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European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C
-- If Approved, SOF/VEL Would be the First All-Oral, Pan-Genotypic Single Tablet Regimen for Chronic HCV in Europe --

-- SOF/VEL Granted an Accelerated Assessment by the European Medicines Agency --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 4, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Marketing Authorization Application (MAA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) 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 November 17, 2015, support the use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.

“Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “If approved, SOF/VEL will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”

The MAA for SOF/VEL is supported by four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Ninety-four percent of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83 percent and 86 percent of patients who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2015, and were also published in The New England Journal of Medicine.

Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea.

SOF/VEL is the third investigational medicinal product from Gilead for HCV infection to receive Accelerated Assessment by the EMA. This, however, does not assure a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. Review of the MAA will be conducted under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union, Norway and Iceland. If approved, SOF/VEL could be available for marketing in the European Union in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the United States.

SOF/VEL is an investigational product and its safety and efficacy has not yet been established.
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Source: press release, 12/04/15. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Sofosbuvir (GS-7977)/Velpatasvir (GS-5816) fixed dose combinationInfectious DiseaseHepatitis CCV polymerase inhibitor/ NS5a protein inhibitorHCV RNA polymerase/NS5a protein

Mechanism of action: Sofosbuvir (GS-7977)/Velpatasvir (GS-5816) fixed dose combination of a HCV nucleotide analog polymerase inhibitor, targeting RNA polymerase and a novel HCV non-structural 5A (NS5A) protein inhibitor.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-07-22

Results:

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European Commission Grants Marketing Authorization for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
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– Epclusa is the First and Only All-Oral, Single Tablet Regimen for all Genotypes (1-6) of Chronic Hepatitis C Virus Infection and is Gilead’s Third Sofosbuvir-Based Treatment –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 8, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

The Marketing Authorization follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of SOF/VEL in all 28 countries of the European Union.

SOF/VEL is Gilead’s third sofosbuvir-based treatment to be granted Marketing Authorization by the European Commission for the treatment of chronic HCV infection. Sofosbuvir-based regimens are recommended by global guidelines across all HCV genotypes and disease severities. Today, nearly one million patients worldwide have been prescribed a sofosbuvir-based regimen.

“Built on the foundation of sofosbuvir, SOF/VEL offers a highly effective and tolerable choice which is protease inhibitor free and ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment,” said Professor Stefan Zeuzem, Professor of Medicine and Chief of the Department of Medicine at the J.W. Goethe University Hospital, Frankfurt, Germany and an ASTRAL-1, 2 and 3 study investigator. “This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe.”

The authorization of SOF/VEL is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of SOF/VEL. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of SOF/VEL with or without RBV or 24 weeks of SOF/VEL alone. The primary endpoint for all studies was the sustained viral response rate 12 weeks after treatment (SVR12).

John Milligan, Ph.D., President and Chief Executive Officer of Gilead said, “The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected. The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible.”

Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving SOF/VEL with RBV for 12 weeks achieved a higher SVR12 rate (94 percent) compared to those who received SOF/VEL for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively.) The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir (400mg) and ledipasvir (90mg) received marketing authorization in the European Union on November 18, 2014 under the trade name Harvoni®.

Epclusa was approved by the U.S. Food and Drug Administration on June 28, 2016 for the treatment of adults with genotype 1-6 chronic HCV infection.
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Source: press release, 7/08/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...

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European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis CDownload PDF Download PDF
--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 27, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The MAA for Epclusa is supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).

Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively). The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir and ledipasvir received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®.

Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Epclusa is an investigational product and its safety and efficacy has not yet been established.
More
Source: press release, 5/27/16. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=...