Readers are referred to the cautionary notes regarding Forward-looking
Information at the end of this release
Listed TSX, Symbol: CNJTORONTO and WINNIPEG, July 30 /CNW/ - Cangene Corporation today announces
that it has withdrawn its Marketing Authorization Applications ("MAA") with
respect to WinRho(R) SDF (Rho (D) Immune Globulin (Human) for Injection) that
were underway in 16 European Union ("EU") countries and it will also cease
marketing the product in the EU countries where Marketing Authorizations had
already been obtained. The Company's decision to exit the EU market is based
on the challenges and cost of obtaining regulatory approval in the remaining
16 EU countries, as well as a re-evaluation of its marketing strategy and the
current competitive landscape, where several products are approved to treat
the same indications.
"We weighed our options carefully and this is the best business decision.
The European market has still been only a very small piece of our WinRho(R)
SDF business; we will focus our attention on our established markets and
building relationships with new customers," said Dr. John Langstaff, president
and CEO of Cangene Corporation.
About WinRho(R) SDF (Rho (D) Immune Globulin (Human) for Injection)
WinRho(R) SDF is a sterile, lyophilized or liquid gamma globulin (IgG)
fraction containing antibodies to the Rho (D) antigen. It is approved in
Canada, the United States and many other countries; its largest market is in
North America.
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 corporate communications 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", "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 labelling 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: about Cangene Corporation, please contact Paul
Brisebois, Vice President Commercial Development at (204) 275-4310 or by email
at pbrisebois@cangene.com
