ZALBIN (also known as JOULFERON®) 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 2006. ZALBIN met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) in two pivotal Phase 3 clinical trials in chronic hepatitis C, and regulatory applications were submitted in the last quarter of 2009 seeking approval to market 900-mcg ZALBIN dosed every two weeks in the United States and Europe. We have received preliminary written feedback from the FDA regarding our application in the United States. Although the FDA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely. In April 2010, we announced that Novartis withdrew its regulatory application in Europe for JOULFERON in the same dosing regimen. HGS and Novartis are considering development of ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN dosing regimen.

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