Express Pharma (Vol.10, No.7) February 01-15, 2015

VOL. 10 NO. 7 PAGES 72

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Cover Story Panacea Biotec: A turnaround story MANAGEMENT ‘The health industry as a whole has a positive future’ 1-15 FEBRUARY 2015,` 40

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CONTENTS ‘THE HEALTH INDUSTRYAS A WHOLE HAS A POSITIVE FUTURE’

Vol.10 No.7 FEBRUARY 1-15, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

In a free-wheeling conversation with Viveka Roychowdhury, Patrick Figgis, Global Health Leader, PwC and Sujay Shetty, Leader,Pharma and Life Sciences, PwC India, predict some of the changes that will unfold in the pharma sector in 2015 | P29

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P18: POST EVENT

Senior Artist Rakesh Sharma

Vibrant Gujarat 2015 notches 201 MoUs worth ` 5000 crores in pharma sector

Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P32: INSIGHT Issues and trends in the Indian pharma industry

P35: INSIGHT Recent surge in pharma patent litigation

P41: VENDOR NEWS

MARKET

12

COMMERCE MINISTRY SENDS MULTI-SECTOR TRADE DELEGATION TO VIETNAM

13

STRIDES, GILEAD SIGN AGREEMENT

14

ROCHE AND FMI TO ENTER INTO STRATEGIC R&D COLLABORATION

15

SINGAPORE EDB GIVES INTERNATIONAL HEADQUARTERS STATUS TO STRIDES PHARMA GLOBAL

BIOTECH SPECIAL PHARMA LIFE

23

FERMENTA BIOTECH LIMITED: TOUGH GETS GOING

26 27

EVOLVA BIOTECH: EVOLVING SPIRIT ‘I EXPECT A NUMBER OF IPOS IN INDIA AND CAPITAL INFLOW FOR NOVEL IDEAS’

62

'A SUPPORT SYSTEM SHOULD ENSURE FOCUSED INVOLVEMENT OF BOTH ACADEMIA AND INDUSTRY'

Safexpress opens logistics park in Faridabad

Scheduling & Coordination Rohan Thakkar

P64: APPOINTMENT

CIRCULATION Circulation Team Mohan Varadkar

Jubilant Pharma appoints GP Singh as CEO

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

The bigger picture vs the nitty-gritty

A

s I write this edit, US President Obama is winding down his second Presidential visit to India and both sides are taking stock of the follow ups required to build on the new theme of 'Shared Effort; Progress for All.' Pharmaceutical industry observers were hoping for hints on how the intellectual property rights (IPR) issue will be resolved but the joint statement merely stated the obvious that current efforts will continue.

While health activists like Leena Menghaney, South Asia Manager of MSF’s Access Campaign had warned that “future access to essential medicines for millions of people will depend on the new Indian government’s decisions and the kind of patent and innovation system it endorses”, the NRI diaspora seems pitted against this stance.

Many lobby groups like the US India Political Action Committee (USINPAC), the Alliance for US Indian business (AUSIB) and many more have become the voice of the Indian-American community and see the recent, growing US-India dialogue as the result of decades of networking on their part to represent the community's interests.

USINPAC claims to be one of the largest political action committees in the US, representing more than three million NRIs and has pursued “track two level diplomacy” on issues relating to fair and free trade like the US allowing LNG exports to India as well as promoting the exchange of trade and technology in the defence sector especially defence IT and cyber security.

On the pharma IPR front, USINPAC’s Chairman Sanjay Puri feels that there will need to be a compromise but he urges the (Indian)

10

EXPRESS PHARMA

February 1-15, 2015

While we are urged to look beyond the sticky issues,one cannot overlook the final impact of decisions on India’s IPR policy

administration as well as Capitol Hill to look at the ‘bigger picture’ to this relationship. “There are certain things that India and Indian companies cannot do and we need to be sensitive towards that. This is a gradual process that we need to work on,” is his take.

The US traditionally lagged Europe as a pharma outbound destination for Indian pharma but this looks set to change, according to a recently released FICCI-EY report, which shows that India's big pharma firms are investing heavily in the US as well. There have been five major deals in the two-year period from October 2012 to December 2014. Piramal Enterprises already has 1000-odd employees in the US and has plans to acquire more companies. Sun Pharma did two acquisitions in this period but is looking at more suitable targets. If the US is welcoming India's pharma companies, should we reciprocate? The important thing to note is that Indian pharma companies are playing by the rules of the US and not lobbying to change them.

As President Obama enters the ‘lame duck’ phase of his second term, the US-India dialogue is very much part of the legacy he hopes to leave behind. While climate change and nuclear power liability are clearly his top priority, can we hope that there will be progress on IPR as well? After all, affordable healthcare is very much at the heart of Obamacare and it will be ironic if his tenure forces a reversal of India's patent policies in favour of monopolies.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET COMPANY WATCH

Commerce Ministry sends multi-sector trade delegation to Vietnam Pharmexcil, with five to six pharma industry members, part of delegation Usha Sharma Mumbai THE MINISTRY of Commerce, Government of India organised a multi-sector trade committee meeting in Vietnam recently to discuss and find solutions to various industry issues. India’s pharmaceutical sector was represented by Pharmaceuticals Export Promotion Council of India (Pharmexcil) along with five to six industry stakeholders.

Indian pharma companies are finding it difficult to operate in Vietnam due to regulatory hindrances . The Drug Regulatory Authority of Vietnam recently ‘red listed’ 53 Indian pharma companies (which includes small, mid and large pharma companies) for regulatory non-compliance. Most recently, the Drug Regulatory Authority of Vietnam ‘redlisted’ products of Flaming Pharmaceutical for the next 12 months and has cancelled 115 product registrations of Ahmedabadbased Intas Pharma. Presently,

the Vietnam pharma market is worth $2.4 billion and growing at seven per cent annually. The Indian exports to the Vietnam market has decreased by 15 per cent from $220 million in 2013 to $195 million in 2014.

Commenting on the trade committee meeting in Vietnam, Dr S Eswara Reddy, Joint Drugs Controller of India, Central Drugs Standard Control Organisation said, “The core reasons for these issues are the differences in the regulatory mechanisms followed in the two countries. The regulatory bodies in Vietnam follow the dual regulatory mechanism which are different for importing countries to their indigenous players. In our meeting we will be discussing the industry’s issues in details and will also be explaining to them the urgency of making the regulatory process uniform.”

On the sidelines of the recent International Pharma Business Meet organised by the Pharmexcil in Ahmedabad, Sudhansu

India approximately imports 15 tonne of artemisinin which is used for making anti-malarial drugs worth of $50 million from Vietnam Pandey, Joint Secretary of Department of Commerce mentioned, “We have realised that several Indian pharma companies are facing difficulties in Vietnam and based on their concerns, we had organised a three-member official delegation from a laboratory, regulator and a technical expert from

Pharmexcil to understand the issues of the industry. The key findings of the visit were that the test protocols which are in practice are different from Indian mechanism and they do not follow good distribution practices. Considering these issues, we have advised them to streamline their regulatory process. In the trade committee meeting, we will be discussing these issues and trying to get the Central Drugs Standard Control Organization (CDSCO) and Vietnam drug authority to sign an MoU for better cooperation so that both countries can exchange information and smoothen the business process.”

Dr PV Appaji, Director General, Pharmexcil said, “We have received the confirmation from Fourrts Laboratories, Glenmark Pharmaceuticals and Aurobindo Pharma to participate in a meeting. This interaction will help the industry in identifying the issues as well as in resolving them.”

MB Radha Krishnan, Country Manager of the Vietnam-

based pharma company Zyanya Healthcare shared, “It is becoming a difficult endeavour for Vietnamese pharma companies to do business with Indian partners. Drug regulatory authorities of Vietnam are making it difficult for India pharma companies to comply with regulatory requirements.”

He also highlighted that as per available information, from 1/1/2014 to 30/08/2014, almost 38 cases of punitive actions were taken against Indian pharma companies, which were initiated by the Ministry of Health Vietnam and their associates and close to 50 per cent cases occurred in July and August 2014.

He also shared the insight that, in the last 18 months, the authority of Vietnam has not given a product registration approval to first time applicant from India.

India approximately imports 15 tonne of artemisinin which is used for making anti-malarial drugs worth of $50 million from Vietnam. u.sharma@expressindia.com

Gujarat FDCA ties up with UL 45 state inspectors to be trained on US FDA's GMP g’lines UNDERWRITERS Laboratories (UL), the global safety science company, for the first time in India, will be implementing a training programme for the Gujarat Food and Drug Control Authority (FDCA).

UL will train their inspectors using a specially designed curriculum that will be conducted online.

The training will be

12

EXPRESS PHARMA

February 1-15, 2015

conducted initially for 45 inspectors from the Gujarat FDCA in the first phase with 20 online modules as a part of the curriculum. The vision is to have the Gujarat FDCA at par with the USFDA guidelines, especially in terms of audit regulations and guidance and to educate the inspectors on good manufacturing practices (GMP) thereby improving

exports of pharmaceuticals and other related products.

According to Dr Kavita Mehrotra, Global Strategic Head, UL EduNeering, the first of these sessions was conducted on December 19 last year and the agreement was signed during Vibrant Gujarat with Dr HG Koshia, Gujarat FDCA Commissioner.

The company is in talks

with other states as well and she indicated that it is their belief and hope that other states will follow Gujarat’s initiative.

Mehrotra indicated that a few mid sized and small pharma companies have reached out to them for their advisory services, both as a preventive as well as a remedial measure. Hoping that this too would pick up, she

said, “It is hoped that in time, both sides (regulators as well as the regulated, i.e. pharma companies) will speak the same language.”

UL’s training arm, UL EduNeering has an exclusive partnership with the US FDA and has trained over 36,000 FDA inspectors and investigators.

EP News Bureau-Mumbai

Strides,Gilead sign agreement To manufacture and distribute Tenofovir Alafenamide (TAF) based HIV treatments in 112 developing countries STRIDES ARCOLAB has entered into a licensing agreement with Gilead Sciences, under which Gilead has extended non-exclusive rights to Strides to manufacture and distribute Tenofovir Alafenamide (TAF), both as a single agent product and in combination with other drugs.

The license being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV.

The license being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV As part of the licensing agreement, pending US Food and Drug Administration (US FDA) approval of the Gilead product, Strides will receive a technology transfer from Gilead, enabling Strides to manufacture low-cost versions of TAF for developing countries.

TAF is a novelnucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.

TAF and TAF-based regimens are investigational products in the US and have not yet been determined safe or efficacious in humans.

EP News Bureau-Mumbai

EXPRESS PHARMA

13

February 1-15, 2015

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MARKET

Roche and FMI to enter into strategic R&D collaboration Partnership includes a broad R&D collaboration wherein Roche is committing to funding of more than $150 million for a minimum of five years and will contribute its expertise and breadth in oncology ROCHE AND Foundation Medicine (FMI) will enter into a broad strategic collaboration to further advance FMI’s market-leading position in molecular information and genomic analysis while providing Roche a unique opportunity to optimise the identification and development of novel treatment options for cancer patients.

Under the terms of the R&D collaboration agreement, Roche is committing to R&D funding of potentially more than $150 million for a minimum of five years and will contribute its expertise and breadth in oncology.

FMI will continue to operate independently and contribute its experience in the development of comprehensive genomic profiling tests for oncology. The initial

Roche will be able to utilise FMI’s proprietary molecular information platform to standardise clinical trial testing focus of the R&D collaboration will be on developing genomic profile tests for cancer immunotherapies and for continuous bloodbased monitoring.

Roche will be able to utilise FMI’s proprietary molecular information platform to standardise clinical trial testing. This aspect of the relationship is designed to enable comparability of clinical trial results for R&D purposes, and ultimately in the clinic.

FMI’s pharma business will not be impacted and

could be enhanced as FMI capabilities increase with the investments and experience in working with Roche as a customer.

The R&D collaboration and FMI’s current and future tests are expected to deliver insights to support development of combination therapies, novel targets, more accurate patient population identification and inclusion in clinical trials, and next generation companion diagnostics.

The intention is to improve decision making and support

Mankind Pharma launches ‘Heal-o-Kind’for topical wounds

optimisation of patient care as oncology management becomes more complex.

In addition to the R&D collaboration, both parties also agreed to a commercial collaboration agreement designed to broaden FMI’s position across clinical and molecular information markets. Specifically, Roche will obtain rights ex-US (under the FMI brand) to existing FMI products, as well as to future co-developed products. In the US, Roche will engage its US medical education team in providing medical information to pathologists.

The collaboration agreements will become effective upon the completion of Roche’s direct investment in FMI and the tender offer, as described below.

THE OTC business division of Mankind Pharma has launched ‘Heal-o-Kind- First Aid ka all rounder’, a four-in-one gel containing nano crystalline silver to treat multiple injuries like wounds, burns, bruises and cuts.

The product has been introduced pan India.

Heal-o-Kind’ has been developed by the scientists at Mankind Pharma’s R&D centre in Manesar, Gurgaon, using the most advanced technology in the regard called the nano crystalline silver which easily get absorbed in the skin and heals wound faster as compared to bigger particle size of competitors.

The gel based ointment, is transparent and stain free in nature. Also Heal-o-kind has an anti-bacterial action formula, making the product ideal for mass use.

EP News Bureau-Mumbai

EP News Bureau-Mumbai

Suven Life secures product patents from Australia, Hong Kong and Japan The granted claims of the patents include the class of selective alpha-4-beta-two compounds discovered by Suven and are being developed as therapeutic agents for major depressive disorder SUVEN LIFE Sciences has received one product patent from Australia (2010337837), two product patents from Japan (5536227, 5588018) and one product patent from Hong Kong (1174913) corresponding to the new chemical entity (NCE) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2030.

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February 1-15, 2015

The granted claims of the patents include the class of selective alpha-4-beta-two compounds discovered by Suven and are being developed as therapeutic agents for major depressive disorder (MDD).

With these new patents, Suven has a total of 19 granted patents from Australia, 14 granted patents from Japan and 15 granted patents from

With these new patents, Suven has a total of 19 granted patents from Australia, 14 granted patents from Japan and 15 granted patents from Hong Kong

Hong Kong.

These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase-I or phase-II. EP News Bureau-Mumbai

MARKET

Singapore EDB gives International Headquarters Status to Strides Pharma Global Proposes to carry out activities for its international business including business development STRIDES ARCOLAB announced that its wholly-owned subsidiary Strides Pharma Global Singapore has been awarded ‘International Headquarters Status’ by the Singapore Economic Development Board (EDB).

Strides Pharma Global proposes to carry out activities for its international business including business development and planning, sales and marketing, intellectual property management, global supply chain management and global

Singapore’s status as a trusted location, with good talent and strong connectivity to the region, enables companies to gain easy access to key regional and global markets regulatory affairs. Mohan Kumar, Chief Executive Officer, Strides Pharma Global said, “We are delighted to collaborate with EDB for housing our international business. Singapore was

selected as the international headquarters after assessing various options. Strides Pharma Global, Singapore will also be building a new manufacturing facility in Singapore in the next

couple of years with focus on the regulated and South East Asia markets”.

“We welcome Strides’ decision to establish its international headquarters and manufactur-

ing facility in Singapore,” said Kevin Lai, Executive Director, Biomedical Sciences and Consumer Businesses of the Singapore EDB. Singapore’s status as a trusted location, with good talent and strong connectivity to the region, enables companies to gain easy access to key regional and global markets. Strides’ decision is a strong endorsement of our commitment to build a diversified and vibrant biomedical sciences hub for Asia and beyond.

EP News Bureau-Mumbai

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EXPRESS PHARMA

15

February 1-15, 2015

MARKET GROWTH TRACKER

IPM clocks ` 7375 crores revenue in December 2014 21 corporates have crossed the growth of IPM amongst the top 50 THE INDIAN pharmaceutical market (IPM) clocked ` 7375 crores in December 2014. It has grown at 13.6 per cent in the said month. Amongst the top 10, Ranbaxy grew by 28.7 per cent followed by Pfizer at 23.1 per cent and Sun Pharma at 21.5 per cent. 21 corporates have crossed the growth of IPM amongst the top 50.

