FDA Advisory Committee Votes in Favour of Cangene's Botulism Antitoxin Product
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WINNIPEG, Feb. 12, 2013 /CNW/ - Cangene Corporation (Cangene) today announces that the U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) voted unanimously in support of the questions posed by the FDA on Cangene's Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) in that there is a likely clinical benefit and an acceptable risk to benefit profile for the product, and that the studies adequately support the proposed dosing in adults. Cangene is seeking licensure for the product for the treatment of symptomatic botulism following documented or suspected exposure to the botulinum neurotoxin serotypes A, B, C, D, E, F or G.
In September 2012, Cangene submitted a Biologics License Application (BLA) for the Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) with the proposed proprietary name BAT™. The product previously received orphan drug designation in June 2011 which provides for seven years of market exclusivity following the approval of the product by the FDA. BPAC provides non-binding recommendations to the FDA which makes the final decision in respect of the approval of the product. The target date for the approval of BAT by the FDA under the Prescription Drug User Fee Act (PDUFA) is March 22, 2013.
BAT is an investigational product containing antibodies specific for the seven botulinum neurotoxin serotypes A, B, C, D, E, F or G. Botulinum neurotoxins are the bacterial toxins that cause botulism. These toxins can occur naturally in improperly processed foods and have also been identified as a potential biological warfare agent. While still an investigational product, Cangene's BAT is the only botulinum antitoxin available in the U.S. for treating naturally occurring non-infant botulism and is administered to patients under emergency conditions.
"We are pleased with the outcome of today's hearing which marks a significant milestone on the path to licensure for our BAT product" says John A. Sedor, President and CEO of Cangene. "Through many years of development, our commitment to patients has never wavered as we seek to address an unmet medical need" adds Mr. Sedor.
BAT has been developed under a $427 Million contract with the U.S. Department of Health and Human Services (HHS) and has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA). Under the terms of the contract, Cangene will receive a supplementary payment if the product is approved by the FDA. BAT was first accepted into the United States Strategic National Stockpile (SNS) in 2007.
About Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G)
Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) is an investigational product that is a purified mixture of polyclonal equine immune globulins (antibodies) with specificity for seven neurotoxins serotypes that can cause botulism. Botulinum toxin is a nerve toxin produced by the bacterium Clostridium botulinum that causes a serious paralytic illness known as botulism. Naturally occurring cases are mainly seen in infants or in adults who have consumed improperly processed foods or have been colonized through exposure to the bacteria. Due to the extreme potency and potential lethality of Botulinum toxin, it has been identified in the U.S. as one of the highest priority bioterrorism threats. Cangene's BAT has been administered to over 200 patients in the United States since 2009 through the Centre for Disease Control expanded access program.
Cangene is a world leader in developing and manufacturing hyperimmune products. Hyperimmunes are highly purified, specialty antibodies made from plasma. BAT is part of Cangene's growing product pipeline and is manufactured in Cangene's Winnipeg manufacturing facility.
About Cangene Corporation
Cangene Corporation (TSX: CNJ), headquartered in Winnipeg, Canada, is one of the nation's oldest and largest biopharmaceutical companies. It is focused on the development and commercialization of specialty therapeutics. Cangene's products are sold worldwide and include products that have been accepted into the U.S. Strategic National Stockpile. Cangene has offices in three locations across North America. It operates manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland (through its wholly-owned subsidiary, Cangene bioPharma, Inc.) where it produces its own products and undertakes contract manufacturing for a number of customers. Cangene also operates a plasma-collection facility in Winnipeg, Manitoba under the name Cangene Plasma Resources. Its U.S. sales and marketing office is located in Philadelphia, Pennsylvania. For more information about Cangene, visit the Company's website at www.cangene.com.
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SOURCE: Cangene CorporationFor further information:
Francis J. St.Hilaire
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