcohol, L-mandelic Acid, acetyl thiophene, formaldehyde, phenyl chloroformate/ethylchlorofor mate, diisopropylethylamine and 2-Methoxy-2methylpropane (MTBE).

Therefore, the amount of components needed to be purchased and included into the formulation is reduced by as much as 10 – 15 per cent.

There is also a notable reduction in overhead costs due to less process steps being involved - equipment costs, labour costs, and energy savings can be reduced by up to 15 per cent.

The streamlined process, which has been dropped from nine steps to five or six, results in higher throughput and financial savings, with more batches being produced in the same timeframe. Combined, these factors have a positive effect on the cost of manufacture.

Besides application in the API industry, which are the other areas of pharma industry where biocatalysis is used?

Aside from its application in API production, biocatalysis has uses in several fields including specialty and fine chemicals.

Other important uses of biocatalysis occur in the energy, polymer, agriculture and cosmetics industries.

MANAGEMENT Who are your clients in India?

What has their response been?

Novozymes are currently working with many of the large innovator and generic manufacturers based in India; however the details surrounding these agreements are currently confidential.

Indian API industry hopes to become the top most producer of API in the world. Will biocatalysis be successful in fulfilling this dream?

As generics are set to be adopted in almost all major markets around the world in the next three to five years as countries try to reduce healthcare costs, India is an important market for biocatalysis in both the generic and intermediate markets. Factors, such as an increase in patent expiries of blockbuster drugs, an increased focus on generics adoption globally and the constant demand for reductions in manufacturing costs, are the driving forces for not only shaping the global API industry, but are behind the resurgences of Indian API companies in the global market.

India has emerged as one of the most-favoured API producing nations, with one reason being its cost competitiveness in

comparison with its foreign counterparts. With the prices of China-made APIs rising (metformin prices have doubled in the last 1-2 years), incorporating biocatalysis within the API manufacturing process can aid Indian manufacturers increase global market share by reducing costs further through raw material input and RMC and overhead cost reductions.

API/Intermediate quality will also be improved by reducing intermediate use, and thus less carry over to final API, a reduction in chiral impurity carry over and less residual solvent carry over due to reduced solvent use.

What strategies have you planned for the Indian market in the next three years?

We have plans to roll out our enzyme offerings (lipases and proteases) to the market while working with the companies to help deliver the products and services they require to develop biocatalytic pathways.

Novozymes is well known in various other industries and we want the Indian pharma market to learn about us and work with us. sachin.jagdale@expressindia.com

'When regulation becomes...

Continued from Page 25

Biotechnology regulations in India are still at a nascent stage. Do you think it will affect the industry in the long run?

Yes of course! Regulation affects industry but at the same time it is necessary both ensuring quality and ethical standards are maintained. Responsible industry usually would like some regulation to ensure that the market does not get spoiled by unethical players. It is when regulation becomes illdefined and ambiguous that sometimes all industry players suffer because of the arbitrariness.

Are there any regulatory guidelines concerning genomic testing for clinical and medical applications?

I personally, and Strand as a company, have taken the position that in genomic testing for clinical and medical applications, industry should not be allowed to directly solicit consumers (patients) and directly report to consumers without a physician intermediary. This dangerous practice has been shut down in the US by the FDA in recent times but continues to thrive in India. I would like to see ICMR take a position on this and have made it known to the concerned officials in the Ministry of Health and Family Welfare. u.sharma@expressindia.com

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MANAGEMENT

Vision 2025 for Indian bioagri sector In a recent released report, Indian Biotech Agriculture Industry:Vision 2025, CII and Accenture attempt to define the industry’s vision for 2025 and recommend the measures various stakeholders must take to realise this vision. Excerpts from the report...

I

ndia is currently facing one of its most formidable economic challenges— addressing the widening demandsupply gap in food grain production. With a growing population and scarcer resources, India needs to produce more with less.

Biotechnology agriculture (bio agriculture) through its wide offering landscape can provide the answers—helping improve the effectiveness of agriculture inputs, bring down input costs and increase output. But there are many challenges before the bio agriculture industry. What is the overall potential of the industry? How can various stakeholders address the challenges of expanding the market?

What kind of growth enablers are needed to realise the sector’s potential? To answer these questions, the Confederation of Indian Industry (CII) and Accenture put together the report, Indian Biotech Agriculture Industry: Vision 2025, to define the industry’s vision for 2025 and recommend the measures various stakeholders must take to realise this vision.

India’s bio agriculture sector is currently estimated at $7.8 billion (including crops produced through the geneti-

28 EXPRESS PHARMA February 1-15, 2014

cally modified (GM) technology). Biotechnology offers multiple innovative techniques to develop high-yielding crops that can counter the biotic and abiotic stress associated with Indian agriculture.

High-yielding seeds Bio agriculture yields better results than traditional techniques while maintaining the stability and fertility of soil. High yielding seeds significantly enhance the productivity potential and provide resistance from adverse environmental stress such as drought and salinity. They are particularly effective and relevant for a country like India that suffers from water scarcity and drought every year. High-yielding seeds also protect crops from diseases and insects. (see Figure 1): It shows key bio agriculture technologies and their applications.

Bio fortification Bio fortification is the development of micronutrientrich staple crops using traditional breeding methods and modern biotechnology. Using this technique, plant breeders focus on crops, such as soybean, that have high nutritional content. This technique is advantageous for developing

MANAGEMENT

countries in providing necessary nutrients especially to the rural population who rarely have access to commercially fortified foods.

Nutrition Biotechnology techniques fulfill plant micronutrient requirements by supplying organic nutrients through microorganisms and their by-prod-

change, urbanisation and limited freshwater resources have made waste water a vital source of irrigation water for farmers. It is particularly important to utilise wastewater from domestic use, institutions and industries. Grey water generated from washbasins, showers and baths—is suitable for reuse and contains nutrients important for agricul-

Agricultural crops face a significant threat from a variety of natural enemies such as predators, parasites and pathogens. These pests can damage crops and impact the nutritional value of the produce ucts. These microorganisms doctor the natural nutrient cycle of the soil and build soil organic matter.

Pest management Agricultural crops face a significant threat from a variety of natural enemies such as predators, parasites and pathogens. These pests can damage crops and impact the nutritional value of the produce. Biotechnology offers a solution to this problem, with minimal harm to the environment.

Wastewater utilisation Population

growth,

climate

tural production. Despite the wide range of bio agriculture offerings, the Government of India has approved only GM Bt cotton seeds for commercialisation since 2002. These seeds were quickly adopted by farmers, and this paved the way for the growth of bio agriculture. After the introduction of GM Bt cotton seeds, the bio agriculture sector registered a compound annual growth rate (CAGR) of 49 per cent from 2003 to 2010 (see case study) and then slowed to 18 per cent during 2009–12. Several factors have contributed to this sector losing steam. 90 per cent of the cotton area is already under Bt

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MANAGEMENT

cotton cultivation leaving little room for growth. Lack of new hybrids, a passive regulatory system and limited investment in R&D too have hurt growth and innovation. The next section discusses in detail the challenges before this sector.

FIGURE 1: KEY BIO AGRICULTURE TECHNOLOGIES

Case study Seeds of hope—Recollecting the success of Bt cotton in India Bt cotton seeds are genetically modified to produce an insecticide that kills bollworm, a common cotton pest in India.

The Government of India allowed Monsanto Company, an American firm, to start selling Bt cotton to local farmers in 2002. Since then, Bt cotton has pervaded cotton farming in India. Today, the Bt cotton acreage accounts for more than 90 per cent of the total area under cotton cultivation.

This has helped India become a net exporter of cotton. Bt cotton has succeeded in transforming cotton into one the most productive and profitable crops in the country.

However, it still requires further research because of the development of Bt cottonresistant pests.

