TORONTO & WINNIPEG, July 17 /PRNewswire-FirstCall/ - Cangene today announces that it has filed a regulatory submission (New Drug Application or “NDA”) for its recombinant human growth hormone product (“rhGH”) with the U.S. Food and Drug Administration (“FDA”) and that the submission has been accepted for review. Cangene’s rhGH, called Accretropin(TM), was tested for its ability to combat short stature in children with growth hormone deficiency and girls with Turner Syndrome. Cangene submitted this NDA under section 505(b) under the United States Federal Food, Drug and Cosmetic Act.
“This is our first recombinant biopharmaceutical to be filed with the FDA and adds to the future potential and diversity of our already strong pipeline, which includes a number of biodefence and infectious-disease-targeted drugs along with the recombinant products,” said Dr. John Langstaff, Cangene’s president and CEO.
About human growth hormone
Cangene’s rhGH is identical in sequence to naturally produced human growth hormone of pituitary origin and is manufactured in the Company’s biotechnology manufacturing facility in Winnipeg, Manitoba. It is the second product in Cangene’s recombinant biopharmaceutical pipeline. Natural human growth hormone is a protein produced by the pituitary gland that acts on the long bones of the body until the onset of puberty and promotes growth to normal stature. A deficiency of this hormone during childhood results in abnormally small stature. A number of approved human growth hormone products made by other companies compete for a large international market.
Turner Syndrome is an X-chromosome-linked genetic disorder in girls that results in short stature and infertility.
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 patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to having four approved products, Cangene has one product in addition to the hGH that has been submitted for regulatory review and a significant clinical trial program. Cangene also provides contract research and manufacturing services 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.
Forward-looking 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; 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. Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information discussed in news releases.
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: about Cangene Corporation, please contact Jean Compton, Manager,Investor Relations, (905) 405-2900, or by email at jcompton@cangene.com
