San Francisco Chronicle - Tuesday, November 2, 1999
Tom Abate, Chronicle Staff Writer

The 13-to-1 vote by the advisory committee was a crushing blow to Gilead Sciences of Foster City, because the FDA usually follows its panels' recommendations in deciding whether to approve new drugs.

"We're obviously disappointed with the committee's decisions," Gilead chief executive John Martin said in a statement. "However, we plan to work closely with the FDA to resolve the outstanding issues and respond to the questions they have raised."

Trading in Gilead shares was halted at $63.19 yesterday during the panel's deliberations. The stock is in for a pounding today as investors digest the disappointment.

Analysts had bet on Adefovir's approval, touting the experimental drug as a remedy for people with strains of HIV resistant to current AIDS drugs. JP Morgan analyst Franklin Berger had estimated Gilead would book $42 million from Adefovir sales in 2000, a big step toward making the company profitable.

The negative vote casts a cloud over those projections as well as Gilead's other successes, notably the royalties it stands to earn from the recent FDA approval of Tamiflu, a pill to relieve flu symptoms.

Yesterday's meeting began badly for Gilead when FDA staff scientists testified that Gilead's Adefovir was not very effective in treating HIV and that even low doses seemed to cause kidney problems in many patients.

In the past, companies seeking approval for HIV drugs could rely on strong support from AIDS activists to shout down such FDA concerns. But leading AIDS groups, like the Treatment Action Group in New York, voiced the same reservations as the FDA scientists yesterday and urged the advisory panel to reject Adefovir.

"Adefovir marks a turning point for the AIDS community," said Martin Delaney with Project Inform in San Francisco. "Nobody has worked harder than we have to get new treatments approved. But with 14 other drugs out there, you tend to look a little more harshly at the new ones."

A recent report by the Frost & Sullivan market research firm estimates that nearly $3 billion worth of AIDS drugs will be sold in 1999. It projects sales will grow an average of 19 percent a year through 2005.

Delaney said the very robustness of the HIV drug market meant AIDS activists and advisory panel members could consider Adefovir's performance without the sense of urgency with which they have scrutinized previous drugs.

Panel members were concerned that Adefovir accumulated in the kidneys of many recipients. Part way through the human trials, Gilead cut the dose of Adefovir in half to reduce possible kidney toxicity. But that left Gilead with less evidence that Adefovir was effective.

"The paucity of data on safety and efficacy is quite obvious to all of us today," advisory panel member Wafaa El-Sadr, an AIDS expert in New York, told Bloomberg News.

Not all AIDS activists cheered Adefovir's rejection. Ronald Baker, editor of HIVandHepatis.com, said AIDS doctors understand the risks of new medications and should have the choice of prescribing Adefovir for patients who are resistant to other drugs.

Even if Adefovir's future as an HIV treatment is uncertain, AIDS activists say Gilead has a more potent and less toxic variant of the drug in the wings. Gilead hopes to get this drug, called Tenofovir, into Phase III trials later this year.

"We advised Gilead two years ago to drop Adefovir and concentrate on Tenofovir," Delaney said, but the company felt it could not afford to wait the extra year or so to get Tenofovir to market.

Gilead officials did not return calls for comment.
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