Amongst the top 50 corporates, Akumentis has the highest growth of 69.4 per cent followed by Merck at 37.8 per cent and Albert David at 32 per cent.

30 corporates showed growths more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Torrent has the highest growth of 31.1 per cent followed by Macleods at 30.1 per cent and USV at 24.9 per cent. Amongst the 51-60 ranked corporates, Panacea grows at 42 per cent followed by Pharmed at 17.7 per cent and Systopic at 17.2 per cent.

Amongst the 61-75 ranked corporates, Boehringer grew by 62.1 per cent followed by Tablets India at 23.3 per cent and Serdia at 18.8 per cent.

Ranbaxy enters the ` 3000crore club, Panacea entered the ` 300-crore club as on MAT December 2014.

Indian companies have grown at 12.1 per cent versus 17.5 per cent for MNCs in December 2014. Amongst the top 50 in MNCs, Merck grew by 37.8 per cent followed by Ranbaxy at 28.7 per cent, MSD at 26.1 per cent and Pfizer at 24.3 per cent.

Under the non-NLEM category Indian companies grew at 13.6 per cent whereas MNCs grew at 18 per cent. For the December quarter, the MNCs have shown a volume growth of 6.4 per cent versus one per cent for the Indian companies.

The DPCO containing molecules market grew at eight per cent whereas the non-DPCO market grew by 14.8 per cent resulting in an overall growth of

16

EXPRESS PHARMA

February 1-15, 2015

With Bonus Units at Full Value Val in Crs CORPORATE

(Val in Crs)

Rank

MAT Dec -14

MAT

MTH

Abbott + Abbott HC + Novo

1

1

Sun Pharma

2

2

IPM

Dec-14

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

83009

100.00

10.2

7375

100.00

13.6

5136

6.19

6.9

484

6.56

17.7

4524

5.45

15.3

422

5.73

21.5

Cipla

3

3

4142

4.99

11.4

372

5.05

12.7

Zydus + Biochem

4

4

3604

4.34

8.7

315

4.27

12.6

Ranbaxy

5

5

3059

3.69

10.7

303

4.11

28.7

Mankind

6

6

2991

3.60

12.5

261

3.55

19.2

Alkem + Cachet + Indchemie

7

10

2912

3.51

11.1

236

3.20

3.6

Glaxo

8

9

2780

3.35

-4.0

239

3.24

2.2

Lupin

9

8

2767

3.33

12.2

240

3.26

12.5

Pfizer

10

7

2472

2.98

12.7

241

3.26

24.3

Macleods

11

11

2406

2.90

26.6

215

2.91

30.1

Emcure + Zuventus

12

14

2218

2.67

7.4

189

2.57

2.0

Intas

13

13

2179

2.63

15.9

201

2.73

19.8

Aristo

14

17

2068

2.49

18.3

169

2.28

10.8

Sanofi India

15

12

2065

2.49

5.8

201

2.73

21.8

Torrent

16

16

1863

2.24

10.5

181

2.46

31.1

Glenmark

17

15

1820

2.19

15.2

182

2.46

21.2 12.8

Dr. Reddys

18

18

1755

2.11

9.0

161

2.19

Micro + Bal

19

20

1637

1.97

8.8

137

1.85

1.5

USV

20

19

1610

1.94

16.9

148

2.00

24.9

Ipca

21

21

1478

1.78

18.6

119

1.61

3.9

Novartis

22

22

1159

1.40

1.6

103

1.39

6.6

Alembic

23

23

1127

1.36

11.5

101

1.37

11.3

Wockhardt

24

24

983

1.18

1.7

85

1.16

-3.4

FDC

25

27

839

1.01

5.2

62

0.85

-3.1

13.6 per cent for December 2014.

The NLEM and Non NLEM category showed unit growth at 0.7 per cent and 3.2 per cent respectively. The DPCO 2013 portfolio for Pfizer grew at 13.9 per cent, GSK 1.7 per cent, Ranbaxy 41.9 per cent.

From therapy perspective four therapies have outgrown the IPM growth and 14 therapies have double digit growths.

Respiratory market grew at 10 per cent, gastrointestinal market grew at 13.5 per cent, pain and analgesics market grew at 11.3 per cent whereas the antiinfectives grew at 5.2 per cent.

The anti-diabetic market

grows at 33.1 per cent and cardiac at 18.2 per cent in chronic business. The derma market grew by 19.6 per cent and urology market at 29.7 per cent.

From a regional perspective, 11 regions have outgrown the IPM growth. The Mumbai market grew the highest at 21.9 per cent followed by Gujarat market at 21.7 per cent and Kerala market at 20.7 per cent. No regions had negative growth in December 2014.

The Amoxycillin + Clavulanic Acid market grew at 8.2 per cent whereas Glimepiride + Metformin grows at 20 per cent at number two. The markets of paracetamol grew at 5.6 per

cent, Atorvastatin 24 per cent, Probiotic Microbes at 26.9 per cent, Cefixime 1.1 per cent, Pantoprazole 15.3 per cent, Montelukast + Levocetrizine at 20.4 per cent, Glimepiride + Metformin + Pioglitazone at 28.1 per cent, Vitamin-D at 29.4 per cent, Hydroquinone + Mometasone + Tretinoin at 34.7 per cent, Voglibose + Metformin + Glimepiride at 57 per cent, Leveteracetam at 37.2 per cent, protein supplements at 24.1 per cent.

Mixtard continues to lead the pack with ` 41.7 crores for December 2014 with a growth of 47.8 per cent. Mixtard grew at 47.8 per cent, Lantus grew at

36.7 per cent and Glycomet- GP grew at 36.3 per cent, Augmentin grows at 16.2 per cent, amongst the top 10 brands.

Amongst the brands who have gained ranks include Clexane (+64), Janumet (+54), Januvia (+43), Shelcal (+38), Panderm Plus (+31), Istamet (+29), Rosuvas & Jalra (+26), Novomix, Susten & Jalra-M (+17), Taxim, Pan & Levipil (+15), Zincovit (+13), Dexorange, Orofer-XT & Tonact (+9), Liv 52(+6), amongst Top 100 Brands over December 2013.

Total 361 SKUs and 185 brands launched in December 2014. Top new brands for December are Biovac V, Ryzodeg

MARKET and Canmab. Two new subgroups got launched as Roflumilast and Cyclobenzaparine + Diclofenac.

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

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

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

Val in Crs

MAT Dec 14

Month Dec-14

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

83009

10.2

7375

13.6

ANTI-INFECTIVES

13272

6.0

1092

5.2

CARDIAC

10363

10.7

964

18.2

GASTRO INTESTINAL

9534

11.4

791

13.5

VITAMINS / MINERALS / NUTRIENTS

7537

11.1

643

12.6

RESPIRATORY

6481

10.4

656

10.0

ANTI DIABETIC

6278

21.3

615

33.1

PAIN / ANALGESICS

5912

9.3

506

11.3

NEURO / CNS

5064

8.2

460

15.4

DERMA

4772

16.1

450

19.6

GYNAECOLOGICAL

4209

5.1

352

8.1

OPHTHAL / OTOLOGICALS

1536

13.0

130

12.9

HORMONES

1402

4.8

123

6.2

ANTI-NEOPLASTICS

1355

25.5

119

12.7

VACCINES

1165

-8.0

103

-5.6

BLOOD RELATED

938

2.2

79

5.8

OTHERS

895

12.5

93

37.9

UROLOGY

877

21.5

80

29.7

ANTI MALARIALS

597

4.1

40

-4.2

SEX STIMULANTS / REJUVENATORS

461

4.1

47

18.8

STOMATOLOGICALS

362

12.1

31

13.2

MARKET POST EVENTS

Vibrant Gujarat 2015 notches 201 MoUs worth `5000 crores in pharma sector Amneal Pharmaceuticals to invest `280 crores to set up formulation facility in the state Usha Sharma Ahmedabad THE THREE-DAY long Vibrant Gujarat Summit held at in Mahatma Mandir, Gandhinagar concluded successfully.

The pharmaceutical sector too received an overwhelming response, with 201 memorandum of understanding (MoUs) worth of `5000 crores signed during the event. Most of these MoUs were in the formulations, active pharmaceutical ingredients (APIs) and medical device segments.

Commenting on the success of the pharma segment at Vibrant Gujarat 2015, Dr Hemant G Koshia, Commissioner, Food and Drug Control Administration - Gujarat said, “In 2011, the Government of Gujarat had initiated Business to Government (B2G) meetings and it has really worked well for the last two summits. This year, with the help of B2G, we have signed 201 MoUs. Out of these, 20-25 MoUs are fresh investments while the rest of them are previously signed MoUs.” While sharing the details of

Most of these MoUs were in the formulations, active pharmaceutical ingredients (APIs) and medical device segments MoUs, Koshia informed, “An American pharma company, Amneal Pharmaceuticals has agreed to invest ` 280 crores for setting up a state-of-the-art formulation facility in Gujarat.

Israel-based Teva in partnership with P&G has finalised the expansion of their business operations in Gujarat.”

During the last Vibrant Gujarat Summit, the state

authority had signed 133 MoUs worth `3160 crores for the pharma sector . “This year's summit has worked for the pharma sector and new companies from the US and Europe have shown keen interest in investing in the state,” shared Koshia.

Most senior officials from the Gujarat State Government were present throughout the event to share the required information with foreign delegations during B2G meeting. u.sharma@expressindia.com

Australian life sciences and tropical medicine delegation promote their capabilities in India To showcase their capabilities and enhance relationships with Indian counterparts as part of ABWI A 19-MEMBER Australian life science delegation is visiting India to showcase their capabilities and enhance relationships with their Indian as part of Australia Business Week in India (ABWI).

Led by the Andrew Robb AO MP, Australia’s Minister for Trade and Investment, ABWI is the largest Commonwealthsponsored trade, investment, education and tourism mission ever undertaken to India, comprising around 450 business delegates.

Nicola Watkinson, Australian Trade Commission’s Senior Trade & Investment Commissioner for South Asia, said this mission reinforces the message that Australia is keen to identify, strengthen and deepen relation-

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ships with India.

“ABWI delegates represent a significant cross section of Australia’s industries and services in areas with significant opportunity for Australian companies to partner with Indian colleagues,” said Watkinson.

“This includes developing globally significant medical research breakthroughs, like the medical use of penicillin, development of cochlear implants, cervical cancer vaccine and the bionic eye. These have been developed and successfully commercialised through partnerships between scientists and Australian biotechnology and global life science companies,” said Watkinson.

Simone Greulich, Life Sciences and Tropical Medicine

Program Leader, said that the delegation will be exploring research collaborations, licensing partnerships, clinical trials, diagnostic services, and investment, especially in the areas of tropical medicine, oncology, infectious diseases and diabetes.

“There are over 470 biotech companies based in Australia. Of these, 62 per cent are in human therapeutics and diagnostics, 16 per cent in agricultural biotechnology, nine per cent in chemical environmental services and eight per cent in biotech services,” said Greulich.

“Australia’s innovative research institutes have specialist and world-class expertise in oncology, neurology, tropical medicine and medical devices.”

“In tropical medicine, Aus-

tralia is one of the few developed economies with domestic experience delivering healthcare in a tropical climate. This has led to extensive research expertise in medicines to tackle diseases like dengue fever, malaria and tuberculosis,” said Greulich.

Significant opportunities also exist to strengthen AustraliaIndia life sciences research partnerships through: Australia’s Cooperative Research Centres (CRC) program, joint R&D programmes with Australian research institutions; and Australian clinical trial and development and contract research services.

Successful Australia-India life sciences partnerships include: Serum Institute of India based in Pune; Australia-India

Trauma Systems Collaboration; and The India Vision Institute a joint initiative established by LV Prasad Eye Institute and Australia’s Brien Holden Vision Institute.

While speaking about treatments for cancer Dr Rajendra Badwe, Tata Memorial Hospital, said, "Unless the Government puts in the fund cost of the advanced treatment will not come down."

Robb said, "Australia has a stronghold in the field of research and we offer good commercial opportunities. Multidiscipliniary collaborations with other parts of the world is going to be important. Healthcare and medical research are among the major strengths of Australia."

EP News Bureau-Mumbai

EVENT BRIEF FEBRUARY 2015 — MAY 2015 18

ASSOCHAM Pharma Summit

ASSOCHAM PHARMA SUMMIT Date:February 18, 2015 Venue: Hotel Le Meridien, New Delhi Summary: Associated Chambers of Commerce and Industry of India is organising the Pharma Summit with the theme ‘Changing Dynamics the Road Ahead,’ in association with Organization of Pharmaceutical Producers of India, Indian Drug Manufacturers’ Association and Confederation of Indian Pharmaceutical Industry and Indian Pharmaceutical Association.

The objective of this summit is towards creating a platform for discussing the various issues to streamline the regulatory framework and imparting more practicability in the Government policies.

Contact details: Bharat Kumar Jaiswal Assistant Director, The Associate Chambers of Commerce and Industry of India 5, Sardar Patel Marg, Chanakyapuri New Delhi – 110021 Tel: 46550514 (D), 46550555 (Hunting line) Fax: 46550550 Mobile: 9971047550 Email: bharat.jaiswal@ assocham.com

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000 pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services.

Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign

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commercial corp, compliance, process engineering, corporate management, procurement department, custom

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PHARMA Pro & Pack Expo 2015

manufacturing/ marketing services and purchase officers.

Contact details: Indian Pharma Machinery

Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg,

Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

cover ) BIOTECH SPECIAL The last few years have been painful for India’s biotech sector but many companies have turned adversity into opportunity.

Express Pharma analyses the success stories of three such companies: Panacea Biotec, Fermenta Biotech, and Evolva Biotech

ALSO INSIDE Interview: Dr P M MURALI, President, ABLE

20 EXPRESS PHARMA February 1-15, 2015

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PANACEA BIOTEC

ATURNAROUND STORY After three consecutive years of negative EBITDA, Panacea Biotec looks set to script a successful revival. Dr Rajesh Jain, Joint Managing Director tells us how

BY VIVEKA ROYCHOWDHURY

T

he 11th survey of the biotechnology industry in India, released by the Association of Biotechnology Led Enterprises (ABLE) in June 2013, showed that the sector recorded ` 23,524 crore in FY 2012-13, with 15.08 per cent growth, the lowest in recorded by the industry in the past 11 years. Biopharma, clinical trials and contract research sectors accounted for 82 per

cent market share while the bioagri sector, which had been growing over 20 per cent during the last few years, crashed to a meager 5.2 per cent growth. In spite of these figures, the industry has set a goal of achieving $100 billion revenues in 2025.

Individual companies too have gone through trying times in the last two years but share this confidence.

Take for instance, Delhibased Panacea Biotec.

Incorporated as Panacea Drugs in 1984 and listed in 1995 as Panacea Biotec, the company’s name change reflects the changed focus from pharmaceuticals to biotechnology in its first decade.

As it caught the biotech bandwagon, Panacea Biotec’s focus on vaccines saw it grow into India’s third largest biotech company as per the June 2011 ABLE Survey as well as rank amongst the top 40 pharma companies in India as per IMS TSA MAT March' 2011.

Panacea Biotec grew into one of India’s largest vaccine manufacturers and

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became a member of the Developing Countries Vaccine Manufacturers Network (DCVMN) which was formed in 2000. It developed and launched the world’s first fully liquid pentavalent vaccine in 2005, got WHO prequalification three years later and by June 2011, had supplied over 45 million doses used in around 31 GAVI/non-GAVI countries.

Besides vaccines, its product portfolio also spanned pain management, diabetes management, renal disease management, osteoporosis, anti-tubercular, and gastrointestinal care products.

The speed breaker But the company hit a speed breaker when its DTP-based combination vaccine (Easy Five, and Ecovac 4) and monovalent Hepatitis B vaccine (Enivac HB) were delisted by the WHO following a routine site audit by a WHO team in July 2011. The delisting was based on certain observations in the Quality management systems (QMS) at the Lalru manufacturing facility (Punjab) but since there

was no evidence of quality defects in the vaccines already distributed in the market, there were no product recalls.

More bad news was to follow. Another routine site audit by WHO of the oral polio vaccine (OPV) manufacturing site in Delhi in September lead to recommendations for some incremental measures to strengthen the QMS at the site, and the company had to cease OPV production as well.