Key outcomes ●

Cotton output increased to 35.2 million bales in 2011 from 13.7 million bales in 2002 ● A 68 per cent rise in per hectare yield ● A 25 point reduction in the use of pesticides, from 46 per cent to 21 per cent ● A 129 per cent increase in farmers’ income per hectare, to ` 16,000 from ` 7,000 in rain-fed areas and higher in irrigated areas—by reducing costs of inputs such as pesticides ● 7 million farmers who were living below the poverty line in 2011 have benefited from cultivating Bt cotton (see Figure 2): Cotton Production in India (Annual Yield)

Challenges Government agencies do

30 EXPRESS PHARMA February 1-15, 2014

not have a single view on the application of GM technology in agriculture. The country also lacks a road map to leverage biotechn. Regulatory approvals are not given on time, and multiple regulatory bodies cause inordinate delays. Currently, 91 applications for field trials are pending for approval, 44 of which are for GM food crops. To overcome such

delays, the government proposed to set up Biotechnology Regulatory Authority of India (BRAI), an independent regulator under the Ministry of Science & Technology, but the proposal is still waiting for Cabinet approval. Going ahead, the challenge for the government will be to establish an effective regulatory system and a communication

mechanism on GM foods, which can help allay fears about the safety of such crops, while ensuring higher productivity and remuneration to farmers.

India’s current R&D spend on agriculture is only 0.6 per cent of the total agriculture gross domestic product (GDP), which is less than the average of 1 per cent spent by

other developing countries.

This problem of inadequate R&D spend is compounded by the need to apportion the budget between numerous public institutions. To improve the chance of converting these investments into commercially viable products, meaningful collaborations between public and private institutions are required at an early stage

MANAGEMENT

of development. However, public-private partnerships are “infested” with glitches such as lack of harmony between the individual objectives of public research centres and their alignment with agricultural challenges, long recovery period of approximately 8–10 years to commercialisation and ambiguity on intellectual property (IP) ownership. Going ahead, the challenge for the government will lie in forming mutually beneficial public-private partnerships.

The real value of this can be realised only when there is a clear, identified path to market. Further, involvement of private sector scientists and industry captains in various decision-making bodies of the government will be a step in the right direction.

India clearly lacks an informed debate on the benefits of biotechnology techniques in agriculture. The current opposition to GM is largely due to the lack of understanding of the technology by a certain group of people. A comprehensive evaluation of GM technology needs to be undertaken, looking at all aspects including social, environmental and economic. Seed pricing in India is largely determined by the government and often remains unchanged for years despite the rise in input costs. The country needs a government-approved framework to enable calculation of licensing fee or trait fee in a transparent manner. Going ahead, the challenge for the government will be to increase awareness of bio agriculture and formulate a transparent framework to encourage farmers to embrace biotechnology.

Recommendations The bio agriculture sector has the potential to expand manifold, from $7.8 billion today to $34–37 billion by 2025 (see Figure 3). However, to realise this market opportunity, the industry needs to implement the following growth enablers:

32 EXPRESS PHARMA February 1-15, 2014

FIGURE 2: COTTON PRODUCTION IN INDIA (ANNUAL YIELD)

Sources: Agriculture statistics 2012, Ministry of Agriculture; news articles; Accenture analysis

FIGURE 3: CURRENTAND PROJECTED MARKET SIZE OFTHE INDIAN BIO AGRICULTURE INDUSTRY The bio agriculture sector has the potential to expand manifold, from US$7.8 billion today to US$34–37 billion by 2025 (see figure 4). However, to realize this market opportunity, the industry needs to implement the following growth enablers:

Note: Current market data based on Association of Biotechnology Led Enterprises (ABLE) biospectrum survey, June 2013; current bio agriculture market adjusted to include output due to existing bio agricultural products; dollar-rupee conversion rate kept constant for the projection period based on FY13 rate Sources: Accenture Market Size Model, primary interviews

Policy framework and regulatory system The policy hiatus and regulatory uncertainties in the country have impeded the growth of Indian agriculture.

The government needs to

streamline the regulatory system in the following ways: ● Lay out the role of various biotechnologies in solving the agricultural challenges faced by the country and identify the technologies relevant to the

Indian context ● Identify priority crops where biotechnology intervention is required; identify crops for self sufficiency and those for exports ● Form a single regulatory au-

thority to govern all bio agriculture domains falling under various ministries and coordinate between the relevant central and state ministries for any approvals ● Reinforce the capabilities of

MANAGEMENT existing supervisory committees to effectively deal with complexities associated with the evaluation of bio safety trials; ensure evaluation is based on scientific facts ● Set up procedures and targets with clearly defined timelines; check implementation and adherence to timelines

Innovation Innovation can play a key role in the success of the bio agriculture sector by enhancing productivity, ensuring self sufficiency of key crops and increasing farmer income. But successful innovation needs the right policies, infrastructure and market structure.

Additionally, promoting crossfertilisation of knowledge and capabilities can drive new, innovative business models and attract investment. The chal-

lenges are enormous, but the opportunity the sector presents is both substantial and achievable. The following steps can be initiated for successful innovation: ● Establish a framework to take to market successful research projects developed at public institutes; ensure concerned scientists get commensurate benefits ● Increase R&D spend for public institutes; revisit existing R&D allotment methodology to ensure a critical mass for effective research ● Develop models to encourage public-private partnerships; transfer any IP generated from such partnerships to the concerned private player ● Allow private players to use underutilised public laboratories by paying a rent

India clearly lacks an informed debate on the benefits of biotechnology techniques in agriculture. The current opposition to GM is largely due to the lack of understanding of the technology by a certain group of people or service fee ● Facilitate pooling of private investments for effective R&D utilisation; create a mechanism to enable private players to jointly share investments, risks and benefits ● Develop a framework for sharing licensing fee/trait fee

in a transparent manner

Targeted initiatives Of late, the bio agriculture sector has been in the news for all the wrong reasons controversies and growing opposition to GM seeds.

In India’s case, this has

been exacerbated by the lack of dissemination of science-based information to all stakeholders to enable them to engage in an objective and transparent debate.

The following steps can be initiated: ● Develop a strategic plan for public communication to improve understanding of biotech and its products ● Work toward achieving public support and consumer acceptance for biotech enabled agriculture products ● Spread awareness of the use and benefits of biotech among farmers, form official groups for farmers to ensure their views and concerns are adequately represented, take initiatives to cater to farmers’ need for funding such as providing low-interest loans for purchase of equipment

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RESEARCH RESEARCH UPDATE

Testosterone therapy not a cure for men's infertility Though testosterone is a treatment for low libido and taking replacement testosterone may increase a man's sex drive, it's not a direct treatment for erectile dysfunction

WHEN MEN are young, testosterone tends to get a bad rap, often blamed for aggressive and overly competitive behaviour.

But as men get older, the bad rap continues, though for a different reason. In older men, it's low testosterone that has captured attention. Testosterone, the male hormone, plays a vital role in many body functions, and low testosterone levels can leave men tired, uninterested in sex, infertile and with thinning bones, according to the US National Library of Medicine.

It's also a fairly common problem in older men. As many as four in 10 men older than 45 have lower than normal levels of testosterone, according to the American Urological Association. But, replacing lost testosterone isn't a panacea, despite what one might have seen on TV. "There's been a lot of advertising, and every guy that comes in now asks about testosterone," said Dr Ryan Terlecki, a urologist at Wake Forest Baptist Medical Center in WinstonSalem, NC “They've been led to believe that it's a fountain of youth, but it's not a cure-all.”

For example, many men hope that testosterone therapy will help treat erectile dysfunction. But, Terlecki said that though testosterone is a treatment for low libido and taking replacement testosterone may increase a man's sex drive, it's not a direct treatment for erectile dysfunction. Testosterone replacement also isn't an option for men who want to preserve their fertility. That's because when a man takes testosterone

34 EXPRESS PHARMA February 1-15, 2014

therapy, the testosterone receptors in the body tell the brain that there's enough testosterone, and, in turn, the brain signals the testes to stop producing sperm.

Terlecki said it's possible that sperm production could return to normal levels after testosterone therapy is stopped.

But there's no solid evidence that it will, so doctors prefer to err on the side of caution if a man believes he might still want to have children. Men who have active prostate cancer or male breast cancer also aren't candidates for testosterone therapy.

However, other men with symptoms of low testosterone may want to consider it. For starters, that includes men who “might notice a drop in energy and low libido,” Terlecki said.

Dr Steven Canfield, Chief of Urology at the University of Texas Health Science Center at Houston, said that symptoms of low testosterone that men might notice also include “the

development of breast tissue, a loss of body hair, small or shrinking testicles, no need for shaving, flushing, sweats and bone loss.” But, he said, there are less specific symptoms, too.

