Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare ...(pany has completed the animal studies ne...),Health

Date:1/12/2009

pany has completed the animal studies necessary to demonstrate the efficacy of ABthrax, the human safety studies necessary for approval, and the manufacture of all bulk drug necessary to supply 20,000 doses of ABthrax to the Stockpile. In May 2008, HGS submitted the final data package to the FDA to support authorization of delivery. ABthrax is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS).

"We believe that 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 Mr. Watkins. "We expect to receive authorization to begin delivery to the Strategic National Stockpile early this year. We are confident that we will receive at least $150 million in 2009 from our $165 million contract with the U.S. Government."

Key goals for ABthrax in 2009:

• Deliver 20,000 doses of ABthrax to the Strategic National Stockpile early in 2009.
• Receive at least $150 million in revenue.
• File a Biologics License Application with the FDA in the second quarter.

Darapladib: GSK Phase 3 Development Program Underway

In December 2008, GSK announced initiation of the first pivotal Phase 3 clinical trial to evaluate the efficacy of long-term treatment with the investigational Lp-PLA2 inhibitor darapladib in men and women with chronic coronary heart disease. Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.

In its announcement, GSK said, "Despite major advances in medical treatment, coronary heart disease remains the leading cause
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SOURCE Human Genome Sciences, Inc. Copyright©2009 PR Newswire. All rights reserved

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