Cangene's Recombinant Human Growth Hormone Accretropin Approved by the U.S. Food and Drug Administration
TORONTO and WINNIPEG, Jan. 24 /CNW/ - Cangene today announces that the U.S. Food and Drug Administration ("FDA") has approved Accretropin (somatropin (rDNA origin)) Injection, Cangene's recombinant human growth hormone ("rhGH"). The drug is indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone, or treatment of short stature associated with Turner Syndrome in pediatric patients whose epiphyses are not closed. "This is a significant accomplishment. Accretropin is our first recombinant product approval. Cangene continues to demonstrate that it can take new products from development to approval effectively," said Dr. John Langstaff, president and CEO of Cangene. "We now have four FDA-approved drugs."
Accretropin was submitted under section 505(b) of the United States Federal Food, Drug and Cosmetic Act in 2006. The product was developed under a research and development agreement with the Apotex Group, Cangene's majority shareholder, and Apotex retains marketing rights for the product. Apotex and Cangene are assessing the current market situation and related patent issues to determine the most effective overall strategy for this product going forward.
About Human Growth Hormone
Cangene's rhGH is identical in sequence to authentic human growth hormone of pituitary origin and is manufactured in the Company's biotechnology manufacturing facility in Winnipeg, Manitoba. Natural human growth hormone is a protein produced by the pituitary gland that acts on the ends of the long bones of the body (epiphyses) 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 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 650 employees in eight locations across North America. 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. In addition, it has a regulatory affairs, sales and investor relations office in Toronto, Ontario (NOTE: this office moved effective January 2008, the new address is 180 Attwell Drive, Suite 360, Toronto, ON, M9W 6A9; phone 416-675-8300; fax 416-675-8301).
The Company uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has four FDA and Health Canada-approved products and a fifth that has been approved in Canada only. 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, anthrax immune globulin and vaccinia immune globulin, a product used to counteract certain complications arising from smallpox vaccination.
Capitalizing on its drug manufacturing expertise, Cangene also operates a significant contract research and manufacturing business using its Winnipeg facilities and the resources of Baltimore, Maryland-based Chesapeake Biological Laboratories, Inc. (a wholly owned subsidiary). An expansion in 2006 at the Winnipeg location increased the Company's capacity to fractionate plasma to accommodate the growing manufacturing requirements.
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 cost 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. 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 presented in news releases. Drug names and prescribing information may differ in various countries.
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 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.
Posted: January 2008
- Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone - March 12, 2007
- Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA - July 17, 2006