The Role of Pharmaceutical Industry in Vaccine R&D

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1 The Role of Pharmaceutical Industry in Vaccine R&D Jean-Paul Prieels 12/03/13 1

2 The Players : 5 majors share over 90% of the global vaccine market 2 new entrants : J&J (Crucell) and Takeda 12/03/13 2

3 Where are they after 25 years of R&D activities against 5 of the most needed new vaccines : HIV Malaria TB RSV and Dengue? Analyses limited to patent and literature searches. ( ) 12/03/13 3

4 Methodology Construction of keyword- and patent code-based filters, with exclusion of antibody preparations A61K39 Medicinal preparations containing antigens or antibodies 12/03/13 4

5 Methodology Select manually pool for 5 big Pharma players: Merck GSK Novartis Sanofi & Pfizer (including subsidiaries, acquisitions) 12/03/13 5

6 Methodology - Background In the analyses, patent portfolio of the 5 big players for the 5 vaccines was compared with the patent portfolio of all other applicants for same fields. Since patent pools for each individual disease were rather small, analyses were done pooling all 5 patent portfolios As the objective was also to highlight differences in strategies and technologies used between the 5 big players and all other players, specific indicators were analyzed : o The technology surface of the high value vaccine patents, o Backward citations of high value patents, o Unique code clustering 12/03/13 6

7 Results Vaccine R&D for RSV, Malaria, Tuberculosis, HIV and Dengue is not at the core of the 5 big players patent portfolios and they have not substantially increased their efforts in vaccine patenting since 80 s 250 total vaccin patent families 200 big 5 vaccin patent families Patent family count /03/13 7

8 The other players in the vaccine patent pool are better at combining different technologies and platforms and at integrating new technologies % patent families with new patent codes 5% 4% 4% 3% 3% 2% 2% 1% 1% 0% % patent families with new codes big 5 Mean unique backward citations of top 50 cited other applicants % patent families with unique code clusters 14% 12% 10% 8% 6% 4% 2% 0% mean backward citations top 50 cited big 5 other applicants % of patent families with unique code clusters big 5 other applicants 12/03/13 8

9 25% of the technology surface of the top 200 cited patents in vaccine research is not shared between the 5 big players and the other applicants G06F17/00 C07D519/00 C12P7/00 C12Y302/00 A61L31/00 A61K31/ A61M1/00 A61K39/00 A61P37/00 C07D401/00 C07F7/00 C12P13/ C07D403/00 A01N63/ A61P43/00 A61P33/ C07D207/00 A61K36/ C07D217/00 C07D265/ C12N9/00 C07C217/ C07C237/00 C07C233/ G01N33/00 C07C255/00 C07D333/ C07K7/00 C07K16/00 other applicants big 5 C07D263/00 C12N5/00 C07C323/00 C12N15/00 C07D521/00 C12N1/00 C07D249/00 C07H21/00 A61P5/00 C07K17/00 A61P13/00 C07K1/00 A61P1/00 C07D307/00 C07D473/00 A61K48/00 A61P25/00 A61P9/00 C12P17/00 A01K67/00 C07D239/00 A61K9/00 C07K5/00 A61K45/00 C07D487/00 C07C311/00 12/03/13 9

10 Conclusions 1. Vaccine R&D for RSV, Malaria, Tuberculosis, HIV and Dengue is not at the core of the 5 big players patent portfolios (Merck GSK Pfizer Sanofi Novartis) and they have not substantially increased their efforts in vaccine patenting since 80 s. 2. The high value patents in vaccine research for Dengue, Malaria, RSV, HIV and Tuberculosis are not owned by the 5 big players. 3. The other players in the vaccine patent pool are better at combining different technologies and platforms and at integrating new technologies 4. 25% of the technology surface of the high value vaccine patents is not shared between the 5 big players and the other applicants. In order to cover the complete technology surface of the most high value vaccine patents cooperation between the big 5 players and smaller players, academics, research institutions and governments would be required. 12/03/13 10

11 Degree of cooperation between big 5, academics, research institutes and governments Figure legend The size of the vertex is based on the degree (= total number of connections) The color of the connection lines is based on the type of vaccine dengue HIV RSV malaria tuberculosis Cooperations of big 5 based on patent and scientific paper coauthorship. The color of the connection line indicates for which of the 5 diseases the cooperation is. The size of the bubble correlates with the total number of cooperations of the big player. The majority of cooperations is by far for HIV vaccination research.

12 Recommendations A change in business model is required in order to achieve a breakthrough in vaccine research for Dengue, HIV, Malaria, Tuberculosis and RSV. There is a need for a collaborative effort and a combination of platforms and technologies in order to develop a successful vaccination strategy. 12/03/13 12

13 Today Status of the Projects 12/03/13 13

14 What do we expect from a Vaccine? Safety & Efficacy Compliance that translate into Efficiency o Public Health Policy o Schedule of Administration o Delivery Mode o Stability o Affordability All aspects that should be part of a collaborative initiative. 12/03/13 14

15 Proposal for an alterna-ve business model for vaccine development 12/03/13 15

16 Thank You! With a special thanks to the CREAX team: Anneleen Spooren Mathieu Mo:rie Jef Vandenberghe