Biotech company Gilead Sciences reported in a press release Monday that two phase 3 studies evaluating its hepatitis C therapy sofosbuvir both hit their primary endpoints. Gilead will use the data learned from the trials as part of its regulatory filing for sofosbuvir.
Gilead's hope is to file for sofosbuvir's approval with the FDA later this year. If approved, the drug -- which Gilead acquired as part of last year's $11 billion acquisition of Pharmasset -- would become the first purely oral treatment for hepatitis C. Analysts have pegged the disease's market to climb substantially in coming years, potentially to $20 billion.
Dr. Norbert Bischofberger, Gilead's chief science officer and executive vice president of research and development, explained the results in the release: "These data support the favorable clinical profile of sofosbuvir as the backbone of a potent, safe, and well-tolerated treatment regimen that is effective across a broad range of HCV patient genotypes. ...The sofosbuvir regimens in these trials allowed us to shorten the duration of effective hepatitis C therapy to just 12 weeks for treatment-naive patients with genotypes 1 through 6."
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