FDA Approves Cangene's Anti-Hepatitis B Product
U.S. FDA Approves Cangene's Anti-Hepatitis B Product
TORONTO and WINNIPEG, January 30, 2006 -- Cangene today announces that the U.S. Food and Drug Administration (FDA) has approved Cangene's HepaGam B for treatment following acute exposure to hepatitis B virus. 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 U.S. 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 U.S.
Source: Cangene
Pharma Industry News Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Jan | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
