ZALBIN is a long-acting investigational treatment for chronic hepatitis C, and is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. ZALBIN has met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) in two pivotal Phase 3 clinical trials in chronic hepatitis C. The results of both Phase 3 trials demonstrate that, with half the injections, 900-mcg ZALBIN achieved efficacy comparable to peginterferon alfa-2a, with a positive safety profile. The submission of global marketing authorization applications for ZALBIN is planned for fourth quarter 2009. Assuming licensure by the FDA and other regulatory agencies, HGS believes that ZALBIN could become a market-leading treatment for chronic hepatitis C.
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