Vaccinia Immune Globulin
Vaccinia Immune Globulin (VIG) is Cangene's first biodefense product licensed by the US Food & Drug Administration (FDA). VIG contains specific antibodies to the vaccinia virus (the virus used to make smallpox vaccine) and is intended for the treatment for adverse reactions that may occur following administration of the smallpox vaccine. VIG is a critical component for national biodefense programs. Cangene was awarded a five-year contract by the United States Centers for Disease Control and Prevention (CDC) to develop and supply VIG. The contract specified a maximum of 100,000 doses of VIG to be ordered on an as-needed basis. Cangene has completed supply of the first order under this contract.
VIG was subsequently approved by the FDA in May 2005.
Cangene has also supplied this product to several other government organizations.
Botulism Antitoxin
Botulism Antitoxin (BAT) is an investigational product containing neutralizing antibodies to the seven botulinum toxin types: A, B, C, D, E, F, and G.
In May 2006, the US Department of Health & Human Services (DHHS) awarded Cangene a five-year, $362M contract under Project Bioshield. The contract requires Cangene to manufacture and supply 200,000 doses of BAT and to apply for and receive licensure from the US Food and Drug Administration (FDA). Cangene has initiated clinical and non-clinical studies in support of product licensure and has completed the first delivery of finished product under this contract.
Anthrax Immune Globulin
Anthrax Immune Globulin (AIG) is an investigational product derived from plasma obtained from donors immunized with the Anthrax vaccine. AIG is to be used for the treatment of toxemia associated with inhalational anthrax disease.
Cangene has been awarded three contracts with the US Government. The first contract was awarded by the CDC for the development a clinical-grade intravenous immune globulin (IGIV) for the treatment of inhalational anthrax infection in critically ill patients, under an Investigational New Drug (IND) application. The second contract was awarded by DHHS to supply AIG for use in preliminary efficacy testing. The current contract was awarded by DHHS to undertake the necessary steps for licensure by the FDA and to supply the US government with 10,000 doses of AIG. Cangene has initiated clinical and non-clinical studies in support of product licensure and has begun the delivery of finished product under this contract.
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