By February 2012, WHO had de-listed Panacea Biotec's OVP as well.

Releasing the financial results for the quarter and nine months ended December 31, 2011, Dr Rajesh Jain, Joint Managing Director, Panacea Biotec had said, “We have taken several corrective and preventive measures and are in active touch with WHO in this respect. We are confident that with these corrective and preventive measures, we will be able to get re-listing of our pentavalent vaccine in the list of WHO prequalified vaccines soon.”

The recovery Things started to look up in

September 2012 when the Drug Controller General (India) approved the OVP facility at New Delhi and the company could resumes OPV supplies to GoI by the end of that year. By this time, the company had also completed the up gradation of QMS, and invited WHO for a re-inspection of the Lalru and Baddi (Himachal Pradesh) facilities.

It was almost two years from the de-listing, before the company’s manufacturing facilities received the go ahead from the WHO inspection team. In a release dated September 19, 2013, Jain announced that WHO had completed the evaluation process of pre-qualification (PQ) of its pentavalent vaccine EasyfiveTT and would intimate UNICEF, the procurement agency for global markets, of the positive outcome of this inspection. After a complete overhaul of the Lalru and Baddi facilities, in tune with a more robust quality management system, Panacea Biotec was ready once again to supply to both global and national agencies.

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BIOTECH SPECIAL

Building for the future

Upgradation involved designing systems and work flows, paying attention to even minor issues like housekeeping rules and discipline. “In the end,” Jain said, “It was a collective and collaborative effort for change and has o continue with even greater enthusiasm to the next level in the coming years.”

But these two years took a toll on the company’s balance sheet. The accumulated losses of these years resulted in the erosion of more than 50 per cent of its peak net worth. The continued losses also led to a cash flow problem, as reported to the Board for Industrial and Financial Restructuring (BIFR). The company’s ranking in 11th ABLE listing slipped to the 23rd position, though some would argue that the ranking is not completely comparable to past years as the survey has expanded to include diagnostic companies as well.

Turnaround strategy But it finally seems that the worst is behind Panacea Biotec.

The company now has a longterm supply order from UNICEF for 2014-2016, and has also won a national tender in Philippines for supply of Easyfive-TT vaccine in addition to the Government of India order for OPV. The current market cap of Panacea Biotec ` 927 crores as on December 31,2014 as per closing price on the NSE. The management’s proposal to restructure its corporate debt was approved in September last year and is under implementation. Secondly, the company has undertaken several risk mitigation measures, as per the half yearly results statement. The company has already filed six ANDAs in the last two years, with more in the development pipeline and it is clear that out-licensing of filed and to be filed ANDAs will be a key future growth driver. Even in this endeavour, the strategy is to focus on difficult to make specialty generics which require expertise in formulation and drug delivery. These become entry barriers to other generic players so with less manufacturers, price erosion is

22 EXPRESS PHARMA February 1-15, 2015

The next FY will be very positive in terms of both topline and bottom line and become profit plus as well. This is our target DR RAJESH JAIN Joint Managing Director, Panacea Biotec

reduced. The company seems to have a healthy pipeline in this sphere, with approximately 30 products including 505(b)(2) NDA products (NDDS products) selected for strategic collaborations with US-based companies for launch in the US and EU markets.

With over 50 brands in the pharma segment, the formulations business segment grew eight per cent in YoY in HYFY15 while the vaccines segment, with four key brands, registered a growth of 194 per cent.

The hexavalent, pneumococcal, dengue and S-IPV vaccines will be key growth drivers. The company is also strategically targeting emerging markets like Philippines, Sri Lanka, Vietnam, Egypt, Iran, Bangladesh, Nigeria, Peru, Uganda and Pakistan amongst others. The focus is on countries with a sizable birth cohort

of around three to five million and tenders in these markets will allow the company to expand in geographies independent of UNICEF tenders.

The strategy looks to be paying off. The company earned a positive EBITDA of ` 504 million during H1FY15 after three years of consecutive negative EBITDA. Jain expects the trend to continue in the second half of this financial year.

Going purely by these numbers, if compared to the previous year, he says it is clear that Panacea Biotec is already a turnaround story. A negative EBITDA and stagnant sales of last year have been replaced by a positive EBITDA and increasing sales, according to Jain.

Manufacturing, utility and engineering, and HR costs are down and all this makes the company a lot more viable today than a year back, he reasons.

Last December, the company announced three collaborations in line with this strategy.

The first announced on December 12, was a strategic alliance with Canada’s largest pharma company, Capote, for research, development, license and supply of two drug delivery-based generic products in the US, Canada, Australia and New Zealand markets. The products use Panacea Biotec’s proprietary platform nanoparticle, liposomal and microparticle drug delivery system. This was an expansion of an existing collaboration and sales of the innovator products are worth around $1 billion in the US market.

This was followed by a similar deal with US-based Rising Pharmaceuticals for an oral controlled release product in the CNS space. The market size of the innovator drug is $300 million in the US and the approximate timeline to the ANDA submission of this product March 2016.

The third collaboration was announced on December 24, with a leading Indian pharma company with extensive global operations, for the development and supply of a modified release immunosuppressant generic product in the US market. Innovator sales of this product are currently around $350 million.

As Jain points out, these are all difficult-to-develop generic products using complex technology, which will be a high entry barrier for other generic manufacturers.

In the case of the Rising Pharmaceuticals deal, the product is under US FDA review and while Jain expects competitor generics, their strategy is such that they expect to be either the first to launch or at least among the top three or top six generic manufacturers of this drug. They expect to launch soon after the US FDA approval, which could be within this year or early 2016.

As Jain explains, since these are difficult to manufacture complex generics, they require a very specific manufacturing set up tuned to this product. That

hurdle is solved by Panacea Biotec’s oral drug delivery platform technology.

The Delhi-based company is set to net research fee milestone-based payments to the tune of $13 million over the next 18 months from these deals. It has already received $2.5 million in the first quarter while close to $1 million was expected in the third quarter of this FY. Of course, these payments are subject to completion of certain product development and manufacturing milestones by Panacea Biotec.

The icing on the cake is that post commercialisation of the product, Panacea Biotec and their partner companies will share profits at a pre-agreed ratio. Jain explains that Panacea Biotec will transfer the goods on cost basis, which includes manufacturing costs and the partner will be able to see the difference between the cost and the selling price which is very dynamic in the US market. The profit sharing ratio will differ from deal to deal. For instance, the profit sharing is in the ratio of 50:50 in the Apotex-Panacea Biotec deal, but could be higher in favour of the latter in certain cases, says Jain. These milestone payments are sure to ease the cash flow problems that the company has faced in the past two years. In addition, the company is clearly not banking on one product partnership and is spreading its risk across many deals.

On another front, Jain points out, “The R&D centres which were a cost on the bottomline have now started contributing to the topline, with R&D costs down and R&D income on the rise.”

“I believe the turnaround story has already happened and it will gain momentum quarter after quarter. If you look at the next FY, it will be very positive in terms of both topline and bottom line, and should become profit plus as well. That is the target for us,” says Jain. Only time will tell if this turnaround story has a happy ending. viveka.r@expressindia.com

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TT H H EE M MA A II N N FF O OC CU US S

Fermenta Biotech Limited

Tough gets going Since the past few years, lack of funding, distrustful investors, and weak global economic conditions have made survival a tall task for the biotechnology industry in India.

However, companies like Fermenta Biotech Limited have survived and thrived, thanks to a clear vision and consistently taking new products to market

By Sachin Jagdale

W

hen the going is tough, the tough get going.

This adage could very well describe the attitude of Mumbai-headquartered Fermenta Biotech Limited (FBL). The company’s turnover dipped slightly in FY2013 to `101.67 crores from `105.30 crores in FY2012, recovered in FY2014 to a much better `127.16 crore

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cover ) across its four business divisions: biotech, pharma, vit D3 and environment solutions.

Describing the current situation in the country’s biotechnology industry, Satish Varma, Managing Director, FBL, says, “The major biotech companies in the pharmaceutical sector are typically doing well. Apart from continuous improvement in the cost and quality of existing products to stay competitive, they also work on introducing new products in their portfolio for overall growth. This principle applies to most of products that can only be manufactured through a biotech / fermentation process.”

Over the last decade, most of the large global pharma companies have focused largely on replacing chemical processes used for existing products with enzymatic / biotech processes. As biotech R&D is time consuming and tricky, very few companies have been able to sustain these efforts. FBL is prominent among these few companies.

Sharma informs, “The further challenge is that existing chemical processes are time tested and have more or less reached their peak efficiencies, (so) the biotech replacement target is already set very high. Moreover, very few companies have the entire skill set and experience in this segment. Companies are now looking at collaborative approaches with academic institutions or specialised service providers.”

“Added to this is the challenge of obtaining patent protection and restricting copycat competition, as minor changes in the production strain or source of strain itself can allow other players to enter the market without the efforts and resources put in by the inventor company. In order to overcome this IPR challenge, companies that develop enzymes and technologies for existing chemical processes are looking at changing their model from

24 EXPRESS PHARMA February 1-15, 2015

BIOTECH SPECIAL

FBL is a leading enzyme manufacturing company in the country having its manufacturing units located at Dahej and Kullu. Set up in 1986, FBL pioneered the manufacture of penicillin G amidase enzyme in the country and emerged as a pioneer of immobilised enzymes and technologies for beta lactams (ß-lactams) synthesis. FBL has regularly introduced enzymes for manufacturing different semi-synthetic penicillin products in India

Satish Varma, Managing Director, FBL

supply of these enzymes to themselves getting into manufacturing of the end product by using their enzymes thereby limiting exposure to technology sharing,” he adds.

Enzymes remain the focus FBL is a leading enzyme manufacturing company in the country having its manufacturing units located at Dahej and Kullu. Set up in 1986, FBL pioneered the manufacture of penicillin G amidase enzyme in the country and emerged as a pioneer of immobilised enzymes and technologies for beta lactams (ß-lactams) synthesis. FBL has regularly introduced enzymes for manufacturing different semi-synthetic penicillin products in India. The company claims that Enzyme. Efficiency. Environment. Economics – are the four guiding principles of their biotech products division.

Sharma informs, “Our experience in this field has been that typically an efficient enzymatic process will always give a cost effective and higher quality product compared to a chemical process. We continue to manufacture and supply enzymes in this segment and enjoy a good market share in India. Our future efforts are towards collaborative efforts with existing pharma companies to target other products for replacing the current chemical processes with enzymatic processes.”

Enzymes for green pharma Chemicals are an integral part of the pharma industry.

As chemicals are always blamed for their negative impact on the environment, their user, the pharma industry, has also been listed among the heaviest environment polluting industries.

However, now the pharma industry has a solution in the form of enzymes to reduce the quantity of pollutants.

“A typical chemical process uses high amount of solvents and other toxic chemical for the reactions, which is completely eliminated (or minutely used) during an enzymatic process.

This results in drastic reduction of effluent load and number of steps (energy consumption) thereby making it green/environment friendly apart from making it a safe process in terms of human exposure. In addition to this, due to reduction of use of other chemicals and solvents, the end product purity and quality also is enhanced,” informs Sharma.

Company with a difference FBL has always been in the forefront, developing proprietary patented technologies

and always committed to next generation approaches. In addition to consistent quality supplies, FBL offers complete technical support in educating and scaling up enzyme based technologies. “We create and add value to customers in their journey of transformation. FBL currently does not supply their enzymes to non-pharma sectors,” says Sharma.

Sharma signs off saying, “We enjoy more than 50 per cent market share in the segments we are present in. FBL is looking at partnering with other pharma and technology companies to bring in more enzymes and technologies in this space. We are also considering the possibility of entering the fermentation-based API segment through the same approach.” Clearly, tough times do not scare this company. sachin.jagdale@expressindia.com

cover )

BIOTECH SPECIAL

Evolva Biotech

Evolving spirit Providing innovative, high value, sustainable ingredients, in particular for the health, wellness and nutrition segment, Evolva Biotech aims to stay ahead in the race and imbibe new discoveries

BY USHA SHARMA

H

eadquartered in Switzerland and having its Indian subsidiary in Chennai, Evolva Biotech is a recognised name not only in the pharmaceutical and biotechnology industry but also in the food and beverage, abd consumer health sectors.

Established in 2005, the company started its business operations in drug development and later decided to focus on high value ingredients with relatively low production volumes in flavour and fragrances segment for varied industries and is now growing impressively.

The HY2014 results for the period January 1- June 30, 2014 show a 25 per cent increase in revenues to CHF 5.0 million, with costs under control, and a strengthened cash position.

About 91 per cent of revenues is from research fees and milestone payments from the company's corporate partners, i.e.

Cargill, IFF, Ajinomoto, Roquette and L’Oréal while the remaining were generated from several research projects funded by the EU and national institutions. Evolva expects revenues for the full year 2014 to reach at least CHF 10 million as against 2013 revenues of CHF 8.7 million.

Dr Panchapagesa Murali, Chief Executive Officer, Evolva

26 EXPRESS PHARMA February 1-15, 2015

Biotech says, “Evolva has a platform technology which is capable of biosynthetically making small molecules. We continue to have the capabilities to carry out pathbreaking ways of synthesising expensive intermediates or complex intermediates which is not very amenable through synthetic chemistry. Small molecules have application in sectors ranging from pharma, agri, Flavour and Fragrance (F&F), health and wellness etc. Our current focus is on the F&F segment where the company has forged a number of partnerships. The core platform technology continues to be same.”

Tech-driven approach The company is capable of stitching a biosynthetic pathway which has a number of steps to make small molecules.

“We are global leaders with respect to optimising the stitched pathways for commercial fermentation. We have also developed important tool kits. For example, our glycosylation platform can improve the characteristics of a molecule making it either more available or soluble,” adds Murali.

Evolva discovers and provides innovative, high value, sustainable ingredients, particularly in the health, wellness and nutrition segment. The company believes in nature

which contains a wealth of ingredients that can benefit humanity. But many, indeed most, of these ingredients cannot be viably and sustainably sourced from nature. Most plants and animals are rare, few are suited to large scale agriculture and none have evolved solely to meet the needs of people.

It may be noted that recently many biotech companies, which believed in diversifying their business, also explored other avenues by not restricting ed their operations to one segment. Observing this trend, Murali emphasises, “The popular saying in the biotech industry is that it is always plan B that works. However, having said that in a lighter vein, generally a biotech company’s core engine will remain mostly unchanged. It is only the application areas that could change.”

While reasoning the key reasons behind lack of funding/investors, weak global economic conditions, inability to meet up to initial expectations of the business of R&D /drug development, Murali strongly feels, “This is largely dictated by requirements of the market needs. 2014 has been a very good year for funding and IPO’s for the biotech market.”

The company believes that modern biology is all about staying ahead and nurturing and imbibing new discoveries.

Murali unveils the company’s

new technologies which are in the pipeline and informs, “Our scientists are constantly working on developing innovate technologies to stay ahead. We have a few hundred patents on important biosynthetic pathways, which has industrial applications. Products like resveratrol, stevia and molecules from saffron are all in the pipeline.”

Growing inorganically Recently, Evolva Holding SA announced that Emergent BioSolutions has acquired Evolva’s anti-bacterial programme, the EV-035 series. The lead compound in the EV-035 series is the broad-spectrum antibiotic GC-072, which is being developed with the US government’s bio-defense funding. This transaction is worth up to $70.5 million plus royalties.

GC-072 has shown efficacy in both in-vitro and in-vivo studies against a wide range of bacterial pathogens, most notably Burkholderia pseudomallei. This bacterium causes the disease melioidosis and is regarded as a potential bio-threat agent. The preclinical development of GC-072 is funded by the Defense Threat Reduction Agency (DTRA) of the US Department of Defense. Evolva and Emergent are working closely with DTRA on the transfer of the funding contract to Emergent, and expect this process to be completed within

the next few weeks.

Commenting on the company’s future plans, he mentioned, “We are a public company and hence I cannot share our future plans. However, like all other companies, ours too is focused on all new product launches for the next two to three years. Whatever manpower and resources that are needed for the successful launch of these products will therefore be deployed by the company. We are upbeat about all the opportunities that Asia is showcasing. We have a good establishment in India since 2006 and happy to see the changes through the initiatives taken by our current Prime Minister.”

