European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment

From Gilead Sciences:

European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide for HIV Treatment

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– If Approved, Would Provide Potential New Backbone for Future HIV Therapy Combinations –

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 28, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company’s Marketing Authorization Application (MAA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). The data included in the application support the use of F/TAF for the treatment of HIV-1 infection in adults in combination with other HIV antiretroviral agents.

TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

“Therapy innovations have transformed HIV into a chronic condition and people with HIV are living longer, necessitating new treatment options that deliver on both high efficacy and long-term safety,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “F/TAF is the latest advance in Gilead’s long history of innovating in HIV therapy and has the potential to become the backbone for the next generation of HIV regimens.”

F/TAF is Gilead’s second F/TAF-based regimen to be validated by the EMA. An MAA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was fully validated on December 23, 2014. In addition, Gilead filed New Drug Applications to the U.S. Food and Drug Administration for E/C/F/TAF and F/TAF on November 5, 2014, and April 7, 2015, respectively.

The MAA for F/TAF is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The MAA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.

Review of the MAA will be conducted by the EMA under the centralized procedure, which, when finalized, may lead to the grant of marketing authorization by the European Commission, which is valid in all 28 member states of the European Union.

F/TAF and TAF are investigational products and have not been determined to be safe or efficacious.

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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement

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 the possibility that the EMA may not adopt a positive opinion in its evaluation and the European Commission may not grant marketing authorization. Further, the FDA and other regulatory authorities may not approve F/TAF, E/C/F/TAF and other F/TAF-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, F/TAF, E/C/F/TAF and other F/TAF-based regimens may never be successfully commercialized. In addition, Gilead may be unable to file for regulatory approval for F/TAF with other regulatory authorities in the currently anticipated timelines. 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 March 31, 2015, 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.

The European SmPCs for Stribild and Viread are available from the EMA website at www.ema.europa.eu.

Stribild and Viread are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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Source: Gilead Sciences, Inc.