Summaries of health policy coverage from major news organizations
VaxGen Moving Ahead With HIV Vaccine, Approval ‘Likely’ within Three Years
VaxGen Inc., a small biotech company in Brisbane, Calif., is in the final stages of clinical testing of an HIV vaccine that is "likely" to be on the market in the next three years. Although major drug companies like Aventis and Merck & Co. are also developing vaccines, Investors Business Daily reports that VaxGen, a spin-off of Genentech Inc., is the only company with a potential vaccine "anywhere near Phase III (clinical trials)." The drug, Aidsvax, is currently being tested in 2,500 intravenous drug users in
Thailand and 5,400 "high-risk" volunteers in the United States, Canada and Amsterdam. The FDA has said it will approve an HIV vaccine shown to be at least 30% effective, but VaxGen hopes to top that with a 50% to 70% efficacy rate. If Aidsvax is only "modestly effective" it will be given to people who are at high risk for the virus, such as health care workers, drug users and people with STDs, said Sharon Seiler of Punk, Ziegel & Co., a specialty investment bank. "But if it's more than 70% effective it could be used universally, like the way hepatitis B vaccines are used today," she added. Sales figures, excluding sub-Saharan Africa where the disease is most prevalent, for a 30% effective vaccine are projected to top $25 million in 2003 and $50 million in 2004, with a 70% effective drug expected to bring in $145 million and $485 million for the same years. In the United States and other developed nations, the vaccine will be paid for by private insurance and government, but developing nations may not be able to afford the vaccine, "just as they can't afford the HIV drugs that have extended the lives of patients in the U.S. and other wealthy nations." VaxGen will not reap all the profits: the company signed a deal with Genentech when it spun-off four years ago, giving the parent company the "option to make and market" Aidsvax and awarding Genentech 70% of American revenue, with VaxGen taking in 70% of revenue in all other countries. Financing has been VaxGen's "biggest hurdle," beginning with a grant denial by the NIH for the company's clinical trials in June of 1994. The company then turned to private investors, including Microsoft co-founder Paul Allen who owns 22% of its stock, to raise more than $113 million. VaxGen hopes to be the first to market and capture the funding "verbally promised" by the World Bank and the Gates Foundation, among others, for the first successful HIV vaccine makers (Lau, Investor's Business Daily, 12/20).
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