Tuesday October 2, 2001
Gilead Drug Gets Positive FDA Staff Review
By Lisa Richwine
The assessment from Food and Drug Administration reviewers was posted on the agency's Web site a day before an advisory panel meets to scrutinize data on the drug, known generically as tenofovir.
The FDA's analyzes of Viread's safety and effectiveness ''support the applicant's results and conclusions,'' the reviewers wrote. Gilead's application ``provides clear evidence of tenofovir's antiviral activity (over 24 weeks) when added to a stable background regimen.''
The reviewers said they want the advisory panel's advice on which patients would benefit most from Viread. The drug, part of a class known as nucleotides, has shown the ability to help patients who have developed resistance to other treatments.
The FDA usually follows its panels' advice, Gilead said it expects a final agency decision on Viread by Nov. 1.
The Foster City, California-based company predicts Viread, if approved, will help the firm make a profit in the second half of 2002, Gilead Vice President John Milligan said in an interview.
``We expect this product to be a very significant HIV product that will help Gilead become profitable,'' he said.
With more AIDS patients failing current therapies each day, Viread should win approval as a last-resort option, industry analysts said.
``I think they've got a very good chance of getting through the advisory panel,'' Prudential Securities analyst John Sonnier said. ``Resistance has become a big issue, and so drugs like (Viread) that have a different profile and that have activity against the resistant strains are badly needed.''
Sonnier estimated sales of Viread would total $125 million in 2002 and $275 million in 2003.
Gilead failed in an earlier attempt to get an HIV-fighting drug on the market. An advisory panel and the FDA both rejected a pill called adefovir over concerns about kidney damage.
The FDA reviewers said Viread did not appear to harm the kidneys. But they expressed concern about bone density reduction in animals given Viread and urged further study to see if that would be a problem for people.
Like adefovir, Viread is a nucleotide, a type of reverse transcriptase inhibitor that keeps the AIDS virus at bay by blocking an enzyme it needs to replicate. Viread, a once-a-day pill, could be the first nucleotide approved for treating HIV infection.
``It's a very solid drug for people who have failed multiple therapeutic regimens,'' said Robertson Stephens analyst Michael King, who has a ``neutral'' rating on Gilead stock. He predicted Viread sales of $175 million worldwide in 2003.
Trading of Gilead shares was halted Tuesday.