Biotech Values

[DewDiligence]

JNJ/GILD’s TMC278+Truvada combo pill moved a step closer to
realization today with JNJ’s announcement that TMC278 met its
primary endpoint of non-inferiority to Sustiva in two phase-3
studies that tested TMC278+Truvada vs Sustiva+Truvada. JNJ’s
NDA submission for TMC278 is expected in 3Q10; following FDA
acceptance of JNJ’s NDA for review, GILD will submit the NDA
for the combo pill in 4Q10.

http://finance.yahoo.com/news/Gilead-Provides-Update-on-bw-2235377411.html?x=0&.v=1

›Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada and Tibotec Pharmaceuticals' TMC278

• Pivotal Phase III Studies of TMC278 Met Primary Objective -

• Gilead Working to Identify Fixed-dose Regimen Candidate Suitable for Registration -

Tuesday April 20, 2010, 8:51 am EDT

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) 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, 25 mg). 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-naïve 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-naïve 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 first such product is, of course, Atripla].‹