NEW YORK, June 19, 2003 (PRIMEZONE) -- Founded in 1996 as an offshoot of Genentech Inc. (NYSE:DNA), VaxGen Inc. (Nasdaq:VXGN) was selected as the only U.S.-based company to develop, manufacture, and clinically evaluate an anthrax vaccine by the National Institutes of Health, Gordon said. Since they acquired the contract in Sept. 2002, the company has "completed all pre-clinical studies, and received permission from the FDA to begin human clinical studies," he added. "We will look at 100 individuals (measuring) the safety of the product, immune responses, and compare these to the levels of antibodies that have shown to be protective in the well accepted (model)," he said. The company is "prepared not only to advance licensure, but also to initiate large scale manufacturers this Fall," if the Government accepts their initial responses in August.
Under their current contract, VaxGen is required to provide the Government with a plan of how "(they would) initiate the manufacturing of a 25-million dose stockpile starting this October," Gordon said. With a manufacturing facility in Inchon, South Korea, and another in Southern San Francisco with a capacity of producing 50-million doses annually, which Gordon said "can be expanded to whatever is needed," he predicted that they will be able to meet the government's standards.
With Congress allocating $5.6 billion for their bio-shield defenses, and with more than 1/2 of that being spent for anthrax and small pox vaccines, Gordon said his company's next goal is to "bid on and win the supply contract," which included $250 million for the purchase of the vaccine stockpile. "They identified about $700 million over a 3-year period for procurement," he said. "It's our goal to satisfy that in its entirety."
VaxGen is also working closely with the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) of Japan, to bring a small pox vaccine that has already been licensed in Japan, to the United States, Gordon said. "Our target is to file an IND for the small pox vaccine in the U.S. by the end of the year," he said, adding that the vaccine has already been tested on 50,000 children in Japan, and has proven to be safe.
The company also has two preventive AIDS vaccine candidates, AIDSVAX B/B and AIDSVAX B/E, in Phase III clinical trials. Each vaccine candidate is designed to induce the human immune system to produce antibodies that prevent HIV infection.
About VaxGen Inc.
VaxGen, Inc. is focused on the commercial development of biologic products for the prevention of and treatment of human infectious disease. Spun off from Genentech in 1995, VaxGen is the only company with AIDS vaccine candidates in Phase III clinical trials. VaxGen is also developing a modern anthrax vaccine with funding from the National Institutes of Health (NIH) and under an agreement with Chemo-Sero-Therapeutic Research Institute (Kaketsuken) of Japan, VaxGen has initiated development of a potentially safer small pox vaccine for use in the U.S. VaxGen is the largest shareholder of Celltrion, Inc., a joint venture that is building two facilities for manufacture of biopharmaceutical products.
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