December 16, 2002 5:04 p.m. EST
HEALTH
FROM THE ARCHIVES: December 16, 2002
FDA Grants 'Fast Track' Status To VaxGen's Vaccine for HIV
By KARA WETZEL
DOW JONES NEWSWIRES
NEW YORK -- Shares of VaxGen Inc. surged Monday, as the company moved a step closer to its goal of getting a vaccine for HIV, the virus that causes AIDS, on the U.S. market.
In late-afternoon trading on the Nasdaq Stock Market, the Brisbane, Calif., biotech firm's stock changed hands at $16.20, up $3.19, or 25%, after announcing its two HIV-vaccine candidates had received fast-track designation from the U.S. Food and Drug Administration.
The designation expedites the FDA review process for VaxGen's AIDSVAX B/B and AIDSVAX B/E vaccines -- the only preventive HIV vaccines that have advanced to late-stage Phase III clinical trials.
The FDA grants fast-track status to certain drug candidates as a way to address unmet medical needs for the treatment or prevention of life-threatening conditions.
"The rapid review allows us to submit our biologics license application [BLA] in parts as it is completed, rather than as a whole," said VaxGen spokesman Jim Key.
Mr. Key said the company expects to be able to file a BLA application by late 2004. In addition to processing and analyzing the data from the Phase III testing, VaxGen must also complete its manufacturing facilities, which need to be licensed as part of an FDA application.
VaxGen said it expects to announce the primary results of its AIDSVAX B/B trial -- a double-blind, placebo-controlled study of 5,400 people in the U.S., Canada, the Netherlands and Puerto Rico -- in the first quarter of 2003.
VaxGen also said it is nearing completion of its Phase III trial of AIDSVAX B/E in Thailand. AIDSVAX B/E is designed to protect against HIV subtypes B and E; the company said it expects to announce primary results of that trial in the second half of 2003. HIV subtype E is prevalent in Southeast Asia and the Central African Republic.
Sharon Seiler, an analyst for Punk Ziegel & Co., said that while the FDA fast-track status is positive for the company, it doesn't come as a surprise given the importance of these drug trials.
The latest advance in VaxGen's stock price comes on the heels of a 23.9% decline Friday, after a study published in the scientific journal Nature doubted the effectiveness of an HIV vaccine.
Mr. Key, the VaxGen spokesman, said the Nature article may have played a role in the stock's volatility, but added that the company doesn't speculate on specific reasons behind stock movement. "We have a small float so our shares are subject to large swings," Mr. Key said.
In addition to the negative Nature article, Ms. Seiler said some of Friday's selling may have had to do with unfounded negative market rumors on the efficacy of the vaccine trials and insider trading.
Ms. Seiler dismissed the rumors. "It's a blinded trial, so no one can have any idea on how it's going," she said.
Ms. Seiler said there may be concern because Vulcan Ventures Inc., the investment vehicle for Microsoft Corp. cofounder Paul Allen, has been selling its VaxGen shares periodically for the past year. In addition, about 15 million of VaxGen's 20 million convertible preferred shares have been converted to common shares, which Ms. Seiler said may be misinterpreted as a negative. Ms. Seiler owns VaxGen shares, and her company has a banking relationship with the company.
Write to Kara Wetzel at [email protected]
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Updated December 16, 2002 5:04 p.m. EST
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