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Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
Date:7/16/2009

CORK, Ireland, July 16 /PRNewswire/ --Tibotec Pharmaceuticals today announced that it has entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride 25 mg) and Gilead's Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for treatment-naive adult patients with HIV-1. Fixed-dose combinations contain multiple medicines formulated into one tablet and help to simplify HIV therapy.

"A simplified regimen may help improve patient adherence and decrease overall pill burden," said Roger Pomerantz, MD, President Tibotec R&D. "We are very pleased to collaborate with Gilead, one of the leading companies in the fight against HIV/AIDS, and look forward to advancing this new fixed-dose product in addition to TMC278 as a single agent."

This agreement represents the first fixed dose combination product collaboration for Tibotec and, when approved, it would become the first complete once-daily antiretroviral treatment regimen for HIV to include an antiretroviral from Tibotec. Tibotec is currently studying the combination of Truvada and TMC278 in its Phase III program; the two ongoing pivotal clinical trials, TMC278-C209 and TMC278-C215 are fully recruited having enrolled over 1,300 treatment-naive adult patients with HIV-1. Current HIV treatment guidelines issued by the U.S. Department of Health and Human Services list emtricitabine and tenofovir (the components of Truvada) in combination with a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor as a preferred regimen for patients initiating therapy.

Tibotec will remain uniquely responsible for the commercialization of TMC278 as a single product and additionall
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