Recently, Human Genome Sciences Inc. (HGSI) announced that the U.S. Food and Drug Administration (FDA) delayed the approval of ABthrax (raxibacumab), the company’s candidate for anthrax treatment, asking for additional information pertaining to the drug.
The agency issued a complete response letter wherein it asked for additional information in response to the Biologics License Application (BLA) filed in May 2009. The company intends to provide the agency with the requested information shortly.
The agency’s decision comes weeks after an FDA advisory panel questioned the drug’s effectiveness when compared to existing anti-bacterial drugs since ABthrax was primarily tested in animals, not humans. Late last month, the panel of experts voted 17 to 6, with one abstention, that the company should submit more evidence on whether adding ABthrax to older drugs is beneficial for anthrax treatment. Consequently, the decision to delay approval does not surprise us.
As a reminder, raxibacumab, which received Fast Track Product and Orphan Drug designations for anthrax disease, 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).
Human Genome is under contract to deliver doses of ABthrax to the U.S. Strategic National Stockpile, which stores huge quantities of medicine and medical supplies to be used in national emergencies like a flu outbreak, terrorist attacks or earthquakes that are brutal enough to deplete local supplies. The company delivered 20,000 doses of the drug to the U.S. Strategic National Stockpile in the first quarter of 2009.The company received more than $160 million in ABthrax revenue in the first two quarters of 2009.
 In July 2009, Human Genome secured a new purchase order for 45,000 doses of ABthrax to be delivered to the U.S. Strategic National Stockpile over a three-year period. Human Genome expects to receive approximately $151 million from this order as deliveries are completed. The company will receive an additional $10 million from the U.S. Government on FDA approval.
Currently we are Neutral on Human Genome.
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