While revealing the company's financial performance, Murali says, “We have revenues to the tune of $9-10 million. The company is not making profits as it is a typical biotech company focusing on research and development.

Our market cap is upwards of $ 400 million.”

The company’s diversification strategy and future success hinges solely on the management's ability to quickly identify future business possibilities leveraging its technology platforms and take swift action in order to evolve to the next level. u.sharma@expressindia.com

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I N T E R V I E W

‘I expect a number of IPOs in India and capital inflow for novel ideas’ The 15th edition of Bangalore INDIA BIO 2015 will focus on showcasing to the world the strides taken by Indian companies in the biotechnology segment. Dr P M Murali, President, ABLE in an interview with Usha Sharma talks about the upcoming event

Brief us about the 15th edition of Bangalore INDIA BIO 2015. The theme for this year’s event is ‘Crystalising India’ s Biotech Future.’

Elaborate more on this.

Indian companies have been practising biotechnology for a number of years now. However, several factors are now favouring an accelerated growth. The positive Initial Public Offering (IPO’s) last year in the US and a single biotech company raising the highest money from market. Costs are dramatically going down in sequencing. Consortiums are working together to decode and understand the mechanisms and workings of living systems.

The younger generation, keen to work in the fusion area of biology and electronics, are paving way to diagnostic and wearable devices. All these things auger very well and Bengaluru is the hub that is emerging for new and innovative companies. This year's event focuses on showcasing to the world the strides taken by Indian companies in the biotechnology segment. Also, mature companies are slowly consolidating on the gains of their research over the years. I expect a number of IPOs in India and also a lot of capital inflow for novel ideas.

The Indian biotech industry is still at a nascent stage.

What should be done to boost its growth? What support do you expect from the government?

ABLE has prepared a road map and has time and again mentioned that an investment of $4-5 billion year-on-year for the next fours years with enabling environment will catapult this industry to a size of about $100 billion in the next few years. We had the stars, aligned very well for us a decade ago which we did not capitalise on due to ambiguous regulatory policies and knee jerk reactions. Hope the lessons learnt from the past will now be used to accelerate growth in the health and agriculture sector.

How many biotech companies are in India and what percentage of growth has been registered in the last three to four years?

Biotech has been growing at about 15 per cent but certainly it slowed down in the past few years which has led to a sense of utter disbelief on why India failed to recognise its potential.

I think there are over 400 pure biotech companies in India and a number of companies using biotech tools. We are looking forward to see biotech sector growth at over 25 per cent yearon-year from now on.

There are a handful of large biotech companies in India and Asia against many small and mid-sized biotech companies. How can these small and mid-sized companies be associated with the larger firms?

Globally, smaller biotech companies feed into the pipeline of large biotech

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companies. The other thing that happens is smaller companies develop lab scale technologies and platforms which are then effectively translated and scaled up by companies. One difference is in India; translation from academics is still not geared up and I hope this grows.

It has been observed that Indian biotech companies are shifting/diversifying their interests to other segments like agri-biotech or bio-fuel.

What are the key reasons for it?

I don’t think this is a shift.

These are very important segments and some companies see opportunities here.

What strategies has ABLE chalked out to attract foreign investments in the Indian biotech sector?

ABLE is now present at most key international events.

ABLE also hosts a number of foreign delegations. A combination of several of these information dissemination strategies help in overseas companies sensing the changed

atmosphere and exploring ways to invest in India. ABLE also is the key inter-phase between the biotech industry and the various governmental departments. A lot of valuable discussions and white papers are generated every year to set the course of this industry. In addition to this, ABLE plays a vital role along with progressive state governments like Karnataka, Gujarat, Uttar Pradesh etc. ABLE is also part of the 'Make in India' strategic planning for this sector.

This year’s event has a special focus on agri-biotech, renewable energy and environment sustainability.

Why is this so?

A number of statistics have been released on what population and environmental challenges the human race is going to face in the next 20-50 years. Technology is going to play a very key role in shaping our destiny. Biotech is thus going to be extensively used in agri and renewable energy segments. Both segments are going to hold the key to the future. Imagine plants that are going to use less water, less pesticides etc. and also exploiting marine forms of renewable energy forms. India has everything that is needed to make it a power house. If the enablers are in place, we will race ahead.

What are your expectations from the Union Budget 201415? Will the industry get some special focus this year?

Rationalising taxes, offering appropriate to help start-ups to flourish and announcing suitable investment in all the enabling environment like regulation, implementation, IP, power, water pollution etc.

FSSAI. Biodiversity organisations require adequate investment to have more manpower to assist industries.

Healthcare, agriculture and energy are the major pillars of the country and biotech is the key enabler for these sectors to grow. So the government should take a long-erm view and look at sustained investments over five years.

Adhoc or piecemeal sops will not be of much help. The government has to think in 10 year cycles for this sector.

What message would you like to give for the success of Bangalore India Bio 2015?

India is once again in the lime light due to the efforts of Prime Minister Modi. His dynamism should be translated into action by the bureaucracy.

The industry will automatically follow on the positive trends.

Bangalore Bio will strive to show case the changed trends in India and reverse the adversities which lead to new initiatives leaving India. Also proactive states like Karnataka will take the lead in conveying the message globally that they will welcome industries and projects laying out the red carpet and cutting the red rape that India has thus far been famous for. u.sharma@expressindia.com

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20 Y E A RS

In Express Pharma’s 20th year, we present the second installment of thought leaders predicting changes to watch out for in the pharmaceutical and healthcare sectors

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‘The health industry as a whole has a positive future’ In a free-wheeling conversation with Viveka Roychowdhury, Patrick Figgis, Global Health Leader, PwC and Sujay Shetty, Leader,Pharma and Life Sciences, PwC India, predict some of the changes that will unfold in the pharma sector in 2015

Intellectual property rights (IPR) have become a bone of contention in the pharma industry in India. The US closed its Fall 2014 Out-ofCycle Review reminding India that the Annual Special 301 Review of 2015 will follow, thereby putting the Indian government under pressure to modify its laws. How do you see the situation evolving in 2015?

Sujay Shetty: Compulsory licensing (CL) and patent litigation have been major irritants for the pharma industry in India and last year, the country has received ‘bad press’ on these issues. So this is not surprising. The global pharma industry’s stance is that India currently has CL in place, and that stricter pricing law and different competitive yardsticks are being used for them. For instance, compare the reaction in India when global pharma companies take over Indian ones and when an Indian pharma company undertakes the same.

MNC pharma companies have reasonably good market access in India, compared to other geographies such as China. The Abbott-Piramal deal is indicative of the fact that global pharma companies have the competence to take over companies in India. If one concedes that India has the sovereign right to price medicines, given that the country is an out-of-pocket market, where the cost of medicines will always be an issue, then the point is to figure out the other issues bothering

L-R: Patrick Figgis and Sujay Shetty

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global pharma in India.

Pharma MNCs are divided on these issues. The common bone of contention (among pharma MNCs) seems to be certain facets of India’s IP laws.

For instance, incremental innovation involving section 3(d) of the patent law. Most innovation is now incremental in nature. However, India does not award patents on this type of innovation. In the earlier scenario, western companies were the only beneficiaries of IP laws but today, Indian companies are also innovating and want to benefit from these laws. In fact, some Indian companies are actually cutting down on their research activities (in the country) to actually strengthen the argument [against section 3(d)].

There seems to be a growing understanding (in the Indian government) that we need a common IP law that helps Indian companies and recognises such innovations.

Also, keep in mind that the IP laws framed will impact sectors beyond pharma, for instance, India’s IT sector.

At some point, maybe there will be a discussion on what comprises CL and pricing levels. If section 3(d) is not up for negotiation then what’s left is maybe easier pricing environment, licensing, faster health insurance, greater access to government tenders, procurement, a softening of patent laws as well as better enforcement of laws by putting in place more patent inspectors. Enforcement of

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laws in the country is weak and India will have to show intent of purpose that the government respects IP laws and will therefore protect data.Again, the area of data protection is grey. MNC pharma companies feel that stricter protection of data can help.

India wants more investment but pharma companies are always going to say that more investment comes with more IP protection.

It is clear that the country will have to resolve the IP issue because only then will investments come to India. For instance, R&D expenditure for global pharma companies has so far gone to China.

Pharma MNCs also want better regulations in India.

Take for instance the clinical research and trials sector in the country which have also suffered because of issues related to the informed consent process, compensation guidelines, the Supreme Court restricting the number of trials per investigator or doctor, etc.

The National Institute of Health, US, has said that it will not take any more data from trials based out of India.

Due to such regulations, pharma MNCs claim that they are unable to conduct more trials in India. The laws are complex and there are delays in the approval process, etc.

These are the issues both sides need to discuss.

In September 2014, Gilead Sciences signed nonexclusive licensing agreements with seven Indian generic pharma manufacturers, for ledipasvir/sofosbuvir to expand access to its chronic hepatitis C medicines in developing countries. Many are seeing this as a new trend of innovator companies working around CL by opting for voluntary licensing (VL).

Going forward, do you see this trend continuing?

Shetty: I think this case is meant to do good things to the discussion around CL. The company’s price for the same product in the US ($84,000 for a 12-week course) sparked

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There will be significant change over the next 10 years. The companies that made up the industry 20 years ago are different from those today, thanks to many M&As. And these will no doubt differ 20 years down the line outrage in the country. In India, the price is one-tenth of the US price. It is an innovative deal and dilutes the argument around CL, and shows working of the patent. This could be an extraordinary way forward but this is a public policy decision.

Do you see this deal influencing the approach of other innovator pharma companies and can they adopt this or variations of this model?

Patrick Figgis: We are in an era where we are seeing extraordinary change in the

pharma environment. We will have to evolve in order to deal with some of the healthcare challenges we are facing.

Over the next few years, we will see a continuation and even an acceleration of the transformation of the industry.

The old way of doing business will no longer be satisfactory and we have seen this in the way deals have been structured in the recent past. It is not just companies merging, but asset and portfolio swaps have also taken place. We are seeing different deal options, business models and practices.

A number of pharma companies themselves have come under significant pressure from their practices on the ground, from the Foreign Corrupt Practices Act of the US, similar regulations in the UK and other countries, in the way their sales forces or practices have been found to be operating. Some companies in China had attracted the headlines, but they are not the only organisations, either in China or elsewhere in other geographies.

The entire industry must look at the way regulatory demands are practised by their workforce right down through the organisation. It is one of the top priorities of CEOs as well as the board members of pharma companies and they are acutely conscious of the reputation of the business.

The challenge for them often is the translation of the policies and discussions at the board level all the way down through the organisation to their workforce around the world. As business models become complicated, third parties have also become a part of the eco-system, and pharma companies have to ensure that they too follow the same processes, policies and systems as their employees.

This is a big challenge and pharma companies are doing a lot to improve practices and processes.

To be ahead in the game, and have a future-proof strategy in place, companies need to always ask, “What are we doing today, that we think is

Global companies are growing by M&As, but Indian companies are organically growing into great sizes. Six years back, there was only $ one-billion company, whereas today there are already $ eight billion companies proper and normal, which in five years time, society or the regulator will say it’s not?”

But even that’s not enough.

You can have the best policies, practices and systems but if they are not in the DNA of the individual, or not practised instinctively, they are redundant.

Hence, company managements are working on the psychology and the DNA of the organisation, defining what it stands for, its ethics as well as moral values. There will always be things that go wrong or mistakes that are made.

However, CEOs want to be confident that in any part of the network, their people are doing the right thing, when nobody is looking, and that defines the culture of the orgnaisation.

Shetty: We advise pharma companies faced with these issues to learn from other industries, particularly those that are also heavily regulated.

Things have gone wrong in these industries as well. For instance, the energy industry, where there have been a number of disasters, either because policies or practices fell short or due to behavioural issues. The financial services sector for instance, where many people believe that things started to go wrong because of the cultural DNA of some of the personnel in that industry.

Nothing comes close to the US FDA issues facing the pharma industry in India.

Companies who have everything going for them are confronted with this issue and they ask, “What can we do about the culture? How much can you train people?”

Express Pharma completed 20 years last December. If you were to predict the changes in the next two decades, what would your predictions be?

Figgis: From a global perspective, I am an optimist about the pharma industry. I do think that there are challenges but the health industry as a whole has a positive future.

There will be significant change over the next 10 years.

The companies that made up the industry 20 years ago are different from those today, thanks to many M&As. And these will no doubt differ 20 years down the line. The family tree of the pharma industry is complex: with a host of births, deaths, marriages, divorces and this complexity will continue.

There will be a new round of different deals, alliances and asset swaps. There will be many new players, some spunoff from existing companies.

There will also be a significant transformation of the existing players on the pitch.

The dynamics between players will also see a change.

MANAGEMENT Partnerships and conversations between the private and public sectors, companies, governments, and regulators will increase because there will be a mutuality of interests. It is not perfect now but in order to deal with many of the challenges facing the industry, we will see a more common conversation.

People will be collaborating much more than they were 20 years ago.

The demand for quality and knowing that the quality standards are met will increase.

This will be driven by the regulator but also by the consumer who will become an ever more active participant in the story. This consumerism and wanting to be part and parcel of the play, is true particularly for those who have grown up as ‘millennials’ using technology and now have some understanding, data and knowledge to become much more active participants in the health eco-system.

What are your predictions for the pharma industry in India?

Shetty: Similar to the global scenario, there will be new entrants. Twenty years from now, the size of the existing companies will change. Global companies are growing by M&As, but Indian companies are organically growing into great sizes. Six years back, there was only one-billion dollar (Indian pharma) company, whereas today there are already eight billion-dollar companies. By 2020, there will be quite easily double that number. Scale breeds more scale after a certain amount of time.

But the interesting part is that there are a lot of new entrants in India. For instance, pharma companies are innovating along with companies who are making apps, different platforms for folding proteins and bioinformatic companies. Some of them will grow to scale as they are being funded by serious private equity players.

This whole eco-system will look different.

Ultimately India needs to produce novel therapeutics, in

We advise pharma companies faced with these issues to learn from other industries, particularly those that are also heavily regulated SUJAY SHETTY, Leader,Pharma and Life Sciences, PwC India

Over the next few years, we will see a continuation and even an acceleration of the transformation of the industry. The old way of doing business will no longer be satisfactory PATRICK FIGGIS, Global Health Leader, PwC terms of biologics and new drugs. Some Indian companies such as Glenmark already are doing some serious science in this area.

Figgis: The scientific needs are shifting as the health needs of the population in the last century were different. If you were to track the health needs of the last century and compare them to those of this century, they are fundamentally different. The challenges due to obesity and diabetes that we face today are enormous ticking bombs for major territories around the world.

This requires a different response from not just pharma companies but from healthcare providers as well.

There is an increasing emphasis to take greater responsibility for our own personal health and well being.

It is no accident that across the world we are seeing many devices, greater emphasis on consumer goods as well as technology companies investing billions of dollars into this market. From wearable devices, to exercising in different ways to eating different foods, you have got dramatically more invigorated consumer populations that want to take more responsibility for their personal health and well being as a preventive measure rather than relying on somebody to fix them when they fall ill.

What about the role of governments 20 years down the line? In India, the

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government is a provider as well as a regulator. There is an argument that they should not be providers but just regulators and implementors of regulation.

For instance, in India we have the Jan Aushadi stores initiative by the government which was supposed to provide affordable medicines from post offices, but this scheme has not taken off. How will the role of governments evolve?

Figgis: We are seeing a trend of similar questions being asked at a global level as well. Health ministries in many countries did and are undertaking several initiatives. They have been regulators, providers, employers, as well as insurers who are now asking,’what are the essential elements, the core ingredients that only we can do? And what are the things that somebody else can do just as well, if not better?’ This can be about regulation, setting quality standards, but might not include being a vast employer of doctors and nurses providing care in hospitals.

Shetty: As far as India is concerned, (on this front), I do not see any trends that will be different 10 years down the line, but where one would hope it goes is that the government tries to get the pricing (of medicines) right. 20 years from now, we will have double the population that we have now. In fact, we might have three billion people by then, with chronic and acute diseases, plus sanitation issues. This will be in

addition to rich world diseases co-existing in phenomenally large numbers. So how do you provide for this population, especially when you do not have a UK-style National Health Services system nor do we have the US-style insurance service?

