Gilead races to FDA after hep C blockbuster hopeful scores 4th win in PhIII

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This morning Gilead ($GILD) announced that it has successfully wrapped up positive top-line data from its fourth and last Phase III study for sofosbuvir, putting the biotech on a short path to the FDA with what promises to be the first oral drug for hepatitis C

This last Phase III was dubbed FUSION and tested sofosbuvir--which had been known as PSI-7977 when Gilead scooped it up in the $11 billion buyout of Pharmasset in November, 2011--in combination with ribavirin in treatment-resistant genotype 2 or 3 patients. And investigators concluded that at 16 weeks 73% of the patients who had failed interferon-based therapies demonstrated a sustained virological response, compared to a predefined historic control rate of 25%. The data follow the news just two weeks ago that two previous Phase III studies had garnered positive data as well.

"This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options," said Norbert Bischofberger, the executive vice president of research and development and CSO. "With positive results from all four Phase III trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter."

The positive results cap a remarkable run for Gilead, which took less than 16 months to put the treatment through its Phase III paces. And the results provide some redemption for a company that faced caustic criticism for buying sofosbuvir in an $11 billion cash deal with nothing but the data from a small, 40-patient study to go on. Now Gilead remains the favorite in one of the hottest R&D races in the industry to make it through a regulatory review for the first hep C treatment that won't rely on interferon, a therapy associated with a long list of side effects that often prevents patients from continuing therapy.

Even now Vertex has seen revenue from its new hep C drug decline precipitously as more and more doctors "warehouse" treatment-naïve patients, looking to start them on what promises to be a new standard of care in a market expected to grow to $20 billion a year. 

More treatments are likely to crowd into the market behind Gilead's drug as developers advance new cocktail treatments for patients. Close behind is AbbVie ($ABBV) with its own Phase III hopeful while Vertex ($VRTX) has paired up with Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK) in an effort to play catchup. Bristol-Myers Squibb ($BMY) is also in the race.

- here's the press release

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