G L O B A L V A C C I N E S A N OT -F OR -P ROFIT V ACCINE C OMPANY.

G L O B A L V A C C I N E SA NOT-FOR-PROFIT VACCINE COMPANY

Photograph by Dr. Clive Gray Photograph by Clive Gray

BiographyRobert E. Johnston, Ph.D.

• Academic Positions

•Assistant, Associate, Full Professor of Microbiology, North Carolina State University (1976-1989)

•Professor of Microbiology and Immunology, University of North Carolina (1989-present)

•Director, Carolina Vaccine Institute, University of North Carolina (2002-present)

• Research

•Molecular Genetics of Viral Disease

•Design of Vaccines

•Development of New Vaccine Technologies

•Vaccine for clade C Human Immunodeficiency Virus

• Fourteen U. S. Patents

• $14.8MM in Active Research Grants

• Business Experience

•Principal Co-Founder, Chairman and CEO of AlphaVax, Inc. (1997-2001)

•Secured over $5MM in licensing, grant and equity funding

Global Vaccines, Inc.

Academic Vaccine Research Center

Fundamental Aspects of Vaccines

Antigenic Structure and Pathogenesis

Vaccine Technologies

Not-for-Profit Business

Vaccine R & D Teams for Diseases

of Resource Poor Populations

Vaccine and Vaccine Technology Development

In-licensing Vaccine Technology

Business Infrastructure for Vaccine Development

Partnerships with Commercial Vaccine Manufacturers

Concept for a UNC Vaccine Center

Global Vaccines, Inc., Research Triangle Park,

North Carolina

Carolina Vaccine Institute, University of North Carolina Chapel Hill


A Not-for-Profit Vaccine Company


Mission Statement

Global Vaccines will apply state-of-the-art vaccine technologies and innovative business strategies to the design and development of affordable vaccines for diseases of resource poor nations.


•Mary Estes, Ph.D. – Baylor College of Medicine; Former Member, Vaccines Advisory Committee, FDA.

•Harry B. Greenberg, M.D. – Stanford University; Former Chief Scientific Officer, Aviron.

•Samuel Katz, M.D. – Duke University; Inventor of the measles vaccine; Chairman, Board of Trustees, International Vaccine Institute, Seoul, Korea; Former Member, Vaccines Advisory Committee, FDA.

•Thomas Monath, M.D. – Former Chief Scientific Officer, Acambis, plc; Adjunct Professor, Harvard School of Public Health; Senior Advisor, Kleiner Perkins Caufield & Byers.

•Peter Palese, Ph.D. – Mount Sinai School of Medicine; Member, Vaccines Advisory Committee, FDA; Member, National Academy of Sciences.

•Barbara Sherry, Ph.D. – North Carolina State University; Veterinary vaccines.

•Catherine Wilfert, M.D. – Duke University; Scientific Director, Elizabeth Glaser Pediatric AIDS Foundation.

Global Vaccines: Scientific Advisors


•Joseph S. Pagano, Chairman

Director Emeritus, Lineberger Comprehensive Cancer Center, Professor of Medicine, University of North Carolina

•Dennis McNamara, Secretary

Vice-President, Business Development, Pozen Corporation

•Robert E. Johnston, Executive Director

Director, Carolina Vaccine Institute, Professor of Microbiology and Immunology, University of North Carolina

Global Vaccines: Founding Board of Directors

Rationale for Global Vaccines, Inc.

• The developing world caries an enormous disease burden, e.g. HIV, tuberculosis, dengue fever and malaria.

• Causative organisms known for decades; still no effective, affordable vaccines.

• Why this stunning lack of success?

• Substantial technological challenges.

• Insufficient projected market potential for the commercial vaccine industry.


AN

EFFECTIVE

UNAFFORDABLE

VACCINE

NO

VACCINE=


Vaccine development and distribution choices are dictated by market forces rather than global public health need.

• Commercial Vaccine Companies – Fiduciary responsibilities to shareholders; internal rate of return relative to other endeavors.

• University Laboratories – We make discoveries, but we seldom make products.

• University Technology Offices – No alternative licensing pathways other than commercial concerns.

• Low Cost Vaccine Manufacturers – Operate like generic drug companies relying on vaccines coming off patent as a product pipeline.

