Cangene Corporation today reports that it has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) regarding the immunoprophylaxis indication of Cangene’s ImmunoGam(TM) (Human Hepatitis B Immunoglobulin). This is the product marketed as HepaGam B(R) in North America and Israel, and is a hyperimmune antibody product containing antibodies specific for the hepatitis B surface antigen. A Marketing Authorization from The European Commission should follow within 67 days following adoption of the opinion.
The Marketing Authorization Application for Cangene’s Human Hepatitis B Immunoglobulin was submitted to the EMA via the centralized procedure. This is the first time Cangene has used this procedure, under which an approval will apply to all 27 member states of the European Union. Details regarding distribution and launch plans are still being determined.
“This is another positive regulatory step for this product, which is our second largest commercial product in North America where it has two approved indications. This approval is for a relatively small and competitive market, nevertheless, it continues to expand our international footprint and our regulatory experience with various jurisdictions,” said Dr. John Langstaff, Cangene’s president and CEO.
Cangene manufactures its Hepatitis B Immune Globulin in its Winnipeg facility using a process similar to that of WinRho(R) SDF, Vaccinia Immune Globulin (“VIG”) and VariZIG(TM), the Company’s other hyperimmune products that have been approved in the United States and/or Canada.
About Hepatitis B virus and Hepatitis B Immunoglobulin
Hepatitis B is a highly infectious virus. A vaccine for hepatitis B is available, yet the virus continues to cause disease worldwide and pose a significant public health problem. There are an estimated 800,000 to 1.4 million chronically infected Americans and approximately 350 million chronic cases worldwide. The risk for developing chronic hepatitis B is higher in infants (incidence of 90%) and children ages 1-5 (25-50%) than in adults and children over 5 years (6-10%). Immunized individuals with pre-existing antibodies to hepatitis B rarely contract the disease. Hyperimmune products such as Human Hepatitis B Immunoglobulin can provide this immunity for individuals who have not been vaccinated or have not responded to vaccine. 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 infective 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. 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, anthrax immune globulin 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.). Cangene’s website, http://www.cangene.com/, includes product and investor information, including past news releases.
“Cangene”, “HepaGam B”, “ImmunoGam”, “VariZIG”, “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 http://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: about Cangene Corporation, please contact Paul Brisebois at (204) 275-4310 or by email at [email protected]