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FDA panel nixes Gilead HIV drug
Study design, other issues, thwart endorsement
By Stephanie O'Brien, CBS MarketWatch
Last Update: 11:42 AM ET Nov 2, 1999 NewsWatch
FOSTER CITY, Calif. (CBS.MW) -- Shares of Gilead Sciences plunged 27.3 percent Tuesday after a U.S. Food & Drug Administration advisory panel recommended the FDA not approve the company's antiviral drug adefovir dipivoxil.
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Updated:
11/2/99 10:53:06 AM ET
Gilead's shares (GILD: news, msgs) plummeted 17 1/4 to 46. The company was pursuing approval to market the drug, known as Preveon, for treatment of HIV and hepatitis. See full story. Shares did not trade on Monday.
On Monday the panel voted 13-to-1 to deny recommendation for approval of Gilead's drug for a number of reasons, including trial design, efficacy and safety issues.
The company said it would meet with FDA staff to discuss the committee's decision.
Michael King, an analyst at Robertson Stephens, lowered his rating and earnings estimates for Gilead as a result of the meeting.
"Due to the difficulties of predicting FDA approval of adefovir, in addition to what we believe will be a more limited market than we initially forecast for the drug, we are cutting our adefovir sales forecasts," King said in a note to clients.
He lowered his rating on Gilead to "long term attractive" from "buy."
Earlier Monday, the panel members expressed concern about data the company presented to support its marketing application, an analyst said.
"The panel expressed concerns about study design and about data showing the effectiveness of the drug," said King, who attended the panel meeting.
Gilead was pursuing approval to market the drug for treatment of HIV and hepatitis. In June, the Foster City, Calif.-based biotech company submitted its application for the drug. The FDA gave it "fast-track" review status, meaning that it could get a review within six months.
Gilead was hoping to market the drug as an alternative to HIV treatments that begin to fail as patients develop resistance to them.
"We are obviously disappointed with the committee's decision," said John Martin, Gilead's chairman and chief executive officer. "However, we plan to work closely with the FDA to resolve the outstanding issues and respond to the questions they have raised."
Although the company has a number of issues to work out with the FDA, not all of the panel's views on the drug were negative.
Most of the committee members said Preveon could be a useful addition to the 14 drugs currently approved to treat HIV and they encouraged Gilead to conduct more studies, according to the trade publication BioCentury.
Last week, Gilead said the U.S. Food & Drug Administration approved its drug, Tamiflu, for marketing in the U.S. See story. |
