FDA approves Gilead's once-daily HIV pill

UPDATE 2-U.S. FDA approves Gilead's once-daily HIV pill
Wed Aug 10, 2011 6:34pm EDT

* Pill Complera combines Gilead's, J&J's components
* HIV drug maker Gilead facing patent expirations
* Says also resolved San Dimas facility issue with FDA (Adds details throughout)
WASHINGTON, Aug 10 (Reuters) - U.S. regulators approved a once-daily HIV pill by Gilead Sciences Inc (GILD.O), giving a new source of revenue to the leading maker of HIV medicines as it faces expiring patents.

The U.S. Food and Drug Administration on Wednesday gave a nod to the pill Complera for patients who have not received prior treatment for the virus that causes AIDS. The $1,705-a-month drug combines Gilead's Truvada with Johnson & Johnson's (JNJ.N) Edurant, which received FDA approval in May. [ID:nN20229122]

Gilead currently sells another once-daily pill, Atripla, that combines Truvada with Bristol-Myers Squibb Co's (BMY.N) Sustiva, but the California drugmaker earns no profit from the Bristol drug and all of the Atripla components lose patent protection in the next few years.
Under the deal with J&J, Gilead would keep up to 30 percent of what it will make off the Edurant component in Complera.

The company's sales of AIDS drugs have benefited from new U.S. health guidelines calling for wider screening for the disease and its earlier treatment, but the magnitude of growth has slowed and the company is under pressure to bring new drugs to the market.
U.S. regulators first rejected Gilead's application for Complera in January, citing insufficient information.

Shares of Gilead rose 2.6 percent to $36.26 on Wednesday in after-hours trading on the Nasdaq after closing at $35.34.

Also on Wednesday, the company said it has resolved all issues raised in an FDA warning letter from September. The FDA at the time raised concerns about manufacturing problems and product quality at a San Dimas, California, plant where Gilead makes many of its drugs.
Now, the company's response and actions have "sufficiently addressed" FDA's concerns, Gilead said.

Gilead last month became the first drugmaker to sign up for a new patent pool, where it plans to share intellectual property rights on its medicines with a goal of making treatments more widely available to the poor. [ID:nL6E7IB0VQ]
Around 33 million people worldwide have the human immunodeficiency virus, HIV, that causes AIDS, most living in Africa and Asia. (Reporting by Alina Selyukh and Anna Yukhananov; editing by Andre Grenon and Carol Bishopric)