ROCKVILLE, Md., Oct. 3 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
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.(13)
For more information about ABthrax, see http://www.hgsi.com/products/ABthrax.html. For more information about anthrax, please visit the Centers for Disease Control and Prevention (CDC) web site on bioterrorism and anthrax at http://www.bt.cdc.gov/agent/anthrax/index.asp. For more information about the FDA’s Fast Track Drug Development Programs, see www.fda.gov. Health professionals interested in more information about trials involving Human Genome Sciences products are encouraged to inquire via the Contact Us section of the company’s web site, http://www.hgsi.com/products/request.html, or by calling (240) 314-4400, extension 3550.
Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.
ABthrax, HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Footnotes: 1. Project BioShield Act of 2004 (P.L. 108-276): http://www.hhs.gov/ophep/bioshield/3prngdprgrm.html. 2. (HGSI Press Release) Human Genome Sciences Catapults to Leadership in Genomics-Based Human Antibody Product Development. February 29, 2000. 3. Subramanian GM, et al. A Phase 1 study of PAmAb, a fully human monoclonal antibody against Bacillus anthracis protective antigen in healthy volunteers. Clinical Infectious Diseases 2005: 41. 4. Subramanian GM, et al. ABthrax (PA mAb) - a novel fully human monoclonal antibody against protective antigen of B. anthracis: results of a Phase 1 dose-escalation study in healthy human subjects. American Society of Microbiology Biodefense Meeting, 2004: Abstract 158D 5. (HGSI Press Release) Human Genome Sciences Reports Results of Phase 1 Clinical Trial of ABthrax for Use in Prevention and Treatment of Anthrax Infection. March 9, 2004. 6. Beebe L, et al. Post-exposure therapeutic potential of PAmAb in an inhalation model of anthrax in New Zealand white rabbits. American Society of Microbiology Biodefense Meeting, 2004: Abstract 167G. 7. Zhang X, Laird M, Choi G, et al. Selection of potent neutralizing human monoclonal antibodies to protective antigen of Bacillus anthracis. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, 2003: Abstract # 3976. 8. Beebe L, Zhong J, et al. Protection against inhalation anthrax- induced lethality by a human monoclonal antibody to protective antigen in rabbits and cynomolgus monkeys. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy, 2003: Abstract # 3836. 9. (HGSI Press Release) Human Genome Sciences Describes Activity of ABthrax(TM) at 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy. September 15, 2003. 10. J.F. Zmuda, et al. Detection of Host-Derived Neutralizing Antibodies Against Anthrax Protective Antigen (PA) in PA mAb-Treated Monkeys Surviving Lethal Spore Challenge: Relationship to Secondary Exposure Immunity. American Society of Microbiology Biodefense Meeting, 2004: Abstract 65H. 11. J.F. Zmuda, et al. Detection of Biologically Active PA mAb (Monoclonal Antibody Against Anthrax Protective Antigen) by Edema Factor-Mediated cAMP-Induction Bioassay During Phase 1 Dose Escalation Studies: Comparison to Traditional Pharmacokinetic Analysis. American Society of Microbiology Biodefense Meeting, 2004: Abstract 168G. 12. D. Kahn. Development and Characterization of a Scalable Purification Process for ABthrax. American Society of Microbiology Biodefense Meeting, 2004: Abstract 169G. 13. (HGSI Press Release) Human Genome Sciences Receives Fast Track Product Designation for ABthrax for Prevention and Treatment of Anthrax Infections. August 19, 2003.
Photo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk photodesk@prnewswire.comHuman Genome Sciences, Inc.
CONTACT: Jerry Parrott, Vice President, Corporate Communications,+1-301-315-2777, or Kate de Santis, Director, Investor Relations,+1-301-251-6003, both of Human Genome Sciences, Inc.
Web site: http://www.hgsi.com/
Company News On-Call: http://www.prnewswire.com/comp/121115.html /
