New Anti-Hepatitis B Product Approved in Canada

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Monday December 17, 1:20 pm Eastern Time Press Release SOURCE: Cangene Corporation Cangene files for anti-Hepatitis B product approval in Canada Listed TSE, Symbol: CNJ TORONTO/WINNIPEG, Dec. 17 /PRNewswire/ - Cangene Corporation (TSE:CNJ - news) announces that it has filed a New Drug Submission for its anti-Hepatitis B hyperimmune in Canada. The submission follows a U.S. licensing application filed earlier this year, and seeks Health Canada (Health Products and Food Branch) approval for use of the drug in the treatment of individuals exposed to hepatitis B. Hepatitis B is spread through contact with infected blood, and sexual or household exposure to an infected person. It can also be transmitted from an infected mother to a newborn during birth. Cangene plans a future filing for Europe and is currently investigating new indications for the drug. This is Cangene's third product to reach this advanced level of development. ``This is another significant step in our new drug development and was achieved right on schedule. I consider hyperimmunes that are aimed at infectious disease targets such as this one to be one of our most exciting areas of product development,'' said Dr. John Langstaff, Cangene's president and chief executive officer. Hepatitis B poses a severe medical risk. The virus is approximately 100 times more infectious than HIV, and the infection can become chronic and produce severe liver problems. Even in those individuals who have had a Hepatitis B vaccine, a hyperimmune product can be used to supplement the body's own antibody response in cases of possible exposure to Hepatitis B virus. Healthcare workers, newborns with Hepatitis B positive mothers, intravenous drug users and individuals with multiple sexual partners are at risk of infection. Approximately two billion people worldwide have been infected with the virus; more than 350 million of these have chronic infections. Worldwide most sufferers contract the disease during childhood; in the U.S. the highest incidence of the disease occurs in 20-49-year-olds. Hyperimmunes are highly purified antibodies made from specialty human plasma used for therapeutic purposes. They differ from vaccines in that they do not require the patient's own immune system to produce immunity; thus, allowing them to act immediately. Cangene is well known for its ability to manufacture high quality hyperimmune products - its first commercial product, WinRho SDF(TM), was the first plasma product to incorporate a combination of solvent-detergent and nanofiltration steps for viral inactivation during its manufacture. Cangene manufactures its anti-Hepatitis B hyperimmune using a process similar to that of WinRho SDF(TM). Cangene is one of Canada's largest and most profitable biotechnology companies. Founded in 1984 in Mississauga, Cangene is now headquartered in Winnipeg and carries on research and development activities in both cities. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. The Company currently has two approved products and a clinical trial program that is progressing well. In addition to the anti-hepatitis B, it has two products that are nearing completion of Phase III clinical trials. Using its drug-manufacturing expertise and its wholly- owned subsidiary Chesapeake Biological Laboratories, Inc., Cangene is also expanding its contract-manufacturing business. The Company's cGMP, ISO 9001- registered manufacturing facilities are located in Winnipeg, Manitoba and Baltimore, Maryland. Cangene's website,www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website iswww.cblinc.com. To the extent that any statements made in this release contain information that is not historical, these statements are essentially forward- looking. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty of predicting the timing of regulatory approvals or outcome of regulatory actions; market and customer acceptance and demand for new pharmaceutical products; ability to market products; the impact of competitive products, services or pricing; timing or success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; progress of clinical trials; dependence on corporate relationships; government policies or actions; or other risks detailed from time-to-time in the Company's filings with Ontario Securities Commission. 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. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements. SOURCE: Cangene Corporation