/PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (NASDAQ:HGSI) today announced that it has begun delivery of 20,000 doses of its human monoclonal antibody drug ABthrax(TM) (raxibacumab) to the U.S. Strategic National Stockpile for use in the treatment of inhalation anthrax.
ABthrax is a first-in-class treatment for anthrax, and the first procurement under Project BioShield of a product discovered and developed after the September 11, 2001 terrorist attacks. It specifically targets the deadly toxins released within the human body by Bacillus anthracis that are the real culprits in most anthrax-related deaths. ABthrax is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS).
"We believe ABthrax offers a significant step forward in the treatment of inhalation anthrax and could play an important role in strengthening America's arsenal against bioterrorism," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "From a business perspective, this announcement is strategically important for HGS, because it marks our Company's first product sales. We expect to receive $150 million in revenue soon after completion of our delivery to the Strategic National Stockpile. We are pleased with the progress of our partnership with the U.S. Government, which has resulted in this important milestone, and we are hopeful that fulfillment of this initial order will result in a long-term relationship involving additional deliveries of ABthrax to the Stockpile."
ABthrax represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. ABthrax targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective.
"We are delighted to have fulfilled this important milestone under our contract with the U.S. Government and we hope we are making a significant contribution to our nation's security," said James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS, and leader of the Company's ABthrax program with the U.S. Government. "We are particularly pleased with the relationship we have had with BARDA in the development of ABthrax, and we look forward to continuing to work together."
About Research Findings to Date
In December 2007, HGS announced that the results of two animal studies demonstrated the life-saving potential of ABthrax (raxibacumab). The results showed that a single dose of raxibacumab, administered without concomitant antibiotics, improved survival rates by up to 64 percent when administered after animals were symptomatic for anthrax disease as a result of inhalation exposure to massively lethal doses of anthrax spores. These dramatic and statistically significant findings demonstrated a survival benefit in two animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism. These data are consistent with the results of previous studies in multiple animal models, which demonstrated that a single dose of raxibacumab given prophylactically provided up to 100% protection against death.
HGS has also completed safety studies of raxibacumab in more than 400 human volunteers. The clinical results to date suggest that raxibacumab was generally safe and well tolerated. In addition, clinical data have demonstrated that co-administration of raxibacumab with the antibiotic Cipro (ciprofloxacin) did not affect the pharmacokinetics of either Cipro or raxibacumab, and suggested that raxibacumab can be administered in combination with antibiotics. This is a key finding given the important role that antibiotics are expected to continue to play in the treatment of anthrax disease.
The Need for New Means to Fight Anthrax Infections
Two options have been available for the prevention or treatment of anthrax infections - a vaccine and antibiotics. Both are essential to dealing with anthrax, but both have limitations. The anthrax vaccine takes several weeks following the initial doses before immunity is detectable, and requires multiple injections over a period of eighteen months, in addition to annual booster vaccination, to maintain protective immunity. Antibiotics are effective in killing anthrax bacteria, but are not effective against the anthrax toxins once those toxins have been released into the blood. Antibiotics also may not be effective against antibiotic-resistant strains of anthrax.
ABthrax is a human monoclonal antibody to Bacillus anthracis protective antigen that was discovered and developed by HGS, using technology that HGS has integrated into the Company as part of its collaboration with Cambridge Antibody Technology. Research has shown that protective antigen is the key facilitator in the progression of anthrax infection at the cellular level. After protective antigen and the anthrax toxins are produced by the bacteria, protective antigen binds to the anthrax toxin receptor on cell surfaces and forms a protein-receptor complex that makes it possible for the anthrax toxins to enter the cells. ABthrax blocks the binding of protective antigen to cell surfaces and prevents the anthrax toxins from entering and killing the cells.
In contrast to the anthrax vaccine, the protection afforded by a single dose of ABthrax would be immediate following the rapid achievement of appropriate blood levels of ABthrax. In contrast to antibiotics, ABthrax acts against the deadly toxins produced by anthrax bacteria. It may also prevent and treat infections by antibiotic-resistant strains of anthrax. ABthrax was the first investigational agent against anthrax infection to be evaluated in a clinical study following the 2001 anthrax attacks in the United States. In 2003, ABthrax received a Fast Track Product designation from the FDA, as well as an Orphan Drug Designation for its use in the treatment of inhalation anthrax disease.
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