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GEN News Highlights : Oct 19, 2009

Human Genome Sciences Earns $75M from Novartis as HCV Drug Gets Prepared for Regulatory Submissions

Upon approval albinterferon alfa-2b will be marketed as Zalbin in the U.S. and Joulferon in the rest of world.

Human Genome Sciences (HGS) received a $75 million milestone payment from Novartis on successful completion of Phase III development with the chronic HCV drug, albinterferon alfa-2b, and the decision to submit regulatory approval applications.

The companies report that applications to the FDA and EMEA are expected to be filed during the fourth quarter of fiscal 2009. The drug (formerly known as Albuferon) will be called Zalbin in the U.S. and Joulferon® in the rest of the world subject to health authority approval. The drug is a genetic fusion of human albumin and interferon alfa, generated using HGS’ albumin-fusion technology.

HGS and Novartis signed their co-development and commercialization agreement for albinterferon alfa-2b in 2006. The overall agreement could be worth up to $507.5 million to HGS in terms of development, regulatory, and commercial milestones. The companies will co-commercialize Zalbin in the U.S. and are sharing clinical development/commercialization costs and profits in the U.S. equally.

Novartis is commercializing Joulferon in the rest of the world and will pay HGS sales royalties. Bulk manufacture of albinterferon alfa-2B will be undertaken by HGS, while Novartis retains responsibility for commercial manufacture, fill, and finish.