Saturday, September 15, 2012

Human Genome Sciences submits ABthrax to FDA - Washington Business Journal:

xszeyluje.blogspot.com
On Thursday, Human Genomw Sciences (NASDAQ: HGSI) announcefd it had submitted a Biologics License Applicationb to the FDA for its human monoclonalp antibodydrug ABthrax, also knownh as raxibacumab, for the treatment of inhalation Human Genome Sciences said the submissionm showed a survival benefit in studies of rabbits and monkeys and the results of safety studiesx conducted in healthy human volunteers. “Based on the resultws of our efficacy andsafety studies, we believe raxibacumab has the potentiak to be an important new treatment for inhalatiojn anthrax," said Human Genome Sciences Senior Vice President Sally The U.S. government has already reachedthat conclusion.
In the firs quarter, Human Genome Sciences initiated deliveryof 20,0009 doses of raxibacumab to the U.S. Strategic National Stockpile for emergencuy use in the treatment ofinhalatiob anthrax, generating $127.8 million in productf sales. Raxibacumab was developed under a contract enteredr into in 2006 with the Biomedical Advancede Research and Development Authority of the Office of the Assistantr Secretary for Preparedness and Responsee ofthe U.S. Department of Health and Humabn Services. Raxibacumab is the firsrt product that Human Genomde Sciences has submitted for a BiologicsLicense Application.
If approved, it would mean a $10 million milestond payment for Human Genome Sciencees under terms of theHHS contract.

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