European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir

Related Feb 10 - Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C

press release
March 27, 2014, 4:10 p.m. EDT

European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection

-- If Approved, Once-Daily Tablet Would Simplify Therapy and Eliminate Need for Interferon and Ribavirin for Genotype 1 Hepatitis C Patients in Europe ---- LDV/SOF Granted an Accelerated Assessment by the European Medicines Agency --

FOSTER CITY, Calif., Mar 27, 2014 (BUSINESS WIRE) -- Gilead Sciences, Inc. /quotes/zigman/72849/delayed/quotes/nls/gild GILD +0.27% today announced that the company’s Marketing Authorisation Application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on February 27, 2014, support the use of LDV/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, depending on prior treatment history and whether they have cirrhosis.

Genotype 1 is the most prevalent form of HCV in Europe, and accounts for 60 percent of infections worldwide. Current treatments for genotype 1 HCV include pegylated interferon and ribavirin (RBV), which may not be suitable for certain patients.

“Based on the results of the Phase 3 ION studies, LDV/SOF has the potential to transform HCV therapy for genotype 1 patients by eliminating the need for interferon injections and ribavirin and reducing the duration of treatment,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “If approved, LDV/SOF would be the first all-oral treatment option that has the potential to cure HCV in as little as eight weeks.”

The MAA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and patients with compensated cirrhosis.

Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 28 member states of the European Union. The EMA has accepted Gilead’s request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest.

LDV/SOF is an investigational product and its safety and efficacy has not yet been established. Although accelerated assessment of this investigational fixed-dose combination could shorten EMA’s review time by approximately two months, it does not guarantee a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, LDV/SOF could be available for marketing in the EU by the end of 2014. Gilead has also submitted regulatory applications for LDV/SOF in the United States and Canada.

SOF as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the tradename Sovaldi®, and is available in the United Kingdom, Ireland, Germany, France, Austria, Sweden and Finland. Sovaldi is also approved in the United States, Canada, New Zealand and Switzerland.

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 and South America, Europe and Asia Pacific.

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 risk that the European Commission and other regulatory agencies, including in the United States and Canada, may not approve the LDV/SOF fixed-dose combination in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. Further, additional clinical studies of LDV/SOF, including results from the 24-week arms of ION-1, may produce unfavorable results. As a result, Gilead may not be able to successfully commercialize LDV/SOF, and may make a strategic decision to discontinue its development 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 Annual Report on Form 10-K for the year ended December 31, 2013, 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.

EU full prescribing information for Sovaldi is available at www.ema.europa.eu .