Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

"Combination antiretroviral therapy has dramatically advanced the field of HIV medicine, but the need remains for new single-tablet regimens that are effective, safe and well tolerated," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Gilead is committed to helping advance HIV treatment by pursuing both scientific research and innovative partnerships that will deliver more options to the healthcare community. We are pleased to work with Tibotec to bring this potentially important new therapy to people living with HIV."

On July 23, 2010, Tibotec submitted an NDA for U.S. marketing approval of TMC278 for once-daily use with other antiretroviral agents. That NDA is supported by 48-week data from two Phase III double-blind, randomized studies (ECHO and THRIVE) that evaluated the safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults, the majority of whom received TMC278 in combination with Truvada. The Gilead NDA for Truvada/TMC278 is supported by a bioequivalence study conducted by Gilead demonstrating that the formulation of the single-tablet regimen achieved the same levels of medication in the blood as the component products dosed simultaneously as individual pills.

On September 3, 2010, the European marketing applications for TMC278 and for the Truvada/TMC278 single-tablet regimen were filed simultaneously by Tibotec and Gilead, respectively.

Gilead entered into a license and collaboration agreement with Tibotec for the development and commercialization of the single-tablet regimen in July 2009. Subject to regulatory approval, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the single-tablet regimen worldwide, excluding the developing world and Japan. Tibotec will be responsible for the commercialization of TMC278 as a stand-alone product and will hold rights to co-promote the single-tablet regimen in these territories. The companies are currently working on an agreement to make the combination product available in the developing world.

Truvada/TMC278 is an investigational product and its safety and efficacy have not yet been established.

Source:

 Gilead Sciences

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