Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
San Francisco Chronicle - Thursday, October 4, 2001
Tom Abate, Chronicle Staff Writer
The recommendation, which the FDA will factor into its final decision due by the end of this month, is just shy of total victory for Gilead Pharmaceuticals, the Foster City company that is expected to have its drug, Viread, on the market in early November.
Tom Dietz, an analyst for San Francisco's Pacific Growth Equities, said even the limited approval suggested by a majority of the panel would allow Gilead to ship a product that could easily have up to $250 million a year in sales. "It's typical that you ask for the moon even if you know you can't get it," Dietz said. "What this means is that they'll get a drug on the market, and they'll expand the use of it once it's there."
Gilead is seeking permission to market Viread for all AIDS patients, not just those who have developed resistance to other medications. Dietz said the FDA could still grant the company that broader marketing authority when it makes its decision by Oct. 31.
But even if the FDA follows yesterday's recommendation, Dietz said Gilead is already working on other clinical trials to prove that Viread is safe and effective for wider use.
Yesterday's advisory committee vote was a comeback for Gilead, whose earlier AIDS drug -- the predecessor to Viread -- was rejected by this same panel two years ago. At that time, the advisory committee thought the previous drug, though effective in fighting AIDS, caused too much kidney toxicity as a side effect. In an unusual move, some AIDS activists opposed approval of the previous drug.
Yesterday, however, AIDS activists were in Gilead's corner, supporting wider use of Viread.
Martin Delaney, a leader of San Francisco's Project Inform, said Viread would be easy to take because it's a one-a-day pill and seemed to have fewer side effects than other AIDS medicines.
"We want it to be for broad-spectrum use for the treatment of HIV," he said. Trading in Gilead shares was halted before the advisory panel meeting. The stock will open today at $56.62. The company's shares have ranged between $24 and $63 during the past year.
E-mail Tom Abate at tabate@sfchronicle.com.
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