-- Product Would Represent Second Truvada-Based Complete
Fixed-Dose Regimen --
Gilead Sciences, Inc. (Nasdaq:GILD) today 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.
“Gilead and Tibotec share a strong focus on bringing safe and effective
treatment options to people living with HIV/AIDS,” said John C. Martin,
PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Fixed-dose
regimens have become the standard of care as HIV treatment has evolved
toward more simplified regimens for patients. We are very pleased to
collaborate with Tibotec and look forward to advancing this new
fixed-dose product.”
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.
