Emergent BioSolutions announced that Health Canada has approved the company's new drug submission, or NDS, for its anthrax vaccine, BioThrax. BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure. BioThrax is administered in a three-dose primary schedule with boosters at three-year intervals recommended thereafter. BioThrax was approved under the extraordinary use new drug regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible. BioThrax is designated by Health Canada as an innovative drug giving it market exclusivity for eight years. Earlier this year, Emergent completed the mutual recognition procedure for BioThrax expanding licensure of BioThrax in five European countries, namely, the U.K., Poland, France, Italy and the Netherlands, in addition to Germany, where BioThrax received market authorization in 2013.
