TORONTO and WINNIPEG, Jan. 30 /PRNewswire-FirstCall/ - Cangene today announces that the U.S. Food and Drug Administration (FDA) has approved Cangene’s HepaGam B(TM) for treatment following acute exposure to hepatitis B virus. HepaGam B(TM) is Cangene’s hepatitis B immune globulin (human), a purified antibody or hyperimmune that is specific for the hepatitis B virus. Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids from an infected person or can be transmitted from an infected mother to a newborn during birth.
“This is Cangene’s fourth approved drug and the third drug to receive FDA approval-a significant accomplishment for a biopharmaceutical company. The depth of our hyperimmune program keeps growing, as does our international reputation,” said Dr. John Langstaff, Cangene’s president and chief executive officer.
Cangene manufactures HepaGam B(TM) in its Winnipeg facility using a process similar to that of WinRho(R) SDF and Vaccinia immune globulin, the Company’s earlier FDA-approved drugs. The Company anticipates that the drug will be distributed in the U.S. by Apotex Corp., a member of the Apotex Group, Cangene’s majority shareholder. The companies expect to launch the product within the next few months.
Specifically, HepaGam B(TM) has been approved for treatment of acute exposure to blood containing hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons with acute HBV infection.
Hepatitis B is a major disease worldwide and a significant public health problem. Approximately two billion people worldwide have been infected with the virus; more than 350 million of these have chronic infections. Approximately 8,500 new cases are reported annually in the U.S.
About Cangene
Cangene is one of Canada’s largest biotechnology companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene carries out research and development in Mississauga, Ontario and Winnipeg. It uses proprietary manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. In addition to its four approved products, Cangene has another product that has been submitted for regulatory review and a significant drug development program. Cangene is also expanding its contract research and manufacturing business using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly-owned subsidiary). The Company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Cangene’s website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake’s website is www.cblinc.com.
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; cost of raw materials, especially the cost 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 uncertainties related to estimates and judgments used in preparation of financial statements in accordance with GAAP and related standards 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 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 the Ontario Securities Commission, 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. 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.
Cangene Corporation
CONTACT: please contact John McMillan, Vice President, CommercialOperations, at (204) 275-4310 or by email at jmcmillan@cangene.com.; Torequest a free copy of this organization’s annual report, please go tohttp://www.newswire.ca and click on Tools for Investors.
