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FDA Approves Gilead-J&J HIV Pill Complera

From Associated Press (August 10, 2011)

FOSTER CITY, Calif. -- The Food and Drug Administration has approved a once-per-day HIV treatment that combines Gilead Sciences Inc.'s drug Truvada with Johnson & Johnson's drug Edurant, Gilead said Wednesday.

The combination pill is called Complera, and it is approved for patients who have not previously been treated for HIV. Gilead's drug Truvada is a combination pill containing the drugs emtracitabine and tenofovir, and it was approved in August 2004. Edurant, or rilpivirine, was developed by Johnson & Johnson's Tibotec unit and was approved in May. Truvada and Edurant are both approved for use as part of a drug cocktail, but Wednesday's decision approves the drug as a stand-alone regimen.

Gilead said Complera is the second once-per-day drug intended for untreated HIV patients. The first was Atripla, which is marketed by Gilead and Bristol-Myers Squibb Co.

Gilead will be in charge of manufacturing, development and marketing in the U.S., European Union, Canada, Brazil, Australia and New Zealand. Tibotec can co-market Complera in those areas. The companies expanded their agreement Wednesday, saying Gilead will be responsible for manufacturing, development and marketing in some European countries, Latin America and the Caribbean, while Tibotec will be responsible for those functions in all other countries.

Shares of Gilead fell 7.3 percent to $35.34 as the markets declined Wednesday. The stock recovered 99 cents, or 2.8 percent, to $36.33 in aftermarket trading. Shares of Johnson & Johnson lost 3.2 percent to $60.20.


Posted: August 2011