1. Vaccine Development and India
Dr. Tarit K. Mukhopadhyay
Dept. of Biochemical Engineering, UCL

2. 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

3. 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

4. The Vaccine Market

5. 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

6. Technology transfer - Transferring
MNC
Expand market base
Increase manufacturing capacity
Additional regulatory pathway
Public Institutions
Provide access to manufacturing process
Specialist knowledge

7. 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

8. 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

9. 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

10. 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)

11. Cost based analysis of manufacture (2010)
MVP
SynCo Bio
Serum Institute of India
FDA
less 0.50c/dose
WHO - Regulatory Pathway

12. Shifting Disease Profile

13. Neglected Diseases

14. Primary Funders

15. 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?