Readers are referred to the cautionary notes regarding Forward-looking Information and non-IFRS Financial Measures at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
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.
Cautionary Note regarding Forward-Looking Information
This document contains forward-looking statements about the Corporation, including its business operations, strategy, and expected financial performance and condition. Forward-looking statements include statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as "expects", "anticipates", "intends", "plans", "will", "believes", "estimates", or negative versions thereof, and similar expressions. In addition, any statement that may be made concerning future financial performance (including revenues, earnings or growth rates), ongoing business strategies or prospects, future use, safety and efficacy of unapproved products or unapproved uses of products, and possible future action by the Corporation are also forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are inherently subject to, among other things, risks, uncertainties and assumptions about the Corporation, economic factors and the biopharmaceutical industry generally. They are not guarantees of future performance. Actual events and results could differ materially from those expressed or implied by forward-looking statements made by the Corporation due to, but not limited to, important factors such as sales levels; fluctuations in operating results; the Corporation's reliance on a small number of customers including government organizations; the demand for new products and the impact of competitive products, service and pricing; the availability and cost of raw materials, and in particular, the cost, availability and antibody concentration in plasma; progress and cost of clinical trials; costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company's competitors; uncertainty related to intellectual property protection and potential costs associated with its defence as well as general economic, political and market factors in North America and internationally; interest and foreign exchange rates; business competition; technological change; changes in government action, policies or regulations; decisions by Health Canada, the United States Food and Drug Administration and other regulatory authorities regarding whether and when to approve drug applications that have been or may be filed, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of drug candidates; unexpected judicial or regulatory proceedings; catastrophic events; the Corporation's ability to complete strategic transactions; and other factors beyond the control of management.
The reader is cautioned that the foregoing list of important factors is not exhaustive and there may be other factors listed in other filings with securities regulators, including factors set out under "Risk and Uncertainties" in the Corporation's Management Discussion and Analysis, which, along with other filings, is available for review at www.sedar.com. The reader is also cautioned to consider these and other factors carefully and not to place undue reliance on forward-looking statements. Other than as specifically required by applicable law, the Corporation has no intention to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Cautionary Note Regarding Non-IFRS Financial Measures
This news release may contain non-IFRS financial measures. Terms by which non-IFRS financial measures are identified include but are not limited to "net cash", "total assets", "sales" and other similar expressions. Non-IFRS financial measures are used to provide management and investors with additional measures of performance. However, non-IFRS financial measures do not have standard meanings prescribed by IFRS and are not directly comparable to similar measures used by other companies. Please refer to the appropriate reconciliations of these non-IFRS financial measures to measures prescribed by IFRS.
SOURCE: Cangene Corporation
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