Healthcare Industry News:  hepatitis B virus 

Biopharmaceuticals FDA

 News Release - March 26, 2008

Cangene's anti-hepatitis B product granted orphan-drug exclusive approval by the U.S. Food and Drug Administration

TORONTO and WINNIPEG, March 26 (Healthcare Sales & Marketing Network) - Cangene Corporation today announces that its HepaGam B(TM) (Hepatitis B Immune Globulin Intravenous (Human)), has received orphan-drug exclusive approval from the United States Food and Drug Administration ("FDA") for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen ("HbsAG")-positive liver transplant patients. This approval gives HepaGam B seven years of market exclusivity and could facilitate the recovery of certain regulatory filing fees.

"This approval is a significant achievement for Cangene, providing seven years of market exclusivity in the United States. This exclusivity further solidifies HepaGam B(TM)'s position in the U.S. market as the only hepatitis B immune globulin approved for the prevention of hepatitis B recurrence following liver transplantation," said Dr. John Langstaff, Cangene's president and chief executive officer.

Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids. Hepatitis B recurrence can occur 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 has remained in the patient's body. The hepatitis B virus continues to pose a significant public health problem. Of the estimated 6,500 liver transplants performed annually in the United States, approximately 5% are a result of hepatitis B infection. The U.S. market is estimated at $40 to $50 million annually.

About HepaGam B(TM)

HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin (human) Injection, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. It is the only intravenous product licensed in Canada or the U.S. for prevention of Hepatitis B recurrence following liver transplantation in adult patients with Hepatitis B who have no or low levels of hepatitis B virus replication. It is also approved 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. Cangene manufactures HepaGam B(TM) in its Winnipeg, Manitoba facility. The Company has four FDA-approved hyperimmunes that it manufactures using similar processes.

HepaGam B(TM) is distributed in the U.S. by Apotex Corp., which has placed 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.

About Orphan-Drug Exclusive Approval

A drug can be granted orphan-drug designation if the disease or condition the drug is intended to treat affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug or preventative drug; will be administered to fewer than 200,000 people per year in the United States. Once a product receives orphan-drug exclusive approval for use in the disease or condition, FDA will not approve another sponsor's product for that use for seven years.

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 650 employees in eight locations across North America. 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 investor relations office in Toronto, Ontario (NOTE: this office moved effective January 2008, the new address is 180 Attwell Drive, Suite 360, Toronto, ON, M9W 6A9; phone 416-675-8300; fax 416-675-8301).

The Company uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has four FDA and Health Canada-approved products and a fifth that has been approved in Canada only. 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 arising 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). 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 labeling 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.


Source: Cangene

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