Human Genome Sciences, Inc announced that Novartis has withdrawn a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market Joulferon (albinterferon alfa-2b, known in the United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.
Zalbin (also known as Joulferon) is a genetic fusion of human albumin and interferon alfa created using proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for approximately 19 days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.