I hope the government then starts thinking along the lines of UK's National Institute of Health and Care Excellence (NICE) or the US’ National Institute of Health (NIH) which set how to determine value from a drug and how to price it.

The price cannot be brought down to the lowest common denominator or given for free.

Hence, there will be a role for the government in India in terms of pricing because at all times, market access and affordability will be key since no matter how wealthy India gets, it will still have large portions of populations underserved. It is unlikely that health insurance will grow fast enough, though it will grow to a certain extent.

Therefore, the role of the government in India as a far more effective regulator, as the body that controls prices will continue. It has got out of providing services (healthcare) because it realises that it does not have the wherewithal to fund the provision of services so it has now moved to the payer side. To continue as an effective payer, its deficits must be in order, which at the moment is rather stretched.

This depends a lot on the economic growth and it’s predicated on the assumption

that we will grow at the rate of eight to nine per cent over the next decade.In order to make sure the government can pay, it will control the prices.

We can see the first two situations (effective payer and controlling prices) unfolding, but we do not see the last part happening, which is about regulation, because the pharma regulatory system in India is under-staffed. It tries but it is not harmonising with the US and the UK, in terms of quicker regulation of products to the market.

These three roles will continue to play an instrumental role in the industry over the next decade, but the question is how effective will they be? Can they do it more efficiently? Will they use health technology assessment tools? Will they look at epidemiological data?

Will they procure more and increase the size of the market?

Will they distribute them more efficiently?

In this aspect, the present government is different from the previous one because it concentrates on implementation as opposed to big bang reforms. So they can get all of these things implemented a lot more smartly.

Figgis: Another trend that will impact the pharma industry is that over the last few years, a large portion of the world’s population has moved out of poverty into the middle-income group and I predict this too will increase.

And the consequence of this trend on healthcare is quite stark. The number one priority for people living in poverty is getting a job. But as income levels rise, other factors pertaining to the quality of life become more important. They demand better quality of education, housing, clean water, infrastructure and of course better healthcare. Health has become a political issue. A number of elections are due to be held in 2015. In emerging markets, particularly, I predict that health will be much higher up the political agenda as voters go to the polls. viveka.r@expressindia.com

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Issues and trends in the Indian pharma industry There is a dire need for carefully balancing the requirements of the public and the industry, opine Bhavik Narsana, Partner, Khaitan & Co and Arijeet Mukherjee, Associate, Khaitan & Co as they examine the legacy and new issues facing this industry

THE INDIAN pharmaceutical industry is one of the most attractive investment destinations in the world. With ever increasing returns, lowering risks and anticipated multifold growth, investors are more interested in this industry than ever before.

Since 2000, the drugs and pharma sector has attracted one of the highest foreign direct investment (FDI) inflows of approximately $12,689 million (April 2000 to September 2014).1 From its nascent stages in the 1970s, the Indian pharma industry has become a mature industry. While, the industry was previously known for manufacturing generic drugs, the industry dynamics have now undergone a sea of change. Presently, the Indian pharma industry stands diversified into various spheres of activities including research and development (R&D), manufacturing of branded, generic and branded generic drugs, manufacturing APIs, laboratory testing and clinical research. The Indian pharma industry ranks fourth in terms of volume and 13th in terms of value globally.2 India has become a prime destination for manufacture of branded, generic and branded generic medicines with a strong export element. It is estimated that around 40 per cent of the generic drugs in the US come from India and with Obamacare being introduced this figure is set to rise further.3 The spending pattern of an erstwhile manufacturing-oriented industry has also changed with the industry spending around 18 per cent of revenue on R&D activities.4

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BHAVIK NARSANA, Partner, Khaitan & Co

ARIJEET MUKHERJEE, Associate, Khaitan & Co

pharma industry and how the scenario is changing.

IPR: A changing face Intellectual property rights (IPR) in the pharma sphere have been a contentious issue globally.

Previously, the IPR debates were typically between the branded pharma companies and generic pharma companies. India was no exception to this IPR tussle and in view of the large poor population in need of basic healthcare, the Indian authorities were initially not keen on granting substantial IPR protection. However, over a period of time, the Indian authorities have become more sensitised to the need and importance of IPR protection for the long-term good of industry.

Better patent protection

Unlike many other countries, the involvement of the Indian government in the pharma industry has been deep and often controversial. The government has made numerous efforts to stimulate organised growth of the industry. In the pursuit of achieving global leadership in the manufacture of end-to-end drugs, the government unveiled its Pharma Vision 2020, which

inter alia, provides for reduction in approval time for new facilities to boost investments. Further, robust mechanisms such as the Drug (Prices Control) Orders and the National Pharmaceutical Pricing Authority (NPPA) have been implemented to address the issue of affordability and availability of medicines.5 The growth story of the Indian pharma industry into a

mammoth industry is an impressive one marked with numerous important turning points. These turning points have typically stemmed from the issues faced by the industry and have changed the nature and mechanisms of the industry, and to a large extent have sculpted the trends in the industry. In this article we aim to explore a few issues that have affected the Indian

The (Indian) Patents Act was enacted in 1970 and inter alia contains provisions relating to pharmaceutical patents. A major change in the patent laws in India was the enactment of the Patent (Amendment) Act, 2005, which made patent laws in India compliant with the TRIPS. Prior to the 2005 amendment, only processes were patentable and not the end product itself. Therefore, if a company chose to manufacture the same product but used a different process, it could do so without violating Indian patent laws.

This regime naturally caused concerns to various companies, especially branded manufacturers, as it did not protect their inventions fully and allowed others to manufacture the same drug, which would have

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otherwise enjoyed patent protection in other jurisdictions.

With the 2005 amendment being enacted, product patents and process patents have been permitted for a period of 20 years and special provisions have been introduced to prevent ever-greening of patents.

The 2005 amendment is viewed as a milestone which substantially changed the protection regime in India. However, patent disputes have regularly arisen in India, recently in the context of compulsory licensing.

who were often reluctant participants in such working mechanisms, have breathed a sigh of relief. Previously, the pharma companies had to participate in certain ‘informal’ arrangements due to a lack of alternatives; these orders of the CCI have paved a way for greater transparency.

Such orders of the CCI have impacted the root market mechanics of drug distribution in India. Now, stakeholders are wary of entering into such arrangements or other “informal” arrangements which may have anti-competitive effects and the industry can look forward to more transparent domestic drug distribution system.

Locking horns on compulsory licensing Though there was an overall improvement in patent protection in India, recent issues such as granting of compulsory licenses (CLs) have been contentious.

Under Indian patent law CLs can be awarded inter alia if: ◗ The reasonable requirements of the public with respect to the patented invention have not been satisfied; or ◗ The patented invention is not available to the public at a reasonably affordable price; or ◗ The patented invention is not worked in the territory of India.6 In the pharma context, the conditions for grant of a CL are aimed at preventing a situation where the public health is prejudiced by the exclusivity granted to the patented product. Recently, the Supreme Court of India dismissed a Special Leave Petition for reversing the CL awarded to Natco Pharma.7 The Natco-Bayer case was the first case on CL, wherein Natco had been granted a CL for Bayer’s patented drug Nexavar, since all the grounds for granting a CL under the (Indian) Patents Act, 1970 had been met.

While CLs have been viewed in the developing world as a necessary evil, they have also caused grave concerns in the industry due to the revenue loss that CLs tend to cause. In a recent order by the Controller of Patents, it has been held that granting a CL should be the last resort and efforts for obtaining a voluntary license should be made first.8 This order provides some comfort to the industry, as it clarifies the legal position that

so long as the patentee’s does not meet the conditions for grant of CLs under the Patents Act, 1970, its patent rights would not be interfered with.

Though there is a lure for short-term decisions which bring relief to the public, but such decisions should not prejudicially affect the pharma industry on the whole. There is a dire need for carefully balancing the requirements of the public and the industry.

Stricter trademark enforcement Another observable trend in the IPR sphere is the stricter enforcement of trademark contraventions in India. In the pharma sphere this trend is comforting as trademark contraventions may lead to use of wrong drugs.

The Indian courts have, through various judgments, taken a very strict view on issues of passing off by using deceptively similar marks and even formulating criteria to examine competing claims. A case in example is of Cadila Health Care Cadila Pharmaceutical Ltd,9 wherein it was held that in an action for passing off on the basis of unregistered trade mark, for deciding the question of deceptive similarity inter alia the following factors have to be considered: ◗ The degree of resemblance between the marks, phonetically similar and hence similar in idea; ◗ The similarity in the nature,

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character and performance of the goods of the rival traders; and ◗ The class of purchasers who are likely to buy the goods bearing the marks they require, on their education and intelligence and a degree of care they are likely to exercise in purchasing and/or using the goods.

Though trademark disputes are common in India, decisions such as the Cadila judgement have helped in bringing clarity to the legal scenario in India.

Anti-trust: Changing the old workings ways The archaic Monopolies and Restrictive Trade Practices Act, 1969 was replaced by the Competition Act in 2002, which established the Competition Commission of India (CCI). Since its inception, the CCI has passed various orders on prevalent working practices of the Indian pharma industry.

The pharma market in India was dominated by a number of national and state level chemist and druggist associations.

Whenever a pharma company wanted to appoint stockists, wholesalers or distributors, it had to obtain a NOC/letter of consent from such associations as pre-condition to such appointment. The CCI has been closely examining this issue and in numerous orders had held such practices as anti-competitive.10 Many pharma companies,

M&A in Indian pharma sphere General outlook towards foreign investments India has a large population with a limited access to affordable healthcare. In this regard, some of the primary concerns in allowing foreign investment in the Indian pharma industry included ensuring (i) continuous availability and supply of drugs, (ii) non-discontinuance of essential medicines, and (iii) an increased supply of drugs over a period of time. Therefore, the policy allowing foreign investment into the Indian pharma sector has to play a balancing act between meeting the needs of the people and the capital needs of the industry.

Presently, FDI up to 100 per cent is permitted in brownfield investments, with prior approval of the Foreign Investment Promotion Board (FIPB) and for greenfield investments, FDI up to 100 per cent is permitted with no requirement of prior FIPB approval.

The drugs and pharma sector has attracted one of the highest FDI inflows in India. It has been a matter of debate whether such investments have indeed benefitted the Indian pharma industry or not. Recently, there have been demands from certain quarters of the government for banning brownfield foreign investments altogether. While increased access to capital is necessary for growth of any industry, in the

pharma context such increased investments should be accompanied with technology sharing, increased production and increased employment generation. FDI coupled with such accompaniments can achieve long-term sustained growth and could ensure world class facilities in India.

It is necessary that FDI fuelled growth should not be artificial in nature and should act as a catalyst in developing a world class pharma industry which takes care of the needs of the vast populace of the country.

Non-competes in M&A An issue typically faced in foreign investment transactions in the Indian pharma industry is that of non-compete clauses which restrain the selling promoters from engaging in similar business. Non-compete clauses have been a constant demand of acquirers/purchasers.

The rationale and effect of non-compete clauses has been contentious and due to the nature of the pharma industry, the effects of non-compete can be positive as well as negative. The CCI frowned upon long periods of non-compete, and in the past contracting parties have modified their transactional documents to reduce the duration of non-compete.11 Since then, the position regarding non-compete clauses has been clarified to a certain degree by the FIPB, now non-compete clauses are not permitted except in special circumstances.12 Presently, there is no clear guidance as to what constitutes ‘special circumstances’ and there remain many grey areas surrounding its interpretation e.g. non-compete clauses in transaction structures such as stock transfers where the selling promoter is still employed by the company, or non-compete clauses for a selling shareholder who does not sell his shareholding completely and remains a party to the shareholding agreement.

It would be interesting to see how non-compete clauses in such structures and other complex structures are treated by the FIPB in the near future.

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MANAGEMENT Pricing: An age old conflict Unlike the pharma sector in countries such as the US, Indian pharma market is a price controlled one. Pricing remains a contentious issue and more often than not, the pharma industry and the regulators lock horns on pricing issues.

The pricing conflict has been raging in India since the 1970s, where for the first time the government had restricted the profitability of pharma companies through Drug (Prices Control) Order (DPCO). Since then a number of DPCOs have been brought in for controlling drug prices.

In 1997, through a resolution of the Ministry of Chemicals and Fertilisers, an independent body of experts was established called the NPPA.13 One of the primary objectives of the NPPA was to fix /revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in India.14 In addition to the National List of Essential Medicines, NPPA’s mandate extends to monitoring the prices of decontrolled drugs in order to keep them at reasonable levels.

Recently, the NPPA has been flexing its muscles and has issued orders for price control of various drugs and some of these decisions have been challenged in the courts of law. This trend of a more active NPPA has been welcomed by the general populace as it prevents patients from being priced out of affordable healthcare. At the same time, price control is seen as a major setback for many pharma companies as consequential revenue losses may make the production of price controlled drugs commercial unviable.

In view of the recent spike in the drug prices in the US, the question of decontrolling the Indian pharma industry has been laid to rest and many believe that price control mechanisms are here to stay. It is expected that with an ever more vigilant regulator and a growing industry, pricing of drugs is to remain a contentious issue.

India: The next R&D destination The privatisation and globalisation policy of the government of

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Recently, the NPPA has been flexing its muscles and has issued orders for price control of various drugs and some of these decisions have been challenged in the courts of law. This trend of a more active NPPA has been welcomed by the general populace as it prevents patients from being priced out of affordable healthcare India in the mid-1990s provided incentives to R&D in the pharma sphere. Innovative products were given exemption from price control, a number of financial schemes were made available to firms for undertaking R&D, technology collaborations were brought under the automatic approval route, and patent rights were granted for a period of 20 years for products as well as processes.15 This incentivisation created a seismic shift from the practice of only manufacturing to a practice of innovation. India was previously known as the generic capital of the world owing to the wide spread reverse engineering industry, this is now changing and companies in India have started to develop and innovate drugs.

More than 870 multinational companies have set up their R&D operations in India since 1985, the first one being Texas Instruments.16 The prime reasons why R&D in India is viewed as beneficial are: ◗ Cost effectiveness: The cost of setting up world class R&D facilities in India cost a fraction of what they do in the west. The overall R&D costs are about one-eighth and clinical trial expenses around one-tenth of western levels;17 ◗ Skill: A large pool of English speaking technical skill power is available at a low cost with highly developed R&D oriented skill sets; ◗ Established R&D centres: Pre-established state of the art R&D centers offer logistic convenience and cost effectiveness; ◗ Growing biotechnology industry: Indian biotechnology industry has grown by leaps and bounds and has some world class players; ◗ Market access: India is one

of the fastest growing markets in the world. R&D in India allows companies to gain a foothold in this new and growing market; ◗ Rising household incomes: The growing middle class in India is an attractive market for drugs. With increasing disposable incomes, the market for non-essential drugs, is set to grow rapidly; ◗ Governmental incentives: Post the liberalisation era, the Indian government has offered numerous incentives to R&D in India; and ◗ Biodiversity: Some drugs aimed at the Indian market require certain gene specific R&D and clinical trials. India’s rich genetic bio diversity offers a perfect destination for such R&D and clinical trials.

Pharma R&D in India is expected to witness exponential growth in the near future, and with the growth of the economy and pharma industry in India, innovation assumes new economic importance in the Indian pharma industry.

Future of Indian pharma The Indian pharma industry has come a long way and made significant progress in infrastructure development and technical and R&D capabilities. With the integration of the Indian pharma market with the global market, new issues are being faced and tackled by the industry. Some old challenges such as IPR and pricing continue to be contentious issues in the market. The trends of increased foreign interest in the markets and increased investments in R&D are expected to stay.

With numerous strengths and a growing consumer

class, the pharma industry in India may face certain legacy and new issues, but it is expected to grow multifold and continue to be an attractive investment destination.

