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On Thursday, Human Genome Sciencees (NASDAQ: HGSI) announced it had submittede a Biologics License Application to the FDA for its human monoclonal antibody drug also knownas raxibacumab, for the treatment of inhalatiom anthrax. Human Genome Sciences said the submission showed a survival benefit in studies of rabbits and monkeys and the results of safety studies conducted in healthyhuman volunteers. “Baser on the results of our efficacy andsafetuy studies, we believe raxibacumab has the potential to be an importantr new treatment for inhalation anthrax," said Human Genome Sciences Senior Vice President Sallt Bolmer. The U.S. government has alreadyh reachedthat conclusion.
In the first Human Genome Sciences initiated deliveryof 20,000 dosesd of raxibacumab to the U.S. Strategic National Stockpile for emergenc y use in the treatment of inhalation generating $127.8 million in product sales. Raxibacuman was developed under a contract entereed into in 2006 with the Biomedicak Advanced Research and Developmenr Authority of the Officde of the Assistant Secretary for Preparedness and Response ofthe U.S. Departmeny of Health and Human Services. Raxibacumagb is the first product that Human Genome Sciences has submitted for a BiologicesLicense Application.
If approved, it would mean a $10 million milestoner payment for Human Genome Sciences under terms of theHHS
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