European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir

FOSTER CITY, Calif.- - (BUSINESS WIRE)- - Sep. 26, 2014- - Gilead Sciences, Inc. (Nasdaq: GILD) today declared that the Committee for Medicinal Products for Human Use (CHMP), the exploratory board of trustees of the European Medicines Agency, has embraced a positive assessment on the organization's Marketing Authorization Application (MAA) for Harvoni®, an investigational once-day by day tablet consolidating the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide simple polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of interminable hepatitis C infection (HCV) contamination in grown-ups.

The CHMP sentiment was received after a quickened audit strategy, which is saved for restorative items that are relied upon to be of real general wellbeing hobby. The CHMP's suggestion will now be investigated by the European Commission, which has the power to endorse solutions for use in the 28 nations of the European Union.

The CHMP positive feeling for Harvoni is bolstered by information from three Phase 3 studies (ION-1, ION-2 and ION-3). These studies assessed 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among about 2,000 genotype 1 HCV patients with remunerated liver sickness. These studies included cirrhotic and non-cirrhotic patients who were new to HCV treatment and the individuals who had fizzled earlier treatment with an interferon-based regimen, including regimens containing a HCV protease inhibitor. The positive conclusion was additionally upheld by preparatory information from the SOLAR-1 trial in decompensated cirrhotic and pre-and post-transplant patients, the ELECTRON-2 trial in genotype 3 patients and stage 2 considers in genotype 4 patients.

Roughly nine million individuals in Europe are contaminated with the hepatitis C infection, a noteworthy reason for liver tumor and liver transplantation. Genotype 1 is the most predominant type of HCV in Europe, and records for 60 percent of diseases around the world. This is trailed by genotypes 2 and 3, while genotypes 4-6 are more predominant in Asia and Africa.

Sofosbuvir as a solitary operators was conceded advertising approval in the European Union on January 16, 2014 under the exchange name Sovaldi®. Sovaldi is likewise endorsed for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.

Harvoni is an investigational item and its security and viability have not been built up in the European Union.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical organization that finds, creates and popularizes inventive therapeutics in territories of unmet restorative need. The organization's central goal is to propel the consideration of patients experiencing life-undermining infections around the world. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press discharge incorporates forward-peered articulations inside of the which means of the Private Securities Litigation Reform Act of 1995 that are liable to dangers, vulnerabilities and different components, including the danger that the MAA may not be endorsed by the European Commission, and advertising regard, if in all actuality, may have critical constraints on its utilization. These dangers, vulnerabilities and different components could bring about real results to vary substantially from those alluded to in the forward-looking proclamations. The peruser is forewarned not to depend on these forward-looking proclamations. These and different dangers are portrayed in point of interest in Gilead's Quarterly Report on Form 10-Q for the quarter finished June 30, 2014, as documented with the U.S. Securities and Exchange Commission. All forward-looking explanations depend on data presently accessible to Gilead, and Gilead expect no commitment to upgrade any such forward-looking articulation