EMA's CHMP issues positive opinion for Cangene's Human Hepatitis B Immunoglobulin product

Dec 18 2009

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.