Cangene Files in Europe for HepaGam B (Human Hepatitis B Immunoglobulin) Solution for Infusion or Injection



    Listed TSX, Symbol: CNJ

    TORONTO and Winnipeg, Sept. 19 /CNW/ - Cangene Corporation today
announces that it has submitted a Marketing Authorization Application ("MAA")
for HepaGam B (Human Hepatitis B Immunoglobulin) Solution for Infusion or
Injection to the European Medicines Agency ("EMEA"). The indications included
in the MAA are immunoprophylaxis of hepatitis B and prevention of hepatitis B
virus recurrence after liver transplantation in patients who are positive for
hepatitis B surface antigen. The submission has been accepted for review. The
MAA was submitted using the centralized procedure, under which, the Company
submits a single application to the EMEA. If marketing authorization is
subsequently granted by the European Commission, it is valid in the 30
European Economic Area ("EEA") countries (all 27 European Union members and
three European Free Trade Association ("EFTA") members - Iceland,
Liechtenstein and Norway) and immediately confers licensure and permission to
market the product.
    "This is another positive milestone for Cangene," said Dr. John
Langstaff, Cangene's president and CEO. "HepaGam B is already approved in the
U.S. and Canada, where it is the only product of its type licensed for the
liver-transplantation indication; approval in Europe would establish its place
as a global product," he said.

    About HepaGam B

    HepaGam B(TM) is a purified antibody or hyperimmune that is specific for
the hepatitis B virus. It is the only intravenous product licensed in Canada
or the U.S. for prevention of Hepatitis B recurrence following liver
transplantation in adult patients who are positive for hepatitis B surface
antigen ("HBsAg"). It has been granted orphan drug exclusive approval in the
U.S. for this indication giving it seven years of market exclusivity. It has
also been approved by the FDA for treatment following acute exposure to blood
containing HBsAg, perinatal exposure of infants born to HBsAg-positive
mothers, sexual exposure to HBsAg-positive persons and household exposure to
persons with acute hepatitis B virus infection. Cangene manufactures HepaGam
B(TM) in its Winnipeg, Manitoba facility. The Company has three FDA-approved
hyperimmunes and a fourth that is approved in Canada only that it manufactures
using similar processes.

    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 700 employees in eight locations across North
America and its products are sold worldwide.
    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.
    Cangene is focused on developing therapeutics for infectious diseases,
and the Company uses patented manufacturing processes to produce
plasma-derived and recombinant therapeutic proteins. Cangene has five FDA
and/or Health Canada-approved products. 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 that may arise 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). Cangene's website,
www.cangene.com, includes product and investor information, including past
news releases. Chesapeake's website is www.cblinc.com.
    "Cangene", "HepaGam B", "WinRho" and "WinRho SDF" are trademarks
belonging to Cangene Corporation.

    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 costs 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 labeling 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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