Rockville, Maryland and Nottingham, UK - May 7, 2009 - Human Genome Sciences, Inc. (NASDAQ: HGSI) and Novozymes Biopharma, a part of Novozymes (NASDAQ: NZYM B), today announced that they have amended an existing license agreement to allow both companies to expand application of their proprietary albumin fusion technology.
Under the amended agreement, HGS and Novozymes each has the opportunity to exclusively license and/or sublicense a number of albumin fusion proteins in exchange for royalties and other consideration. No existing HGS or Novozymes products or product rights, including rights licensed to other companies, are affected by these amendments. Financial or other terms of the agreement were not disclosed.
"Genetic fusion of therapeutic proteins to albumin can improve the pharmacology of the proteins, resulting in important benefits to patients," said Barry A. Labinger, Executive Vice President and Chief Commercial Officer, HGS. "For example, with certain therapeutic proteins, albumin fusion may make it possible to dose less frequently and reduce side effects associated with injections. We are pleased to work with Novozymes to broaden the application of albumin fusion technology to new classes of proteins and peptides."
Thomas Videbæk, Executive Vice President, Novozymes, said, "We are delighted to expand this license agreement with HGS. We license both the fusion protein and the yeast expression systems, which have been optimised for producing albumin fusion proteins as the solution that provides an efficacious half-life in patients. Our strength lies in the fact that we focus on solutions and that is why Novozymes is an ideal partner for the pharmaceutical industry. This enables Novozymes to continue to further develop albufuse®, our proprietary albumin fusion technology, and advance our existing and new partnerships."
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Human Genome Sciences Submits Biologics License Application For ABthrax To FDA -
(RTTNews) - Thursday, (5-21-09) biotechnology company Human Genome Sciences, Inc. (HGSI: News ) announced the submission of a Biologics License Application or BLA with the U.S. Food and Drug Administration or FDA related to human monoclonal antibody drug Abthrax for the treatment of inhalation anthrax.
Anthrax infection is caused by a spore-forming bacterium, Bacillus anthracis, which multiplies in the body and produces lethal toxins.
The Rockville, Maryland-based company said the BLA was submitted on the results of the efficacy tests of raxibacumab carried out on rabbits and monkeys. The results exhibited a survival benefit in both rabbits and monkeys, which is needed for launching the efficacy of new drugs used to counter bioterrorism. The submission also includes the results of safety studies of raxibacumab conducted in healthy human volunteers.
Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority or BARDA.
In the first quarter of 2009, under the BARDA contract, HGS achieved its first product sales by initiating the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for emergency use in the treatment of inhalation anthrax.
HGS said it generated revenue of $153.8 million in raxibacumab in the first quarter, including $127.8 million in product sales. The company has now completed delivery and expects to recognize at least $8.0 million in additional raxibacumab revenue in the second quarter of 2009.
Commenting on the submission, HGS' senior vice president, development and regulatory affairs, Sally Bolmer said, "Based on the results of our efficacy and safety studies, we believe raxibacumab has the potential to be an important new treatment for inhalation anthrax. In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our company."
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Human Genome Sciences to Host July 20 Conference Call to Discuss Top-Line Phase 3 Results for Benlysta(TM) (Formerly Lymphostat-B(R)) in Systemic Lupus Erythematosus
July 1, 2009 7:00 AM ET All PR Newswire news ROCKVILLE, Maryland, July 1 /PRNewswire-USNewswire/ -- Human Genome Sciences, Inc. HGSI today announced that it expects to have top-line results available on Monday, July 20, from BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) in systemic lupus erythematosus (SLE).
Senior management will host a conference call to discuss the results on Monday, July 20, 2009 at 8:15 AM Eastern. The BLISS-52 data will be submitted for full presentation at an appropriate scientific meeting.
Investors may listen to the call by dialing 888-632-5010 or 913-312-0402, passcode 8364417, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 8364417.
This conference call also will be webcast and may be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. The archive of the conference call will remain available for several days.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
HGS, Human Genome Sciences, BENLYSTA and LymphoStat-B are trademarks of Human Genome Sciences, Inc.