Gilead Sciences Inc. (GILD) said the U.S. Food and Drug
Administration has allowed it to remove a warning about potential
liver injury from its Letairis treatment for pulmonary arterial
hypertension.
Gilead, known for its HIV drugs, said patients who use Letairis
no longer will be required to obtain monthly liver function tests.
Fourth-quarter sales of Letairis rose 23% to $64 million from a
year earlier, representing about 3.2% of the company's total
revenue.
In addition to its HIV business, the biopharmaceutical company
also receives royalties from Roche Holding AG (ROG.VX, RHHBY) for
the antiviral medication Tamiflu, which Gilead discovered. Gilead,
however, cut its expectations for product sales multiple times last
year due to the effects of currency fluctuations and the potential
impact of the U.S. health-care overhaul.
Wall Street has been concerned about the company's pipeline
development since several of its drugs face patent expirations
later this decade.
The company in January reported that its fourth-quarter profit
fell 22% on restructuring and acquisition-related charges and
higher expenses. At the time, Gilead also reported a setback in
getting its latest HIV treatment to market as the FDA requested
more information.
Shares are up 0.4% at $40.16 premarket. The stock is up 10% this
year.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
Tess.Stynes@dowjones.com