Limitations of the Vaccine Enterprise


Proof-of-Concept

Traditional Technology Licensing Strategy

License Fee

License to Company

Commercial Company

Global Vaccines

Non-Commercial Vaccine Markets; Orphan Vaccines

Commercial Vaccines; Non-Vaccine Applications

Royalties, etc.

License for Resource Poor Countries


• Black eye syndrome

• Gray market product

• Technology leakage

University Vaccine Technology

Proof-of-Concept


License Fee

License to Company

Commercial Company

Global Vaccines



Royalties, etc.

Wait 20 years for patent expiration




Proof-of-Concept


License Fee

License to Company

Commercial Company


Royalties, etc.


Government Grants

Philanthropies

The useful benefits of academic science, overwhelmingly funded from government and philanthropic sources, are most often provided only to wealthy countries with little or no benefit to those populations most in need.

How does Global Vaccines propose to intervene in this cycle and overcome

these limitations?



Proof-of-Concept

Global Vaccines

License to GVI

License Fee, Royalties, etc.

GVI Technology Licensing and Partnering Strategy

Initial License

Fee

Commercial Partner

Commercial Vaccine Markets; Non-Vaccine Applications

Global Vaccines



HIV

Dengue Added Value

Low CostManufacturing

Partner

VaccineProduct


Commercial Sublicense

Grant Supported Joint Research


Everyone Wins

• Poor populations get needed vaccines.

• Inventors and their universities get a potentially larger and more timely return on their inventions.

• Developing country manufacturers get a high technology product pipeline relevant to the populations they serve.

• Commercial vaccine companies get the opportunity to license more mature and less risky technology for use in commercial vaccine markets.

Is there any chance at all that Global Vaccines can succeed?


• Are there high quality platform vaccine technologies available for Global Vaccines to license?

• YES. A number of exciting, early stage technologies are available for licensing.

• Can Global Vaccines compete in licensing University technologies?

• YES. We have successfully licensed two important new technologies from the University of North Carolina.

• Can Global Vaccines pursue proof-of-concept research?

• YES. We have successfully competed for grant funding in support of our two licensed technologies. International AIDS Vaccine Initiative (12/1/05-12/30/12, $3.5M); Bill and Melinda Gates Foundation through IAVI (7/13/06-7/12/11, $1.75M); and National Institutes of Health (9/1/06-8/31/10, $5.4M).

• Can Global Vaccines finance business development and patenting strategies?

• MAYBE. These costs must be covered with non-research grant funds such as private contributions, foundation support or partnering revenue.

Philanthropic Support Needed:

Business Infrastructure

Initial License Fees / Patent Costs

Preliminary Data in Support of Research Grant Applications

Link with Low Cost Partners


Proof-of-Concept

Global Vaccines

License to GVI

Grant Supported Joint Research


GVI Technology Licensing and Partnering Strategy

Initial License

Fee

Commercial Partner

Commercial Vaccine Markets; Non-Vaccine Applications

Global Vaccines



HIV

Dengue Added Value

Low CostManufacturing

Partner

VaccineProduct


Commercial Sublicense

GVI Licensed Technologies

• Live Virus Vaccines – Vaccines designed and built from scratch.

Chimeric Particle Production in Vero Cells

Carolina Vaccine Institute

GVI Licensed Technologies

• Live Virus Vaccines – Self-replicating immunogens designed and built from scratch.

• Mucosal Adjuvant – System capable of boosting the effectiveness of inactivated vaccines like polio, influenza and HPV by 10-100 fold and inducing protection against pathogens transmitted by the respiratory or sexual routes.

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Footpad Immunization with Inactivated Influenza Virions and Null VRP

Academic Vaccine Research Center

Fundamental Aspects of Vaccines

Antigenic Structure and Pathogenesis

Vaccine Technologies

Not-for-Profit Business

Vaccine R & D Teams for Diseases

of Resource Poor Populations

Vaccine and Vaccine Technology Development

In-licensing Vaccine Technology

Business Infrastructure for Vaccine Development

Partnerships with Commercial Vaccine Manufacturers

Vaccines at the University of North Carolina

Knowing is not enough; we must apply.Willing is not enough; we must do.

(Goethe)Photograph by Dr. Kim Lindblade

G L O B A L V A C C I N E SA NOT-FOR-PROFIT VACCINE COMPANY

G L O B A L V A C C I N E S A N OT -F OR -P ROFIT V ACCINE C OMPANY.

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