Paratek Awarded BARDA Project BioShield Contract for NUZYRA
Paratek Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, has announced that the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a 5-year contract, with an option to extend to 10-years, to support the development of Paratek’s NUZYRA (omadacycline) for the treatment of pulmonary anthrax, and the option to procure up to 10,000 treatment courses of NUZYRA for the Strategic National Stockpile (SNS) for use against potential biothreats.
BARDA’s Project BioShield program was created to accelerate the research, development, purchase, and availability of effective medical products against chemical, biological, radiological, or nuclear agents. Project BioShield provides the government with the authority and funding to develop, acquire, stockpile, and distribute the medical products needed to protect the United States against biothreats.
“BARDA is encouraged by the opportunity to partner with Paratek Pharmaceuticals to further develop this critical antibiotic that will help us to combat antimicrobial resistance and treat anthrax infections,” said Dr. Rick Bright, BARDA Director and Deputy Assistant Secretary for Preparedness and Response. “This award is an important step in BARDA’s efforts to enhance our national health security preparedness.”
Under the terms of the agreement, BARDA will award initial funding of approximately $59 million for the development of NUZYRA for the treatment of pulmonary anthrax and the purchase of an initial 2,500 treatment courses of NUZYRA to add to the current SNS. The contract provides for additional potential time-based funding including: approximately $77 million for existing FDA post-marketing requirements commitments, and approximately $20 million for manufacturing-related requirements. T
he remaining staged, milestone-based funding includes the potential for approximately $13 million to support the development of NUZYRA for the prophylaxis of anthrax and a maximum of approximately $115 million to provide for three additional purchases of NUZYRA for the SNS, each of which will be triggered upon development milestones related to the anthrax treatment development program. NUZYRA is a broad spectrum, once-daily oral and intravenous (IV) modernized tetracycline that was approved in October 2018 to treat community-acquired pneumonia and skin infections.
“We would like to thank BARDA, ASPR, and HHS for their commitment to this innovative and long-term private-public partnership recognizing Paratek’s commitment to studying NUZYRA in the treatment and prophylaxis of anthrax. Through Project BioShield, BARDA has identified and validated the important role that Paratek and NUZYRA will play in helping to enhance the biodefense preparedness of our country, saving lives and protecting Americans,” said Evan Loh, M.D., CEO of Paratek. “Paratek has been studying the potential utility of antibiotics against bioterrorism threats for over a decade. Through these activities, we have generated promising in vitro and in vivo animal data with NUZYRA against select biothreat pathogens. For these reasons, we believe that NUZYRA is well-positioned to help address potential public health emergencies at a time when antibiotic resistance is a growing global threat.”