Benzinga | Sep 27, 2021 04:06PM EDT

Paratek Pharma Reports $19M In Added Funding Under BARDA Contract To Advance Development Of NUZYRA For Post-Exposure Prophylaxis, Treatment Of Pulmonary Anthrax; BARD Contract Now Valued At $304M

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

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

-- Development Milestones Specified for Future Procurements

BOSTON, Sept. 27, 2021 (GLOBE NEWSWIRE) -- 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(r) (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.

BARDA and Paratek have formalized their previously communicated agreement to trigger the next procurement upon BARDA's receipt of positive top-line data from the pilot efficacy treatment study of inhalation anthrax in rabbits, which Paratek currently anticipates will be available in the second half of 2022.

BARDA and Paratek have also agreed on specific development milestones to trigger the third and fourth procurements. The third procurement will be triggered by BARDA's receipt of positive top-line data in PEP and treatment of inhalation anthrax from a combination of pilot and pivotal efficacy studies in animal models, which Paratek anticipates will be fully available in 2024. The fourth procurement will be triggered by Paratek's receipt of sNDA approval from the FDA for treatment of inhalation anthrax, which Paratek anticipates will follow the third procurement by approximately 18-24 months. Paratek intends to provide further specificity on timelines as the anthrax development program progresses.

Paratek reaffirms that based upon its current operating plan, the Company anticipates its existing cash and cash equivalents will provide for a cash runway through the end of 2023 with a pathway to cash flow break even.