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Human Genome Sciences Inc. gets discouraging
feedback from FDA on Zalbin for hepatitis C
  By Balasubramanyam Seshan | June 14, 2010 7:58 AM EDT
Human Genome Sciences Inc., a biopharmaceutical company, said it has received preliminary written comments from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) seeking approval in the United States to market 900-microgram Zalbin (albinterferon alfa-2b), known in Europe as Joulferon dosed every two weeks for the treatment of chronic hepatitis C.
Unfortunately, the comments were discouraging. The FDA expressed concerns regarding the risk-benefit assessment of Zalbin dosed at 900-mcg every two weeks. Although the BLA review is ongoing, Human Genome has concluded that getting approval for this dosing regimen is unlikely.
In April 2010, Human Genome said Novartis withdrew its Marketing Authorization Application for Joulferon from the European Medicines Agency.
Zalbin (Joulferon) is being developed by Human Genome and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006.
Human Genome and Novartis are considering development of Zalbin dosed every four weeks, and Human Genome previously reported the positive interim results of a Phase 2b study of this ZALBIN regimen.
Zalbin is a genetic fusion of human albumen and interferon alfa created using proprietary Human Genome albumen-fusion technology. Albumen is the most prevalent naturally occurring blood protein in the human circulatory system. It persists in circulation in the body for about 19 days. Research shows that genetically attaching proteins to human albumen prolongs the therapeutic efficacy of proteins.
The shares of Human Genome Sciences (NASDAQ: HGSI) closed up 2.87 percent (= $0.74) at $26.51 on Friday.
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