FDA Declines New Drug Application for Rilpivirine/Truvada Combination Pill

	SUMMARY: Gilead Sciences announced this week that the U.S. Food and Drug Administration (FDA) did not accept its recent New Drug Application seeking approval of a new single-tablet regimen combining the investigational NNRTI rilpivirine (TMC278) plus tenofovir/emtricitabine (the drugs in Truvada). The agency did not rule out approval of the new coformulation, but requested more information about its chemical composition and manufacturing. The company said it expected "only a minor delay."

Researchers reported at the International AIDS Conference this past summer that rilpivirine plus tenofovir/emtricitabine demonstrated potent antiviral activity and good tolerability in the Phase 3 ECHO and THRIVE trials. Gilead submitted a New Drug Application for the coformulation in November.

Gilead said in a conference call with financial analysts that the FDA is seeking more information about a "degradation product" discovered in the combination pill during testing, according to Bloomberg News.

By declining to accept the application, the FDA does not start the clock on the 6-month window for accelerated approval.

"I am confident this will result in only a minor delay in bringing this important new treatment to patients," Gilead CEO John Martin said during the call.

Below is the text of a Gilead press release explaining the recent developments.

Gilead Sciences Receives Refuse to File Notification From U.S. FDA on New Drug Application for Single-Tablet Regimen of Truvada(R) and TMC278

Additional CMC Information Required Before Resubmission of New Drug Application

Foster City, Calif. -- January 25, 2011 -- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has received a "refuse to file" notification from the U.S. Food and Drug Administration (FDA) regarding Gilead's New Drug Application (NDA) 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.

In its communication, the FDA requested additional information with respect to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission. The letter stated that the application does not contain sufficient information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine.

"We are working to validate the methodology to resolve this issue and provide the required information to the FDA," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We expect to be in a position to resubmit the Truvada/TMC278 NDA with the additional requested information prior to the end of the first quarter of this year."

The FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on November 23, 2010.

About Gilead

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.

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).