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-- Third procurement to be split into two procurements based on the achievement of specific anthrax development milestones
-- Next procurement expected in early 2024
BOSTON, July 10, 2023 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today 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® (omadacycline).
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 (PEP) 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 (NHPs). 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.
"We thank BARDA for the continued funding of our comprehensive NUZYRA development program for PEP and treatment of pulmonary anthrax and are pleased to announce these important contract modifications to further build on our promising in vitro and in vivo animal data generated to date," said Randy Brenner, Paratek's chief development and regulatory officer. "Our anthrax program remains vitally important since antimicrobial resistance and bioterrorism continue to be public health and national security risks."
In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for treatment of anthrax.
Posted In: PRTK