Men with low testosterone might also notice "a decrease in self-confidence, feeling sad or depressed, problems with sleeping, memory problems, reduction in body mass, and a decrease in work performance," Canfield said.

All it takes to tell if a man's testosterone level is low, he said, is a simple blood test. Although low testosterone is common in older men, it's not necessarily a normal part of ageing. Other conditions that are common with ageing, such as obesity or depression, can cause lower levels of testosterone, according to research presented at the Endocrine Society meeting in Houston this year. Canfield said that testosterone levels can drop if testicular tissue is lost, which can happen with age. And

Terlecki said that prior testicular trauma, undescended testicles and radiation treatment to the testicles also can cause lower testosterone levels. Testosterone levels can drop because of a pituitary tumour, though that's rare, he said. And some medications, such as narcotics, can also lower testosterone levels. Several options exist for treating low testosterone. For men who want to keep their fertility, Terlecki said, the drug clomiphene can be prescribed.

In men for whom that's no longer an issue, testosterone replacement therapy can boost testosterone levels. Options for testosterone replacement, Canfield said, include injections, patches, a gel and implantable pellets. He said that a pill form of testosterone is available in other parts of the world, but not in the US. Injections are given once every two weeks, Terlecki said.

The downside to this option is that injections provide a large

dose of testosterone in the beginning but it drops fairly quickly. Topical formulations, such as testosterone gel, are put on in the morning and absorbed within two to six hours and, if used consistently, provide a steady consistent dose of testosterone. "But, men have to remember to do it," Terlecki said.

"And, they have to wait while the gel dries. It may leave the area feeling a little tacky."

Also, it's important not to expose children, pregnant women or women who may become pregnant to the testosterone on the skin because it can alter their hormonal balance. Patches can provide a longer-term steady dose of testosterone, but they may cause irritation, Terlecki said. And implantable pellets, according to Canfield, can provide a steady, long-acting dose of testosterone. They're injected just underneath the skin on your backside during an outpatient office procedure.

This option is becoming increasingly popular because it lasts for four months and generally is inexpensive, Terlecki said.

Risks of testosterone therapy include an increase in the size of the prostate, water retention, worsening sleep apnea, a lower sperm count and an increase in the platelet count, which could increase the risk for blood clots, according to Canfield.

"The most important thing men need to know is that testosterone therapy isn't a substitute for taking care of overall health," Terlecki said.

EP News Bureau – Mumbai

Promising new biomarkers linked to early diagnosis of breast cancer Studies show new methods for early diagnosis of breast cancer and prediction of its spread TWO NEW papers in the "Advancing Women's Health" issue of Clinical Chemistry, the journal of AACC, show for the first time that measuring the amount of certain protein fragments and microRNAs in a woman's blood and breast tissue might enable the early diagnosis of breast cancer or prediction of its metastasis, respectively. Cancer is the second leading cause of death in both men and women in the US. However, women have a higher chance than men of being diagnosed with cancer before the age of 60 due to breast cancer development. Metastases in breast cancer's later stages cause the majority of deaths associated with the disease, making early detection crucial to patient survival. Testing for the right biomarkers, biological molecules whose presence

indicates a disease could increase survival rates more than current screening methods such as mammography. Until recently, however, scientists have discovered disappointingly few useful cancer markers.

A team of researchers led by Ye Hu, PhD, of Weill Cornell Medical College of Cornell University, New York, has discovered several promising new biomarkers that could revolutionise the way breast cancer is diagnosed. In their paper, they show that levels of the enzyme carboxypeptidase N (CPN) are higher in breast cancer tissue than in healthy tissues.

This enzyme produces six protein fragments, or peptides, that then enter the bloodstream.

Hu's team found that a rise in blood concentrations of these six peptides strongly correlates with in-

creases of CPN, which in turn indicates the presence of breast cancer. "Our results represent a first demonstration, to our knowledge, that clearly links the proteolytic activity of CPN, particularly at tumour sites, to the cleavage patterns of its catalytic substrates in the blood," said Hu. "These biomarkers show strong potential for the noninvasive and early diagnosis of breast cancer.

We advocate their use certainly to be detected and identified before metastasis, and perhaps even before the tumour presents with any observable characteristics commonly used in the clinic."Another research team headed by Evi Lianidou, PhD, of the University of Athens, Athens, Greece, set out to address the current inability to predict at the time of breast cancer diagnosis whether a

patient will experience a relapse or metastasis. Many recent studies have shown that microRNAs (miRNAs), a type of molecule that turns genes on and off, can play a critical role in the metastasis process. Upon examining this further, Lianidou's team found that breast cancer patients who experienced quick relapses tended to have high and low levels of the microRNAs miR-21 and miR-205, respectively, in their tumour tissue. The team also discovered a connection between low levels of miR-205 and reduced overall survival. Testing for these miRNAs or CPN-catalysed peptides in early or potential breast cancer patients could ensure that women at risk of metastasis receive life-saving preventative treatment.

Eylea injection and the new combination treatment is to treat wet age-related macular degeneration (wet AMD) - the leading cause of blindness in the elderly. "Given the multifactorial nature of wet AMD, there is a potential for additional benefits to patients by addressing different pathways responsible for this devastating condition", Bayer HealthCare global develop-

ment head Kemal Malik said.

Regeneron will hold marketing rights to the drug in the US, while Bayer will have rights outside the US. The two companies will split the profits from outside the US. Regeneron is eligible to get up to $40 million in option and milestone payments once the drug is approved. AMD is a chronic condition that requires visually impaired pa-

ARQULE SAID an independent committee recommended a late-stage study of the company's cancer drug continue with a lower dose, months after liver cancer patients who received a greater dose showed a higher incidence of a blood disorder.

A lower dose of the company's drug, Tivantinib, reduced the incidence of a low white blood cell count,

EP News Bureau – Mumbai

Regeneron,Bayer to co-develop Eylea combination treatment US BASED-REGENERON Pharmaceuticals and Germany's Bayer AG said they would co-develop an antibody for use in combination with Eylea, their treatment for a form of age-related blindness.

Bayer's unit, Bayer HealthCare, will pay Regeneron $25.5 million upfront and share global development costs for the program, the companies said. Both the

Panel favors continuation of ArQule liver cancer drug study

tients to make monthly visits to the clinic. Since its launch in late 2011, Eylea has become one of the fastest-growing medicines in the history of biotechnology, grabbing market share from rivals such as Roche AG's Lucentis. Bayer and Regeneron are also collaborating on the development of Eylea

ArQule said citing a recent review of safety data. The drugmaker and its partner Daiichi Sankyo are testing the drug as a treatment for patients with previously treated hepatocellular cancer, the most common type of liver cancer. A data monitoring committee recommended last September that the drug's dosage be reduced from 240 mg twice daily to 120 mg, and that patients be monitored to confirm the safety profile of the lower dose. The drug, however, failed to show statistically significant improvement in overall survival in another late-stage trial on patients suffering from a type of lung cancer, ArQule said.

Reuters

Reuters

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February 1-15, 2014

RESEARCH

Drug combination effective for blood cancer in older patients A new combination of drugs might prolong life in certain older leukemia patients, a new study suggests

GERMAN SCIENTISTS report obinutuzumab-chlorambucil combination improved outcomes for the older chronic lymphocytic leukemia patients better than two other treatment options. The research, led by German scientists, included nearly 800 older people (average age 73) who had been diagnosed with chronic lymphocytic leukemia (CLL). CLL is a cancer of the blood and bone marrow, the tissue inside bones in which blood cells are created. The study was published online January 8, in the New England Journal of Medicine. Study participants none of whom had received treatment for their illness before the start of the research were randomly assigned to one of three groups.

One group received an oral medication called chlorambucil (also known by the brand name Leukeran), the standard chemotherapy drug for older patients with CLL. The second

group received chlorambucil plus a drug called rituximab (Rituxan). This drug has been used effectively in combination with other forms of chemotherapy for more than a decade to treat younger, fitter patients with CLL, an expert said. The third group received chlorambucil plus a new antibody drug called obinutuzumab. The rituximab and obinutuzumab were given intravenously. The researchers, whose study was funded by the manufacturer of both obinutuzumab and rituximab, reported that the obinutuzumab-chlorambucil combination improved outcomes for the older CLL patients better than the other two treatment options.

