Gilead Says Hepatitis C Drug's Trial in Japan Meets Endpoint

Gilead Sciences Inc. (GILD) said topline results from a Phase 3 clinical trial in Japan involving the company's hepatitis C pill, sofosbuvir, in combination with ribavirin showed the study met its primary efficacy endpoint.

Based on the trial results, Gilead expects to submit a new drug application for sofosbuvir to the Japanese Pharmaceutical and Medical Devices Agency by mid-2014, said Norbert Bischofberger, Gilead's chief scientific officer and executive vice president of research and development.

If approved, sofosbuvir would be the first product to be launched and marketed by Gilead in Japan, the company noted.

The drug, under the brand-name Sovaldi, is the first in a new generation of hepatitis C therapies that promise to cure more patients than older therapies. It could ring up $5 billion in U.S. sales this year if current prescription patterns hold. Some analysts say the figure might reach $9 billion. By comparison, AbbVie Inc.'s (ABBV) Humira, a treatment for rheumatoid arthritis, was the biggest-selling drug last year with $10.7 billion in world-wide sales.

While Gilead is known for its treatments for HIV/AIDS, it has been looking to diversify its portfolio. Sovaldi, new to the market, has won praise for being the first pill approved to treat some types of hepatitis C without interferon, an injected drug that can cause flulike symptoms. The treatment won U.S. Food and Drug Administration approval in early December.

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