Druggists Association (Suo motu – Case no. 02/2012) and Reference Case No 01/2013 filed under section 19(1) (b) of the Competition Act, 2002 by Dr Chintamoni Ghosh, Director, Directorate of Drugs; M/s Arora Medical Hall, Ferozepur vs Chemists and Druggists Association, Ferozepur and Ors (Case No 60/2012); M/s Santuka Associates Pvt Ltd vs All India Organisation of Chemists and Druggists and Ors (Case No 20/2011); M/s Sandhya Drug Agency vs Assam Drug Dealers Association and Ors (Case no. 41/2011); and M/s Peeveear Medical Agencies, Kerala vs All India Organization of Chemists and Druggists and Ors (Case no. 30/2011).

References 1. FDI statistics, Department of Industrial Policy and Promotions, Ministry of Commerce and Industry, Government of India.

Available at (http://dipp.nic.in/English/Publications/FDI_Statistics/2014/in dia_FDI_September2014.pdf) 2.“Indian Pharmaceutical Industry”, available at (http://www.indianmirror.com/i ndian-industries/pharmaceutical.html) 3.“Obamacare Has Hidden Benefits – For India”. Available at (http://www.bbc.com/news/worl d-us-canada-24407452) 4. Available at (http://www.investindia.gov.in/pharmaceuticals-sector/)Available at 5. http://www.ibef.org/industry/pharmaceutical-india.aspx) 6.Section 84 of the (Indian) Patents Act, 1970 7.Order of the Hon’ble Supreme Court of India dated 12 December 2014 in Special Leave Petition (C) NO(S). 30145/2014 8.CLA 1 of 2013, BDR Pharmaceuticals International Private Limited v. Bristol Myers Squibb Company, order dated 29 October 2013.

9.Cadila Health Care v. Cadila Pharmaceutical Ltd [(2001) PTC (SC) 561] 10. In Re: Bengal Chemists and

11. Please see Order of CCI dated 21 December 2012 in Combination registration No C2012/09/79. Available at (http://www.cci.gov.in/May2011 /OrderOfCommission/CombinationOrders/C-2012-09-79.pdf) 12.“Foreign Direct Investment in Pharmaceuticals sector – clarification”. Available at (http://rbidocs.rbi.org.in/rdocs/n otification/PDFs/APDIR124NT 0414.pdf) 13. Available at (http://www.nppaindia.nic.in/re solu1.htm) 14.Available at (http://www.nppaindia.nic.in/A boutNppa.htm) 15.Reji K Joseph, “The R&D Scenario in Indian Pharmaceutical Industry”, available at (http://www.ris.org.in/images/RIS_images/pdf/dp176_pa p.pdf) 16. “Global R&D Summit 2013Destination India”, report available at (http://www.ficci.com/spdocument/20284/FICCI-Battell e-Knowledge-Paper-GlobalR&D-Summit-2013[1].pdf) 17.“Biotechnology and Pharmaceutical Opportunities in India”, Sector Briefing, UK Trade & Investment, available at (http://www. clustercollaboration.eu/ documents/10147/101938/Biotechnology+and+Pharmaceutical+ Opportunities+in+India.pdf)

MANAGEMENT INSIGHT

Recent surge in pharma patent litigation The next decade or so in the pharmaceutical patent space in India will be interesting to watch out for. As more product patents get granted there will be an increase in the pharma patent litigation space, predicts Gowree Gokhale, Partner, Intellectual Property and Pharma regulatory practice and Ajay Chandru, Senior Member, Intellectual Property practice, Nishith Desai Associates, Legal & Tax Counseling Worldwide THE RECENT surge in India in pharma patent litigation is mainly attributable to the amendment made to the Patents Act, to bring it in line with Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS is administered by the World Trade Organisation (WTO). The importance of the TRIPS stems from the fact that it lays down minimum standards that the member countries need to provide to protect intellectual property (IP).

TRIPS was a result of intense lobbying by developed countries like US and Japan, who wanted to have uniform standards for the protection of IP, throughout the world, primarily to protect the interests of innovator drug companies. Under TRIPS, if a member country does not adhere to its obligations then another member country can lodge a complaint with the Dispute Settlement Body (DSB) of the WTO. IP laws of several developed countries like India and least developing countries did not meet the minimum standards laid down under TRIPS. The developing countries were given a period of ten years from the ratification of TRIPS to amend their domestic laws to bring them in line with TRIPS. The most important amendment that India was required to make in its patent law by 2005 was the introduction of product patent for pharma substances in India.

Under the first codified Indian patent law viz. the Patent and Designs Act, 1911, product patents were allowed for pharma substances in India. During this period the pharma industry in India was dominated by foreign companies with

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over 80 per cent market share. Most of the drugs in India were not locally manufactured but were imported. This resulted in the cost of drugs being significantly high. In 1970, the Indian Government, with an objective to bring down cost of drugs and to develop a robust domestic pharma industry, amended the Indian patent law that allowed only grant of process patents and not product patents. As a result, domestic pharma companies could reverse engineer patented drugs to make generic copies of the patented drugs. Thus, the prices of the drugs significantly decreased which fostered the growth of the domestic pharma industry.

In 2005, due to its commitment under TRIPS, India introduced product patents for pharmaceutical patents. It was feared that this would result in drug

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MANAGEMENT prices becoming significantly higher and would affect the domestic pharma industry and would also affect access to essential medicines. In order to allay such fears the Indian government introduced certain safeguards in the amendment to the Patents Act, such as Section 3 (d) that prevents evergreening of patents and also revised compulsory licensing chapter.

The introduction of products patent resulted in innovator foreign drug companies launching their patented products in India. During the interim period from 1995 to 2005 the Indian Patent Office (IPO) under TRIPS was required to accept product patent applications, also known as mail box application. However, this application would be examined only after 2005, i.e. once product patents were allowed in India.

So, essentially any launch of patented drugs would have to happen only after 2005. During this period around 9000 mail box applications were filed.

A majority of the product patents started getting granted only in 2009. As a result, the innovator foreign drug companies started filing infringement suits against domestic pharma manufacturers, which led to a sudden increase in patent litigation in the pharma space. These litigations over the past few years have resulted in a number of decisions being rendered by patent office, Intellectual Property Appellate Board (IPAB) and Indian courts who have established jurisprudence on the substantive provisions of the Indian Patent law, which were introduced in 2005. A well-developed jurisprudence provides certainty based on which key decisions in patent strategy, patent prosecution and patent infringement analysis can be taken.

However, some recent decisions of the Indian courts have raised concerns among foreign innovator drug companies, on whether Indian patent law is TRIPS compliant. The recent decision of the Indian Supreme Court in Novartis vs. Union of India, where the Court upheld the decision on the rejection of a patent application by Novartis for its beta-crystalline form

36 EXPRESS PHARMA February 1-15, 2015

Recently, there has been some initiatives by the Indian government to increase the numbers of examiners at the IPO and also to improve the infrastructure including digitising the records to reduce pendency rates. The IPO has recently issued guidelines to examiners for examining pharmaceutical patent applications after consultation with stakeholders of Imatinib Mesylate (Gilvec), and the decision of the IPAB and the Bombay High Court upholding the decision of the Controller of the Patents for grant of Compulsory License to an Indian pharma company NATCO Pharma Limited for Bayer’s Indian patent on Sorafenib Tosyalte (Nexavar) have raised concerns.

Such decisions have brought the attention of the US pharma lobbies claiming that Section 3 (d) and compulsory licenses provisions are not TRIPS compliant. The Indian government has stated that the current Indian patent law is TRIPS compliant. Whether, provisions such as Section 3 (d) and compulsory licenses are TRIPS compliant or not is a question for the WTO DSB to decide.

There have been talks in past from the Health Ministry to issue the second compulsory license for Dastanib after Nexavar. However, Department of

Industrial Policy and Promotion (DIPP) rejected this proposal.

Another major cause of concern for the foreign innovator drug companies has been the delay in the grant of patent and the lack of transparency at the Indian Patent Office. Currently, on an average it takes around four to five years from the date of filing of the patent, for a patent application to be granted or rejected. A patent is valid for a period of 20 years from the date of filing the application irrespective of when it is granted.

Such a long delay affects the foreign innovator drug company’s ability to recover their investment, as the life of the patent gets significantly reduced from twenty years. Further, unlike the US and Europe, there is no provision under Indian law to extend the validity of the patent in view of the time taken to obtain regulatory approval.

Recently, there has been some initiatives by the Indian government to increase the numbers of examiners at the IPO and also to improve the infrastructure including digitising the records to reduce pendency rates. The IPO has recently issued guidelines to examiners for examining pharmaceutical patent applications after consultation with stakeholders. These guidelines are likely to bring in uniformity to examinations of the patent applications and as a result may reduce the pendency of patent applications. On the transparency front, the IPO has in the past few years made all the patent prosecution history data files available online on their website. This has proven to be a boon, especially for patentees as it increases the accountability of the IPO. It has been almost 10 years since the product patent regime was introduced. It was initially

believed that it would let multi–national companies take over the major market share from Indian domestic pharmaceutical companies and it would disrupt their business model of selling generic reverse engineered drugs, but this has proven to be far from the truth.

The pharma market in India is dominated by branded generics, making up for 80 per cent of the retail market. It is estimated that only one to two per cent of the pharma market in India is made up of patented drugs, which are being sold by multinational innovator drug companies.

One of the main reasons for such a low market share for patented drugs in India is that most of the patented drugs have been in the life saving diseases segment. Accordingly most of the patent litigation in India has been concentrated in the life saving diseases segment.

However, recently there has been a change in this trend, as patent litigation has started in non-life saving diseases segment such as diabetes. India has the largest pool of diabetic patients in the world and the number of diabetic patients in India is expected to double in the next 10 years.

The next decade or so in the pharma patent space in India will be interesting to watch out for as more and more product patents get granted there will be an increase in the pharma patent litigation space. There will also be a shift to patent litigation in the non-life saving drug space, which is mainly attributable to increase in affluence, rise in life expectancy and the onset of lifestyle related conditions among Indians.

As Indian companies mature from generics to innovator drug companies they will also desire that Indian patent law becomes more patentee friendly. There is definitely a need to relook at some of the provisions of the Indian patent law and ascertain whether they are really achieving the intended objective, or merely creating a hurdle for growth of the pharma industry. Availability of affordable drugs can be achieved through other mechanisms such as price control and government procurement.

RESEARCH CLINICAL UPDATE

Novartis’Cosentyx gets approval in Japan Cosentyx approval is based on phase III programme demonstrating high, sustained efficacy in the skin clearance of moderate-to-severe plaque psoriasis JAPANESE MINISTRY of Health, Labour and Welfare (MHLW) has approved Novartis' Cosentyx (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis (PsA) in adults who are not adequately responding to systemic therapies (except for biologics).

This approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A (IL-17A) inhibitor to receive regulatory approval in either of these indications in Japan.

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA[14-19].

As approximately 30 per cent of psoriasis patients are also affected by PsA globally[12], this approval means that these patients in Japan now have a new treatment option that effectively treats both diseases.

In psoriasis clinical trials, 70 per cent of patients achieved clear or almost clear skin within the first 16 weeks of treatment with Cosentyx 300 mg (p<0.0001), which was maintained in the majority of patients up to Week 52 (with continued treatment)[1]. In the PsA trials, Cosentyx demonstrated significant and sustained efficacy versus placebo in improving signs and symptoms of PsA, as measured by a 20 per cent reduction in the American College of Rheumatology response criteria (ACR 20), which is a standard criteria to assess the effectiveness of arthritis treatments. Between 50- 54 per cent of Cosentyx patients achieved at least ACR 20 in two pivotal studies, FUTURE 1 (150 mg; p<0.0001) and FUTURE 2 (150 and 300 mg; p<0.0001)[4],[5].

Psoriasis is a chronic immune-mediated disease characterised by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life[6],[20],[21]. Closely linked with psoriasis, PsA causes joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis and irreversible joint damage[13]. Up to 40 per cent of people can suffer from joint destruction and permanent physical deformity[22].

This approval was based on the safety and efficacy results from more than 10 phase II and phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis[1-3],[13] and supported by two pivotal phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA[4],[5]. In all studies, Cosentyx demonstrated a favourable safety profile, with similar incidence and severity of adverse events (AEs) between Cosentyx treatment arms (300 mg and 150 mg)[1-5],[23].

US Food and Drug Administration (FDA) approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

References [1] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis: results of two phase three trials. N Engl J Med. 2014. Jul 9;371(4):326-38.

[2] Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Administration by Pre-filled Syringe: Efficacy, Safety, and Usability Results from a Randomized Controlled

To subscribe: bpd.subscription@expressindia.com

Trial in Psoriasis (FEATURE). Br J Dermatol. 2014; [published online ahead of print August 16, 2014].

[3] Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014; [published online ahead of print September 22, 2014].

[4] Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, improves active psoriatic arthritis and inhibits radiographic progression: efficacy and safety data from a phase 3 randomized, multicenter, double-blind, placebocontrolled study. Oral presentation at: ACR/ARHP Annual Meeting, Boston, MA, USA, 2014. Presentation number 948.

[5] McInnes IB. Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study Using Subcutaneous Dosing.

Oral presentation at: ACR/ARHP Annual Meeting, Boston, MA, USA, 2014. Abstract number: L1.

[6] Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries

a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp. 2004;9(2):136-9.Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009; 361(5):496-509.

[12] Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.

[13] American College of Rheumatology (ACR) website.

"Spondylarthritis (Spondylarthropathy)."http://www.rheu matology.org/Practice/Clinical/P atients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed December 2013.

[14] Gaffen SL. Structure and signaling in the IL-17 receptor family.

Nat Rev Immunol. 2009;9(8):55667.

[15] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.

[16] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-18.

[17] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 func-

tion in disease. Immunology.

2010;129(3):311-21.

[18] Krueger J, Fretzin S, SuárezFariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol.

2012;130(1):145-154.

[19] Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin.

Brit J Dermatol.

2009;160(2):319-24.

[20] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.

[21] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.

[22] Medscape Reference website.

"Medical Care in Psoriatic Arthritis." http://emedicine. medscape.com/article/331037overview#a30. Accessed October 2014.

[23] Novartis data on file. 2013: Clinical study reports for CAIN457A2302 [ERASURE] ; CAIN457A2303 [FIXTURE] ; CAIN457A2307 [JUNCTURE] ; CAIN457A2308 [FEATURE].

EP News Bureau-Mumbai

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RESEARCH RESEARCH UPDATES

Researchers find clues on how melanoma resists effective treatments The two-year study looked at tumour samples from 15 melanoma patients RESEARCHERS believe they have discovered a mechanism by which tumours eventually evade effective combination treatments for melanoma, providing clues that could lead to longer-lasting therapies for the deadliest of skin cancers.

The two-year study, led by Dr Roger Lo, UCLA Jonsson Comprehensive Cancer Center, looked at tumour samples from 15 melanoma patients prior to therapy that combined a BRAF inhibitor with an MEK inhibitor and after they developed resistance to the drugs.

Previous research found that adding an MEK drug to a BRAF drug significantly lengthened the time before the disease began to worsen. That led to GlaxoSmithKline’s Tafinlar and Mekinist combination, and the combination of Roche’s Zelboraf with the experimental Exelixis drug cobimetinib awaiting US approval. The so-called targeted

therapies are designed to turn off specific molecular pathways associated with tumour growth. The approach can have dramatic effects, until tumour cells develop resistance.

“The resistance is basically a matter of time, but if we figure out the strategies by which the resistance happens we can propose new ways to suppress these mechanisms,” Lo said.

“If we can understand better what type of (genetic) mutations occur in melanoma we

can design better and better drugs to suppress these. Either new drugs, better combinations of drugs or better regimens of drugs,” Lo said. By studying genetic material from tumors that developed resistance to the combination therapy, Lo’s team found highly unusual changes in key cancer genes.

“What we found was genetic alterations were much more exaggerated,” Lo said.

“Most of the time when a gene is increased for the bene-

Europe recommends approval for first stemcell therapy

fit of cancer, usually you see four copies, 10 copies,” Lo said. “Here, we’re finding 80 or 100 copies.”

“This is the result of a severe evolutionary pressure imposed on the cancer by the drugs. It’s almost a signature of resistance to the combo drug.”

Along with the findings, published recently in the journal Cancer Cell, Lo’s group proposed potential ways of fighting the resistance, including intermittent therapy that would take a break from exposing the tumour to the drugs.

