TORONTO & WINNIPEG, Canada, Jan. 31 /PRNewswire-FirstCall/ - Cangene today announces that the U.S. Food and Drug Administration (FDA) has approved an expanded access investigational new drug (IND) protocol for use of VariZIG(TM), Cangene's Varicella immune globulin. This approval means that at- risk patients will be able to receive VariZIG(TM) if exposed to Varicella zoster, which is the virus that causes chickenpox. Varicella zoster infection can cause complications in certain individuals. The only U.S.-licensed manufacturer of a similar product has discontinued production; consequently, the FDA anticipates a product shortage in the near future. Cangene will be the sole provider of Varicella immune globulin under this IND. VariZIG(TM) is approved in Canada and Cangene is now the sole supplier of the product to Canadian Blood Services and Hema-Quebec.
"Cangene is pleased to be able to supply this specialized product to those patients that require it. As well, this approval further expands the reach of our hyperimmune program," said Dr. John Langstaff, president and chief executive officer of Cangene Corporation.
The following types of patients, if exposed to Varicella, are at-risk for serious infection: immune compromised pediatric or adult patients, neonates (infants less than one year old), pre-term infants, pregnant women and newborns whose mothers had Varicella zoster infection within five days before delivery or two days after delivery. A summary of this expanded access protocol and drug availabilty will soon be available on the FDA website at www.fda.gov.
VariZIG(TM) is a purified antibody preparation or hyperimmune, specific for Varicella zoster virus. Cangene manufactures VariZIG(TM) in its Winnipeg, Manitoba facility and has three FDA-approved hyperimmunes made using similar proprietary processes.
About Cangene
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 proprietary manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to its four approved products, Cangene has another product that has been submitted for regulatory review and a significant drug development program. 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 has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is 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. Risks and uncertainties are discussed more extensively in the MD&A section of the Company's most recent annual report and annual information form, which are available on the Company's website or on SEDAR at www.sedar.com.
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 CorporationCONTACT: Michael Graham, Chief Financial Officer at (204) 275-4040 or byemail at mgraham@cangene.com.; To request a free copy of thisorganization's annual report, please go to http://www.newswire.ca and clickon Tools for Investors.