Gilead Says Hepsera Will Benefit From New Competition In Hep B Market
This article was originally published in The Pink Sheet Daily
Executive Summary
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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Gilead expects its chronic hepatitis B treatment Hepsera will generate net sales of $160 mil.-$180 mil. in 2005 despite new entries in the market. The company is maintaining its earlier guidance for Hepsera (adefovir dipivoxil) with the expectation that new competitors will help expand the category. First quarter global sales of Hepsera were $42.7 mil., more than double the $18.9 mil. from the year-ago period, driven by volume increases in all regions, Gilead said. The U.S accounted for $18.3 mil. in sales during the first quarter. Approximately 11,000 U.S. patients are being treated with Hepsera, representing roughly 56% of the patients who are receiving antivirals for chronic hepatitis B, Exec VP-Commercial Operations Kevin Young said during an April 19 earnings call. Approximately 13,000 patients are being treated with the drug in Europe. Much of the European growth is occurring in France, Germany, Italy and Greece, where the prevalence of chronic hepatitis B is higher, Young said. Gilead expects that education and screening programs sponsored by new competitors in the U.S. and European markets will increase awareness about chronic hepatitis B, thereby expanding the market. "We believe this will help drive increased diagnosis and treatment of HBV, and that the profile of Hepsera and the long-term safety data available will provide continued opportunities to increase the number of patients on Hepsera therapy," Young said. FDA approved Bristol-Myers Squibb's hepatitis B therapy Baraclude (entecavir) in March (1 (Also see "Bristol-Myers Squibb’s Hepatitis B Therapy Baraclude Will Be Available April 8" - Pink Sheet, 30 Mar, 2005.)). Roche's Pegasys (peginterferon alfa-2a) received EU approval for hepatitis B earlier this year. In the U.S., Roche filed an sBLA for a hepatitis B indication for Pegasys in July (2 (Also see "Roche Pegasys sBLA Filing For Hepatitis B Could Receive Priority Review" - Pink Sheet, 21 Jul, 2004.)). - Jessica Merrill |