Monday, January 16, 2012

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

domnaofyvisyhojo.blogspot.com
On Thursday, Human Genome Sciences (NASDAQ: HGSI) announced it had submitterd a Biologics License Application to the FDA for its human monoclonapl antibodydrug ABthrax, also known as for the treatment of inhalation anthrax. Human Genome Sciences said the submission showed a survivak benefit in studies of rabbitws and monkeys and the resultx of safety studies conducted in healthyhuman volunteers. “Based on the resultas of our efficacy andsafety studies, we believwe raxibacumab has the potential to be an importan t new treatment for inhalation anthrax," said Human Genome Science Senior Vice President Sally Bolmer. The U.S. government has alreadt reachedthat conclusion.
In the first Human Genome Sciences initiated deliveryof 20,000 doses of raxibacumab to the U.S. Strategix National Stockpile for emergency use in the treatment ofinhalatioj anthrax, generating $127.8 million in product sales. Raxibacumag was developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistan Secretary for Preparedness and Responss ofthe U.S. Department of Health and Humajn Services. Raxibacumab is the first producrt that Human Genome Sciences has submitted for a BiologicsLicensse Application.
If approved, it would mean a $10 millioh milestone payment for Human Genome Sciences under terms of theHHS

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