Paratek Gets Added BARDA Funding for Anthrax Treatment

 Additional ~$19M Funding for Expanded Anthrax PEP Development Program

-- BARDA Contract Now Valued at Up to ~$304M

-- Development Milestones Specified for Future Procurements

Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has awarded an option under the Company’s Project BioShield contract. This option provides additional funding to continue the development of NUZYRA® (omadacycline) under a U.S. Food and Drug Administration (FDA) Animal Efficacy Rule development program to support a supplemental new drug application (sNDA) to the FDA for post-exposure prophylaxis (PEP) and treatment of pulmonary anthrax. The additional studies supported by this option increase the value of the BARDA contract by approximately $19 million.

“Our Project BioShield contract creates a comprehensive NUZYRA development program for PEP and treatment of pulmonary anthrax, as described in the original contract,” said Randy Brenner, Chief Development and Regulatory Officer of Paratek. “Paratek has been studying NUZYRA against select biothreat pathogens for over a decade and we are excited to build on the promising in vitro and in vivo animal data and advance the pulmonary anthrax development program for treatment and PEP. This program is particularly important at a time when antimicrobial resistance is both a national security risk as well as a growing threat to global health.”

In December 2019, BARDA awarded Paratek a contract valued at up to approximately $285 million. With the additional development program funding, the contract is now valued at up to approximately $304 million. The contract supports: 1) the development of NUZYRA for both the treatment and PEP of pulmonary anthrax; 2) all FDA 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 anthrax.

https://finance.yahoo.com/news/paratek-pharmaceuticals-announces-additional-funding-200500591.html