Vaccine Development and India

Dr. Tarit K. MukhopadhyayDept. of Biochemical Engineering, UCL

Historical Perspective (1980)

Product Public Sector Private Sector

DTP $0.15 $0.30

OPV $0.35 $1.60

MMR $2.71 $7.24

Source: United States CDC, 2001

Historical Perspective (2000)

Product Public Sector Private Sector

DTaP $9.25 $16.64

IPV $6.99 $15.42

MMR $14.69 $28.19

Varicella $35.41 $45.56

Source: United States CDC, 2001

The Vaccine Market

Vaccine Manufacture in India

•Very active

•One out of every two children in the world is immunized by a vaccine made by the Serum Institute of India

•Primarily motivated through cost savings of production

•Manufacture old vaccines, less profitable, but no IP

•That landscape is changing with MNC / Public Institutions collaborating with Indian companies – facilitating tech transfer

Technology transfer - Transferring

•MNC

•Expand market base

• Increase manufacturing capacity

•Additional regulatory pathway

•Public Institutions

•Provide access to manufacturing process

•Specialist knowledge

Technology transfer - Receiving

•22% pipeline products with MNC

•Fill bulk

•Restrictive market access

•70% pipeline products with academic and public research institutions

•Better equity of benefits

•Full knowledge transfer

Impact on Hib-vaccines

Bulk import Partnership License new product technology

Market control by recipient

Limited to local market

Negotiated, but often limited to local

None, based on royalty payment

Ability to pass on technology

None Possible to sell bulk, advice

Yes

Independent production

Little or none

Yes, conditional Yes

Examples Bharat and Pfizer, Panacea and Novartis

Serum Inst. with MVP (Men A), Biological E and NVI

Several with NIH

Companies of Note

•Bharat Biotech Int.

•Contract with Pfizer for Hib

•NIH (US) license agreement for rotavirus

•HepB vaccine patent

•Biological E

•Working with NVI to develop new Hib combination vaccine

•Collaborate with small biotechs, divide profits and global market share

Companies of Note

•Panacea Biotec

•Experienced IP management

•DTP-HepB-Hib combination vaccine with Novartis V&D

•Serum Institute of India

•Avoids MNC - Past work based on scale up

•Focus more on PPP

•Meningitis Vaccine Project (MenA)

•WHO (aerosol measles vaccine)

Cost based analysis of manufacture (2010)

SynCo BioSerum Institute of India

less 0.50c/dose

MVP

FDA

WHO - Regulatory Pathway

Shifting Disease Profile

Neglected Diseases

Primary Funders

Final Remarks

• Historically, India focused on less innovative, old off patent vaccines

• Highly trained persons capable of licensing in new technology

• Converging markets due to shifting disease profile

• Opportunities to collaborate and gain on cost reduction strategies

• More competition – cheaper healthcare for all?