How and Why Vaccines Are Developed by Industry. Stanley A. Plotkin

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1 How and Why Vaccines Are Developed by Industry Stanley A. Plotkin Merieux

2 Why Vaccines are Different than Drugs 1) Given to healthy people, high safety required 2) Larger governmental role 3) Low efficacy unacceptable 4) Often used in infants 5) Given once or a few times 6) Manufacturing larger part of cost 7) High regulatory and quality control burden 8) Generic vaccines more difficult 2

3 Types of Vaccines Live Attenuated Reassortants Vectored- e.g. measles, BCG e.g. rotavirus, LAIV e.g. dengue Inactivated Whole microbe Subunit Polysaccharide Conjugate - Toxoid VLP- Proteins- e.g. rabies, IPV e.g. Influenza e.g. typhoid Vi e.g. pneumococcal e.g. tetanus e.g. HPV, Hep B e.g. pertussis 3

4 The BIG 5 Vaccine Manufacturers GlaxoSmithKline Merck Novartis Pfizer-Wyeth Sanofi Pasteur 4

5 Smaller Market Share or Limited Range: Astellas Baxter Avant Crucell-Berna Bioport CSL ID Biomedical MedImmune-AstraZeneca Intercell Serum Institute of India North American Biologicals RIVM Solvay Statens Serum Inst. 5

6 Producers Outside North America and Europe Japanese Local Producers: Biken, Takeda, Kitasato, Kaketsuken, Japan BCG Indian Local Producers: Panacea, Bharat, Shanta, Biological E., Indian Immunologicals, Zydus Korean Local Producers: Green Cross, LG Latin American Local Producers: Butantan, Fiocruz, Birmex, Bio-Manguinhos, Finlay Inst. Biofarma [Indonesia] Saovabha [Thailand] Razi [Iran] IVAC, Vabiotech [Viet Nam] Microgen [Russia] 6

7 The Growing Chinese Vaccine Industry 46 different companies producing 24 vaccines Many recently consolidated as Sinopharm Most important producers are LanZhou, Chengdu, Wuhan, Changchun, Hualan Joint ventures with GSK, Novartis, Sanofi Already world s largest producers 7

8 Vaccines $18B = 2.1 % TOTAL Pharma : $880B in 2011* * Source: Thompson Reuters Pharma Fact book, 2012 WMA 2011, SP Internal 8

9 Projected Growth of the Vaccine Market by Adult And Pediatric Segments Vaccine Fact Book, 2012 Pharma, page 53 9

10 Why is There an Increase in the Vaccine Market? New vaccines give higher profits Hib, Hepatitis B and Pneumococcal vaccines changed the paradigm of a cheap vaccine 10

11 Vaccine Fact Book, 2012 Pharma, page 53 11

12 Pfizer 22% 2011 Market Share US Market 7B Others 3% Sanofi Pasteur 25% Novartis 3% Merck 32% GSK 12% Source: Internal Sanofi Pasteur World Market Analysis, derived from publicly available data 12

13 Worldwide Vaccine Market Share (Doses) 2011 Market Share Global Market 17B Pfizer 16% GSK 22% 2.7 B 3.8 B Others 24% 4.1 B 3.0 B 719K 2.8 B Merck 16% Sanofi Pasteur 18% Source: Internal Sanofi Pasteur World Market Analysis, derived from publicly available data Novartis 4%

14 The Free market has allowed rapid growth in Emerging Economy producers (DCVMs). 14

15 Why is a Vaccine Developed by Industry??? 15

16 The Road to Vaccine Development Academia and Biotech 1. Identify the mechanism of natural protection 2. Isolate the antigen(s) responsible for the protection 3. Show in animals that the vaccine protects 4. Find the best formulation of the antigen Industry 5. Increase yield and purity of vaccine 6. Show the safety of the vaccine in animals 7. Produce a lot under GMP Perform Phase 1, 2, 3, 4 clinical trials

