Published on March 18, 2010 at 12:06 AM
Readers are referred to the cautionary notes regarding Forward-looking information at the end of this release
Cangene Corporation today reports that it has received European Commission approval to market Cangene's ImmunoGam(TM) (Human Hepatitis B Immunoglobulin), indicated for immunoprophylaxis of hepatitis B. 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. As the application for this Marketing Authorization was submitted via the centralized procedure, its issuance means that ImmunoGam(TM) is approved for sale and use in all 27 member states of the European Union. Details regarding the distribution and launch plans have not yet been finalized.
"This approval extends the reach of this product, which is our second largest selling commercial product in North America where it has two approved indications. While this market is relatively small compared with North America, this is nevertheless a positive development," said Dr. John Langstaff, Cangene's president and CEO. "With an increased strategic focus on our commercial products, this European approval complements our efforts in the United States where we are currently building our sales force to strengthen our market position."
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.
Source: CANGENE CORPORATION