Cangene Corp.’s animal studies on an experimental antidote for a toxin considered a bioterrorism threat are sufficient enough to suggest the treatment will work in humans, U.S. regulators said.
The antitoxin for botulism is safe and the benefits exceed the risks, Food and Drug Administration staff said today in a report ahead of a meeting Feb. 12 of agency advisers to discuss the product. Cangene, based in Winnipeg, Canada, currently supplies the antitoxin to the U.S. government under an exemption for use in an emergency situation.
The company is now seeking FDA approval based on safety studies in humans, as well efficacy studies in guinea pigs and monkeys. The U.S. government awarded Cangene in 2006 a contract now valued at $476 million for late-state development of the antitoxin and 200,000 doses, according to the arm of the Department of Health and Human Services responsible for the nation’s approach to preparing vaccines and drugs for national emergencies.
A human dose used in monkeys “statistically increased survival and median time-to-death,” FDA staff wrote.
The FDA may decide on Cangene’s application for approval by March 20, according to the staff report.
Cangene fell 1.2 percent to C$2.55 at 9:30 a.m. in Toronto trading. The shares gained 43 percent in the 12 months through yesterday.
Botulism causes paralysis that can lead to death once the airway and breathing muscles stop moving. An average of 110 cases of botulism are reported each year, according to the Occupational Safety and Health Administration.
The botulinum toxin can be used as a bioterror weapon if deliberately released as an aerosol or in food or drink. Naturally occurring cases can occur in food or drink as well, often in inadequately canned foods, and contaminated wounds, according to the Center for Biosecurity of the University of Pittsburgh Medical Center in Baltimore, Maryland.
In the study on the monkeys, 14 of 30 that received the Cangene antitoxin survived compared to none out of 30 in a placebo group that had been intoxicated with botulism.
Cangene reported $111 million in revenue for the fiscal year ended in July.
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