Paratek Pharmaceuticals announces modification of BARDA contract

Paratek Pharmaceuticals announced a modification to its Project BioShield contract with the Biomedical Advanced Research and Development Authority, BARDA, part of the Administration for Strategic Preparedness and Response, ASPR, within the U.S. Department of Health and Human Services. The modification provides new development milestones associated with the achievement of specific anthrax development milestones for the next BARDA procurement of NUZYRA. BARDA and Paratek have agreed the next procurement of NUZYRA anthrax treatment courses will be split into two equal procurements based on the achievement of specific development milestones toward both treatment and post-exposure prophylaxis indications of pulmonary anthrax. The first of these procurements will be triggered by the delivery of positive top-line data from a dose-ranging efficacy study for PEP of inhalation anthrax in non-human primates. The company expects this data to be available in the first quarter of 2024. The second of these procurements will be triggered by BARDA’s receipt of positive top-line data from a combination of two studies, a dose-ranging efficacy study in NHPs and a pivotal efficacy study in rabbits for the treatment of inhalation anthrax, which the company anticipates could be available as early as the fourth quarter of 2024. The trigger for the final procurement of NUZYRA continues to be Paratek’s receipt of sNDA approval from the FDA for the treatment of inhalation anthrax. The company will provide further specificity on these timelines as the anthrax development program progresses.