Cangene Corporation has received approval from the Israeli Ministry of Health for the use of HepaGam B (Hepatitis B Immune Globulin Intravenous (Human)) for two indications. The product has been approved for treating acute exposure to the hepatitis B virus (post-exposure prophylaxis or PEP) and preventing re-infection in liver transplant recipients who are positive for hepatitis B infection.
This is the first non-North American approval for this product. HepaGam B is 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. HepaGam B is the first, and still the only hepatitis B immune globulin to receive approval in Canada and the United States for both the PEP and liver transplant indications.
"This product is gaining strength in the North American marketplace and receiving an overseas approval is another positive step in its commercial development," said Paul Brisebois, Cangene's vice president, Commercial Development.
Cangene manufactures HepaGam B in its Winnipeg facility using a process similar to that of WinRho SDF, Vaccinia Immune Globulin (VIG) and VariZIG, the company's other hyperimmune products that have been approved in the United States and/or Canada. HepaGam B is distributed in Israel by Tzamal Bio-Pharma Ltd.
Cangene is one of Canada's largest and earliest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba.