Vaccine Development and India Dr. Tarit K. Mukhopadhyay Dept. 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 20 years ago, vaccines mainly produced by public sector 1980 – BCG, DTP, MMR – these vaccines on the market 10 years Price fixed – recombinant technology not yet established Liability from pertussuis vaccine FDA 8 years Today – blockbuster vaccines Vaccine selection changed Prices higher – people and government willing to pay more 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 20 years ago, vaccines mainly produced by public sector 1980 – BCG, DTP, MMR – these vaccines on the market 10 years Price fixed – recombinant technology not yet established Liability from pertussuis vaccine FDA 8 years Today – blockbuster vaccines Vaccine selection changed Prices higher – people and government willing to pay more 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 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) MVP SynCo Bio Serum Institute of India FDA less 0.50c/dose 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?