Novartis withdraws EMA MAA for JOULFERON

Apr 19 2010

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that Novartis has withdrawn a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C.

The decision to withdraw the application was based on feedback from European regulatory authorities in preliminary response to the EMA application, indicating that additional new data would be requested which could not reasonably be generated within the timeframe allowed in the European Centralized Procedure. Feedback included whether the therapeutic benefit offered by JOULFERON dosed once every two weeks is sufficient relative to risk.

ZALBIN (JOULFERON) is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. In November 2009, HGS submitted a Biologics License Application (BLA) to the FDA in the United States for ZALBIN dosed every two weeks, which continues under review. HGS and Novartis are also developing ZALBIN dosed every four weeks, and HGS previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.