Gilead Sciences Announces Agreement With Tibotec Pharmaceuticals
Gilead Sciences, Inc. announced that it has entered into a license and collaboration agreement with Tibotec Pharmaceuticals for the development and commercialization of a new once-daily fixed-dose antiretroviral regimen containing Gilead’s Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg) for treatment-naïve HIV-infected individuals. Fixed-dose combinations contain multiple medicines formulated into one tablet and help to simplify HIV therapy.
Subject to regulatory approval, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the fixed-dose combination of Truvada and rilpivirine worldwide, excluding the developing world and Japan. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-promote the fixed-dose combination in these territories. The companies will also work towards an agreement to make the fixed-dose combination of Truvada and rilpivirine available in the developing world.
If approved, the new product would become the second complete antiretroviral treatment regimen for HIV available in a single tablet taken once daily. The first and only such therapy available today, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), was approved by the U.S. Food and Drug Administration (FDA) in 2006. Both Atripla and the new fixed-dose combination contain a nucleoside reverse transcriptase inhibitor (NRTI) backbone of Truvada.
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 an NNRTI or a protease inhibitor as a preferred regimen for patients initiating therapy. Tibotec is currently studying the combination of Truvada and rilpivirine in Phase III clinical trials.
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