Human Genome Sciences Awarded Two-Phase Contract to Supply ABthrax(TM) for the Treatment of Inhalational Anthrax Disease to the U.S. Government
Monday October 3, 7:00 am ET
- Under the first phase, the company will supply ten grams of ABthrax to the U.S. Government for testing -
- At the U.S. Government's option, the second phase includes the right to purchase up to 100,000 doses for the national stockpile -
ROCKVILLE, Md., Oct. 3 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq:HGSI - News) today announced that it has been awarded a two-phase contract to supply ABthrax(TM), a human monoclonal antibody developed for use in the treatment of anthrax disease, to the U.S. Government. Under the first phase of the contract, Human Genome Sciences will supply ten grams of ABthrax to the U.S. Department of Health and Human Services (HHS) for comparative in vitro and in vivo testing. Under the second phase of the contract, the U. S. Government has the option to place an order within one year for up to 100,000 doses of ABthrax for the Strategic National Stockpile, for use in the treatment of anthrax disease. The HHS comparative testing results, along with Human Genome Sciences' own preclinical and clinical study results, will form the basis of the U.S. Government's decision process for exercising its option for additional product for the Strategic National Stockpile.
Under terms of the contract (Contract Number HHSO10020050006C), Human Genome Sciences within two months will supply ten grams of ABthrax (raxibacumab) manufactured under cGMP conditions for use in comparative testing to be conducted by HHS. Human Genome Sciences also will provide support necessary to aid HHS in conducting its independent testing. Human Genome Sciences is entitled to receive approximately $1.8 million for the first phase of the contract. The second phase of the contract would be awarded by HHS under the Project BioShield Act of 2004, which is designed to accelerate the development, purchase and availability of medical countermeasures for the Strategic National Stockpile.(1)
James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel of Human Genome Sciences, said, "We are pleased that the U.S. Government has chosen to award this contract to Human Genome Sciences. We are ready to supply the initial quantity of material. We are hopeful that the Government can quickly complete the testing phase, so that we can supply ABthrax to the national stockpile for use in the event of a bioterrorist attack."
H. Thomas Watkins, Chief Executive Officer, said, "I am very proud of our Human Genome Sciences research and development team for their excellent work in bringing ABthrax to this point without government funds. We hope that our country never faces the need to use this product, but would be grateful for the opportunity to make ABthrax available for the treatment of our citizens and first-responders in case the need should ever arise. We have the manufacturing, R&D and other resources needed to fulfill both the first and second phases of the contract announced today. We are fully prepared to move forward rapidly, once the U.S. Government completes its laboratory testing and places an order for therapeutic doses in quantity."
ABthrax is a human monoclonal antibody to Bacillus anthracis protective antigen that was discovered and developed by Human Genome Sciences. ABthrax was developed using technology that Human Genome Sciences has integrated into the company as part of its collaboration with Cambridge Antibody Technology.(2) ABthrax used for preclinical and clinical studies was produced in the company's manufacturing facilities in Rockville, Maryland. Human Genome Sciences has demonstrated the preventive and therapeutic efficacy of ABthrax in multiple preclinical studies in relevant animal models of inhalational anthrax, and has demonstrated the safety and tolerability of ABthrax in a Phase 1 clinical trial in healthy adults.(3-12) In 2003, ABthrax received a Fast Track Product designation from the FDA.... |
