Cangene announces FDA approval of Botulism Antitoxin

Licensure of BAT(TM) 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 
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 
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 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. 
Investor Relations Contact Jeff Lamothe Chief Financial Officer Tel: (204) 
SOURCE: Cangene Corporation 
To view this news release in HTML formatting, please use the following URL: 
CO: Cangene Corporation
ST: Manitoba
-0- Mar/25/2013 11:36 GMT
Press spacebar to pause and continue. Press esc to stop.