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| HUMAN GENOME SCIENCES ANNOUNCES $75 MILLION MILESTONE PAYMENT FOR ZALBIN™ PROGRESS | |
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- Two pivotal Phase 3 clinical trials completed successfully in patients with chronic hepatitis C - ROCKVILLE, Maryland – October 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.” About the Collaboration with Novartis
About ZALBIN (albinterferon alfa-2b)
ZALBIN dosed once every two weeks has completed Phase 3 development. In April 2009, positive Phase 3 results of ZALBIN in patients with chronic hepatitis C were presented at the 44th annual meeting of the European Association for the Study of the Liver in Copenhagen. Data from two pivotal Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, showed that ZALBIN met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a). With half the injections, ZALBIN achieved a rate of sustained virologic response comparable to Pegasys in these studies; rates of serious and/or severe adverse events were also comparable. In addition, Novartis is currently conducting a Phase 2b trial to evaluate ZALBIN/JOULFERON dosed once every four weeks. About Human Genome Sciences
The Company’s primary focus is rapid progress toward the commercialization of its two lead drugs, BENLYSTA™ (belimumab) for lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C. BENLYSTA has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus erythematosus, and results of the second BENLYSTA Phase 3 trial are expected in November 2009. ZALBIN has now completed Phase 3 development, and the submission of global marketing applications is expected in fourth quarter 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. In July 2009, the Company secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the U.S. Strategic National Stockpile over a three-year period, beginning near the end of 2009. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody HGS-ETR1 (mapatumumab) and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria® (albiglutide), currently in Phase 3 development in patients with type 2 diabetes. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (877) 822-8472. HGS, Human Genome Sciences, Albuferon, BENLYSTA, and ZALBIN are trademarks of Human Genome Sciences, Inc. Safe Harbor Statement
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