After Cyfendus’ full approval, Emergent clinches $75M anthrax … – FiercePharma

Armed with a full FDA approval after four years of supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.

The nations Biomedical Advanced Research and Development Authority (BARDA) is laying out $75 million to exercise an option on an existing deal for additional doses of Emergents two-dose anthrax shot Cyfendus, according to a securities filing.

The FDA signed off on Emergents vaccineformerly known as AV7909in July. Prior to the shots formal green light, Emergent had been furnishing the U.S. Department of Health and Human Services with the product since 2019.

The immunization includes anthrax vaccine absorbed (AVA) and an adjuvant and is administered as two doses over 14 days. Its intended for post-exposure prophylaxis in adults 18 to 65.

Under the newly modified deal, deliveries of Cyfendus are expected to begin this year and wrap up by the end of March 2024, Emergent said. The company did not specify how many doses its supplying to the U.S.

BARDA and Emergent first extended their partnership to develop and manufacture Cyfendus back in 2016. After submitting a pre-emergency use authorization package in December 2018, Emergent delivered the first pre-EUA doses of Cyfendus to the U.S. government in 2019.

For years, supplying medical countermeasures to the government has formed Emergents bread-and-butter business. Aside from its anthrax shot, Emergent produces vaccines for smallpox and Ebola, as well as the popular opioid overdose reversal agent Narcan.

Emergents 4mg Narcan nasal spray, for its part, won a historic over-the-counter approval back in March, teeing up direct-to-consumer sales at places like drug stores, convenience stores, supermarkets and gas stations.

Meanwhile, big changes have been brewing at Emergent this year. In late June, Emergents long-time CEO Robert Kramer stepped down from all his posts, lining up an interim replacement in Haywood Miller, the managing director of Berkely Research Group.

Come August, Emergent announced it was de-emphasizing its CDMO services business to shore up its work on core medical countermeasures and Narcan. In turn, the company unveiled plans to eliminate its chief operating officer and ax hundreds of jobs.

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After Cyfendus' full approval, Emergent clinches $75M anthrax ... - FiercePharma