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Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)
Date:5/21/2009

- First-in-class treatment for inhalation anthrax -

ROCKVILLE, Md., May 21 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its human monoclonal antibody drug ABthrax(TM) (raxibacumab) for the treatment of inhalation anthrax.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )

The BLA submission includes the results of two randomized placebo-controlled studies conducted in rabbits and monkeys to evaluate the efficacy of raxibacumab. These studies showed a survival benefit in two relevant animal species, which is the requirement for establishing 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.

"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," said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. "In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our Company."

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 (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS).

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SOURCE Human Genome Sciences, Inc.
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