Gilead Sciences, Inc. GILD announced that the Japanese Ministry of Health, Labour and Welfare has approved its hepatitis C virus (HCV) drug Harvoni as a once-daily single tablet regimen for the suppression of viremia in patients with genotype 1 chronic HCV infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
This March, Gilead had announced that another of its HCV drugs, Sovaldi, was approved in Japan for the suppression of viremia in patients suffering from genotype 2 chronic HCV infection with or without compensated cirrhosis. Sovaldi is the first product to be marketed by Gilead in Japan.
According to the company’s press release, Japan has one of the highest rates of liver cancer in any industrialized country, resulting primarily from HCV. More than 1 million people suffer from chronic HCV in Japan of which 70–80% are infected with the genotype 1 strain of the virus.
We note that both Harvoni and Sovaldi are approved in the U.S. for the treatment of chronic HCV infection. HCV is one of the key focus areas at Gilead. The company has entered into agreements with several pharmacy benefit managers and health care service companies for its HCV drugs. The company is also undertaking several pricing measures including an increase in discount, charge back and rebates.
The HCV market has a huge commercial potential and several companies are working on bringing new and better treatments to the market. Last December, the FDA approved AbbVie’s ABBV Viekira Pak.
With new entrants like Viekira in the HCV market as well as pricing competition, we expect investor focus to remain on Sovaldi's and Harvoni’s performance.
Gilead carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Avalanche Biotechnologies, Inc. AAVL. Both carry a Zacks Rank #2 (Buy).
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