Cangene Receives an Approvable Letter From the FDA for Human Growth Hormone
- Category: Proteins and Peptides
- Published on Tuesday, 13 March 2007 02:00
- Hits: 3117
TORONTO and WINNIPEG, Canada | Mar 12, 2007 | Cangene today announces that it has received an approvable letter from the United States Food and Drug Administration ("FDA") for Accretropin(TM), Cangene's recombinant human growth hormone ("rhGH").
The drug's indication is treatment of growth failure in children with growth hormone deficiency and short stature associated with Turner Syndrome. Accretropin(TM) was submitted under section 505(b) of the United States Federal Food, Drug and Cosmetic Act last summer. In its action letter, the FDA requested additional support data regarding manufacturing processes. As fulfilling this requirement does not involve further clinical trials, Cangene anticipates being able to respond quickly. Cangene has three drugs already approved by the FDA, but this is the first of its recombinant products to be filed in the United States. Accretropin(TM) was developed under a research and development agreement with the Apotex Group, Cangene's majority shareholder.
"This is a significant milestone and we intend to continue working closely with the FDA to complete the process as quickly as possible," said Dr. John Langstaff, Cangene's president and CEO. "While Cangene may be better known for its hyperimmune products, we have developed considerable expertise in the production of recombinant protein therapeutics and consider this side of our business to have significant future potential for the Company".
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. 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.
Cangene is one of Canada's largest and earliest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and in Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Along with rhGH in its pipeline, Cangene has three FDA-approved products and a fourth that has been approved in Canada, a recombinant product that has been submitted for regulatory review in Canada, and several more products in development at various stages. 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 will increase the Company's capacity to fractionate plasma to accommodate the growing manufacturing requirements. Cangene's website, http://www.cangene.com">www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is http://www.cblinc.com">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 http://www.sedar.com">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. 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.