(By Balaseshan) Human Genome Sciences (NASDAQ:HGSI) said it has resubmitted the Biologics License Application (BLA) for inhalational anthrax treating drug to the U.S. regulatory authorities.
Raxibacumab is a human monoclonal antibody that represents a novel way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by bacteria into blood and tissues.
The U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the BLA for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.
The FDA has deemed the resubmission a complete, class 2 response to its November 14, 2009 response letter, which requested further analyses of existing data as well as additional information.
The BLA resubmission contains additional evaluation of histopathology of survivors and non-survivors in animal studies, evaluation of potential added benefit of using raxibacumab with antibiotics versus antibiotics alone, and additional validation to confirm previous data.
Raxibacumab 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).
In 2009, HGS delivered the first 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile, and, in July 2009, the U.S. Government exercised its option to purchase 45,000 additional doses for the Stockpile for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period.
HGSI ended Monday's regular session up 0.37% at $13.67. The stock has been trading between $6.51 and $24.79 for the past 52 weeks.