Paratek Pharmaceuticals, Inc. announced the commercial availability of U.S.-produced NUZYRA (omadacycline) tablets. This milestone follows a successful technology transfer by Paratek and its tablet manufacturing partners in the U.S. and Europe.
 
NUZYRA is the company’s broad-spectrum, novel antibiotic available in both intravenous and oral formulations.
 
Onshoring of the manufacturing process for the tablets is the first completed step in the technology transfer process, with the active pharmaceutical ingredient (API) for NUZYRA and NUZYRA vials scheduled to be completed in 2023 and 2024, respectively.
 
The commercial availability of NUZYRA tablets manufactured in the U.S. represents the first of several steps to create an end-to-end U.S. supply chain for NUZYRA under the Project BioShield public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
 
“As supply chain interruptions continue to threaten availability of essential medicines, Paratek is advancing our efforts with BARDA to onshore the manufacturing of NUZYRA to the United States. Creating a U.S.-based supply chain for NUZYRA means we can ensure supply of this essential antibiotic for use in patients as the antimicrobial resistance (AMR) crisis continues,” said Randy Brenner, chief development and regulatory officer, Paratek. “We are excited to reach this first milestone towards creating a fully integrated manufacturing supply chain for NUZYRA on U.S. soil. We are grateful to BARDA, as well as our manufacturing partners, for their expertise and teamwork in completing this first milestone and important technology transfer.”
 
In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the U.S. onshoring and manufacturing security requirements, this contract supports the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax; all FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for anthrax.