The most common side effects for obinutuzumab are infusion reactions, low blood cell counts, fever, cough and musculoskeletal disorders, according to the manufacturer's website.

Dr William Wierda, a professor

in the department of leukemia at the University of Texas MD Anderson Cancer Center, said older patients don't tend to tolerate intensive chemotherapy with rituximab as well as younger patients. That has left older CLL patients with limited drug options, including chlorambucil, he said. "We've been wanting to find a treatment that is effective and well tolerated in the elderly population," said Wierda, who was not involved with the new research. "A standard treatment for older patients with CLL has been chlorambucil, a type of chemotherapy that's been used for many years."

"The trial shows improvement in outcome remission rates and duration favoring patients who got chlorambucil and obinutuzumab," he said. "This was a head-to-head comparison of the two antibody arms of the study the rituximab and the obinutuzumab and obinutuzumab won out."

There also was an improvement in overall survival among the patients who received the obinutuzumab-chlorambucil combination treatment versus those who received chlorambucil alone, Wierda said. Leukemia strikes both men and women, and the cause is unknown. In 2013, there were nearly 16,000 new cases of CLL diagnosed in the US, according to the American Cancer Society. Statistics from the US National Cancer Institute show the five-year survival rate for CLL is about 83 per cent. Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society, said, "Chronic lymphocytic leukemia has been an incurable disease that has typically manifested in patients who have a median age of 72." Greenberger said elderly

patients can't tolerate the most aggressive treatment therapies due to other health issues, so this study is good news. "This focuses on a very significant improvement in therapy for elderly people with CLL," he said. "It could become the new standard of care for elderly patients.

That's very exciting news for these patients." Although the study results are positive, Greenberger cautioned that the new drug cocktail is not a cure.

It only delays the progression of the disease. "But there are many other therapies for CLL in development," Greenberger said. One drug in particular, called ibrutinib, which is currently in phase 3 drug trials, is showing great promise, he said.

EP News Bureau – Mumbai

Auxilium drug to treat bent penis condition gets FDAnod US HEALTH regulators approved Auxilium Pharmaceuticals’ Xiaflex injections to treat a condition that causes a painful curvature of the penis called Peyronie's disease. It marks the second US approval for Xiaflex, which in 2010 received a Food and Drug Administration nod to treat Dupuytren's contracture a condition in which hardening of the connective tissue collagen in the hands bends fingers toward the palm, leaving a patient un-

36 EXPRESS PHARMA February 1-15, 2014

able to straighten their hand or use their fingers properly.

Xiaflex is now the first FDA-approved non-surgical treatment option for men with Peyronie's disease who have a plaque buildup in the penis, the agency said. The drug is injected directly into the collagen buildup to break it down in order to help restore normal function to the penis or hands.

Cowen and Co is forecasting that Peyronie's approval will add

$100 million to annual Xiaflex sales by 2018. Treatment for Peyronie's would consist of a maximum of four treatment cycles, the FDA said. Each treatment cycle consists of two Xiaflex injections directly into the collagen-containing structure of the penis, and one penile modeling procedure a massaging of the treated area by a health care professional to help further break down the plaque or scar tissue. In clinical trials, Xiaflex

significantly reduced penile curvature deformity and related bothersome effects compared with a placebo, the FDA said. A potential serious side effect of treatment with Xiaflex is penile fracture - a rupture within the penile shaft. As a result, a condition of the approval is the implementation of a Risk Evaluation and Mitigation Strategy (REMS).

The REMS requires participating health care professionals

to be certified by completing training in the administration of Xiaflex for Peyronie's disease.

The REMS also requires health care facilities to ensure that Xiaflex is dispensed only for use by certified health care professionals, the FDA said. The most common adverse reactions associated with Xiaflex for Peyronie's treatment include penile bruising, swelling and pain.

Reuters

RESEARCH

FDAapproves Mekinist in combination with Tafinlar

Gene therapy offers promise for Parkinson's disease

Melanoma is the most aggressive type of skin cancer

THIS WEEK the US Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).

In May 2013, the FDA approved both drugs as single agents to treat patients with unresectable or metastatic melanoma. Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease. The National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma and 9,480 would die from the disease in 2013. Mekinist and Tafinlar are used to block signaling in different sites of the same molecular pathway that promotes cancer cell growth.

They are specifically indicated as a combination therapy for patients with melanoma whose tumours express gene mutations called BRAF V600E and V600K. The BRAF protein is involved in the regulation of normal cell growth, but it is mutated in approximately half of melanomas arising from the skin.

“Mekinist and Tafinlar are the first drugs approved for combination treatment of melanoma,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research. “Their development for combination use is based on the strong understanding of the biological pathways of the disease. This approval illustrates the value of continuing to study drugs in combina-

tion for clinical development.”

The safety and effectiveness of Mekinist in combination with Tafinlar were demonstrated in a clinical trial of 162 participants with unresectable or metastatic melanoma with the BRAF V600E or V600K mutation, most of whom had not received prior therapy. Participants received either Mekinist in combination with Tafinlar or Tafinlar as a single agent until their melanoma progressed or side effects became intolerable. Results showed that 76 per cent of participants treated with Mekinist in combination with Tafinlar had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. In contrast, 54 per cent of participants treated with Tafinlar as a single agent experienced objective responses that lasted an average of 5.6 months. Clinical trials are ongoing to determine whether Mekinist in combination with Tafinlar improves survival.

The most common side effects reported in participants receiving Mekinist in combination with Tafinlar included fever, chills, tiredness, rash, nausea, vomiting, diarrhoea,

abdominal pain, peripheral edema (swelling in the hands and feet), cough, headache, joint pain, night sweats, decreased appetite, constipation and muscle pain. During clinical testing, the incidence and severity of fever increased when Mekinist was used in combination with Tafinlar.

One of the serious side effects of Tafinlar—the development of a new squamous cell carcinoma of the skin was reduced when the drug was used in combination with Mekinist; this is consistent with the biology of the effects of these two drugs on the targeted molecular pathway. The incidence of squamous cell carcinoma of the skin in this trial was seven per cent with the combination compared to 19 per cent with single agent Tafinlar. Other clinically significant side effects include kidney injury. Women of child bearing potential should be advised that Mekinist and Tafinlar can cause birth defects in a developing fetus.

Men and women should also be advised that Mekinist and Tafinlar treatment may cause infertility.

The FDA approved the combination of Mekinist and Tafinlar under the agency’s accelerated approval program, which allows the FDA to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

EP News Bureau – Mumbai

A NEW, preliminary treatment involving triple-gene therapy appears safe and effective in helping to control motor function in Parkinson's disease patients, according to new research. The therapy, called ProSavin, works by reprogramming brain cells to produce dopamine, the chemical essential for controlling movement, the researchers said. Lack of dopamine causes the tremors, limb stiffness and loss of balance that patients with the neurodegenerative disease suffer.

"We demonstrated that we are able to safely administer genes into the brain of patients and make dopamine, the missing agent in Parkinson's patients," said researcher Kyriacos Mitrophanous, head of research at Oxford BioMedica in England, the company that developed the therapy and funded the study. ProSavin also helps to smooth out the peaks and valleys often produced by the drug levodopa, the current standard treatment, Mitrophanous said. The treatment uses a harmless virus to deliver three dopamine-making genes directly to the area of the brain that controls movement, he explained. These genes are able to convert non-dopamine-producing nerve cells into dopamineproducing cells. Although the study results are promising, the researchers suggest they should be "interpreted with caution" because the perceived benefits fall into the range of "placebo effect" seen with other clinical trials. Hoping to improve on their results, the researchers have since re-engineered the therapy. "We have a new version which makes more dopamine in patients, and this new version is undergoing safety studies before we initiate trails in patients," he said.

Experts reacted positively but cautiously to the findings,

which were published online Jan. 10 in The Lancet.

"The ProSavin study was a positive and important first step for a potential gene therapy for Parkinson's disease," said Dr Michael Okun, national medical director at the National Parkinson Foundation.

"The results of this preliminary study revealed a promising safety profile, and it will be interesting to observe longerterm benefits and how ProSavin will compare to other therapies such as deep brain stimulation."

