Gilead Says Hepsera Will Benefit From New Competition In Hep B Market
This article was originally published in The Pink Sheet Daily
Chronic hepatitis B market will be expanded by competitors' disease-awareness campaigns, Gilead says. Bristol-Myers Squibb's Baraclude cleared FDA in March; Roche's Pegasys user fee deadline is in May.
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Entecavir clears FDA after a six-month priority review. Baraclude labeling includes data showing superior efficacy versus GlaxoSmithKline’s Epivir-HBV. Bristol will detail the product to the 3,500 physicians who treat most U.S. cases of hepatitis B using a Baraclude-specific sales force.
Roche announced simultaneous U.S. and European submissions July 21; six-month review would set user fee date at mid-January. Roche is likely to highlight superiority to GlaxoSmithKline’s Epivir-HBV and efficacy in HBeAg-negative patients in promotions.
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