- Pivotal Phase III Studies of TMC278 Met Primary Objective -
- Gilead Working to Identify Fixed-dose Regimen Candidate Suitable for Registration -
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 fixed-dose single-tablet combination of Truvada and TMC278 is an investigational product and the safety and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead’s ability to identify a formulation of the fixed-dose combination of Truvada and TMC278 that meets bioequivalence. In addition, safety and efficacy data from additional clinical studies may not warrant further development of this fixed-dose combination, regulatory agencies may not approve the fixed-dose combination for the treatment of HIV, and marketing approval, if granted, may have significant limitations on its use. As a result, the fixed-dose combination may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of the fixed-dose combination if, for example, we believe commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Gilead directs readers to its Annual Report on Form 10-K for the year ended December 31, 2009. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)
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