Cangene receives an approvable letter from the FDA for human growth hormone



    Listed TSX, Symbol: CNJ

    TORONTO and WINNIPEG, March 12 /CNW/ - 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.

    About Cangene

    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,
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 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.

    %SEDAR: 00002351E




For further information:

For further information: Jean Compton, Manager, Investor Relations at
(905) 405-2900, or by email at jcompton@cangene.com

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