Mitrophanous thinks this new treatment will eventually outperform deep brain stimulation or levodopa. Patients can then try deep brain stimulation, which involves putting wires into the brain that are attached to a battery pack, Mitrophanous said. "With our approach, the brain cells are permanently modified to make their own dopamine, so you wouldn't have to rely on external stimulation," he said. "But the hope is that we would give patients an additional five years before the disease progresses further," Mitrophanous said. "If you imagine you get five to 10 years of good control of symptoms with levodopa, we hope we would lengthen that. An extra five years, maybe longer, would be a real benefit to these patients," Mitrophanous said.

Dr Andrew Feigin, a neurologist at the Movement Disorders Center of the Cushing Neuroscience Institute in Manhasset, NY, said the study adds to growing evidence that "gene therapy for Parkinson's disease can be undertaken in a safe and well-tolerated manner." But the findings can't be considered conclusive because the trial did not include a placebo or sham procedure, he said.

EP News Bureau – Mumbai

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February 1-15, 2014

PHARMA ALLY INSIGHT

Desktop virtualisation — Bringing business advantages to pharma sector Nilesh Goradia, Head-PreSales, India Subcontinent, Citrix explains the importance of desktop virtualisation and highlights how it can serve as time saving solution for pharma sales executives PHARMACEUTICAL COMPANIES are increasingly facing the pressure to safeguard research data, sensitive information and staying ahead of their competitors. In this scenario, many companies are adopting technologies to address the challenges and meet business objectives. One of the technologies that see mainstream adoption among pharmaceutical companies is Desktop Virtualisation. It is a natural technology evolution to deliver high value, high performance end-user computing that is simple to consume and optimised for operational efficiency. To ‘dejargonise’ the concept, the applications and user data is hosted in the data centre and decoupled from the endpoint rendering it as a mere access point for users. So the user gets the same experience as his original PC terminal, but the data is secure in the data centre with no transactions happening at the end point devices and no data being stored there.

Due to the inherent advantages carried by desktop virtualisation, many of the challenges faced by pharma companies gets automatically addressed through the adoption of this technology.

Protection of IP Pharma companies have a lot of sensitive data such as research material, patent document etc and it is supremely critical to protect them. A key concern area for IT managers in pharma companies is how to deal with data leakage at endpoints. This is underpinned by a growing concern over compliance, driven by a growing desire to prevent data loss and more

38 EXPRESS PHARMA February 1-15, 2014

stringent data access requirements. Desktop virtualisation provides a compelling answer to both these issues. As the user data resides in a centrally controlled datacentre as opposed to being stored on thousands of distributed end-points, users are disarmed to save any data on their devices. But not at the price of reduced flexibility! An organisation can most definitely allows users to bring their own mobile devices to work; all of which will serve as mere access points while the data is still centrally secured. This tantamount to mitigated security risks at the endpoint coupled with tighter controls centrally managed inside the data centre. Even if the mobile device gets stolen, IT will be able to remove sensitive information from the device remotely.

Anywhere anytime Access Pharma field representatives are constantly on the go.

During their visits to doctors, they need to be constantly updated on order and delivery information even when they are not in the office. Desktop virtualisation enables to work with data from anywhere, thereby enabling real-time access. Field representative would be able to log in orders faster and sales order management becomes streamlined. Another advantage is that the representatives can use their own mobile devices and tablets for the work.

Pharma companies are welcoming this trend because their representatives can become more productive without the company having to incur extra costs for such devices. With IT becoming increasingly con-

sumerised and businesses now

ice. It gives mobility a new

cation in all devices manually, which results in loss of productivity and time. Through desktop virtualisation, applications can be centralised and delivered seamlessly to the end points as and when required. The IT team is saved from installing the applications in all the devices. In case of an application upgrade, the application can be updated centrally and the changes will simultaneously be reflected in all devices.

Mobile device management

operating in a heterogeneous mobile environment; security is emerging as a big issue. Desktop virtualisation is a solution to both these issues as it empowers organisations to adopt mobile workstyles but at the same time, secures enterprise data on these mobile devices by storing it only on the central server.

Easy accessibility to desktops Pharma sales executives get very limited time to interact with physicians and a lot of time gets wasted if an executive uses a laptop or tablet to access company data from outside locations. Today’s sales executives require company data accessibility on the move, delivered on demand, without being in the confines of an organisational network. This can be made possible through desktop virtualisation that makes available desktops on demand as a serv-

meaning where you aren’t just accessing corporate emails but are being able to have the same office desktop experience on your mobile device and tablets.

Once, the user has authenticated himself on his mobile device and has logged in, his personal desktop is delivered to him on his mobile device (with his original personal settings, access rights, privileges). As a result, desktop virtualisation has emerged as one of the most preferred technologies among sales executives in the pharma segment.

Application delivery There is a large number of agents who require heavy usage of applications and the IT team needs to install each application in every device individually. The situation becomes all the even worse when these applications need to be updated. The IT team has to update each appli-

Pharma companies have a large workforce who access corporate information from their mobile devices, hence managing these devices becomes an issue.

MDM (Mobile Device Management) solution enables the IT team to manage corporate data in the employee’s mobile devices, hence even in the event of the device getting lost or stolen, the corporate data can be wiped off remotely. The solution provides identity-based provisioning and control for all apps, data and devices, policy-based controls, such as restriction of application access to authorised users, automatic account deprovisioning for terminated employees and selective wipe of apps and data stored on lost, stolen or out-of-compliance devices.

Thus we can see in the era of mobile workstyles, pharmaceutical companies are highly dependent on technologies that can aptly address their business challenges and desktop virtualisation is turning out to be a mainstream technology which can address the industry imperatives.

PHARMA ALLY VENDOR NEWS

Lonza extends partnership with Pharmacyclics To support manufacturing of recently approved oncology therapeutic, Imbruvica

LONZA ESTABLISHED an agreement with Pharmacyclics, to support the commercial and clinical production of its first-in-class oral oncology drug, Imbruvica (Ibrutinib).

This agreement follows a successful multi-year partnership, including the development and clinical manufacturing, which was utilised for Pharmacyclics’ NDA submission and now first FDA approval of their lead product for oncology treatment. Under the long term agreement, Lonza will continue to support the production of commercial and clinical material.

Pharmacyclics received final FDA approval of Imbruvica on November 13 2013 for

the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Imbruvica is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signalling complex that plays an important role in the survival of malignant B cells.

Imbruvica blocks signals that tell malignant B cells to grow and divide uncontrollably. It has been granted three breakthrough therapy designations by the FDA, a first for an oncology drug.

These designations are intended to expedite the development and review of drugs for serious or life-threatening

Imbruvica is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK).

BTK is a key signaling molecule of the B-cell receptor signalling complex that plays an important role in the survival of malignant B cells conditions. To date, nine phase III clinical trials have been initiated with imbruvica and 38 clinical trials are currently registered on www.clinicaltrials.gov.

“We are proud to support Pharmacyclics through both clinical and commercial supply of their breakthrough oncology drug,” said Dr Stephan Kutzer, Chief Operating Offi-

cer Lonza Pharma and Biotech. “This extended partnership is an example of Lonza’s commitment to our client’s complete product life cycle and our dedication to the advancement of potentially life-saving treatments like imbruvica.”

“Our multi-year partnership with Lonza helped us rapidly move imbruvica from clinical development to our first FDA filing”, said Heow Tan, Chief of Quality and Technical Operations at Pharmacyclics.

“Based on this successful collaboration, we are pleased to announce the partnership with Lonza, in support of both our clinical and commercial supply.”

EP News Bureau-Mumbai

GE acquires strategic assets from Thermo Fisher Extends bioprocessing manufacturing footprint in Asia, the Americas and Europe Thermo Fisher Scientific entered into an agreement for GE Healthcare to acquire Thermo Fisher’s HyClone cell culture media and sera, and gene modulation and magnetic beads businesses for approximately $1.06 billion. The acquisition will allow GE to expand its offering of technologies for the discovery and manufacturing of innovative new medicines, vaccines and diagnostics in its growing Life Sciences business.

The complementary product offerings and strong strategic fit of the acquired businesses will enable GE Healthcare to expand and accelerate the development

of innovative “end-to-end” technologies for cell biology research, cell therapy and for the manufacture of innovative biological medicines and vaccines.

