Cangene Corp.’s experimental antidote for a toxin considered a bioterrorism threat won the support of U.S. regulatory advisers.
Animal studies to determine if the antitoxin for botulism works and research on safety in humans are sufficient, along with data from limited government use, to determine that the benefits outweigh the risks, a panel of 14 advisers to the Food and Drug Administration voted unanimously today. Cangene, based in Winnipeg, Canada, currently supplies the antitoxin to the U.S. government under an emergency-use exemption.
Regulators may decide on Cangene’s application for full FDA approval by March 20, according to a report by agency staff last week. The U.S. 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.
Cangene rose 3.9 percent to C$2.91 at the close of trading in Toronto. The shares have surged 57 percent since the start of the year.
The company reported $111 million in revenue for the fiscal year ended in July.
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 a study on monkeys, 14 of 30 that received the Cangene antitoxin survived compared to none out of 30 in a placebo group that had been infected with botulism. The FDA has suggested Cangene use a registry to further study the safety and efficacy of the antitoxin for three years post-approval, according to the report.