“Other ideas includes inhibitors that would inhibit certain types of signaling that specifically target mechanisms of resistance,” Lo said.

“We need to study iterative resistance to therapies so we can construct better and better therapies to push the curve to increased survival.”

EUROPEAN regulators have recommended approval of the first medicine containing stem cells to treat a rare condition caused by burns to the eye. The European Medicines Agency said that Holoclar, from privately held Italian company Chiesi, had been given a green light for moderate to severe limbal stem cell deficiency due to physical or chemical burns. Left untreated, the condition can result in blindness.

Holoclar is a living tissue product made from a biopsy taken from a small undamaged area of the patient’s cornea and grown in the laboratory using cell culture.

The recommendation by the European agency will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

Reuters

Reuters

Achillion data shows promise of shorter-duration hep C treatment DATA FROM Achillion Pharmaceuticals's hepatitis C drug trials showed the company could develop a shorter-duration treatment rivaling offerings from Gilead Sciences and Abbvie. The company said it would test a combination of two of its experimental hepatitis C drugs after they showed promise against the virus in separate studies.

Data from the first study, testing a combination of Achillion’s NS5A inhibitor, ACH-3102, and Gilead's blockbuster Sovaldi, showed signs that the virus disappeared

38 EXPRESS PHARMA February 1-15, 2015

within four weeks, following a six-week course of therapy.

Gilead's Harvoni, which combines Sovaldi with the company's own NS5A inhibitor, achieves this response only after eight weeks of therapy. The main goal of Achillion’s ongoing mid-stage study is to achieve a sustained virological response 12 weeks after therapy that would constitute a cure.

The market for hepatitis C drugs has developed at a lightening pace in recent years, with several companies working on producing newer drugs to treat the disease that affects about

The company said it would test a combination of two of its experimental hepatitis C drugs after they showed promise against the virus in separate studies 150 million around the world.

The US health regulator recently approved Abbvie's hep C cocktail. In a separate earlystage study, Achillion's nu-

cleotide inhibitor, ACH-3422, also demonstrated potent antiviral activity.

William Blair’s Katherine Xu said the company's ACH-

3422 was slower to exert its effects than Sovaldi, adding that its nucleotide inhibitor needs to be equally effective for Achillion to attract takeover interest. Achillion, one of the few companies developing hepatitis C drugs independently, said it planned to start mid-stage studies to evaluate the combination next year. Wells Fargo's Brian Abrahams said an allAchillion combination could still have an edge over competition as ACH-3102's high barrier to resistance will offset ACH-3422's slower effect.

Reuters

RESEARCH

Cooling brain protein could aid search for Alzheimer’s treatment Researchers were able to simulate the effects of body cooling in mice and pick apart the workings of a so-called ‘cold-shock’ protein in the brain, RBM3 SCIENTISTS HAVE found a mechanism that kicks in when the body is cooled and prevents the loss of brain cells, and say their find could one day lead to treatments for brain-wasting diseases such as Alzheimer's.

Studying mice, the researchers were able to simulate the effects of body cooling and pick apart the workings of a so-called ‘cold-shock’ protein in the brain, RBM3, which has previously been linked with preventing brain cell death.

“We’ve known for some time that cooling can slow down or even prevent damage to brain cells, but reducing body temperature is rarely feasible in practice (because) it's unpleasant and involves risks such as pneumonia and blood clots,” said Giovanna Mallucci who led the research.

“By identifying how cooling activates a process that prevents the loss of brain cells, we can now work toward finding a means to develop drugs that might mimic the protective effects of cold on the brain.”

Scientists already know that lowering body temperature can protect the brain. People can survive hours after a cardiac arrest with no brain damage after falling into icy water, for example, and artificially cooling brains of babies with oxygen deprivation at birth can also protect against brain damage.

Cooling and hibernation in animals prompts production of certain brain proteins known as ‘cold-shock’ proteins. One of these, RBM3, has been linked with preventing the death of brain cells and synapses, but scientists are not sure how it works.

Knowing how these proteins affect synapse regeneration might help researchers find a way of mimicking them without the needing to cool the body down.

Mallucci’s team reduced healthy mice's body temperatures to 16-180 cel-

Cooling and hibernation in animals prompts production of certain brain proteins known as ‘cold-shock’ proteins

sius -- similar to that of a hibernating small mammal, for 45 minutes and found that the mice's synapses dismantled on cooling and regenerated when re-warmed.

The team then repeated the cooling in mice that had been specially bred with features of neurodegenerative diseases like Alzheimer’s and found the capacity for synapse regeneration fell as the disease progressed, and that RMB3 levels also dropped.

When the scientists artificially boosted levels of RBM3 they found it protected the Alzheimer’s mice, preventing synapse and brain cell depletion.

Hugh Perry, chairman of Britain's Medical Research Council's neurosciences and mental health board, which funded the research, said the finding may be important step forward.

"We now need to find something to reproduce the effect of brain cooling.

We need to find drugs which can induce the effects of hibernation and hypothermia," he said.

Reuters

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RESEARCH

Scientists find key gene mutations behind inherited heart disease Researchers sequenced the gene encoding the muscle protein 'titin', known to be linked to this leading cause of inherited heart failure SCIENTISTS HAVE identified the crucial genetic mutations that cause a common heart condition called dilated cardiomyopathy (DCM), paving the way for more accurate diagnosis and screening of high-risk patients.

In a study of more than 5,000 people, researchers sequenced the gene encoding the muscle protein ‘titin’, known to be linked to this leading cause of inherited heart failure, to try to find which variations in it caused problems.

“These results give us a detailed understanding of the molecular basis for dilated cardiomyopathy,” said Stuart Cook, a professor at Imperial College London who led the study. “We can use this information to screen patients’ relatives to identify those at risk of developing the disease, and help them to manage their condition early.”

DCM is thought to affect around one in 250 people. It causes the heart muscle to be-

come thin and weak and often leads to heart failure.

Mutations in the titin gene that make the protein shorter are the most common cause of DCM, accounting for about a quarter of cases. But truncations in the gene are very common, around one in 50 people have one, and most of them are not harmful, making it difficult

to develop an accurate genetic test.

For their study, published in the Science Translational Medicine journal recently, Cook’s team sequenced the titin gene from 5,267 people, including healthy volunteers and patients with DCM, and analysed levels of titin in samples of heart tissue.

Their results showed that

mutations that cause DCM occur at the far end of the gene sequence, while mutations in healthy people tend to be in parts of the gene that aren't included in the final protein, allowing titin to remain functional.

“This study defines a comprehensive list of mutations in the titin gene, which of these are associated with dilated cardiomyopathy, and which are harmless,” said Jeremy Pearson, associate medical director at the British Heart Foundation charity which part-funded the research. He said this information would prove ‘extremely valuable’ for future diagnosis and treatment “as we enter an era when many people’s genes will be sequenced.”

The findings could also help researchers develop therapies to prevent or treat heart disease caused by titin mutations.

trial is currently being analysed and will be disclosed in the coming months, the company added.

With potential superior efficacy, UBS said in a research note that sales of GSK's vaccine might exceed $1 billion a year. Shingles is caused by the varicella-zoster virus, the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerve tissue but in older people in can reappear in the form of shingles.

TRIALS OF GlaxoSmithKline's experimental Ebola vaccine are likely to move to a second phase in February, later than previously suggested, after a meeting of national regulators said they needed more information. The World Health Organization, which hosted a meeting of national regulatory authorities and ethics committees recently, said they had thoroughly discussed all aspects of the proposed trials at the two-day meeting.

Countries where the trials are planned, Cameroon, Ghana, Mali, Nigeria and Senegal, should receive and review the additional information.

The GSK vaccine is already undergoing phase I trials, to check its safety in humans, in Switzerland, Britain, Mali and the US, and is one of the two leading candidate vaccines for Ebola already undergoing tests. The other vaccine, from NewLink Genetics is also still in phase I trials. One of its trials, in Geneva, was suspended earlier this month after some patients complained of joint pains. Johnson & Johnson plans to start clinical trials with a third vaccine shortly. WHO officials have said they hope the unprecedented fast-track trials mean vaccines may be widely available around the middle of 2015, although they also hope the outbreak will be over by then. So far it has killed almost 7,000 people. There are still many unresolved questions about the use of experimental vaccines, including whether subjects will need one or two injections.

Reuters

Reuters

Reuters

GSK shingles vaccine shows promising results GSK's vaccine, known as HZ/su, reduced the risk of shingles by 97.2 per cent in adults aged 50 years AN EXPERIMENTAL shingles vaccine from GlaxoSmithKline has produced impressive results in a late-stage study, giving the group's expanding vaccine unit a potential $1 billion boost.

The data suggests the British company's new shot could be a strong competitor for Merck & Co's established vaccine Zostavax, which is currently the only product on the market.

GSK's vaccine, known as HZ/su, reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo in the

40 EXPRESS PHARMA February 1-15, 2015

phase III clinical trial involving more than 16,000 individuals, the drugmaker said.

That result looks compelling compared to Zostavax, which has showed 69.8 per cent efficacy in patients aged 50 to 59 years, and lower efficacy in older people. However, the design of different clinical trials means direct comparisons are tricky.

The two vaccines work in different ways. Zostavax is a so-called live attenuated virus vaccine while HZ/su combines a protein found on the virus that causes shingles with an adjuvant, or booster, which is

intended to enhance the immunological response. The adjuvant includes a component from US biotech firm Agenus, which is entitled to royalties on any future sales.

GSK has not said when HZ/su might reach the market and a company spokeswoman said more data would be collected on the experimental shot next year.

Additional trials to evaluate the ability of HZ/su to prevent shingles are also underway in people aged 70 and older and in immunocompromised patients. The full set of safety data from the phase III

GSK Ebola vaccine trial seen moving to wider phase in February

PHARMA ALLY VENDOR NEWS

Safexpress opens logistics park in Faridabad Spanning over an area of 1,80,000 sq feet, logistics park is located on NH 2 LOGISTIC FIRM Safexpress recently launched its state-ofthe-art logistics park in Faridabad. Spanning over an area of 1,80,000 sq feet, logistics park is located on NH 2. Safexpress provides services to a vast array of business verticals ranging from healthcare, apparel and lifestyle, Hi-Tech, publishing to automotive, engineering and electrical hardware, FMCG and consumer electronics and institutional.

Pawan Jain, Chairman and Managing Director, Safexpress said, “Supply chain and logistics has a vital role to play in the growth of numerous industrial centres spread across the Haryana region. Safexpress has developed an ultra-modern facility at Faridabad, which will serve as a transhipment hub as well as a warehousing facility.

Safexpress, with its logistics park at Faridabad, will bridge the infrastructure gaps and serve the supply chain and logistics requirements of the entire region.”

Jain further said, “Safexpress has formed a separate firm by the name of ‘Safexpress

B2C’ to develop its e-commerce logistics business. Safexpress B2C has tied up with large number of e-commerce companies to provide its specialised logistics services to them. We have made massive investments to further strengthen our capacity and boost the infrastructure to cater to the e-commerce business. The company plans to procure 1000 Maruti Suzuki Eeco vehicles in 2015 to build its ecommerce delivery muscle further. This will be a very unique and pioneering initiative.

Presently, e-commerce business in India has a two-wheeler delivery model with most companies relying on bikers for delivery.

But, Safexpress B2C will bring

a huge paradigm shift towards a 4-wheeler delivery model.”

Highlighting the USP of the logistics park at Faridabad, Vineet Kanaujia, VP – Marketing, Safexpress said, “Our logistics park at Faridabad has a columnless span of over 151 feet and enables loading/unloading of over 26 vehicles simultaneously. The dedicated bays and docks at our logistics park in Faridabad provide an uninterrupted and unidirectional flow of inbound and outbound goods. The logistics park has a floor load capacity of six metric tonne per square metre and has a truck docking area width of over 73 feet. To provide safe and smooth movement of goods within the park we have

installed high-tech equipment.

Moreover, to make our park ecofriendly, we have taken special go-green initiatives by investing in rainwater harvesting and developing special green zones.”

Kanaujia said, “This logistics park will be operational 24x7,

365 days in a year to provide time-definite deliveries. Due to our non-stop operations, we will be providing the fastest transit time for deliveries all across India to over 610 destinations from Faridabad.”

EP News Bureau-Mumbai

Honeywell starts production of propellant and insulating agent Honeywell’s Louisiana manufacturing facility is producing HFO-1234ze for aerosols HONEYWELL HAS started full-scale commercial production of a low-global-warming-potential (GWP) material used as an aerosol propellant, insulating agent and refrigerant. The material, known by the industry designation HFO-1234ze and marketed by Honeywell under its Solstice line of low-globalwarming materials, is being produced at the Honeywell Fluorine Products facility in Baton Rouge, La.

Ken Gayer, Vice President and General Manager, Honeywell’s Fluorine Products business, said, “Honeywell’s Baton Rouge production facility is ready to serve customers around the world with this innovative material, which has an ultra-low GWP of less than one.

We are seeing increasing demand for our entire Solstice line of low GWP materials, and this new product has already been adopted by a range of customers

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globally.”

Honeywell’s Baton Rouge facility was built in 1945 and continues to serve as one of Honeywell’s main manufacturing sites for its Performance Materials and Technologies business. The site employs more than 200 people.

Bobby Jindal, Governor, Louisiana Governor said, “Honeywell helps support hundreds of jobs in our state, and we are proud the company is expanding

in Baton Rouge with a brand new product line. This project is a good example of how Louisiana’s outstanding business climate is convincing companies like Honeywell to reinvest in our state, retain great existing jobs and create additional new career opportunities for our people.”

At a recently held event sponsored by the White House, Honeywell announced that it will increase production of its low GWP refrigerants, insulation

materials, aerosols and solvents, and, prior to 2020, will drive a 50 per cent reduction in its annual production of high GWP hydrofluorocarbons (HFCs) on a CO2 equivalent basis. The company projects that use of its low GWP Solstice materials to replace HFCs will eliminate more than 350 million metric tonne in CO2 equivalents by 2025, equivalent to removing 70 million cars from the road for one year.

EP News Bureau-Mumbai

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Thermo Fisher,Cynvenio Biosystems pact To distribute LiquidBiopsy platform THERMO FISHER Scientific has signed an agreement with Cynvenio Biosystems, a molecular testing company focused on the genomic analysis of tumour biomarkers in the bloodstream, for rights to distribute its LiquidBiopsy platform.

The addition of Cynvenio’s rare cell enrichment technology complements Thermo Fisher’s Ion Torrent Personal Genome Machine (PGM) workflow and positions the company as the only one in the industry to offer a comprehensive sample-to-genomic data solution for research using a single blood draw for analysis of circulating tumour cells (CTC), cell-

free DNA (cfDNA) and normal DNA in less than 48 hours. The workflow enables researchers to conduct highly multiplexed analyses on serially collected blood samples.

The molecular analysis of CTCs and cfDNA that are released into the bloodstream offers a promising new research tool to aid in the development of future solutions for early cancer detection and therapy selection without the need for a tumour tissue biopsy. Studies have shown that serial monitoring of molecularly profiled CTCs and cfDNA both during and after therapy holds great potential to better understand the mechanisms of therapy

The automated LiquidBiopsy platform is designed to efficiently extract and isolate CTCs from a standard blood draw in preparation for both high content imaging and genomic analysis response and tumour recurrence. Alternative methods include tissue biopsies, which are costly, highly invasive and vary in the amount of sample that can be

retrieved.

The automated LiquidBiopsy platform is designed to efficiently extract and isolate CTCs from a standard blood draw in preparation for both

high content imaging and genomic analysis. The high CTC purity rate, in conjunction with the Ion Torrent PGM’s capability to accurately sequence as little as 10ng of DNA, enables highly multiplexed interrogation on one Ion 318 sequencing chip from a single blood sample. The workflow also incorporates the Ion Torrent Chef System for automated sample prep and the Ion Torrent AmpliSeq Cancer Hot Spot Panel v2, which targets about 2,800 specific gene mutations for sequencing prior to final analysis with the Ion Torrent Reporter software.

EP News Bureau-Mumbai

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42 EXPRESS PHARMA February 1-15, 2015

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Q A &

PHARMA ALLY

WITH SCHOTT GLASS INDIA

PRODUCT

Industrial Equipwash launches powder samplers and liquid samplers

Q

What is a type III glass and what is this usually used for?

