INDIA

PUBLIC: PRIVATE PARTNERSHIP MODELS FORR&D (INFECTIOUS DISEASES) –

OPPORTUNITIES AND CONSTRAINTS

Prof. V.K.Vinayak

Senior Advisor

Department of Biotechnology

Ministry of Science & Technology

Block # 2, CGO Complex, Lodhi Road

New Delhi – 110003

INDIA

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

R&D RELATING TO INFECTIOUS DISEASES

- Diagnostics for Infectious Diseases.

- Vaccines:- New Generation.

- Drug Delivery System.

- New Therapeutics.

- Genomics – Applications for better diagnostics/vaccines/new

drug molecules.

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)� RAPID agglutination of erythrocytes for HIV 1&2.

� Peptide based ELISA System for HIV-1 & 2.

� Western immunoblot for HIV-1 & 2 infection.

� Mac IgM ELISA for detection of Dengue infection.

� Mac IgM ELISA/RT-PCR for Japanese Encephalitis.

� PCR for detection of Pulmonary/ Extrapulmonary tuberculosis.

� LDH Based Test System for Malaria.

� DAT for Toxoplasmosis.

� IFA for Rabies - Monoclonal antibody to nuclear protein.

� Haemagglutination Assay for Visceral Leishmaniasis.

� ELISA for H.pylori.

� IgM ELISA System for Leptospirosis.

� ELISA for Amoebiasis.

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CURRENT STATUS ON VACCINE TECHNOLOGIES

DEVELOPMENT IN INDIA

APPROACHES:

•Avirulent organism

•Recombinant Vaccines

•Tissue cultured based vaccine

•Genetically modified microbe

•DNA candidate vaccines.

•Plant – based vaccines.

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CANDIDATE VACCINES/VACCINE DEVELOPMENT

�ANTI LEPROSY VACCINE Commercialized.

�ANTI CHOLERA CANDIDATE In Phase-II Clinical Trial

�ANTI ROTA VIRAL DIAORRHEAL VACCINE In Phase-I Clinical Trial

�JAPANESE ENCEPHALITIS Under Preclinical Studies

�ANTI RABIES VACCINE Awaiting approval for commercialization

�ANTI TUBERCULOSIS Under Preclinical Studies

�ANTI MALARIA Preclinical/Phase-I Clinical Studies

�ANTI HIV CANDIDATE VACCINE Animal Experimentation (HIV-I - Subtype c)

�PLANT BASED VACCINES – Cholera/Rabies Animal Experimentation

2005(Projected)

20001997

145600 (100)94000 (100)71540 (100) TOTAL

3970 (02.7)1300 (01.4)430 (00.6)OTHER BIOTECH PRODUCTS

36470 (25.0)28850 (30.3)24470 (34.2)INDUSTRIAL PRODUCTS

47680 (32.8)28880 (30.7)20270 (28.3)AGRICULTURE (INCLUDINGSEEDS)

57480 (39.5)35320 (37.6)26370 (36.9)HUMAN & ANIMALHEALTHCARE PRODUCTS

CONSUMPTIONBIOTECH SECTOR

INDIATRENDS IN INDIAN BIOTECH

INDUSTRY (RS. IN MILLION)

9575*53572950INDIA

2258560330400234135GLOBAL

200520001997

(RS. IN MILLION)

* Estimated potential 3-5 times

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MARKET SCENARIO

� CURRENT MARKET SIZE - RS. 300 CRORES

� ANNUAL GROWTH RATE - 25%

� MARKET POTENTIAL (2005) - RS.500 CRORES

� EXCL. IMPORTERS - 70%

� INDG.PRODUCERS - 30%

� STATUS : IMPORT INTENSIVE

LIMITEDPRODUCTION

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IMMUNODIAGNOSTICSCOMMERCIAL RELEVANCE

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BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

* Key Academic Institutes involved in Research & Development forInfectious Diseases

- Academic Institutes: -National Institute of Immunology - Central Institute of Medicinal & Aromatic Plants

-Jawahar Lal Nehru University - Centre for Cellular & Molecular Biology

-University of Delhi (South Campus) - Centre for DNA Fingerprinting & Diagnostics

-All India Institute of Medical Sciences - National Centre for Cell Sciences

-Centre for Biochemical Technology - Indian Institute of Chemical Biology

-Institute of Microbial Technology - Central Drug Research Institute

-Indian Institute of Science -JN Centre for Advance Research

-Postgraduate Institute of Medical Education & Research

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

* Key Academic Institutes and Pharma involved in Research &Development for Infectious Diseases

B) Major Pharma:

-Shantha Biotech Ltd. - Ranbaxy Labs.

- Bharat Biotech Ltd. - Zydus Cadila

- Sudershan Biotech Ltd. - Cadila Pharmaceuticals

- Biological E. Ltd. - Dabur Research Foundations

- Reddy’s Laboratory - Panacea Biotech

- Wockhardt

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

PUBLIC : PRIVATE PARTNERSHIP MODELS

THREE APPROACHES:

•Transfer of validated technologies to Pharmaceuticalcompanies / entrepreneurs.

