Cangene Corp. (CNJ.TO) announced that the United States FDA has approved Cangene's Botulism Antitoxin, Heptavalent, or BAT for treatment of suspected or documented exposure to the botulinum neurotoxin A, B, C, D, E, F or G. Cangene said the product 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.
Botulism Antitoxin received orphan drug designation and as a result of its approval, the product now has seven years of market exclusivity. Cangene developed BAT as part of a $427 million contract with the Biomedical Advanced Research and Development Authority, or BARDA. With BAT's licensure by the FDA, Cangene 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.
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