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The drug is indicated for treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone
TORONTO and WINNIPEG, Canada | January 24, 2008 | Cangene today announces that the
U.S. Food and Drug Administration ("FDA") has approved Accretropin(TM) (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(TM) 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(TM) 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.
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. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is www.cblinc.com.
SOURCE: CANGENE |