•Entrepreneurs/Pharmaceutical Companies and Public/Academic Institute joint development of technologies/products.

•Public Institute/Academic Centres partnership before initiationof R&D.

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

Bio-Medical Technologies transferred and launched in themarket

Technology Developed By Launched By

Leprosyimmunomodulator

NII, New DelhiM/s Cadilapharmaceuticals, Ahmedabad

Leishmaniasis detection kit CDRI, Lucknow Span Diagnostics Ltd.

Western Blot for HIV-I & II CRI, Mumbai

M/s J.Mitra & Co., New Delhi

Naked Eye agglutination system for HIV-I&II

University of Delhi, South Campus

Cadila pharmaceuticals,

Ahmedabad

Xcytron, BangaloreHepatitis C DiagnosticsELISA Based

ICGEB, New Delhi

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

Bio-Medical Technologies Transferred (not yet Launched)

Technology Developed By Transferred to

The IgM Mac ELISA -Dengue

NIV, Pune Zydus Cadila HealthCare, Ahmedabad

The IgM Mac ELISA -Japanese Encephalitis

-----do----- -----do-----

The IgM Mac ELISA - West Nile-----do-----

-----do-----

ELISA -alphafeto protein levels. IICB,Kolkata

Shantha Biotechnics, Hyderabad

An IgM - Hepatitis A. NIV, PuneBharat Biotech Ltd.,Hyderabad

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)Bio-Medical Technologies Transferred (not yet

Launched)

hCG expression Pichiapatoris system.

IISc, BangaloreCadila Pharmaceuticale,Ahmedabad

Recombinant candidate Anthrax Vaccine

JNU, NewDelhi andCBT, Delhi.

Panecea Biotech, Delhi

Urine based systems (ELISA)- FourReproductive Hormones.

IRR,Mumbai

Zydus Cadila HealthCare, Hyderabad

Yarrowia lipolytica expressing system.University ofBaroda,Baroda

Biological evans Ltd.,Hyderabad

Technology Developed By Transferred to

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JOINT DEVELOPMENT OF PRODUCT/PROCESS

- Anti-Rota Virus Vaccine: AIIMS/Bharat Biotech

- Antimalaria Vaccine: ICGEB/MRC/Bharat (recombinant) Biotech

- Anthrax Vaccine: JNU/ Panacea Biotech. (recombinant)

- Antirabies DNA Vaccine: IISc/Indian Immunologicals

INDIA

PUBLIC: PRIVATE INTERACTION LEADING TOCOMMERCIALIZATION OF PRODUCTS

- Antileprosy Vaccine: NII/Cadila Pharmaceuticals

- r Hepatitis B Vaccine: CCMB/ Shantha Biotech

- NEVA diagnostic forHIV-I/II: DU(sc)/Cadila

Pharmaceuticals-Western immunoblot for

HIV-I/II: CRI/ J Mitra & Co.

- ELISA for Hepatitis C ICGEB/ Xcytron Co.

- Amoebiasis detection kit NII/ Span diagnostics.

� 12 PRODUCTS APPROVED

HUMAN INSULIN FSH*STREPTOKINASE ERYTHROPOIETIN*HBsAg HGHINTERLEUKIN GSFGCSF *a INTERFERON

BLOOD FACTOR VII g INTERFERON

* Products indigenously manufactured

INDIA

INDIAN SCENARIO

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CONSTRAINS IN TRANSFER OF TECHNOLOGIES

• Lack of interactions at the initial stages of technology processdevelopment.

• Market need & techno-economic feasibility not conductedseriously

• Lack of funds/facilities at inventor level to upscale bench levelprocesses

• Entrepreneurs – do not take risks with unproven/untriedtechnologies.

• Procedural delays in various approvals.

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

FOUR DISTINCT ROUTES:

•Diversification from chemical manufacturing to use of

Biotechnological tools/tie up with MNC.

•Start up on indigenous production of first generation

recombinant therapeutics/vaccines.

•Investing profits in discoveries (R&D set up).

•Utilising / grafting biology onto IT – Bioinformatics & genomic

companies.

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OPPORTUNITIES FOR INDIAN PHARMA

A) Global Partners Tie Up With Indian Pharma

- Low cost of innovation in India

- Chemical capabilities – Cheap & World class

- Drug discovery: 80-90% cheaper in India

- Alliance of upstream & down stream activities.

B) Positioning to partners to enter American & European markets.

INDIA

BIOTECHNOLOGY FOR HEALTH (INFECTIOUS DISEASES)

SIGNIFICANT BARRIERS:

•Complicated regulatory system.

•Uncertainty about Intellectual property protection

•Slow pace of integration between academic and pharma companies.

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TO OVERCOME BARRIERS

•Government – Environment for innovation & entrepreneurship

•Strong patent protection

•Predictable regulatory mechanism(s).

•Create more business friendly environment.

� Several lessons have been learnt.

� Great opportunities for public/private partnership.More successes with mid level and start uppharmaceuticals companies.

� Need to create business friendly environment.

� Indian industry is looking out for global partnersfor joint innovation research.

INDIA

SUMMARY