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Gilead Says European CHMP Adopts Positive Opinion For HIV-1 Combination Drug Eviplera

European CHMP Adopts Positive Opinion For HIV-1 Combination Drug Eviplera
from RTT News, September 23, 2011

and Complera Counterpart Eviplera Recommended for European Approval
from AIDSMeds, September 23, 2011 

(RTTNews) – Biopharmaceutical company Gilead Sciences, Inc. (GILD:News ) Friday said the Committee for Medicinal Products for Human Use [which is the scientific committee of the European Medicines Agency], or CHMP, has adopted a positive opinion on its Marketing Authorization Application for[European approval of] the once-daily single-tablet regimen combination drug, Eviplera, [ the brand equivalent of the U.S. Food and Drug Administration–approved fixed-dose combination tablet Complera (rilpivirine, tenofovir and emtricitabine),] for the treatment of HIV-1 infection in antiretroviral-naïve adults.

Eviplera is a combination of Gilead’s Truvada with Tibotec Pharmaceuticals Ltd.’s non-nucleoside reverse transcriptase inhibitor Edurant to treat HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

Truvada is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate. Truvada was approved by the FDA in August 2004.

Tibotec Pharmaceuticals is the Irish subsidiary of Tibotec-Virco Comm. VA, a pharmaceutical research and development company based in Mechelen, Belgium. It was in July 2009 that Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of the Eviplera single-tablet regimen.

Gilead noted that the CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. The company expects the European Commission to issue its decision on the marketing authorization for Eviplera later this year.

John Martin, chairman and chief executive officer of the company said, “There is a need for the simplification of treatment regimens featuring co-formulated, fixed-dose medicines as patients stay on therapy longer. We are pleased to move one step closer to making this potentially important new simplified treatment option available to physicians and patients in Europe.”

Last month, the product received regulatory approval from the U.S. Food and Drug Administration under the trade name Complera. The approval was Gilead’s second successful collaboration to develop a complete single-tablet regimen for HIV/AIDS following its collaboration with Bristol-Myers Squibb for Atripla, that combines efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.

GILD is currently trading at $38.04, down $0.30 or 0.78 percent, on a volume of 1.53 million shares on the Nasdaq.

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