Gilead's (GILD) Epclusa Receives Label Expansion In Canada

Gilead Sciences Inc. (NASDAQ:GILD) announced that Health Canada has granted a Notice of Compliance (NOC) for updated label of hepatitis C virus drug, Epclusa.

The drug’s label has been expanded to extend the drug’s use for patients co-infected with HIV-1.

The drug was approved in Canada in July 2016 for the treatment of adults with genotype 1-6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin.

We expect the drug’s sales to increase with this label expansion as HCV co-infection remains a major cause of morbidity in HIV-infected individuals.

Last month, Health Canada granted a NOC for single-tablet regimen, Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg), for chronic HCV infection.

Gilead is known for its presence in the HCV market, courtesy of its blockbuster HCV drugs, Sovaldi and Harvoni. The HCV portfolio received a huge a boost when Epclusa gained approval in both the United States (June 2016) and EU (July 2016) and became the first and only all-oral, pan-genotypic, STR consisting of Sovaldi and velpatasvir (an NS5A inhibitor), for the treatment of adults with genotype 1-6 chronic HCV infection. The approval of Vosevi is expected to boost Gilead’s strong HCV portfolio further.

However, the HCV franchise is under pressure due to competition and pricing issues. We note that Harvoni, Sovaldi and Epclusa, face competition from AbbVie Inc. (NYSE:ABBV) Viekira Pak and Viekira XR among others. Competition as well as pricing pressure intensified further with the launch of Merck & Co., Inc.’s (NYSE:MRK) Zepatier.

Gilead’s stock has gained 17.5% year to date against the industry’s 17.3%.

Gilead recently announced plans to acquire Kite Pharma, Inc. (NASDAQ:KITE) to foray in the emerging field of cell therapy. Kite is a pioneer in cell therapy having developed engineered cell therapies that express either a chimeric antigen receptor (CAR) or an engineered T-cell receptor (TCR), depending on the type of cancer. The acquisition will diversify Gilead’s portfolio and poise the company in a dominant position in cellular therapy space. We note that investors were expecting Gilead to announce an acquisition in the near term given the decline in the once lucrative HCV market due to competitive pressure.

Zacks Rank

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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