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Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.
Emergent BioSolutions announced on Mar. 25, 2015 that it had received FDA approval for its inhalable Anthrax treatment, Anthrasil (anthrax immune globulin intravenous [human]). The drug also received Orphan Drug designation qualifying it for seven years of market exclusivity. The approval triggered a $7 million milestone payment to Emergent under a development contract with the Biomedical Advanced Research and Development Authority (BARDA). The development of Anthrasil was began after a $160 million contract was signed between Emergent and BARDA, within the office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services. Under the contract, Anthrasil was delivered to and stored in the US Strategic National Stockpile.
"Emergent is pleased to receive FDA approval of Anthrasil, the only FDA-approved polyclonal therapeutic for the treatment of anthrax disease. Anthrasil remains an integral part of the United States government's strategic national stockpile, and we are committed to working collaboratively with BARDA and CDC [the Centers for Disease Control] to further advance this program,” said Adam Havey, executive vice-president and president of the biodefense division at Emergent BioSolutions, in a press release.
Anthrasil is a sterile solution of purified human immune globulin G that contains polyclonal antibodies to target the anthrax toxins of Bacillus anthracis. Plasma is taken from healthy patients who have been immunized with Emergent’s BioThrax (anthrax vaccine absorbed). The plasma is then used to develop the Anthrasil.
Emergent announced on Mar. 24, 2015 that it signed a contract with BARDA to develop NuThrax (anthrax vaccine absorbed with CPG 7909 adjuvant), an anthrax vaccine candidate. The $31-million contract consists of a 30-month base period of performance to develop NuThrax, which is a combination of BioThrax and the immunostimulatory oligodeoxynucleotide compound CPG 7909. According to Reuters, Anthrax is considered one of the most likely agents to be used in biological warfare and has been used for nearly a century.
Source: Emergent BioSolutions