HHS to buy 20,000 courses of anthrax antitoxin

Anthrax
Public Health

Jun 20, 2006 (CIDRAP News) – The federal government announced plans today to buy 20,000 treatment courses of an experimental anthrax antitoxin from Human Genome Sciences Inc. (HGS) for $165 million.

Full payment for the product, called ABthrax, is contingent on its licensing by the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS) said in a news release.

"This important addition to the Strategic National Stockpile will provide physicians a way to neutralize the deadly toxin anthrax bacteria produces," Dr. Gerald Parker, HHS's acting assistant secretary for public health emergency preparedness, said in the news release.

No product for blocking anthrax toxin is currently available. The disease can be prevented with a vaccine and treated with antibiotics. But antibiotic treatment for inhalational anthrax must begin fairly early in the course of illness, because antibiotics are not effective after Bacillus anthracis has released its toxin into the blood.

"We found it is the toxin which accounted for the majority of anthrax-related deaths during the anthrax attacks of 2001," said Parker. Five people died of inhalational anthrax in that episode, and another 17 people had anthrax illness.

ABthrax (raxibacumab) is described as a human monoclonal antibody to protective antigen, a component of the anthrax toxin. In October 2005, HHS awarded HGS, based in Rockville, Md., a $1.8 million contract to supply 10 grams of the product for testing purposes, with an option for HHS to buy up to 100,000 doses within a year.

H. Thomas Watkins, HGS president and CEO, today called ABthrax "a significant step forward" in treating inhalational anthrax. "HGS has demonstrated the efficacy of ABthrax in multiple preclinical studies in relevant animal models, and its safety and tolerability in a Phase 1 clinical trial in healthy adults," he said in a news release.

Watkins said the company expects to start delivering ABthrax to HHS in 2008, making it the first HGS product to the reach the market. But the HHS announcement predicted that delivery will begin in 2009.

According to HGS, the HHS decision to award the new contract was based on the combination of HHS's testing of ABthrax and the company's preclinical and clinical trial results. Under the contract, HGS said it must complete additional laboratory and clinical testing to support a license application to the FDA and to support the use of ABthrax in patients with inhalational anthrax if the need arises before licensing.

HGS said ABthrax was the first experimental treatment for anthrax to be evaluated in a clinical study after the 2001 anthrax attacks.

See also:

Jun 20 HHS news release
http://archive.hhs.gov/news/press/2006pres/20060620.html

Oct 6 2005 CIDRAP News story "HHS to buy two anthrax drugs for testing"

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