The HHS’s Biomedical Advanced Research and Development Authority (BARDA) announced last week it was to replenish its expired stockpile of anti-anthrax drugs with 60,000 doses of the monoclonal antibody Raxibacumab from GSK as part of an effort to prepare the US in the event of an anthrax attack.
“Raxibacumab is manufactured at GSK’s plant in Rockville, Maryland,” GSK spokesperson Robin Gaitens told Biopharma-Reporter.com. “The Rockville facility is able to produce enough medicine to meet our contract with the US Government.”
The drug was developed in 2001, in response to anthrax attacks in the US and was the first monoclonal anti-toxin to be approved for inhalational anthrax. It works by blocking the activity of the anthrax toxin, offering an additional mechanism to antibiotics that target the anthrax bacteria.
On top of the $196m BARDA is paying GSK, the authority is shilling out a further $63m to Canadian firm Cangene in order to purchase 10,000 treatment courses of Anthrax Immune Globulin (AIG) in the form of plasma.
In total “BARDA has provided $949 million since 2005 to support the advanced development and purchase of multiple anthrax antitoxin candidates towards FDA approval and stockpiling,” HHS spokesperson Ashley Small told us.
However, on top of this, “HHS is acquiring several hybridoma cell lines - [at a cost of $1.6m] expressing the monoclonal antibodies to anthrax antitoxins,” she continued, “to test in an animal challenge study comparing the efficacy of these antitoxin candidates developed with support from BARDA.”
The cell lines will be purchased from GSK and a number of other manufacturers including Elusys, Emergent, and PharmAthene, who recently merged with Theraclone to continue developing its mAb programme.
Though Small said the goal of this latest procurement “is to maintain the current level of preparedness by replenishing expiring doses of anthrax antitoxins,” the deal builds on efforts by all five companies and the federal government to develop anthrax antitoxins.
In 2010, BARDA signed a deal with Pfenex for $18.8m to use its Expression technology in order to produce bulk recombinant protective antigens in order to respond more effectively to a terrorist threat.
According to Small: “If additional product - in excess of what is in the U.S. Strategic National Stockpile currently - was needed, the time to manufacture and release the product is approximately 2 months.”