Emergent BioSolutions Gets FDA OK for Anthrax RemedyBy
Emergent BioSolutions Inc. a specialty biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for Anthrasil [anthrax immune globulin intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Achievement of this milestone triggers a $7 million payment to the company under a development contract with the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services (HHS). Anthrasil received orphan drug designation, and as a result of this approval, the product qualifies for seven years of market exclusivity.
Anthrasil is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis, the bacteria that causes anthrax disease. It is prepared using plasma collected from healthy, screened donors who have been immunized with Emergent’s BioThrax (anthrax vaccine adsorbed) vaccine, the only FDA-licensed vaccine for the prevention of anthrax disease.
In support of the U.S. government stockpiling strategy for AIGIV, Emergent continues to perform under a $63 million BARDA contract awarded in 2013 for the collection and storage of anti-anthrax human plasma. This plasma is necessary for the potential future manufacture of bulk drug substance and AIGIV final drug product. Anthrasil was developed as part of a $160 million contract with BARDA, within the office of the Assistant Secretary for Preparedness and Response in HHS. Under this contract, which was awarded in 2005, Anthrasil has been delivered to and is stored in the US Strategic National Stockpile.
In other news, Emergent has signed a contract withBARDA for the advanced development of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company’s next generation anthrax vaccine candidate. The contract, valued at $31 million, consists of a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease. Activities to be completed under the contract include process validation, consistency lot manufacture, assay validation, non-clinical studies, and start-up activities in preparation for the Phase III clinical trial. NuThrax is comprised of BioThrax (anthrax vaccine adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909.