European Medicines Agency Validates Gilead’s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara Miller, 650-522-1616 (Media)
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, which was submitted to the European Medicines Agency (EMA) on April 17, 2013, has been fully validated and is now under assessment. The data submitted in this MAA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
Chronic HCV is a major cause of liver cancer and liver transplantation in Europe and around the world. The current standard of care for HCV involves 24-48 weeks of therapy with RBV and peg-IFN, which has to be injected and is associated with significant side effects.
“The clinical and economic burden of untreated HCV is substantial and growing rapidly. An estimated five million Europeans are living with hepatitis C, the majority of whom have not yet been diagnosed or are not in care. In addition, many are not suited to receive the current treatment regimens,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “If approved, sofosbuvir has the potential to improve cure rates, while reducing the duration of HCV therapy and reducing or eliminating the need for interferon injections.”
The MAA for sofosbuvir is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union (EU). EMA has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Although accelerated assessment could shorten EMA’s review time of sofosbuvir 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, sofosbuvir could be available for marketing in the EU in the first half of 2014. Gilead submitted a U.S. regulatory application for sofosbuvir in April 2013.
Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.
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 Asia Pacific.
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 EMA, the U.S. Food and Drug Administration and other regulatory agencies may not approve sofosbuvir, and that any marketing approvals, if granted, may have significant limitations on its use. Further, additional studies of sofosbuvir, including in combination with other products, may produce unfavorable results. In addition, even if approved, Gilead may not be able to successfully commercialize sofosbuvir, 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 Quarterly Report on Form 10-Q for the quarter ended March 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.