FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD - News) announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.
Gilead previously submitted an NDA for the single-tablet regimen of Truvada/TMC278 on November 23, 2010. The company announced on January 25, 2011 that it had received a “refuse to file” notification from the FDA regarding that submission. Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling.
The FDA has up to 60 days to conduct a preliminary review to assess whether the NDA is sufficiently complete to permit a substantive review. The FDA will establish a target action date for the NDA, under the Prescription Drug User Fee Act (PDUFA), if the application is formally filed.
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 the fact that the FDA may not be satisfied with the additional informational submitted by Gilead and may not approve Truvada/TMC278 for the treatment of HIV-1 infection in adults. In addition, any marketing approval, if granted, may have significant limitations on its use. Further, Gilead and Tibotec may make a strategic decision to discontinue development or commercialization of Truvada/TMC278 if, for example, the market for the product fails to materialize as expected. 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. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit www.gilead.com or
call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)