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GLOBAL VACCINE MARKET PLACE

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Estimated 2013 Global Vaccine Market $32 Billion

2013 US Vaccine Market for the 78 Licensed Vaccines was ~ $13.2 Billion; combination of 1/3rd Adult and 2/3rd Children (Pediatric & Adolescents)• CDC recommends an immunization schedule for persons aged 0 – 18

years of age totaling 14 vaccines• CDC recommends an immunization schedule for Adults of 11 vaccines

Global Vaccine Market is estimated to grow to over $84 Billion by 2022 backed by advances in technology and vaccines towards emerging infectious diseases, cancers and allergies; leading to personalized vaccine treatments.• Projected growth rate of 10-15% per year versus 5 – 7% for

Pharmaceuticals. • More than 295 vaccines in various phases of development by 102

Companies.

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Global Vaccine Market GAP

In 1990, 1 in 100 children died before reaching five years of age; by 2002 that rate had improved to 1 in 143. Scandinavian countries enjoy the lowest rate of child mortality* Source: Unicef

Developing Countries

85%

93%

Vaccine Sales  82% 18%

Source: WHO

Population                    15%

BoD                                     7%

36 Industrialised Countries Developing Countries

85%

93%

Vaccine Sales  82% 18%

Source: WHO

Population                    15%

BoD                                     7%

36 Industrialised Countries

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5 Large Global Companies represent 80% of the Vaccine Market

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Emerging Manufacturers help supply UNICEF & PAHO with ~$1.5 Billion of Vaccines in 2012

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Vaccines are Becoming an Engine for the Pharmaceutical Industry

Resulting in:• Growing concentration in the 34 OECD countries• Newer and more expensive vaccines are coming into the market• Vaccine development: increasing Investment for industrialized markets• New business model for vaccines are emerging in developing countries: Manufacturer & Country Partnerships,

Risk sharing with countries and funders, Increased presence of Sales forces like the Pharma model

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US FDA Licensed VaccinesManufacturer and their number of Vaccines

Sponsor Count

Sanofi Pasteur, Inc 25GlaxoSmithKline Biologicals 13

Merck & Co, Inc 12Novartis Vaccines and Diagnostics Ltd 6ID Biomedical Corporation of Quebec 4

MedImmune, LLC 3CSL Limited 2

Organon Teknika Corp LLC 2Wyeth Pharmaceuticals Inc 2

Barr Labs, Inc. 1Berna Biotech, Ltd 1

BioPort Corp(not available) 1Emergent BioDefense Operations Lansing Inc. 1

Greer Laboratories Inc. (not available) 1Intercell Biomedical 1

MassBiologics 1Protein Sciences Corporation 1

Research Foundation for Microbial Diseases of Osaka University 1

Total 78NB: Products are listed in the Appendix

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Vaccines Can Prevent Twenty-Eight Diseases

Source: CDC

99

Vaccine Challenges

Sources: PRTM & Industry Data

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SEASONAL & PANDEMIC INFLUENZA

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Influenza Vaccine

1212

Influenza Vaccine DevelopmentGoal: more and better vaccines sooner

1313

Pipeline and Marketed Influenza Vaccine’s

Sources: Assistant Secretary for Preparedness and Response

1414

Global Influenza Vaccine Production

Sources: Assistant Secretary for Preparedness and Response

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Production types of Seasonal and Pandemic Influenza Vaccines

Production types1. Egg based: 99.8% of 2013

doses2. VLP: Medicago, Novavax,

Technovax3. Recombinant Proteins: Protein

Sciences

4. Cell-derived: Novartis

5. Viral Vectors

6. DNA

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Comparison of Vaccine Production Timelines

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Manufacturers to supply 139.25 M Seasonal Flu Vaccine doses for the 2014

2014 Manufacturers1. Sanofi Pasteur: 60M doses

a. Quadravalent

2. Novartis: 30M dosesa. Quadravalent will be available only for

Flucelvax , site transferred from Marburg, Germany

3. GSK: 22 – 24M dosesa. Quadravalent will be available only

with Fluarix (10 M doses from Germany)

4. Medimmune: 13 – 15Ma. Quadravalent

5. CSL: 10M

6. Protein Sciences: 0.250M

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Universal Vaccine StrategiesLeveraging Old and New Discoveries

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Timeline for Production of Inactivated Pandemic Influenza Vaccine

2020

Pandemic Vaccine preparedness; May 2009 H1N1 experience

• The World Population is 6.84 Billion People living in 206 countries. • The World production capacity for each of the vaccines, Pandemic and Seasonal

Influenza, is ~876 Million doses produced by ~36 manufacturers. • Actual vaccine output has many factors; two key drivers are (1) The viral strains

selected by the World Health Organization and (2) The platform technology used to manufacture vaccine.

• Once vaccines are produced; Countries draw against this capacity in different ways. – The chart below shows the H1N1 Pandemic Vaccine by segment:

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Recombinant Influenza Vaccines Pandemic and Seasonal Pipeline

Low cost to produce

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The Role of Distribution Delivering Vaccines to the Place of Vaccination

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There is so much promise on the horizon ….