Chronic HCV infection affects up to four million Americans particularly individuals born between 1946 and 1964. The disease is the leading cause of liver cancer and liver transplantation in the United States. Treatment for HCV currently includes 24-48 weeks of therapy with peg-IFN which has to be injected and is associated with significant side effects leaving some patients unable to complete therapy. If approved sofosbuvir would shorten HCV therapy to 12 to 16 weeks and depending on the genotype would either eliminate or reduce the duration of peg-IFN injections.
“Current therapies are not suitable for large numbers of patients with HCV infection and are challenging to take and tolerate” said John C. Martin PhD Chairman and Chief Executive Officer of Gilead Sciences. “Sofosbuvir’s antiviral potency safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease.”
The sofosbuvir NDA 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). Patients who achieve SVR12 are considered cured of HCV.
Gilead plans to file for regulatory approval of sofosbuvir in other geographies including the European Union in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission.
About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein which plays an essential role in HCV replication. Unlike ribavirin and pegylated interferon sofosbuvir is a direct-acting agent meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Sofosbuvir is intended to become a cornerstone of interferon-free all-oral treatment regimens for HCV that achieve higher cure rates more rapidly and with fewer side effects than current therapeutic options. Sofosbuvir is an investigational product and its safety and efficacy has not yet been established.
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 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 FDA EMA and other regulatory agencies may not approve sofosbuvir and that any marketing approvals if granted may have significant limitations on their use. In addition additional studies of sofosbuvir including in combination with other products may not produce favorable results. Further 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 Annual Report on Form 10-K for the year ended December 31 2012 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 the company’s website at www.gilead.com follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or1-650-574-3000.
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