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Emergent BioSolutions announced that its CEO Daniel Abdun-Nabi will be retiring and that its board of directors has unanimously appointed Robert Kramer, the company's current president and COO, to succeed him as president and CEO, effective April 1. Abdun-Nabi has also indicated that he plans to step down as a member of the Emergent board of directors, and Emergent expects the board of directors to appoint Kramer to fill the board vacancy created by Abdun-Nabi's retirement.

Emergent BioSolutions announced the submission of an application to the U.S. Food and Drug Administration for potential emergency use of NuThrax in the event of a public health emergency involving Bacillus anthracis. NuThrax, also known as AV7909, is being developed as a next generation anthrax vaccine for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure, in conjunction with the recommended course of antimicrobial therapy. This submission is anticipated to undergo review by FDA through 1H19. NuThrax is comprised of Anthrax Vaccine Adsorbed in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909. NuThrax was designed to have a two-dose schedule and may elicit a faster immune response than currently available anthrax vaccines. Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of NuThrax. The FDA submission package was completed under the company's 2016 contract with the Biomedical Advanced Research and Development Authority that includes a five-year base period of performance valued at approximately $200M to develop NuThrax for post-exposure prophylaxis of anthrax disease and to deliver to the Strategic National Stockpile an initial three million doses following EUA pre-approval by FDA.

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.