Cangene's anti-hepatitis B product granted orphan-drug exclusive approval by the U.S. Food and Drug Administration

    Listed TSX, Symbol: CNJ

    TORONTO and WINNIPEG, March 26 /CNW/ - Cangene Corporation today
announces that its HepaGam B(TM) (Hepatitis B Immune Globulin Intravenous
(Human)), has received orphan-drug exclusive approval from the United States
Food and Drug Administration ("FDA") for the prevention of hepatitis B
recurrence following liver transplantation in hepatitis B surface antigen
("HbsAG")-positive liver transplant patients. This approval gives HepaGam B
seven years of market exclusivity and could facilitate the recovery of certain
regulatory filing fees.
    "This approval is a significant achievement for Cangene, providing seven
years of market exclusivity in the United States. This exclusivity further
solidifies HepaGam B(TM)'s position in the U.S. market as the only hepatitis B
immune globulin approved for the prevention of hepatitis B recurrence
following liver transplantation," said Dr. John Langstaff, Cangene's president
and chief executive officer.
    Hepatitis B is a highly infectious virus that can be spread through
contact with blood and other bodily fluids. Hepatitis B recurrence can occur
after liver transplantation in patients who are HBsAg-positive at the time of
transplant. Recurrence results from the infection of the liver graft with
hepatitis B virus that has remained in the patient's body. The hepatitis B
virus continues to pose a significant public health problem. Of the estimated
6,500 liver transplants performed annually in the United States, approximately
5% are a result of hepatitis B infection. The U.S. market is estimated at
$40 to $50 million annually.

    About HepaGam B(TM)

    HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin (human) Injection,
which 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 with Hepatitis B who have no or low levels of hepatitis B virus
replication. It is also 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
four FDA-approved hyperimmunes that it manufactures using similar processes.
    HepaGam B(TM) is distributed in the U.S. by Apotex Corp., which has
placed the drug within Novation LLC's product line-up, making HepaGam B(TM)
directly available to Novation's nearly 2,500 member healthcare organizations
in the United States.

    About Orphan-Drug Exclusive Approval

    A drug can be granted orphan-drug designation if the disease or condition
the drug is intended to treat affects fewer than 200,000 people in the United
States or, if the drug is a vaccine, diagnostic drug or preventative drug;
will be administered to fewer than 200,000 people per year in the United
States. Once a product receives orphan-drug exclusive approval for use in the
disease or condition, FDA will not approve another sponsor's product for that
use for seven years.

    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
    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,, includes product and investor information, including
past news releases. Chesapeake's website is

    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 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
    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: Michael Graham at (204) 275-4040 or by email at

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