Listed TSX, Symbol: CNJ
TORONTO and WINNIPEG, April 9 /CNW/ - Cangene Corporation today reports
that the United States Food and Drug Administration ("FDA") has approved
HepaGam B(TM) for use to prevent hepatitis B recurrence following liver
transplantation in hepatitis B surface antigen ("HBsAg")-positive liver
transplant patients. HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin
Intravenous (Human), which is a purified antibody or hyperimmune that is
specific for the hepatitis B virus. Patients who undergo hepatitis B-related
liver transplantation require long-term post-transplant therapy with
hepatitis B immune globulin. Clinical trial data showed HepaGam B(TM) was
highly effective at preventing hepatitis B recurrence and the dosing regimen
used consistently yielded anti-HBsAg levels that exceeded target therapeutic
levels. HepaGam B(TM) is distributed in the U.S. by Apotex Corp., which
recently expanded its distribution by successfully placing 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.
"This is a very important approval and addresses a significant medical
need," said Dr. John Langstaff, Cangene's president and chief executive
officer. "And with the recent agreement for distribution of this product with
Novation, the timing could not be better," he said.
HepaGam B(TM) was approved last year 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, and was
approved earlier this year by Health Canada for prevention of Hepatitis B
recurrence following liver transplantation in adult patients.
Hepatitis B is a highly infectious virus that can be spread through
contact with blood and other bodily fluids and it can recur 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 had remained in circulation.
Cangene manufactures HepaGam B(TM) 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.
A vaccine for hepatitis B is available, yet the virus continues to cause
significant disease worldwide and pose a significant public health problem.
Hyperimmune products can be used in situations where a vaccine is not
applicable. Approximately 60,000 new infections are seen annually. There are
an estimated 1.25 million chronically infected Americans, 20-30% of whom were
infected as children. Severe liver disease is seen in 15-25% of chronically
Important Safety Information
HepaGam B(TM) is Hepatitis B Immune Globulin Intravenous (Human), a
purified gamma globulin fraction of human plasma. Products made from human
plasma may carry a risk of transmitting infectious agents, e.g. viruses and,
theoretically, the Creutzfeldt-Jakob disease ("CJD") agent. Individuals known
to have severe, potentially life-threatening reactions to human globulin
should not receive HepaGam B(TM) or any other immune globulin (Human).
Individuals who are deficient in IgA may have the potential for developing IgA
antibodies and have severe, potentially life-threatening allergic reactions.
The maltose contained in HepaGam B(TM) can interfere with some types of blood
glucose monitoring systems. Only testing systems that are glucose-specific
should be used in patients receiving HepaGam B(TM). This interference can
result in falsely elevated glucose readings that can lead to untreated
hypoglycemia or to inappropriate insulin administration, resulting in
The most common expected adverse drug reactions for immune globulins like
HepaGam B(TM) are chills, fever, headaches, vomiting, allergic reactions,
nausea, arthralgia and moderate low back pain.
For prevention of hepatitis B recurrence following liver transplantation
in HBsAg-positive liver transplant patients, HepaGam B(TM) should be
For post-exposure prophylaxis, HepaGam B(TM) must be administered only
intramuscularly. In patients who have severe thrombocytopenia or any
coagulation disorder that would contraindicate intramuscular injections,
HepaGam B(TM), should be given only if the expected benefits outweigh the
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 carries out research and development in Mississauga, Ontario and in
Winnipeg. It uses patented manufacturing processes to produce plasma-derived
and recombinant therapeutic proteins. Cangene has three FDA-approved products
and a fourth that has been approved in Canada. One of its recombinant protein
products has received an approvable letter from the FDA and another has been
submitted for regulatory review in Canada. In addition, the Company has
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 increased 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.
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
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.
For further information:
For further information: John McMillan at (204) 275-4310 or by email at