Cangene Corporation has announced that the United States Food and Drug Administration ("FDA") has approved Cangene's Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) ("BAT") product for treatment of suspected or documented exposure to the botulinum neurotoxin A, B, C, D, E, F or G.
Cangene's BAT received orphan drug designation and as a result of its approval, the product now has seven years of market exclusivity.
BAT is the only botulism antitoxin available in the U.S. for treating naturally occurring, non-infant botulism, and for administering to patients under emergency conditions.
Cangene developed BAT as part of a $427 million contract with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Under the terms of the contract signed in 2006 between Cangene and BARDA, Cangene will deliver 200,000 doses of BAT to the US Strategic National Stockpile, which was established to provide medicines to the American public in the event of a public health emergency.
Cangene began supplying doses of BAT to BARDA under this contract in 2007, and will deliver the remaining doses contracted by 2018.
With BAT's licensure by the FDA, the Company will receive a holdback payment from BARDA under the contract of approximately $18.5 million and remaining product deliveries will be paid at full contract price.
John A. Sedor, President and CEO of Cangene, said: "The licensure of BAT is a significant milestone for Cangene as well as the US Government as we work together to ensure preparedness against the threat of botulism. The U.S. Department of Health and Human Services and BARDA have been excellent development partners, and we are very proud to have received FDA approval for this important countermeasure to naturally occurring botulism and a significant potential bioterrorism threat. We look forward to delivering the remaining BAT doses to BARDA over the coming years and to continuing our successful relationship."