A

A Type III glass usually is a soda-lime glass with a higher content of alkali and alkaline earth metals like sodium (Na), potassium (K), barium (Ba), calcium (Ca) and magnesium (Mg). The glass is therefore softer and easier to convert. They have a CTE of higher than 9.0 10-6/K. This makes them more prone susceptible to the thermic shock breakage and they are not recommended to be used for lyophilisation processes, as also written in the Ph. Eur. Due to this composition it also has a much lower hydrolytic resistance. This is why in the USP and the Ph. Eur. it is described as ‘Type III are not used for parenteral products or for powders for parenteral use.’ Type III containers are very well suitable for orals.

Q

Why is the CTE of a glass important to know?

A

The Coefficient of Thermal Expansion (CTE) is a measure for how much the glass expands and shrinks in volume when it is heated and cooled down again. The smaller the CTE the less is the movement. Pure quartz glass e.g. has a CTE of below 1 10-6/K. The CTE is a consequence of the chemical composition of the glass. The higher the amount of Alkali (Na, K) and Alkaline earth (Ca, Mg, Ba) metals in the glass is, the higher is also the CTE. Among the Borosilicate glasses there are basically three groups: The group of 3.3 CTE glasses. That is where the Boro8330TM, Duran(R) and Pyrex glasses are located. Then we have the group of around 5.0 CTE glasses, where FIOLAX(R) belongs to. And at last there is the group of 7.0 CTE glasses, to which most of the cheaper glasses belong. Apart from indicating the quality of the glass the CTE is also quite important for temperature applications.

Especially for freeze-drying applications glasses with CTE of 3.3 or 5.0 are highly recommended.

During freezing and heating the temperature difference can be quite high so that breakage due to temperature shock can occur. And this comes easier for 7.0 expansion or soda-lime glasses than for 3.3 and 5.0 CTE glasses.

INDUSTRIAL Equipwash has developed powder samplers and liquid samplers for the chemical, pharma, food and allied process industries.

Powder samplers These powder samplers with interchangeable dies for unitdose sampling are available in different diameters, lengths and models. Made of 316 stainless steel, these samplers may have one sample port or multiple sample ports for simultaneous sampling at several locations. Any number of sample ports may be blocked with blank dies.

Single, duplicate or triplicate sampling at each sample port is possible. Duplicate and triplicate samples are obtained from exactly the same spot at each sample port with just one insertion of the sampler into the powder bed. Segmented design samplers facilitate sampling from large blenders with roof height limitation. Stainless steel inner shaft is hollow to make the sampler lighter. Inner shafts, custom-made of Teflon are available. The samplers are passivated and easily cleanable with movable conical end pieces.

Powder samplers

Liquid samplers This liquid sampler is custom-made to suit the customer’s sampling bottles and it takes samples directly into the bottles. The bottles are (preferably plastic) held inside stainless steel cups and do not get wet outside. The same sampler may be used with different size bottles by simply changing the bottle adapters. The bottle adapters and the bottle sealing closures are made of FDA ap-

44 EXPRESS PHARMA February 1-15, 2015

Liquid samplers

proved plastics while the rest of the sampler is made of 316 stainless steel. The stainless steel cups are welded to the shaft so that they do not have a chance to drop into the tank. Sampler is sterilizable, easily cleanable, and is ideal for sampling of large volumes (20cc and up) from drums, tanks, mixers, reactors, etc.

Contact details Industrial Equipwash 8B, Surat Singh Indl Estate, B/h. Agarwal Indl Estate, Off SV Road, Jogeshwari (W), Mumbai 400 102 Tel: (022) 2679 7941 Fax: 2679 2936 e-mail: iewi@mtnl.net.in website : www.iewi.net

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

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

Microbial Detection & Identification

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Non-GMO ISO CERTIFICATION

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Sterile Packaging Products

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Wrapping Crepe Paper & Non Woven SMMMS Paper

Amcor Sterilization Reel Bowie - Dick Test Pack & Sheets

Autoclavable Tape & Dry Heat Tape

Class 5 Integrator & Class 6 Emulators

Class 4 Multiparameter Indicator

Container Seals

Self Contained BI (Steam & EtO)

Pro Amp

Spore Strips (Steam, EtO)

Spore Suspension & Spore Ampoule

SS Coupons

Sealing machine with & without Printer

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Veridoc (System for labeling & documentation of sterile barrier systems)

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PHARMA LIFE I N T E R V I E W

‘A support system should ensure focused involvement of both academia and industry’ Dr SD Gupta, President, Indian Institute of Health Management and Research (IIHMR) University Jaipur discusses the challenges being faced by the pharma industry in finding talented manpower and shares the university's future plans and campus recruitment mechanisms with Usha Sharma Recently, Indian Institute of Health Management and Research University (IIHMR) Jaipur conducted a discussion on the recruitment by the pharma industry. What was forecast made?

In December 2014, IIHMR University conducted a national seminar on ‘Pharmaceutical Industry Perspective’ in response to academia, where various challenges faced by the industry and their expectations were discussed.

Institutes need to partner with organisations to train their students so that they become skilled and employable. Since the pharma industry is facing a talent crunch and there is a need to unlock the potential of the Indian pharma market with immense opportunities, experts from the pharma industry along with educationists came together at the seminar to discuss the gaps in the output provided by the education sector vis-àvis the need of the pharma industry.

To highlight the discussion, Hemant Dande, President, Raptakos Brett, who took part in the discussion said that the pharma industry intends to grow at 12-15 per cent per

62 EXPRESS PHARMA February 1-15, 2015

annum for the next five years and will need a workforce of about 50,0000 personnel per annum. However, the challenge is to find the right employee. He appealed to the pharma academia to make students employable through skill development programme which will be beneficial to the industry in the long run.

The recently held seminar attended by the experts has predicted that around 45000 jobs are likely to be created in 2015.

Initially, pharmacy education started with limited courses/training centres and later got converted into training and degrees. However, after such a paradigm shift the industry still demands better and diversified education at campus itself.

How can this problem be solved?

In India, a lot of emphasis is given on theoretical education and qualifications rather than practical training or work experience. Even though pharmacy education has no longer limited courses/ training centres and a large number institutions have got themselves converted into medical and training degree institutions,

Research says that by the year 2022, India will need a workforce of 700 million, out of which 0.72 million will be needed by the chemical and pharma alone

many pharmacy students are still taught the same old curriculum which is prevalent in the education system for many years. To overcome this demand supply gap between the industry and the academia, educational institutions must ally with multinational corporations, training institutions for internship or practical training.

Educational institutions should also tie-up with organisations on specific initiatives such as guest faculty lectures providing industry insights to the pharma management / pharmacy students, internships, curriculum revision workshops, research incubation, live projects where students can directly get involved with the management of the organisation.

Pharma academia should groom students as per their areas of interest at the graduate level. A support system is needed to ensure a focused involvement of both the academia and industry.

Academic institutions should develop systems and procedures to ensure that industry expectations are met without any compromise on academic aspirations.

Industry should give a fresh

look to its R&D efforts offered by the academia and interact with researchers at a stage when they are pursuing their doctoral degree through industrybased projects. Industry PhDs should teach in classes since they can provide realworld experiences. Apart from classes, biotech/pharma/healthcare industry needs to be on campus with clear offerings for internships. It has been observed that there is a major disconnect in the academia output vis-a-vis industry expectations, hence it is evident that students should be given soft skills training and trained for employability. Industries should conduct large scale collaborative projects with the students in research institutions as well.

Students should be given more exposure and hands-on experience in organisations.

Despite more than 3,000 government and private pharmacy colleges across India why is the industry facing a huge talent crunch?

The number in terms of manpower and working force in India is commendable. It is expected that the manpower in India would be about

1.2437 billion, in the year 2026 and is expected that 64.8 per cent of India’s population would be in the working age of 15-64 years.

By 2020, out of the total population of 1.3 billion, it is cited that 0.8 billion population is in the working age which can be looked forward to. Research says that by the year 2022, India will need a workforce of 700 million, out of which 0.72 million will be needed by the chemical and pharma alone.

A few challenges need to be taken care of. Out of a total headcount of the available manpower, the numbers of which are extremely commendable, the industry faces a lack of skilled workforce, which means a large part of the manpower is still unemployable. Taking a look at the skill supply side one sees an exponential growth in the number of institutes and a steep decline in the quality of education being provided. It is seen that the growth of the institutes is not planned, but is a fad.

To overcome these challenges faced by the pharma industry, combined efforts need to be undertaken from several stakeholders.

Considering the situation's gravity, the government is coming up with various initiatives. A National Skill Development Coordination Board (NSDCB), coordinated by the Planning Commission was established by the then Prime Minister in 2008 with a target of skilling 700 million people by 2022.

Individual states are also coming up with programmes and policies to face this problem. However, the success of these efforts without active involvement of ‘actors’ of this process is doubtful. Thus sincere efforts to ensure partnership between the source of skills (colleges, students etc.), and their destination (the corporate) are a must. It is imperative to educate them about each others expectations so that

There are plans to establish 50,000 skill development centres. Several ministries/departments and state governments are engaged in skill development initiatives.

Several ministries/departments and state governments are engaged in skill development initiatives

informed plans for future can be prepared.

Globally companies are reporting great difficulties in filling key roles. While most of them do have access to plentiful people they do not have access to much talent.

Hence, it is important that the pharma academia trains its students with the right skill sets such as the one that drives innovation, efficiency and competitive advantage by engaging their students to involve themselves in live projects that can later become case studies.

What has been the recruitment trend in the last one decade? Do you see any changes in the trend?

A number of changes have been seen in recruitment trends. Many organisations, both government and private institutions, have begun hastening their efforts to tap the potential youth power and are keen on reaping the demographic dividend.

Today, companies are keen to recruit an individual who fits the role rather than just who fits the educational qualifications. Many organisations now have psychometric tests and tests that highlight the analytical capabilities of an individual.

Companies today also focus more on the number of years of work experience along with internship terms.

Various steps have been undertaken both by the academia and the industry to select the right talent. These include the formulation of

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the national skills development policy, delivery of modular employable schemes, upgradation of existing institutions through World Bank and Government of India funding, as well as upgradation of training institutes under Public Private Partnership mode and setting up of the NSDCB. There are plans to establish 50,000 skill development centres. Several ministries/departments and state governments are engaged in skill development initiatives. However, all these efforts would count for nothing, if a partnership between the source or reservoir of manpower and the destination or refinery of manpower is not maintained.

It would require joint efforts from the government, talent suppliers (institutes/academia), and talent absorbers (corporates/employers).

Can technical education play a pivotal role?

Institutions provide part time and full time courses for pharmacy students.

However, one must not ignore the evolutions in healthcare and pharmacy practice which are presenting many new opportunities for pharmacists to perform functions and provide services not considered as traditional roles any more.

The profession of pharmacy is working to achieve a pervasive model and standard of care determined

only by the needs of patients and populations. Hence, considering the pace of the growing opportunities, it is important that technical education in the pharma education is a must.

Enhanced medical infrastructure along with innovative business models and their exposure should be provided to students time to time.

The pharma industry should give a fresh look to its R&D efforts offered by the academia. Apart from classes, campus recruitments should be offered for interns.

How do you engage your students with the industry and provide them practical knowledge and update them with regulatory changes regularly?

The MBA course in pharma management provided by IIHMR University is jointly designed by academicians and pharma industry experts. Students are exposed to real life case studies and pharma industry-based examples are provided to develop technical, reasoning, planning, organising, analytical and decision making skills. Students also undergo live trainings through summer internships with various pharma companies. Dissertation reports are submitted which are further assessed by our academicians. During the two-year programme, students not only are

exposed to various software and business models which are an essential part of pharma industry operations, but also learn soft skills such as leadership and self development which are included by them in dissertation reports. We at IIHMR University also invite guest personnel’s/ lecturers from the industry, who provides information on current practices and regulations from the industry.

Medical /hospital industry has been unable to attract students into the profession. Why ?

It is not right to say that that the medical or the hospital industry has not been able to attract students into the profession. Yes, there is a dearth of students with no training in soft skills which is much needed for the profession. As mentioned earlier, technical education and exposure to the industry is a mission. We need to introduce specialisations even at the degree level which will allow students to plan their career in the industry.

What measures are taken into account by pharma companies while hiring?

It has become imperative for most of the pharma companies to look at the organisations' talent needs.

It has also become essential for companies to study the market dynamics to understand if the talent they need is available and if the company is equally competent to attract talent.

The next step followed by the organisation is screening, where qualified candidates are selected after a selection procedure, which includes analytical tests. It will help qualify them to the next round of selection. While screening various parameters are set by the company depending on its internal compliance policies.

Gone are the days when a simple resume scan followed

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PHARMA LIFE by interviews could result in an offer. With evolution of recruitment and involvement of technology in the recruitment process, selection process is as long as eight rounds. Assessment centres which claim to have the best success rate are being implemented along with various other practices that are cost effective.

Technology is being excessively used to manage and monitor the process and to reduce the time that is spent in transactional activities; instead the focus is on making the processes more effective.

Do you plan to start new courses/programmes at IIHMR University?

At IIHMR University, Jaipur, we constantly believe in adding value in the field of academics. MBA in pharma management is a flagship course, which has been designed to develop trained professionals with requisite skills in planning and operating management techniques; diagnosing and solving management problems and acquiring consultancy skills.

The new courses introduced by IIHMR University, Jaipur are: ◗ MBA-Health Economics Finance and Insurance (MBA-HEFI) ◗ MBA-Human Resource Management in Health and

64 EXPRESS PHARMA February 1-15, 2015

At IIHMR University, Jaipur, we constantly believe in adding value in the field of academics

Hospitals (MBA HRM in Health and Hospitals) ◗ MBA-Logistics & Supply Chain Management in Health Care (MBA LSCM in Healthcare) Are there any tie-ups with pharma companies for training and campus jobs?

IIHMR University Jaipur has signed an MoU with Sun Pharmaceuticals for providing scholarships to students who excel in academic performance every year.Sun Pharma offers cash rewards and certificates of appreciation to IIHMR students from MBA Pharma Management with top academic performance in the batch.

IHMR University pharma management students are recruited for

summer internship, dissertation and the final jobs by leading pharma organisations like Ranbaxy Laboratories, Novartis Pharmaceuticals, Abbott Healthcare, Claris Lifesciences, MSD, Zydus, Cadilla Pharmaceuticals, IMS Healthcare, ZS Associates, Nestle and many more.

During the training, students learn through assisting the manager / administrator in daily operational management, and, if possible, help the management study and address some identified issues/ problems associated with specific operational area /programme. The main purpose of the training is to get exposure about the functioning of the organisations.

In the last few years, our students were placed in various pharma organisations throughout the country and abroad.

Most of them came up with reports that stood useful for the organisations.

During a training, students are expected to acquaint himself/herself with various departments and functioning of the organisation. The training is expected to substantiate classroom teaching with practical exposure in reputed organisations. u.sharma@expressindia.com

APPOINTMENT

Jubilant Pharma appoints GP Singh as CEO JUBILANT LIFE Sciences Limited (JLL) has appointed Gurpartap Singh Sachdeva (Singh) as the Chief Executive Officer (CEO). Singh will have overall responsibility for the operations under Jubilant Pharma and will report to the Jubilant Pharma Board. He will be based in the US. Prior to Jubilant, Singh had served as President of Sun Pharmaceuticals, US and contributed to the growth of Sun’s US business. He has worked extensively both in India and in the US in various leadership roles pertaining to Strategy, M&A, Commercial and Operations.

The appointment of Singh as the CEO of Jubilant Pharma strengthens the management structure of the company and follows the appointment of Pramod Yadav and Rajesh Srivastava as co-CEOs of the Life Science Ingredients business of JLL. Shyam S Bhartia, Chairman and Managing Director and

Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences said, “We are pleased to welcome Singh into the Jubilant family to complete our pharma consolidation. Our pharma segment has attained significant scale and the businesses therein have great potential for growth. Singh’s rich experience in pharma industry will help the company to enhance its focus and competitiveness thereby unlocking shareholder value.”

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.