Paratek Pharmaceuticals announced the Biomedical Advanced Research and Development Authority (BARDA) has initiated funding 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, the Biomedical Advanced Research and Development Authority (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: 1) the development of NUZYRA for the treatment of pulmonary anthrax; 2) all of the U.S. Food and Drug Administration post-marketing requirements associated with the initial NUZYRA approval; 3) U.S. onshoring and manufacturing security requirements and 4) the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
“We are committed to studying NUZYRA in the fight against antimicrobial resistance and the treatment and prophylaxis of anthrax and believe that NUZYRA will play an important role in supporting the biodefense preparedness of our country,” said Evan Loh, MD, CEO, Paratek. “Establishing our entire manufacturing process in the United States and ensuring that these facilities are secure is an important step for protecting Americans and for pandemic preparedness. This initiative helps to further secure NUZYRA’s overall supply chain, adding a comprehensive secondary supply chain to our existing infrastructure, and over the projected collaboration timeframe, will provide for a secure, United States based manufacturing supply chain. We look forward to working with BARDA to meet all of these goals.”
Under the terms of the contract that has now been initiated, Paratek will commit to ensure that all current suppliers meet BARDA security requirements and to onshore a secondary supply chain in the United States for NUZYRA.
NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains.