contractpharmaApril 03, 2020
Tag: Paratek Pharmaceuticals, Inc. , NUZYRA , BARDA , pulmonary anthrax
Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company, has received funding from Biomedical Advanced Research and Development Authority (BARDA) to support the onshoring of Paratek manufacturing activities for NUZYRA. The reimbursement cost for the onshoring and security requirement activities is projected to total approximately $20 million.
In December 2019, BARDA, part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, awarded Paratek a five-year contract, valued at up to $285 million, to support: the development of NUZYRA for the treatment of pulmonary anthrax; all of the U.S. FDA post-marketing requirements associated with the initial NUZYRA approval; U.S. onshoring and manufacturing security requirements and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
Under the terms of the contract, Paratek will commit to ensure that all current suppliers meet BARDA security requirements and to onshore a secondary supply chain in the U.S. for NUZYRA.
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