Emergent BioSolutions, Inc. received approval from the FDA for Anthrasil  [Anthrax Immune Globulin Intravenous (Human)] for the treatment of inhalational anthrax in combination with antibacterial drugs, triggering a $7 million milestone payment under a development contract with the Biomedical Advanced Research and Development Authority (BARDA). Anthrasil also received Orphan Drug designation, qualifying for seven years of market exclusivity.
 
Anthrasil is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that target anthrax toxins. It’s prepared using plasma from healthy, screened donors who have been immunized with Emergent’s BioThrax (Anthrax Vaccine Adsorbed) vaccine, the only FDA-licensed vaccine for the prevention of anthrax disease.
 
Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions, said, “Emergent is pleased to receive FDA approval of Anthrasil, the only FDA-approved polyclonal therapeutic for the treatment of anthrax disease. Anthrasil remains an integral part of the U.S. government’s strategic national stockpile and we are committed to working collaboratively with BARDA and CDC to further advance this program.”
 
Emergent continues to collect and store anti-anthrax human Plasma for the potential future manufacture of bulk drug substance to support the U.S. government stockpiling. Anthrasil was developed as part of a $160 million contract with BARDA, which was awarded in 2005. Anthrasil has been delivered to and is stored in the U.S. Strategic National Stockpile.