TUESDAY, JUNE 19, 2018

U.S. includes BioThrax, Anthrax Immune Globulin in PREP Act

ROCKVILLE, Md. — Emergent BioSolutions Inc. announced Oct. 9, 2008, that two medical countermeasures included in its anthrax franchise — BioThrax (Anthrax Vaccine Adsorbed) and Anthrax Immune Globulin (AIG) — have been included as covered countermeasures under the Public Readiness and Emergency Preparedness Act pursuant to a declaration issued by the U.S. Department of Health and Human Services.

In issuing this declaration, the secretary of HHS determined that there is a credible risk that the threat of exposure to anthrax and the resulting disease constitutes a public health emergency. The declaration will remain in effect until Dec. 31, 2015.

This HHS declaration under the PREP Act provides liability protections to activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using both of the company’s anthrax medical countermeasures in preparation for, and in response to, a potential anthrax attack.

In addition to this declaration, in 2006 BioThrax was certified under the Support Anti-Terrorism by Fostering Effective Technology Act (the “SAFETY Act”), which Congress enacted to encourage the development and deployment of anti-terrorism technologies by providing certain liability protections for providers of qualified anti-terrorism technologies for claims arising out of acts of terrorism.

BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax infection.

Emergent BioSolutions is developing an Anthrax Immune Globulin product candidate as a single dose intravenous therapeutic for treatment of patients with manifest symptoms of anthrax disease resulting from the release of anthrax toxins into the body. If successful, the AIG therapeutic would be prescribed for administration either as a monotherapy or in conjunction with an antibiotic.

Emergent BioSolutions has obtained National Institute of Allergy and Infectious Diseases grant funding to support non-clinical safety and efficacy studies and clinical trial planning.