|
|
| HUMAN GENOME SCIENCES SUBMITS BIOLOGICS LICENSE APPLICATION TO FDA FOR ZALBIN™ | |
|
ROCKVILLE, Maryland – November 25, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C. The BLA submission includes the results of two pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every two weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) dosed once each week. The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naïve patients with chronic hepatitis C. In both studies, albinterferon alfa-2b, with half the injections, achieved sustained virologic response comparable to that achieved by peginterferon alfa-2a. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2255 patients. “We look forward to continuing to work closely with Novartis to advance albinterferon alfa-2b to the market under the brand name ZALBIN in the United States,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “Assuming licensure by the FDA and other regulatory agencies, HGS believes ZALBIN could become an important treatment for chronic hepatitis C. Novartis targets submission of marketing authorization applications under the brand name JOULFERON® in the rest of the world later this quarter, beginning with Europe.” About the Collaboration with Novartis
HGS has primary responsibility for the bulk manufacture of albinterferon alfa-2b, and Novartis will have responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $207.5 million received to date. The remaining payments to HGS under the agreement relate to the achievement of certain regulatory approval and commercial milestones. 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. About Hepatitis C
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. Phase 3 development has been completed successfully for both BENLYSTA and Zalbin. The submission of marketing applications for BENLYSTA is planned in the U.S., Europe and other regions in the first half of 2010. A BLA has been submitted for ZALBIN to the FDA in the United States, and Novartis targets submission of marketing authorization applications under the brand name JOULFERON® in the rest of the world, beginning with Europe in fourth quarter 2009. In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for use in the event of an emergency to treat inhalational anthrax. In July 2009, HGS secured a new purchase order for 45,000 doses of raxibacumab to be delivered to the Stockpile over a three-year period beginning near the end of 2009. In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax. The Company also has several drugs in earlier stages of clinical development for the treatment of cancer, led by the TRAIL receptor antibody mapatumumab and a small-molecule antagonist of 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. For an Electronic Press Kit on this announcement, please click here. Safe Harbor Statement
###
Media Contact: |