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Gilead's HCV Drug Epclusa Gets Regulatory Nod in Canada

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Gilead Sciences Inc. (GILD - Free Report) announced that Health Canada has issued a Notice of Compliance to Epclusa (Sovaldi 400 mg/velpatasvir 100 mg), the first once-daily, pan-genotypic single-tablet regimen for the treatment of adults with genotype 1–6 chronic hepatitis C virus (HCV) infection.

The 12-week Sovaldi/velpatasvir combination was approved for the treatment of patients without cirrhosis or with compensated cirrhosis and in combination with ribavirin (RBV) for patients with decompensated cirrhosis. Epclusa is also the first single-tablet regimen approved for the treatment of HCV genotype 2 and 3, without the need for RBV.

We remind investors that in Jun 2016, Epclusa was approved in the U.S. for the treatment of adults with genotype 1–6 chronic HCV. Last week, the drug gained approval in the EU for the same indication.

Epclusa is Gilead’s third sofosbuvir-based treatment to gain approval for the treatment of chronic HCV infection.

We are encouraged by the company’s efforts in expanding its HCV franchise, which already boasts two approved drugs – Harvoni and Sovaldi.

We note that competition in the HCV market is intense with drugs like Viekira Pak, Zepatier, and Olysio crowding the space. Competition and pricing pressure have intensified further with the entry of Merck & Co. Inc.’s (MRK - Free Report) Zepatier.

Meanwhile, Gilead is evaluating a once-daily fixed-dose combination of Sovaldi/velpatasvir plus GS-9857 (an experimental NS3 protease inhibitor) in phase III studies for the treatment of chronic genotype 1–6 HCV.

Gilead currently holds a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector are Merrimack Pharmaceuticals, Inc. and Innoviva, Inc. (INVA - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).

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