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. We have submitted a Biologics License Application to the FDA for ZALBIN in the United States, and we expect submission of marketing authorization applications soon in other regions of the world, beginning with Europe in fourth quarter 2009. Assuming licensure by the FDA and other regulatory agencies, HGS believes that ZALBIN could become an important treatment for chronic hepatitis C.
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