HGS Earns $75m Milestone Payment From Novartis

Published: 19-Oct-2009

Two pivotal phase 3 clinical trials completed successfully in patients with chronic hepatitis C

Human Genome Sciences, (HGSI) has achieved a $75m milestone payment from Novartis, related to successful completion of the phase 3 development program and the decision to submit applications seeking regulatory approval to market Zalbin (albinterferon alfa-2b) for the treatment of chronic hepatitis C.

Reportedly, HGS and Novartis have completed pre-submission meetings with the FDA and European regulatory agencies. They plan to submit marketing authorisation applications for albinterferon alfa-2b, an investigational treatment for chronic hepatitis C, in the fourth quarter of 2009.

Moreover, the companies have reported that they have selected Zalbin as the brand name for albinterferon-alfa 2b (formerly Albuferon) in the US and Joulferon has been selected as the brand name in the rest of the world. These brand names will be subject to confirmation by health authorities at the time of product approval.

Thomas Watkins, president and CEO at HGS, said: “We are pleased with the progress of this program and look forward to continuing to work closely with Novartis to advance Zalbin to the market. Submission of global marketing authorisation applications for Zalbin and Joulferon lanned for later this quarter. Assuming licensure by the FDA and other regulatory agencies, HGS believes Zalbin could become a market-leading treatment for chronic hepatitis C.”

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