Cangene receives first overseas approval for HepaGam B(R)



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

    Listed TSX, Symbol: CNJ

    TORONTO and WINNIPEG, June 4 /CNW/ - Cangene Corporation today announces
that it has received approval from the Israeli Ministry of Health for the use
of HepaGam B(R) (Hepatitis B Immune Globulin Intravenous (Human)) for two
indications. The product has been approved for treating acute exposure to the
hepatitis B virus (post-exposure prophylaxis or PEP) and preventing
re-infection in liver transplant recipients who are positive for hepatitis B
infection. This is the first non-North American approval for this product.
HepaGam B(R) is a purified antibody or hyperimmune that is specific for the
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 the first, and still the only hepatitis B immune globulin to receive
approval in Canada and the United States for both the PEP and liver transplant
indications.
    "This product is gaining strength in the North American marketplace and
receiving an overseas approval is another positive step in its commercial
development," said Paul Brisebois, Cangene's Vice President, Commercial
Development.
    Cangene manufactures HepaGam B(R) in its Winnipeg facility using a
process similar to that of WinRho(R) SDF, Vaccinia Immune Globulin ("VIG") and
VariZIG(TM), the Company's other hyperimmune products that have been approved
in the United States and/or Canada. HepaGam B(R) is distributed in Israel by
Tzamal Bio-Pharma Ltd.

    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.
    "Cangene", "HepaGam B", "VariZIG", "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 Paul
Brisebois at (204) 275-4310 or by email at pbrisebois@cangene.com

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