Provides Update on Development of Fixed-Dose Regimen of Truvada
and Tibotec Pharmaceuticals' TMC278
Phase III Studies of TMC278 Met Primary Objective
Working to Identify Fixed-dose Regimen Candidate Suitable
City, Calif. -- Apr 20, 2010 -- Gilead Sciences, Inc. provided
an update today on the development of the fixed-dose combination
of Truvada (emtricitabine and tenofovir disoproxil fumarate) and
Tibotec Pharmaceuticals' investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride,
As part of its First Quarter 2010 earnings call, Johnson &
Johnson, which owns Tibotec Pharmaceuticals, announced today that
the two pivotal Phase III studies evaluating TMC278 as a treatment
for HIV in treatment-naive patients met the primary efficacy objective
of non-inferiority as compared to efavirenz
based on the proportion of patients achieving HIV RNA levels
of less than 50 copies/mL at 48 weeks. Johnson & Johnson also
announced that full study results will be presented at a scientific
meeting later this year, and that the submission of TMC278 for
regulatory review is on track for the third quarter of this year.
Gilead is working to identify a formulation of the fixed-dose
combination of Truvada and TMC278 that meets bioequivalence. A
bioequivalence study is required to demonstrate that a co-formulated
product results in the same levels of medication in the blood
as achieved when the individual products are dosed simultaneously
as separate pills.
In July 2009, Gilead announced that it had 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 Truvada and TMC278 for treatment-naive
HIV-infected individuals. The companies are also working toward
an agreement to make the fixed-dose combination of Truvada and
TMC278 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 fixed-dose single-tablet combination of Truvada and TMC278
is an investigational product and the safety and efficacy have
not yet been established.
For more information on Gilead Sciences, please visit www.gilead.com.
Sciences. Gilead Provides Update on Development of Fixed-Dose
Regimen of Truvada and Tibotec Pharmaceuticals' TMC278. Press
release April 20, 2010.