17 What Does Preclinical Development Mean? How to formulate antigen? Is adjuvant needed? Compatibility of antigen and adjuvant? How to measure antigen? How long is antigen stable? Can yield be increased? Toxicology and safety in animals Standardization of immunological assays What animal species is surrogate for immunogenicity? Consistency of manufacture? 17

18 Reasons Why Vaccine Manufacturers Launch a Development Program 1) Market 2) Market 3) Market 18

19 How Market is Determined 1. Epidemiologic data e.g. Pneumococcal conjugate 2. Demand from consumers in developed countries e.g. Lyme Disease, Acellular Pertussis 3. Demand from authorities in developed countries e.g. Mening C 4. Expert opinion e.g. Mumps 5. Guesses, buttressed by precise but inaccurate 19 data. e.g. Hepatitis B

20 Public Health Interest Development programs for HIV vaccines based more on this than on expectation of profit 20

21 Technical Feasibility Breakthroughs come from academia and government, and now biotech Importance of proof of concept. An approach is useless unless it can be scaled up. e.g. vectors Mice lie, or at least exaggerate. 21

22 Intellectual Property A quagmire May block development or sale e.g. Hepatitis B Lyme 22

23 Fit with Other Vaccines Combinations Travel Vaccines Syndrome Coverage e.g. Meningitis 23

24 Phases of Clinical Development Phase 1 - Safety and Immunogenicity (10-100) Phase 2 - Dose, Schedule, Safety, Immunogenicity ( ) Phase 3 - Efficacy, Safety (10,000 70,000) Consistency Phase 4 - Safety (100,000 -, 1,000,000) 24

25 Estimates of Clinical Development and Approval Times Mean Time Duration in Months Study Phase Time (mo.) Phase I 19.5 Phase II 29.3 Phase III 32.9 Registration, Review and Launch 16.0 Total Excluding Preclinical 97.7 (8+ Yrs.) 25

26 Estimates of Transitional and Cumulative Success Probabilities for Vaccines Cumulative Launch Probability Preclinical to Launch 0.22 Phase I to Launch 0.39 Phase II to Launch 0.64 Phase III to Launch 0.68 Registration to Launch

27 Changes in Vaccine Costs for Childhood and Adolescent Immunization, CDC Catalog CDC Catalog TOTAL $33.70 $ $1, $1, $1, $1, Prices as of 10/31/06 Representative series; other choices are possible. Excise tax of $0.75 per dose per disease prevented (e.g., IPV=$0.75, DTaP=$2.25) is included. CDC and catalog includes 3 doses of HPV recommended for females, $288 and $360, respectively. 27

28 Prices of Childhood Vaccines Madsen LB, et al. Perspectives

29 For New Vaccines, Prices Can Only be Higher R&D Costs/ Risks/ Length of Development Cost of Patents Regulatory Requirements / Quality impacts Current estimate per vaccine: $ million 29

30 30

31 Vaccines for Poor Countries 1. Tiered pricing 2. Local manufacture 3. Donations by rich countries or philanthropists 4. More investment by governments 31

32 The free market has given rise to tiered pricing 32 32

33 Some Examples of Technology Transfer (RIVM) Micro-carrier technology Measles vaccine to China Serum-free medium Hib conjugation Influenza vaccine in eggs Sabin - IPV 33

34 Safety Issues Less and less tolerance of reactions Higher and higher levels of regulation False issues may be as costly as true issues 34

35 Critical Needs for Vaccinovigilance More epidemiologic studies of background incidence of serious events e.g. Guillain-Barré, myocarditis Better vaccinovigilance in low income countries Phase IV studies including 1 million vaccinees 35

36 Vaccine Supply Limited production facilities Large capital investment needed Need for new factories/producers in developing countries or pharmaceutical alliances 36

37 Conclusions The Vaccine industry is thriving: interest in vaccines is high and technology is exploding. However, there are insufficient manufacturers doing research; successful development is complicated and expensive; and without the Gates Foundation, the hopes of extending vaccination to all would be limited. 37

Stanley A. Plotkin ADVAC /10/2010 2:35 PM

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