Opportunities in the India Biopharma Sector

October 2011

Anil Vaidya-Sector Specialist Life science Team

UK Trade & Investment

Source: Ingram Publishing/the Agency Collection/Getty Images

The India Conundrum ?

More than just call centres ?

Outsource: Processes

ChemistryClinical TrialsBiologyMedical StatisticsMedical WritingAnimal workBABE (PK Studies)

Outsource: Higher Value Drug discovery & IP Creation

Rough India Biopharma Timeline

API/Generic Pharmaceuticals

India entry into bio-similiars

India enters the service industry

Entry into stem cell banking

Drug Discovery

1990 2000 2010 2020

API/Pharmaceutical Manufacturing

First overseas acquisition by India biopharma (RLS & Genemedix) ?

First government approved stem cell clinical trial

Clinical trial registry set up

Indian Life Science CompaniesGeneric Pharmaceutical

Rank Company Revenue ($m)

1 Cipla 1348.51

2 Ranbaxy Laboratories

132.56

3 Dr Reddyʼs Laboratories

1178.00

4 Lupin 929.84

5 Aurobindo Pharma 865.19

6 Dabur India 700.30

7 Sun Pharma 673.99

8 Cadila Healthcare 629.45

9 Jubliant Life Sciences

561.03

10 Piramal Healthcare 480.26

Rank Company R&D Pipeline Products

1 Biocon Diabetes, Oncology Insulin, EPO, GCSF, Streptokinase, monoclonal antibodies, API

2 Serum Institute of India

Vaccines: meningococcal A, Meningitis, Bladder Cancer, Pnumococcal, Recombinant GCSF, Inteferon Alpha, EPO

Vaccines: bacterial, viral, recombinant & combination, Anti-sera, plasma, anti-cancer

3 Panacea Biotec Oncology: breast, brain, ovarian, pancreatic, prostate, colorectal - TBC

HIV/AIDS, TB, Lymphatic Filariasis, Nephrology, Diabetes, Cardiovascular, pain, osteoporosis, respiratory, vaccine

4 Reliance Life Sciences

SiRNA, Monoclonal antibodies Plasma proteins, EPO, Interferon alpha, R-GCSF, oncology, steroids, hormones, peptides

5 Syngene International

Not applicable - CRO

6 Bharat Biotech Malaria Vaccine Candidates, PVcII, Rotavirus Vaccine Candidates, ORV116E, Anti-infectives, Lysostaphin

Vaccines: Pentavalent, Typhoid,, Poliomyelitis, Anti-rabies, rhEGF,

7 Indian Immunologicals

Information not available Vaccines: rabies, MMR, Hepatitis B,

8 Shantha Biotech (Sanofi Pasteur Group)

Vaccines: cholera,Hib,DTw-Hib, DPT-+ H vaccine

Infectious diseases, oncology,

9 Jubilant Life Sciences

Oncology, Cardiovascular and Diabetes

API, Advanced intermediates, fine chemicals, radiopharmaceuticals,

10 Cadila Pharma Conventional and recombinant vaccines, Anti cancer bio-therapeutics

Gastrointestinal drugs, topical preparations,

Biotech / Similar Biologics Manufacturers

Own Drug Discovery WorkCompany Industry Sector Pipeline Note

1

2

3

4

5

6

7

8

9

10

11

12

Strand Life Sciences Bio-informatics N/A Translation medicine research oncology with MSCC

Cellworks Bio-informatics RA

V Life Sciences Technologies Contract Research N/A Discovery for client

Lupin Pharmaceutical Anti-migraine, Anti-TB, Anti-psoriasis agents, herbal & synthetic routes

Glenmark Pharmaceuticals Pharmaceutical Anti-diarrhoea, diabetes, asthma, COPD, pain, MS

Aurigene Contract Research Oncology, Rheumatoid arthritis, cancer, anti-infectives, anti-viral

Advinus Therapeutics Contract Research Metabolic, inflammatory, neglected diseases

Suven Life Sciences Contract Research CNS Collaborative research with Eli Lilly. Fee-for-service AZ, BMS, J&J, Pfizer, Abbott, Eli Lilly, Lundbeck, Reviva, Theravance, Onconova, Kareus.

Dr Reddyʼs Pharmaceutical Bacterial infections, metabolic disorders, pain & inflammation

Piramal Life Sciences Pharmaceutical Oncology, inflammation, diabetes, infectious diseases

Wockhardt pharmaceutical Antibiotic

Sun Pharma Advanced Research pharmaceutical Anti-allergy, anti-inflammatory, anti-convulsant, muscle relaxant

Snap Shot - Not a Comprehensive List

Regional Biopharma Clusters

Mumbai

Ahmedabad

Bangalore

Hyderabad

New Delhi

City State Notes

Lucknow Uttar Pradesh Indian & USA companies, a mix of ago-bio and healthcare companies including DNA banking, GMP stem cell facilities,

Hyderabad Andhra Pradesh Alexandria Knowledge Park & Genome Valley

Kochi Kerala Pilot facility to promote traditional medicine, medicinal herbs, spices

Bangalore Karnataka To be structure into three components, Institutional & Research & Development Block; Biotech Incubation Centre and Common Instrumentation Facility

