Status: not approved; being added to U.S. biodefense (civilian) stockpile
Organizations involved:
Cangene Corp. – Manuf.; R&D; Tech.
Centers for Disease Control & Prevention (CDC) – USA mark.
Cross ref.: See also the Immune Globulin Products entry (#743), the main Anthrax Vaccine entry (#404), and the other entries for Anthrax Immune Globulin products, particularly the entry for Anthrax Immume Globulin/DVC, the first/current product.
Description: Anthrax immune globulin is an intravenous formulation of immune globulin containing high levels of Bacillus anthracis (anthrax) antibodies derived from pooled plasma of adult volunteers recently immunized with Anthrax Vaccine (BioThrax from Emergent BioSolutions; see related entry).
Unlike the prior anthrax immune globulin product (see entry above), with only small supplies available, this immune globulin has been recently developed, has a higher anthrax-specific immune globulin (antibody) titer, will seek full FDA approval, and is being manufactured in large quantities for biodefense stockpiling.
Nomenclature: Anthrax immune globulin [BIO]; AIG [SY]
Companies.: In Aug. 2002, Centers for Disease Control and Prevention (CDC) issued a 5-year contract to Cangene for development and manufacture of AIG for the U.S. biodefense stockpile. In Aug. 2006, CDC placed an order with Cangene for 10,000 therapeutic courses of AIG for a total of $143,833,719 million (~$14,800/course or individual treated). The price per dose is a discounted fixed price. This initial delivery of AIG was made on Aug. 30, 2007; and additional deliveries will extend into 2009. This acquisition was via modifications to the original contract. An additional payment will be awarded if AIG receives FDA approval during the contract period, but the contract allows for delivery of the product before licensing for emergency use if needed. In addition to the base contract, there is a possibility of optional task orders for product manufacture and additional clinical testing. Cangene manufactures AIG at its Winnipeg, Canada, facility but will use its U.S. subsidiaries and other U.S. companies for all key subcontracting activities. In Aug., 2007, the original 2002 contract was extended another five years.
To meet the “usable product” requirement, the AIG must be manufactured under GMP conditions and meet certain safety and regulatory conditions. Once FDA approval is received, the Company may receive a supplemental payment. Cangene is relying on the FDA animal rule, which allows use of animal studies, pharmacokinetic trials, etc. to support approvals where testing is infeasible or unethical, e.g.,, challenge studies using live B. anthracis.
Status: As discussed above, ~10,000 doses are being added to the U.S. biodefense stockpile. Cangene will receive payments following the delivery of these additional doses of usable product into the SNS.
Index Terms:
Companies involvement:
Full monograph
745 Anthrax Immune Globulin/Cangene
Nomenclature:
Anthrax Immune Globulin/Cangene [BIO]
FDA Class: Biologic BLA
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, Fab fragments <!-- immunoglobulins -->
anthrax prophylaxis
BHK-21 (C-13)
conjugates
implants
North American coral snake
EU000 Not yet/Never filed with EU
UM100 Controlled/Gov't Distribution in US
US000 never filed/no plans
US666 Biodefense stockpile
EM999 Not Available/Not Marketed in EU
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