Licensure of BATTM is Key Milestone in Highly Successful Collaboration with BARDA to Ensure U.S. Preparedness Against Potential Botulism-Related Public Health Risks
Readers are referred to the cautionary notes regarding Forward-looking Information at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
WINNIPEG, March 25, 2013 /CNW/ - Cangene Corporation ("Cangene") today announces 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."
About Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G)
Botulism Antitoxin (Equine), Heptavalent (A, B, C, D, E, F, G) is a product that is a purified mixture of polyclonal equine immune globulins (antibodies) with specificity for seven neurotoxin 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 treat over 200 cases of naturally-occurring, non-infant botulism in the United States since 2009 through the Centre for Disease Control expanded access program.
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.
SOURCE: Cangene Corporation
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