TORONTO and WINNIPEG, Oct. 18 /PRNewswire-FirstCall/ -- Cangene Corporation today reports that the U.S. Centers for Disease Control and Prevention (CDC) intends to negotiate a sole-source agreement with Cangene to provide up to 200,000 doses of botulinum toxin immune globulin. Citing unusual and compelling urgency, the Department of Health and Human Services (DHHS) and the CDC identified Cangene as the only prospective contractor possessing the necessary experience, capability and capacity to fulfill its requirements. Cangene intends to develop and manufacture product for use under an Investigational New Drug Application with the further intention of seeking U.S. Food and Drug Administration licensure.
“We are extremely pleased to be identified as the only potential supplier for this contract. It supports our belief that we are a world leader in developing and manufacturing hyperimmune therapies, and this is the best kind of recognition of our capabilities that we could hope for,” said Dr. John Langstaff, Cangene’s president and chief executive officer.
Botulinum toxin, which causes botulism, is one of the most poisonous substances known and since naturally occurring cases are rare, the population has no immunity to the toxin. Botulism was one of the key targets identified in the US$5.6 billion Bioshield legislation enacted by Congress earlier this year.
Cangene has several government biodefence contracts underway already, including a botulinum antitoxin contract with the CDC that was awarded in January 2003.
Cangene is one of Canada’s largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to two approved products, Cangene now has three products that have been submitted for regulatory review, and a significant clinical trial program including human growth hormone, which is nearing regulatory submission. Cangene is also expanding its contract research and manufacturing business using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly-owned subsidiary). The Company’s internationally-compliant, manufacturing facilities are located in Winnipeg, Manitoba and Baltimore, Maryland. Cangene’s website, http://www.cangene.com/, includes product and investor information, including past news releases. Chesapeake’s website is http://www.cblinc.com/.
The reader should be aware that Cangene’s businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, actual results may differ materially from past results and those expressed or implied by any forward-looking statements. Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the regulatory environment including the difficulty of predicting regulatory outcomes; changes in the value of the Canadian dollar; the Company’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; cost of raw materials, especially the cost and antibody concentration in plasma; fluctuations in operating results; government policies or actions; progress and cost of clinical trials; reliance on key strategic relationships; 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 cost associated with its defence; the Company’s exposure to lawsuits and uncertainties related to estimates and judgments used in preparation of financial statements in accordance with GAAP and related standards and other matters beyond control of management.
The cautionary statements referred to above should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by the Company or by persons acting on its behalf and in conjunction with its periodic filings with the Ontario Securities Commission, including those contained in the Company’s news releases and most recently filed Annual Information Form. Forward-looking statements can be identified by the use of words such as “expects”, “plans”, “will”, “believes”, “estimates”, “intends”, “may”, “bodes”, and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should management’s assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly make or update any forward-looking statements.
Cangene Corporation
CONTACT: Ms. Jean Compton, Manager, Investor Relations at (905) 405-2900(email at jcompton@cangene.com);To request a free copy of this organization’s annual report, please go tohttp://www.newswire.ca/ and click on reports@cnw.