Tibotec Pharmaceuticals has entered into an agreement with Gilead Sciences for the development and commercialization of a new, once-daily fixed-dose antiretroviral product.
It contains 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.
This agreement represents the fixed dose combination product collaboration for Tibotec and, when approved, it would become the complete once-daily antiretroviral treatment regimen for HIV to include an antiretroviral from Tibotec.
Roger Pomerantz, president of Tibotec R&D, said: A simplified regimen may help improve patient adherence and decrease overall pill burden. 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.
Tibotec is currently studying the combination of Truvada and TMC278 in its phase III program. The two ongoing clinical trials, TMC278-C209 and TMC278-C215 have enrolled over 1,300 treatment-naive adult patients with HIV-1.
Current HIV treatment guidelines issued by the US 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 and Gilead are committed to working together to make the fixed-dose combination of TMC278 and Truvada available in the developing world, and will work towards a separate agreement for these countries.