Himachal Pradesh Shimla Not available

Cluster Region States

Northern Cluster

Delhi, Haryana, Uttar Pradesh, Madhya Pradesh, Himachal Pradesh, Rajasthan

Eastern Cluster

N/A

Southern Cluster

Andhra Pradesh, Karnataka and Tamil Nadu

Western Cluster

Maharashtra, Gujarat and Goa

Cluster Developments

Government Science Parks

Overseas Collaborations

India Pharmaceutical Company

Partnering Company Activity

Piramal Healthcare Abbot Acquired domestic formulation business

Zydus Cadila Abbot Commercialisation agreement

Torrent AstraZeneca Commercialisation agreement for generics

Biocon Pfizer Commercialisation biosimilar insulin

Strides Arcolab Pfizer Off patent pharmaceuticals

Claris Lifesciences Pfizer Off patent pharmaceuticals

Aurobindo Pharma Pfizer Off patent pharmaceuticals

Ranbaxy Daiichi Sankyo M&A

Shantha Biotech Sanofi Aventis M&A

Matrix Mylan M&A

Ref: BioSpectrum, Asia Edition Vol 6, Issue5, May 2011, March 2011

In-licensing Activity

Sun Pharma & Merck - molecule developmentSun Pharma & CC (UK) - inhaler technologyGlenmark & Chromos (Canada) - monoclonal antibodyPanacea Biotech -

Funding in Biopharma

Private Equity & Venture Capital Funds

Corporate Funds Government Departments

FidelityKotak Private Equity Group (KPEG)Sequoia Capital IndiaOrbiMedEvolence CapitalNew Silk Route (NSR)US Overseas PE investors

2002-2009 investments approx $500m. Not necessarily from the above funds.

Tata Capital ($800m fund)Reliance Venture Asset Management

Not exclusive pharma/healthcare related investments

Department of Biotechnology

2009-2010 approximate investments $700m including infrastructure

Funding from DBT

Fund Amount Sector Note

The Small Business Innovation Research Initiative (SBIRI)

Grant-in-aid loan Rs 50 Lakhs to 10 Crore medical, agriculture, food, industrial, environment, biomedical devices, instrumentation

Biotechnology Industry Research Assistance Programme (BIRAP)

Programme in partnership with ABLE & Biotech Consortium India for R&D of biotech products to support emerging biotech entrepreneurs

HIV, Tuberculosis, Malaria, Influenza, Dengue, Pneumococcal, Hepatitis C, Rotavirus Jap Encephalitis, Improved Typhoid, Cholera, Cancer Vaccines, Diabetes, Cardiovascular neurological

250 Proposals received to date with 20 accepted

Funding Requirement

Min 51% of company to be owned by Indian National

Opportunities I

UK Out-license Drug Discovery Opportunities

Chronic Diseases in India:

Coronary Heart DiseaseDiabetesAsthmaObesityCancer

Infectious Diseases

a) Does research match that of potential in-licensee ?

b) Risk appetite

c) Assign rights for Indian market

d) Pharma / CRO / Outliers

Inbiopro

Looking to in-license or buyHigh expression mammalian cell based platform / cell lines Products - Biobetters & NBE’s beyond proof of concept stage in oncology & RA Novel expression platforms such as Fucose knock-out cell lines, FAb Fragment expression in E.Coli Protein modification technology Novel formulation & drug delivery systems for existing biological blockbusters

Large Biotech Company (Name withheld)

Interests in the following therapeutic areas:Diabetes & Metabolic diseases Oncology Inflammation ( Arthritis, Psoriasis, etc) Immunology and other autoimmune diseases NephrologyOrphan diseasesWould like to evaluate new technologies in:Pharmaceutical space Platform technologies Enabling technologies

Century Pharmaceuticals

Partnership on developing their own internal novel molecule for Asthma treatment

Bharat Biotech

New vaccines in a variety of therapeutic areas

Panacea Biotech

Vaccines & biological in-license interestsTherapeutic areas: Diabetes, pain management, oncology, antibiotics

Opportunities II

Clinical Trials & Services

Access to large naÏve patient population

Disappointingly untapped market

a) Raise standards

b) Risk share on patients

c) Increase territorial footprint

d) Other services: medical writing, statistical analysis etc

Opportunities III

Technology Transfer

Need to access leading technology

Willing to buy technology & company to access market

a) Unassigned technology

b) Risk development in India & UK

c) Potential access to funds

IKP Knowledge Park (NPO), HyderabadLooking for technology that can be transferred to Indian companies.

Technology Areas:

1. Therapeutics & vaccines in phase 1 clinical trials (infectious diseseas, cancer)2. Biosimilars with significant data for regulatory approval (MAbs, therapeutic proteins)3. Point of care diagnostics that can be low priced4. Molecular PCR diagnostics - infectious diseases, genetic diseases5. ELISA based diagnostics - infectious diseases, genetic diseases6. Rapid diagnostics (paper strip tests)7. Enzymes for diagnostics biochemical tests (GOD, POD, etc)8. Enzymes with industrial applications9. Economic and green production of pharmaceutical intermediates and API’s10.Cardiac stents improvements, designs11.Inexpensive medical devices

Some Final Thoughts.......

• India pharma is changing• Pharma, Bioinformatics, Agricultural companies entering field• Smaller SME’s setting up • Money is available• Returnees & Expats looking to India• Opportunities depend on who you are• Position work in India for certain molecues• India not failed as yet• Confident and can do so attitude• National Centre for Biological Sciences

By 2020 there will be 100 million Indian’s with a $100,000 pay cheque (unassigned quote)

$3 billion biotech market now

India supplies over 50% of global vaccines

Visit the market & then dismiss it if necessary !