ZALBIN™: Preliminary Feedback Received from FDA on BLA; MAA Withdrawn in Europe
HGS received preliminary written feedback from the FDA regarding the Company’s Biologics License Application seeking approval to market 900-mcg ZALBIN dosed every two weeks for the treatment of chronic hepatitis C. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely, as previously reported. In April 2010, HGS announced that Novartis withdrew its Marketing Authorization Application for JOULFERON®, as ZALBIN is known outside the United States, from the European Medicines Agency. HGS and Novartis are considering development of ZALBIN dosed every four weeks. ZALBIN is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006
Under an exclusive worldwide co-development and commercialization agreement entered into in 2006, HGS and Novartis will co-commercialize albinterferon alfa-2b in the United States under the brand name ZALBIN™, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization of albinterferon alfa-2b in the rest of the world under the brand name JOULFERON®, and will pay HGS a royalty on those sales. HGS has primary responsibility for the bulk manufacture of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $132.5 million received previously and a $75 million payment expected in fourth quarter 2009. The remaining payments to HGS under the agreement relate to the achievement of certain regulatory approval and commercial milestones.
Lijkt mij toch een optie dat Novartis de hele lijn in handen wil hebben van Hepatitis C