Cangene developing Immune Globulin Intravenous (IGIV) - a widely used
anti-infective plasma product
Readers are referred to the cautionary notes regarding Forward-looking Information at the end of this release
Listed TSX, Symbol: CNJ
TORONTO and WINNIPEG, June 14 /CNW/ - Cangene Corporation today announces that it is developing an Immune Globulin Intravenous product, commonly known as IGIV. IGIV is a widely used anti-infective with a variety of indications including treating primary immune deficiency, immune thrombocytopenic purpura and other inflammatory and autoimmune diseases. A number of competitors share an estimated annualized global market of $4.5 billion and industry forecasts are for continued growth based on expanded applications. This is the product included but unidentified in Cangene's pipeline for the last two years. Cangene is increasing its R&D activities on this product as it moves toward clinical development. The Company is currently scaling up the process in order to begin manufacturing product for clinical trials. The process for manufacturing this product will incorporate a different platform technology for plasma fractionation than the one the Company uses for its specialty hyperimmune products such as WinRho(R) SDF and HepaGam B(R). The Company has already begun to build an inventory of the source plasma needed for the manufacture IGIV to be used in clinical trials, which are expected to begin in 2011. Source plasma differs from the specialty plasma Cangene uses to manufacture its hyperimmune products in that it has not been selected for the presence of specific antibodies.
"The potential uses of IGIV continue to expand. We believe this product has great potential for us and that it would be a good addition to our hospital-based commercial product line-up. We are also working with some new technology for manufacturing this product, which may in turn be used for future products," said Dr. John Langstaff, Cangene's president and CEO.
About Cangene Corporation
Cangene is one of Canada's largest and earliest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene has approximately 750 employees in eight locations across North America and its products are sold worldwide. It operates three large manufacturing facilities - two in Winnipeg, Manitoba and one in Baltimore, Maryland - where it produces its own products and undertakes contract manufacturing for a number of companies. Cangene operates three U.S. and one Canadian plasma-collection facilities branded as Cangene Plasma Resources (www.cangeneplasma.com). In addition, it has a regulatory affairs, sales and corporate communications office in Toronto, Ontario.
Cangene is focused on developing therapeutics for infectious diseases, and the Company uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has five FDA and/or Health Canada-approved products. In addition, the Company has several more products in development at various stages. Three of Cangene's products have been accepted into the U.S. Strategic National Stockpile - botulism antitoxin (investigational product), anthrax immune globulin (investigational product) and vaccinia immune globulin, a product used to counteract certain complications that may arise from smallpox vaccination. Capitalizing on its drug manufacturing expertise, Cangene also operates a significant contract research and manufacturing business using the resources of Baltimore, Maryland-based Cangene bioPharma, Inc. (a wholly owned subsidiary; formerly Chesapeake Biological Laboratories, Inc.; www.cangenebiopharma.com). Cangene's website, www.cangene.com, includes product and investor information, including past news releases.
Forward-looking and risk information
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; availability and cost of raw materials, especially the cost, availability 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 costs associated with its defence; the Company's exposure to lawsuits; 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 preceding cautionary statements 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 Securities Commissions, 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 (including negative and grammatical variations). 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, except as required by applicable law.
"Cangene", "HepaGam B", "WinRho" and "WinRho SDF" are trademarks belonging to Cangene Corporation.
%SEDAR: 00002351E
For further information: about this release, please contact Paul Brisebois at (204) 275-4310 or by email at [email protected]
Share this article