U.S. government agrees to purchase US$143 million of anti-anthrax drug from Cangene
Cangene announced that the U.S. Department of Health and Human services ("HHS") has exercised its option to purchase 10,000 doses of anthrax immune globulin ("AIG") under a modification to an earlier development and supply contract. The AIG is to be made available for treating or preventing inhalational anthrax, which is an acute infectious disease that is caused by inhaling spores of the bacterium Bacillus anthracis.
The value of this modification to the Project BioShield contract is approximately US$143 million and comes as a result of successful preliminary efficacy testing done earlier under the contract, which was originally signed in September 2005. Cangene has already delivered a small number of doses under this contract into the U.S. Strategic National Stockpile ("SNS"); however, additional deliveries will commence in the later part of 2007 and will be completed by the end of 2009. Cangene will receive payments following the delivery of these additional doses of usable product into the SNS. The contract also requires that Cangene apply for and receive authorization for marketing from the U.S. Food and Drug Administration.
Under the contract, the price per dose will be a discounted fixed price. To meet the "usable product" requirement, the product must be manufactured under licensable conditions and meet certain safety and regulatory conditions. Once FDA authorization for marketing in the U.S. is received, the Company may receive a supplemental payment. In addition to the base contract, there is a possibility of optional task orders that could increase the final value of the contract. These tasks could include maintaining product manufacturing and additional clinical testing in special populations. Cangene will manufacture this product at its Winnipeg facility but will use its U.S. subsidiaries and other U.S. companies for all key subcontracting activities.
AIG is a hyperimmune to be used in treating inhalation anthrax. Hyperimmunes are purified preparations of specific immune globulins isolated from blood plasma. Immune globulins are the class of proteins that function as antibodies. Cangene's proprietary manufacturing process allows it to produce high-quality hyperimmune products aimed at a wide variety of targets.
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