Cangene meets all regulatory and manufacturing requirements for "Usable Product" on two U.S. government contracts


    Listed TSX, Symbol: CNJ

    TORONTO and WINNIPEG, Aug. 13 /CNW/ - Cangene Corporation today reports
that it has met all the regulatory and manufacturing requirements for the
"Usable Product" milestone on contracts with the U.S. government for products
to treat botulism and inhalational anthrax. The contracts, the largest in
Cangene history, were signed last year and are managed by the U.S. Biomedical
Advanced Research and Development Authority ("BARDA") within the Department of
Health and Human Services ("HHS"). The Usable Product designation means the
Company has met specific regulatory and manufacturing requirements that allow
it to deliver the products to the U.S. Strategic National Stockpile and begin
invoicing once delivery has been accepted. The Company anticipates that
delivery is imminent. Meeting this milestone allows the Company to receive
ongoing revenue for product deliveries and project costs. The initial
payments, expected to be in the range of $US 18-22 million, will include
reimbursable development costs incurred to date, as well as payment for the
initial product delivery. Cangene has manufactured initial quantities of both
products. The combined total value over the terms of the contracts is
approximately $US 505 million, excluding contractual options that may be
exercised by the U.S. government.
    "Meeting the Usable Product milestone for these products has been a major
goal for us. While portions of the revenues from these contracts will be
received throughout the terms of the contracts, this initial delivery and
sale, when complete, will have a significant and positive financial impact in
the current fiscal period," said Dr. John Langstaff, Cangene's president and
CEO. "Being able to deliver these critical biodefence products to the U.S.
Strategic National Stockpile demonstrates the success of this public
sector/industry partnership; we look forward to continuing this productive
relationship".
    Both contracts are for products developed under the U.S. Project
BioShield. Under the first contract, Cangene has developed botulinum toxin
immune globulin (heptavalent botulism antitoxin), a product designed to treat
individuals who have been exposed to the toxins that cause botulism, and will
supply 200,000 doses over the five-year term of the contract. Under the
second, Cangene has developed anthrax immune globulin, a product designed to
treat inhalational anthrax, and will supply 10,000 doses over approximately
three years.

    About Botulism

    Botulinum toxin is a nerve toxin produced by the bacterium Clostridium
botulinum that causes a serious paralytic illness known as botulism. Naturally
occurring cases are mainly seen in infants or adults who have consumed
improperly processed foods. Botulism can also be used as a bioterrorist weapon
and has been identified as one of the highest priority bioterrorism threats.

    About Anthrax

    Anthrax infection, resulting from contact with spore-forming Bacillus
anthracis bacteria, occurs most commonly in herbivores such as sheep, cattle,
goats and camels. Human infections usually result from contact with infected
animals. Due to the stability of the infectious spores, however, anthrax is
considered to be a Category A biological agent. As well as through inhalation,
human anthrax infection can be acquired through the skin or by ingestion, and
in all forms fatality rates are high.

    About Hyperimmunes

    Hyperimmunes are purified preparations of specific immune globulins
isolated from blood plasma. Immune globulins are the class of proteins that
function as antibodies. Cangene's proprietary manufacturing process allows it
to produce high-quality hyperimmune products aimed at a wide variety of
targets. The Company has been manufacturing its WinRho(R) SDF hyperimmune
product for more than 25 years, which has established the manufacturing
technology. As such, new Cangene hyperimmune products tend to enter the
regulatory process at a more advanced stage, which may shorten the development
time. Most recently, the Company's development efforts have been concentrated
on developing products with infectious disease and bioterrorism targets.

    About BARDA

    The Biomedical Advanced Research and Development Authority, within the
Office of the Assistant Secretary for Preparedness and Response in the U.S.
Department of Health and Human Services, provides an integrated and systematic
approach to the development and purchase of the necessary vaccines, drugs,
therapies, and diagnostic tools for public health medical emergencies. BARDA
manages Project BioShield, which includes the procurement and advanced
development of medical countermeasures for chemical, biological, and
radiological, nuclear agents, as well as the advanced development and
procurement of medical countermeasures for pandemic influenza and other
emerging infectious diseases that fall outside the auspices of Project
BioShield. In addition, BARDA also manages the Public Health Emergency
Countermeasures Enterprise.

    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 and Health
Canada-approved products and a fourth that has been approved in Canada only.
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.

    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
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.

    %SEDAR: 00002351E



For further information: please contact John McMillan at (204) 275-4310
or by email at jmcmillan@cangene.com