Cangene's Hepatitis B Therapeutic approved in Canada for a second indication



    
    Readers are referred to the cautionary notes regarding
    Forward-looking Information at the end of this release

    Listed TSX, Symbol: CNJ
    

    TORONTO and WINNIPEG, April 23 /CNW/ - Cangene Corporation ("the
Company") today reports that its HepaGam B(R) (Hepatitis B Immune Globulin
(Human) Injection) has been approved by the Biologics and Genetic Therapies
Directorate of Health Canada for treating acute exposure to hepatitis B virus.
This is the second approved indication in Canada. HepaGam B(R) is a purified
antibody or hyperimmune that is specific for hepatitis B virus. Hepatitis B is
a highly infectious virus that can be spread through contact with blood and
other bodily fluids from an infected person or can be transmitted from an
infected mother to a newborn during birth. HepaGam B(R) is also approved by
the U.S. Food and Drug Administration ("FDA") for this indication and for use
in liver transplant recipients; HepaGam B(R) is the only hepatitis B immune
globulin product approved for both these indications in North America.
    "This approval is another good addition to our product line-up. It
represents the culmination of a great deal of work by our clinical and
regulatory teams. Data supporting this indication was collected from a very
large study that was conducted largely in India; it was one of the largest
clinical trial programs ever conducted there," said Dr. John Langstaff,
Cangene's president and CEO. "This approval also allows us to market the
product to a broader customer base," he said.
    Specifically, this approval is for post-exposure prophylaxis ("PEP") use
of HepaGam B(R), i.e. for treatment of acute exposure to blood containing
hepatitis B surface antigen (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 infection. Health Canada
has granted a full Notice of Compliance ("NOC") with no conditions for this
use of the drug. A two-year-earlier Canadian approval ("NOC/c") for use in
liver transplant recipients, which made the drug available for those in need
of the treatment, included the condition that the Company complete a
confirmatory clinical study. An NOC/c is granted to provide patients who are
suffering from serious, life-threatening or severely debilitating illnesses or
conditions, accelerated access to promising new therapies.
    Cangene manufactures HepaGam B(R) in its Winnipeg facility using a
process similar to that of WinRho(R) SDF, vaccinia immune globulin and
VariZIG(TM), the Company's other hyperimmune products that have been approved
in Canada and/or the United States. HepaGam B(R) is distributed in Canada by
Canadian Blood Services and Héma-Québec, and in the U.S. by Apotex Corp.

    About Hepatitis B virus

    Hepatitis B is a highly infectious virus. A vaccine for hepatitis B is
available, yet the virus continues to cause disease worldwide and pose a
significant public health problem. There are an estimated 800,000 to 1.4
million chronically infected Americans and approximately 350 million chronic
cases worldwide. The risk for developing chronic hepatitis B is higher in
infants (incidence of 90%) and children ages 1-5 (25-50%) than in adults and
children over 5 years (6-10%). Immunized individuals with pre-existing
antibodies to hepatitis B rarely contract the disease. Hyperimmune products
such as HepaGam B(R) can provide this immunity for individuals who have not
been vaccinated or have not responded to vaccine. In a clinical trial using
HepaGam B(R) and vaccination, 98% of at risk infants were protected from
hepatitis B.

    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.
    "HepaGam B", "VariZIG", WinRho", "WinRho SDF" and "Cangene" 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
Michael Graham at (204) 275-4040 or by email at mgraham@cangene.com

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