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VAXGEN INC. (VXGN) BUSINESS DESCRIPTION: VaxGen Inc. is developing preventive vaccines for worldwide use against HIV. VaxGen Inc. is conducting two large-scale Phase III clinical trials of their AIDSVAX vaccines, one principally in North America and one in Thailand. To date, VaxGen Inc. the only company to advance an HIV vaccine into Phase III clinical trials. If the Phase III clinical trials are successful, VaxGen Inc. will apply to the United States Food and Drug Administration and foreign regulatory authorities for licenses to manufacture and sell AIDSVAX in the United States and abroad. Initial development of AIDSVAX was funded by Genentech at a cost of over $50 million during a period of nearly ten years. VaxGen Inc. was formed in November 1995 to complete the development of, and commercialize, AIDSVAX in partnership with Genentech. Genentech licensed to VaxGen Inc. the technology necessary for development and commercialization of AIDSVAX. COMPETITION: VaxGen Inc. estimates that approximately 30 other companies have been engaged in research to produce an HIV vaccine. Only AIDSVAX and a vaccine once developed by their former competitor, Chiron Vaccines, have progressed to, and completed, Phase II testing. Chiron Vaccines has since abandoned that particular vaccine effort. Subsequently, a combination vaccine developed by Chiron Vaccines and Pasteur Merieux Connaught, also competitors of VaxGen Inc., entered Phase I/II testing in 1997. That vaccine effort, too, has since been terminated. Two other notable efforts at producing HIV vaccines have failed as well. A collaboration between Merck & Co., Inc. and Repligen Corporation was terminated because their vaccine failed to protect chimpanzees from live HIV infection. Similarly, MicroGeneSys, Inc. designed a vaccine that failed in early stage human testing. It appears that the principal differences between these vaccines and VaxGen's has been the choice of viral protein as antigen or the methods used for manufacturing. VaxGen believes that it now leads all competitors worldwide in the development of an HIV preventive vaccine. Of the two HIV vaccines that have reached human clinical trials, VaxGen has full control of the leading product (AIDSVAX) and plans to become a partner in the second (the Pasteur Merieux Connaught/VaxGen combination regimen). (Information from S-1 filed 5/7/99 and IPO.com) | ||||||||||||||
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