DOW JONES NEWSWIRES
Gilead Sciences Inc. (GILD) said the U.S. Food and Drug
Administration has approved Complera, a single-tablet HIV treatment
for patients new to therapy.
Shares were up 2.5% at $36.23 after hours.
The treatment combines three antiretroviral medications in one
pill. Chairman and Chief Executive John C. Martin said the drug
reflects the company's vision of simplifying HIV therapy.
Complera is the second complete antiretroviral treatment regimen
for treatment-naive adults--those new to HIV therapy--in a single
once-daily pill. The first, Atripla, is marketed by Gilead and
Bristol-Myers Squibb Co. (BMY).
The biopharmaceutical company has dominated the HIV-treatment
market. Its retroviral products drove revenue growth in the most
recent quarter, offsetting a decline in royalties for Tamiflu.
In a separate release, Gilead said it has resolved all
outstanding issues at its San Dimas, Calif., plant that the FDA
raised in a warning letter last year. The agency sent the company
the warning after an inspection found multiple quality-control
problems, but earlier this year it reinspected the site and found
nothing worrisome.
The company had been awaiting a confirmation from the FDA.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291;
joan.solsman@dowjones.com