The acquisition is consistent with GE’s strategy to invest in high-technology, innovative businesses that deliver strong topline growth and expanded margins. GE’s acquisition of the businesses, which is subject to regulatory approvals, is anticipated to close in the first part of 2014. John Dineen, President and Chief Executive Officer, GE Healthcare said, “Life Sciences is one of our strongest and fastest-growing business areas,

driven by the world’s demand for improved diagnostics and new, safer medicines. Combining GE’s engineering expertise with our capabilities in life sciences is already bringing great benefits to industry, research and patients. This deal makes a good business even better and will help us realise our vision of bringing better healthcare to more people at lower cost.”

GE Healthcare will also acquire Thermo Fisher’s gene modulation technologies, which strongly complement GE’s established technologies for drug discovery research, and the innovative Sera-Mag magnetic

beads product line, which extends GE’s existing technologies in protein analysis and medical diagnostics.

Kieran Murphy, President and Chief Executive Officer, GE Healthcare’s Life Sciences division said, “We look forward to the HyClone cell culture and other businesses joining the GE family. They are a great fit with our key areas of focus, and bring exciting new technologies, enhanced manufacturing capabilities as well as a great group of talented people to help grow our business.” “In addition to providing us with new approaches to drug discovery and biomedical

research,” Murphy said, “This acquisition is a significant step forward for our customers in biopharmaceutical manufacturing. They will benefit immediately from an expanded range of “start-to-finish” technologies that will help them improve product yields and reduce timeto-market. By expanding our production facilities to three continents, we will be able to offer the biopharmaceutical industry greater confidence in the security of supply of cell culture media and sera, a key part of their production process.”

EP News Bureau-Mumbai

EXPRESS PHARMA

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February 1-15, 2014

PHARMA ALLY PRODUCTS

Labtop instruments launches Laminar air flow cabinet LABTOP LAMINAR air flow cabinet is a carefully enclosed bench designed to prevent contamination of semiconductor wafers, biological samples, or any particle sensitive device. The cabinet is made of mild steel or stainless steel. These laminar airflow units are used for applications such as tissue culture, media preparation, sterile handling, PCR sample preparation and many more.

Labtop laminar flow chamber exist in both horizontal and vertical configuration. These laminar air flows are widely used in pharma industries, hospitals, manufacturing facilities, blood banks and research centres.

direct drive highly efficient centrifugal blower to provide adequate air flow over the entire surface of HEPA filter.

These are directly coupled to an inbuilt motor and operate with minimum noise level i.e. lower than 65 db on scale and vibration less than 2.5 um.

Laminar flow cabinets may have a UV-C germicidal lamp to sterilise the cabinet and contents when not in use.

Construction All laminar flow clean air cabinets are basically constructed with an outer body of mild steel duly powder coated. The inner work table is made of stainless steel. The front of the cabinet is provided with motorised glass door which is very easy to use.

The micro controller controls the ON/OFF for blower operation, UV germicidal light, fluorescent light, and mains. A high quality air velocity sensor helps in sensing the actual air

Air flow and filtration

flow in FPM. This microprocessor warns for any deviations in the air velocity from normal velocities.

Blower motor assembly Dynamically balanced,

Laminar air flow principle involves double filtration of air. Atmospheric air is drawn through pre filter and is made to pass through highly effective HEPA (High Efficiency Particulate Air) filters having efficiency rating as high as 99.99 per cent with cold DOP and 99.97 per cent with hot DOP, thus retaining

all airborne particles of size 0.3 micron and larger.

Contact details Byju George, Director, Labtop Instruments Labtop House, Plot No. 59, Opp. Amarson, Waliv Phata, Sativali Road, Vasai (E), Dist – Thane - 401 208 Maharashtra Tel: +91 250 6457 376 - 99 (24 Lines) Email: byju@labtopinstruments. com Web: www.labtopinstruments. com NB: Specifications are subject to change without prior notice.

Heat sealing equipments Vacuum with gas purging/flushing

Adapted to vacuum packing and gas flushing Good sealing pressure 1, 2 or 3 vacuum pipes

Aluminium bag sealing machines suitable for pharma and food industry.

MSB11 M (bi active 10 mm) Sealing width of 10 mm Double sealing: front and back bars heating

MSB11 P ID (Impulse Driver) Pneumatic sealing machine Good sealing pressure Ergonomic Adjustable and swiveling sealing head Applications: thick liners, clean room environment

MSB11 MVI

40 EXPRESS PHARMA February 1-15, 2014

MSB11 M (bi active 10 mm)

Impulse driver Pneumatic sealing machine

MSB11 P ID (Impulse Driver)

Double impulse sealing 10 mm

MSB11 MVI

Sealing temperature regulation

Contact details For technical specifications and more details please contact: Nilesh Phadnis - Director ACCURA PHARMAQUIP Plot No B-16, TTC Industrial Area, MIDC, Digha, Navi Mumbai - 400 708 Maharashtra, India.

Tel: +91 22 2779 1333 /0334 Email: nilesh.phadnis@accurappl.net Web: www. accurappl.net NB: Specifications are subject to change without prior notice.

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4($( E(#(6","#$ .+('$%'"/ %# 1 2@; V;I1 (+" !"/%6#"! $) "#/=+" $)$(9 %#$"6+%$<7 /"'=+%$< (#! &(/$"/$ +"$+%"J(9 )& !($(W

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Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

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PHARMA LIFE

TRACKING THE RIGHT

TALENT Identifying and grooming the right talent has been an uphill task for the biotechnology industry in India

BY SACHIN JAGDALE

O

ver the years, biotechnology industry in Indiahas become more application oriented. The changed approach has made it necessary to look for a workforce that is not just academically well qualified but also multi-skilled. With this new criteria, tapping the right talent has become more challenging.

However, biotech players are well aware of the developments in the industry and have their own plans and methods to sail through this changing scenario.

Current trends Though finding a candidate who would fulfill all the requirements of a biotech company is considered a difficult task, nowadays, social media has become a platform to search for the right recruit for a company. “As in any other industry, social media has changed the hiring landscape in the biotech industry too. For mid-level and senior level positions, Linkedin is one of the best options. At the entry level, we prefer interns from Biotech Consortium India Ltd. (BCIL). Here talented people are screened and can be trained,” says Anu Acharya, Chief Executive Officer, Mapmygenome.

Satish Khanna, Former Group President, Lupin-India and Director , Valmax Corporate Service informs, “Just like any sector, even biotech sector has two levels of hiring, the entry level and the mid-senior management level. In case of entry level hiring, recruiters prefer candidates with educational background in bio-sciences (microbiology, biotechnology, biochemistry and so on).”

Khanna adds, “These candidates usually are for the R&D

60 EXPRESS PHARMA February 1-15, 2014

teams of the company where academic excellence in bioscience is given highest preference. However, modern day employers seek more skills in the candidate that go beyond the academic skills. Unfortunately, Indian courses till date do not sharpen candidates’ managerial skills or skills to apply acquired knowledge in real life market scenarios. Even teachers are not updated about the current trends and developments of the industry to share it with their students. Some top institutes have realised this gap and have started upgrading their curriculum as per the need of the recruiters but the proportion of skilled talent is still very less.

This is one of the reasons that employers have started giving preference to students who have US or European degrees as they have an extra edge over Indian candidates.”

Khanna also pointed out that realistically 100 per cent recruitment of students with international qualification is not possible and thus every batch of new recruits is usually a blend of students from Indian and international institutes at the entry level. He informs, “When it comes to mid and senior level designations, most of the biotech companies prefer professionals who have worked in the US or European environment and are willing to relocate to India. ”

In quest of talent Locating talent needed for different branches of biotech, that too in different regions of the country, is an uphill task for biotech recruiters. Acharya explains, “Locating talent with perfect match of skill sets is not easy, given the number of subdomains, platforms, and technologies available. Entry-level people often take quite some time to fit in, and people with one to two years experience also require thorough grooming.”

Though multi-skilled candidates are the preferred choice for any biotech company, finding a complete package is a rare

phenomenon. However, in many instances, companies have an array of roles where each candidate might require different skill sets. In such cases, company management can employ a mechanism wherein exchange of skills among employees can be facilitated.

