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.
Write to Anna Prior at anna.prior@wsj.com
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