Cangene's recombinant human growth hormone approved by the U.S. Food and Drug Administration



    Listed TSX, Symbol: CNJ

    TORONTO and WINNIPEG, Jan. 24 /CNW/ - 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. 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. 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;
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.

    %SEDAR: 00002351E




For further information:

For further information: about Cangene Corporation, please contact Jean
Compton at (416) 675-8280 or by email at jcompton@cangene.com

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Cangene Corporation

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