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Approval for new hep C drug sought

Human Genome Sciences files with FDA

Updated: Wednesday, 25 Nov 2009, 3:45 PM EST
Published : Wednesday, 25 Nov 2009, 3:45 PM EST

Human Genome Sciences Inc. said Wednesday it has filed for marketing approval of its hepatitis C drug Zalbin.

The Rockville, Md., company did not say when it expected a response to its biologics license application, which was submitted to the Food and Drug Administration. Human Genome Sciences said its partner Novartis AG will file for European Union approval before the end of 2009.

In the U.S., the companies will share marketing costs and profits. In the rest of the world, Novartis wants to market the drug under the name Joulferon. Novartis could pay Human Genome Sciences as much as $300 million if the drug is approved and reaches sales targets. Human Genome Sciences has received $207.5 million from the collaboration so far.

 

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