Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

Oct 19 2009

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has earned a $75 million 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.

HGS and Novartis have completed pre-submission meetings with the FDA and European regulatory agencies, and plan to submit marketing authorization applications for albinterferon alfa-2b, an investigational treatment for chronic hepatitis C, in the fourth quarter of 2009. HGS and Novartis have selected ZALBIN as the brand name for albinterferon-alfa 2b (formerly Albuferon®) in the United States. 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.

“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,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Submission of global marketing authorization applications for ZALBIN and JOULFERON is planned 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.”