Readers are referred to the cautionary notes regarding Forward-looking information at the end of this release
Listed TSX, Symbol: CNJ
TORONTO & WINNIPEG, March 29 /CNW/ - Cangene Corporation today reports that it has signed a no-cost modification to extend its botulism antitoxin contract with the Biomedical Advanced Research and Development Authority ("BARDA"). BARDA is the department within the U.S. Department of Health and Human Services ("HHS") that manages the two biodefence-related, stockpiling contracts Cangene has with HHS. Under the contract, Cangene is required to pursue licensure from the U.S. Food and Drug Administration ("FDA") for use of this product. Both parties have agreed to this two-year extension to allow for additional time to pursue licensure. This modified contract also extends the product delivery schedule to better align it with licensure activities. Cangene was on target to deliver 200,000 doses by May 2011 as specified under the original terms of the contract. This modified contract extends the product delivery schedule out to May 2013, with deliveries spread evenly over the next three contract years. Cangene has delivered approximately half of the contracted doses to date.
"This extension alters the timing of deliveries and will have the effect of spreading the related revenues over the next three years, while also continuing to support licensure activities. Contracts of this nature are always somewhat fluid - we continue to have constructive discussions with BARDA regarding our existing contracts and potential new ones," said Dr. John Langstaff, Cangene's president and CEO.
About botulism and botulism antitoxin
Botulinum toxins are nerve toxins produced by the bacterium Clostridium botulinum that cause a serious paralytic illness known as botulism. Naturally occurring cases are mainly seen in infants or in 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. Botulinum toxin was specifically identified as a target for products developed under the U.S. Project BioShield. Cangene's botulism antitoxin is a hyperimmune product whose safety and efficacy are currently being investigated in ongoing clinical studies; it is a heptavalent hyperimmune preparation that contains neutralizing antibodies to the seven different botulinum toxin types. The United States Centers for Disease Control and Prevention recently announced that Cangene's product will be used in non-infant, public health situations under an Investigational New Drug protocol, replacing similar products that have expired.
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 nearly 30 years, which has established the manufacturing technology. Most recently, the Company's development efforts have been concentrated on developing products with infectious disease and bioterrorism targets.
Hyperimmune products are purified from blood plasma; standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded. This risk also applies to unknown or emerging viruses and other pathogens.
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 branded as Cangene Plasma Resources (www.cangeneplasma.com). 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 (investigational product), anthrax immune globulin (investigational product) 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 the resources of Baltimore, Maryland-based Cangene bioPharma, Inc. (a wholly owned subsidiary; formerly Chesapeake Biological Laboratories, Inc.; www.cangenebiopharma.com). Cangene's website, www.cangene.com, includes product and investor information, including past news releases.
"Cangene", "WinRho" and "WinRho SDF" are trademarks belonging to Cangene Corporation.
Forward-looking and risk 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.
The preceding cautionary statements 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: about Cangene Corporation, please contact Mike Graham at (204) 275-4040 or by email at firstname.lastname@example.org