Tibotec Pharmaceuticals 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-naïve 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, 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 programme; the two ongoing pivotal clinical trials, TMC278-C209 and TMC278-C215 are fully recruited having enrolled over 1,300 treatment-naïve 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 will remain uniquely responsible for the commercialization of TMC278 as a single product and additionally will have the right to promote the fixed-dose combination product to healthcare professionals in all countries except Japan and the access countries. Gilead will assume the lead role in manufacturing, registration and, subject to regulatory approval, commercialization of the fixed-dose combination of TMC278 and Truvada throughout the territory.
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.
TMC278 is an investigational non-nucleoside reverse transcriptase inhibitor, and the safety and efficacy of it, in combination with other antiretroviral agents, has not been established.
Tibotec Pharma, based in Cork, Ireland, is a pharmaceutical research and development company.