The US Food and Drug Administration has approved Cangene's HepaGam B for treatment following acute exposure to hepatitis B virus.
According to the company release, HepaGam B 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 in its Winnipeg facility using a process similar to that of WinRho SDF and Vaccinia immune globulin, the company's earlier FDA-approved drugs. The company anticipates that the drug will be distributed in the US 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 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 US.
Cangene, one of Canada's largest biotechnology companies, 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 programme.