According to Khanna, in India, qualified talent is available in abundance but is difficult to find. He points out that students have a strong academic background but lack skills to apply knowledge in real life market scenario. Khanna says, “The entire pool of talent cannot comprise candidates with international degrees or from top institutes of the country. Thus, the pool of the talent in any team is typically a blend of students from Indian and international institutes where the skilled talent helps in training the rest of the team by sharing knowledge.

In-house activities and workshops are also conducted on a regular basis by many companies to create a skilled labour force. Companies nowadays are taking proactive approaches to facilitate this process, as business management does boil down to talent management.”

Tie ups with educational institutes Educational institutes are perhaps the most apt places for sourcing the necessary workforce. Grooming a newly recruited employee to become a productive contributor to the company is an expensive process. It also consumes precious time of the company and its management. If a company ties up with a biotech institute and starts training selected candidates in practical applications, it might save on extra expenses and time, both at the company and industry level.

Acharya opines, “Adopting and recruiting happens in research. Most universities have incubators where students are adopted and their knowledge is of value. Funding is not always easy because biotech ed-

The modern day employers seek more skills in the candidate that go beyond the academic skills Satish Khanna former Group President, Lupin-India and Director Valmax Corporate Service

As in any other industry, social media has changed the hiring landscape in the biotech industry too Anu Acharya Chief Executive Officer, Mapmygenome

ucation is expensive. Also, project methodology doesn't work as not every company follows the trending technology. This can leave many students disheartened.”

“This trend is not restricted to just the biotech industry.

Progressive companies are doing this for other functions too, where skill-set is extremely critical to the success of business ventures,” informs Khanna.

He adds, “Companies realise that most academic institutes do not develop certain important traits among students that are required for the job, as a part of the curriculum. And thus while associating with the institute for campus recruitment they help fine-tune the curriculum that they would want the institute to include in the course. This helps

in grooming the talent as per the employers' needs. Several industries, including pharma has adopted this practice as since its assists in creating employment for the students. At the same time, companies have to spend less time training the employee once they are on board.”

The mind set for Indians educated abroad is that the conditions for employment in India is a lot better than in the US or Europe. It will be interesting to see whether this fact really applies to the Indian biotech industry.

Acharya says, “Indian biotech industry is in its golden age. India is a democracy and the private sector has a lot more freedom to flourish. However, for practical knowledge, US or Europe may be a better option, especially at the entry level.”

Khanna opines, “Well, the global slowdown has affected opportunities in US and Europe.

On the other hand Indian market is growing. This is the status currently but one cannot say that India will continue to offer more opportunities than Europe and US as this slow down could be temporary and things might change possibly in the near future. However, whatever may be the global economic situation, going forward India too will continue to offer exciting opportunities to good talent.”

Too small to offer big?

The global market share of the Indian biotech industry is around two per cent. With such minuscule presence on the world map will this industry be in a position to offer good job opportunities and better future prospects to the employees? “From global aspects, India has always been two or three per cent of the global scene of everything except for few aspects, one of that being the population,” says Khanna. He informs, “Total GDP of India compared to the world is also two-three per cent. In very rare scenarios, India has more than two or three per cent of the world’s total market share. And

the biotech industry is no exception either.

However, Indian pharma industry, including exports, is more than three per cent of the global market share, whereas biotech industry is relatively less emerged. Now that companies are shifting their focus towards R&D in biotech, the market is expected to grow and offer more opportunities, going forward.”

According to Acharya, most of the bigger organisations have global reach and diversity with multi-talented people from many countries and this is causing a reverse brain drain today.

Acharya asserts, “People from developed countries get better opportunities in India today.”

“For companies such as Mapmygenome, this means better access to the local talent pool. However, in India, background is not strong as far as genetics and natural sciences are concerned, they are better at programming. They lack understanding in current trends and basic knowledge. Personal genomics is set to open new avenues for budding biotech professionals.,” she adds.

Together we can Job aspirants, educational institutes and job providers are the three stakeholders in the process of tapping and grooming talent. To try and become industry ready is the aim of the student and it is expected that educationalists will help them to achieve this goal. To spot and offer an opportunity to such talent and groom him/her to become a part of a productive workforce should happen at the industry level. Overall, tapping and grooming talent for the biotech industry should be a collective effort. With industry experts predicting a good future for the biotech industry, such collective efforts are bound to ensure growth opportunities for not just the biotech industry but also for the job seekers. sachin.jagdale@expressindia.com

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PHARMA LIFE

APPOINTMENTS

Semler Research Center US appoints Dr Nuggehally Srinivas as the President of Specialty Pharma Dr Srinivas is a trained clinical pharmacologist and drug development specialist

SEMLER RESEARCH Centre US (SRC US) has announced its formation of a new business unit within Arnold A Semler, which also owns SRC India, and the appointment of Dr Nuggehally Srinivas as the President. Srinivas will leverage his expertise to build and develop a business strategy for the seamless execution of a Specialty Pharma vertical which will be designed to assist academics, biotechs, start-ups and VCs in evaluating investment decisions on product selection inclusive of clinical and regulatory strategy. Specialty Pharma will also focus on risk: reward sharing models with collaborating partners within the scope of the chosen therapeutic areas with differentiated products in areas such as oncology, pain/inflammation, and neurosciences among others.

Srinivas is a trained clinical pharmacologist and drug development specialist with over two decades of experience in the

pharma industry. In his most recent position, as the CEO of Vanthys Pharmaceutical Development, a JV between Eli Lilly, USA and Jubilant Life Sciences, India, Srinivas led, strategised and operationalised the virtual drug development concept of advancing compounds from a preclinical stage of development to obtain a human proof of concept.

Prior to this Srinivas has worked in senior positions at ClinTec International, Dr Reddy Laboratories and Bristol Myers & Squibb, US. Srinivas has participated in several LCM initiatives.

Srinivas was nominated as the fellow of American College of Clinical Pharmacology in 2002.

Srinivas is on the editorial board of several international journals including Journal of Clinical Pharmacology, Bioanalysis, Biomedical Chromatography, Current Pharmaceutical Analysis, Asian Journal of Pharmaceutics, Journal of Applied Biopharmaceutics and Pharmacokinetics. Srinivas has

Srinivas is a trained clinical pharmacologist and drug development specialist with over two decades of experience in the pharma industry authored over 200 research articles and reviews that encompasses areas of clinical pharmacology, metabolism/ pharmaco-kinetics, bionalysis and clinical drug development.

He has written a book entitled “Drug Development Perspectives: considerations, challenges and strategies” [HNB Publishers, New York, US].

Ronald Semler, Chairman, commented that “We are extremely delighted to have Dr Srinivas on board, since he brings strong scientific, business and operational excellence in the novel drug development space.

His contribution to the board will further strengthen our leadership and commitment in the integrated drug development area.”

Ravi Achar, Managing Director and Co-Founder, said, “Dr Srinivas brings in extraordinary skill set that encompasses drug discovery and development of novel chemical entities as well as his proven leadership and entrepreneurial skills. His exposure to virtual drug development concepts and involvement in Specialty products inclusive of 505(b)(2) concepts, would be de-

Ron Piervincenzi named next CEO of USP To assume leadership from February 1

RON PIERVINCENZI will become the Chief Executive Officer of United States Pharmacopeial Convention (USP) and chair of USP’s standardssetting body, the Council of Experts. Piervincenzi will assume these responsibilities February 1, 2014. This announcement was made

62 EXPRESS PHARMA February 1-15, 2014

by USP. “I am excited and honoured to lead USP’s mission to improve global health,” said Piervincenzi. “This is an outstanding organisation doing life-changing work around the world, and I look forward to focusing the collective energy, expertise and knowledge of

USP’s global volunteers and staff on the challenges of the future.”

Piervincenzi was a Partner and leader in McKinsey & Company's Global Pharmaceutical and Medical Products Practice for 12 years where, among other responsibilities, he launched McKin-

sey's global drug safety, medical and regulatory service line. Piervincenzi earned his MS and Ph D from Duke University in biomedical engineering with research focused on protein engineering.

EP News Bureau - Mumbai

cisive in building the Specialty Pharma portfolio. We set up SRC US as a new business unit of Arnold A Semler to take advantage of the resources and opportunities in the US. This will also establish a link to Arnold A Semler’s existing division SRC India, its leadership and scientific team to enhance our integrated value proposition to our global clients.”

Speaking on this occasion, Dr Krathish Bopanna, President and CEO, SRC, India, said, “I have known Dr Srinivas for a while and always known him for his ability to make decisions on choosing right candidates for new drug development and the investments that are required.

He is a well known clinical pharmacologist and a thought leader in this space. We are sure his addition to SRC will bring significant benefits to our current and new customers” EP News Bureau - Mumbai

PHARMA LIFE

Cipla appoints Sameer Goel as Country Head – India

D APrasanna is ACRO India’s newChairman

Sameer comes to Cipla with rich professional experience of over 26 years with GlaxoSmithKline

ACRO promotes responsible clinical research under new Chairman D A Prasanna

CIPLA, A global pharma company has announced the appointment of Sameer Goel as Country Head – India, effective 20th January 2014.

Sameer comes to Cipla with rich professional experience of over 26 years with GlaxoSmithKline. In his last assignment, he has led a USD 0.4 bn business, based out of Johannesburg, with responsibility for 44 markets in SubSaharan Africa. He was responsible for managing the full P&L in these markets with regional hubs and multiple manufacturing sites across South Africa, Nigeria and Kenya. He established Africa as a new “region” for the company, and has worked closely alongside the pharma business to establish a leadership position in this key emerging market.

Sameer played a significant role in driving the entry strategy and growth agenda across a spectrum of new and established markets. He had initiated the sales and marketing route for Indian market, where he combined sales management experience in progressively larger territories, with marketing leadership roles. In his last India-based role, he led the sales function comprising a team of direct and indirect field force of 4500. He has driven a number of initiatives including expert marketing, professional detailing force, key account management, customer marketing, rural drive, and computerisation of the distributors which won several global awards for the GSK team.

Sameer will be reporting

In his last India-based role, he led the sales function comprising a team of direct and indirect field force of 4500. He has driven a number of initiatives like expert marketing and professional detailing force

to the Managing Director and Global CEO Subhanu Saxena.

Sameer holds a graduation degree in Economics from St.Stephens College, New Delhi, and has an MBA from the Indian Institute of Management, Ahmedabad.

Speaking of the appointment, Managing Director and Global CEO, Subhanu Saxena said, “This appointment signals the continuation of Cipla's strategy of strengthening the highly experienced senior management team and to show our strong determination to increase the market share in India. Sameer brings a keen sensibility and understanding of the India market, and drivers for success in this market. This combined with his strong reputation for managing teams for stakeholders, both external and internal, makes him well placed to lead our India business into its next level of growth.”

Goel said, “Cipla has been a pioneer in the healthcare industry ensuring access to high quality and affordable medicines, thus being a support apparatus for millions of patients across the world. My first interaction with the Cipla management has been quite a memorable experience that has given me reassurance and a sense of comfort. It will be a great privilege and honour for me to be a part of the Cipla team and I look forward to an exciting journey that lies ahead of us.”

EP News Bureau - Mumbai

MEMBERS OF Association of Contract Research Organizations (ACRO INDIA) recently elected D A Prasanna unanimously as the Chairman of the Association. He took over from the previous Chairman Apurva Shah, Group Managing Director, Veeda Clinical Research.

Speaking on the appointment, D A Prasanna said, clinical research in India has contributed to bringing vaccines, drugs, devices to needy patients at affordable prices.

From neglected diseases like kala azar to tropical disease like malaria, Indian clinical research has alleviated suffering. India has made a name in the world in lowering health care costs through generics and building a reputation in development of biotech drugs and medical devices. In the last few years, clinical research has come under criticism as being unsafe and severe regulation has been imposed.

ACRO India’s priority is to promote safe conduct of clinical research without impeding the development of much needed drugs for Indian patients. ACRO India will promote global best practice to make Indian research data useful to market drugs developed in india, across the world.

As the Founder-Chairman of Ecron Acunova CRO, Prasanna has built an Indian CRO with presence in 28 countries and helped bring advanced cell therapy drugs to generic drugs to Indian and global patients. He has experi-

ence in leveraging Asian competitiveness building successful global business in medical technology for GE and software for Wipro. Considered a thought leader in life sciences, he has held global CEO positions in GE Healthcare and was Vice Chairman of Wipro.

He serves on biotechnology vision group of Karnataka government.

ACRO India founded and registered in India in 2005 has been formed under the aegis of Confederation of Indian Industry (CII) for bringing all CRO’s operating in India on one common platform. ACRO India will be used to promote quality research, uphold ethics, share best practices, promote synergies amongst members, to deliberate and act upon common concerns, specially with regard to Indian regulations and industry environment. ACRO India will represent the interests of Indian CROs to regional, national and international authorities and organisations.

EP News Bureau - Mumbai

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PHARMA LIFE

AWARD

Abbott receives Golden Peacock Innovation Management Award Award Recognises Abbott’s strong focus on fostering a culture of innovation

ABBOTT RECENTLY awarded with the prestigious Golden Peacock Innovation Management Award at the 8th International Conference on Corporate Social Responsibility held in Bangalore.

The Golden Peacock Innovation Management Award honors organisations that have successfully embedded innovation into the basic tenets of their corporate cultures demonstrated in every function of the business and its operations. The Award aims to promote a ‘culture of innovation' in

India and recognises the efforts of companies that work toward strengthening this goal.

Abbott in India received the award in recognition of the company’s strong scientific heritage and leadership in innovation, commitment to an approach that caters to patients’ evolving needs, and its focus on institutionalised innovation.

“With over 12,000 employees in India, Abbott is committed to delivering healthcare solutions that are relevant to patients and consumers while providing value to physicians

Abbott in India received the award in recognition of the company’s strong scientific heritage and leadership in innovation

through our dedication to innovation in medicine, nutrition, devices, diagnostics and our overall business,” said Bhasker Iyer, Divisional Vice President, Established Pharmaceuticals, Abbott India. “Abbott’s success in driving its innovation agenda is deeply rooted in a philosophy that focuses on achieving results effectively and impactfully for the people of India.”

Over the years, Abbott has established a strong footprint in India, with a dedicated development centre for pharma in

Mumbai and a state-of-the-art research and development centre for nutrition in Bangalore.

These centres spearhead Abbott’s innovations for Indian requirements, many of which also have global application. Local innovation is important to Abbott and its employees, who are committed to advancing revolutionary technology and delivering localised innovation, which will translate into relevant products in the Indian market.

EP News Bureau - Mumbai

CAMPUS BEAT

Biocon Academy starts flagship programme in collaboration with KGI The 16-week, full-time Biocon KGI certificate programme will be delivered by renowned faculty from KGI and Biocon Academy BIOCON ACADEMY has commenced its flagship programme, the ‘Biocon KGI Certificate Programme in Biosciences,’ in collaboration with Keck Graduate Institute in Claremont, California. The 16-week, full-time Biocon KGI certificate programme will be delivered by renowned faculty from KGI and Biocon Academy. The programme’s broadbased international curriculum encompasses R&D, Production as per GMP, quality assurance, regulatory,

64 EXPRESS PHARMA February 1-15, 2014

product development and professional skills, which will enhance the career prospects for fresh biotech graduates as well experienced biotechnologists.

Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, said, “I would like to extend a warm welcome to our first batch of students for the Biocon KGI Certificate programme. This programme will provide a unique opportunity for life sciences students to take advan-

tage of the world class advanced learning and training programme that straddles both theory and project-based learning. I am pleased to see the quality of the students who have enrolled for this programme. Biocon Academy aims to address the skill deficit and develop high-end talent that catapults the Indian biopharma sector to the next level of growth.”

Sheldon M Schuster, President, Keck Graduate Institute,

said, “KGI is known for developing innovative, highly focused educational programmes for those interested in pursuing a career in the life sciences. Built on the KGI graduate-level curriculum, the Biocon Academy-KGI certificate in bioscience is a nextgeneration offering for students who want to develop the skills they need to work in a complex, global, highly regulated industry. For potential employers, such as Biocon, the creation of this pro-

gramme means having a wider pool of life science professionals who are ready to contribute to their goals on day one.”

The academy received over 150 applications from all across India for the first batch of the ‘Biocon KGI Certificate Programme in Biosciences.'

Following a rigorous selection process, 30 students were chosen to be a part of the inaugural batch.

EP News Bureau - Mumbai

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