Johnson & Johnson, Gilead HIV Drug Wins U.S. FDA Approval

Johnson & Johnson and Gilead Sciences Inc. won U.S. approval of a once-daily HIV treatment that combines multiple medicines into one tablet.

The Food and Drug Administration cleared the therapy that combines New Brunswick, New Jersey-based J&J’s Edurant and Gilead’s Truvada, Foster City, California-based Gilead said today in a statement. A single, or fixed-dose, daily tablet simplifies HIV therapy, said John Martin, Gilead’s chairman and chief executive officer, in the statement.

The combination product, called Complera, is expected to generate $567 million in revenue in 2013, said Joel Sendek, an analyst with Lazard Capital Markets in New York. He called the drug a “catalyst” for Gilead, the world’s biggest maker of AIDS drugs, in a July 27 note to clients.

“The concept of a single-tablet regimen has become a goal in HIV drug development and the standard of care in medical practice in the United States,” Tony Mills, an investigator in Complera studies, said in the Gilead statement. “Given its efficacy, safety and convenience, the availability of Complera represents an exciting milestone in addressing the individual needs of patients new to HIV therapy.”

About 1.2 million people in the U.S. have HIV with about 48,100 new patients contracting the virus in 2009, the Centers for Disease Control and Prevention said Aug. 4 in a report.

Gilead’s Pill

Gilead now sells the only single-pill HIV regimen, Atripla, a triple-drug combination approved in 2006 that includes Sustiva from Bristol-Myers Squibb Co. Atripla was Gilead’s top seller in 2010, generating $2.9 billion.

Gilead and J&J announced an agreement June 28 to develop a fixed-dose HIV treatment combining Gilead’s experimental cobicistat and Prezista from J&J. Cobicistat increases blood levels of certain HIV medicines to allow for once-daily dosing, according to a statement from Gilead.

The companies also said they are negotiating the terms of an agreement to develop a single-tablet regimen combining Prezista with Gilead’s Emtriva, cobicistat and investigational GS 7340.

Truvada is Gilead’s second-highest selling drug behind its Atripla with $2.6 billion in sales last year, according to Bloomberg data. The FDA approved Edurant May 20, in combination with other antiretroviral agents, for patients who have never taken HIV treatment before.

The companies originally filed an application for the Truvada and Edurant combination Nov. 23. The FDA told the drug manufacturers Jan. 25 the agency needed more information, which Gilead and J&J included when they refiled their application Feb. 10, according to a statement from Gilead.

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