As part of ongoing national preparedness efforts, BARDA has purchased and begun accepting delivery of the antibiotic NUZYRA (omadacycline) from Paratek Pharmaceuticals of Boston, Massachusetts, to treat infections caused by anthrax.
The contract with Paratek was BARDA’s first under Project BioShield to expand the use of an existing antibiotic to treat anthrax infections. The U.S. Food and Drug Administration (FDA) approved the drug in October 2018 as a broad spectrum, once-a-day oral and intravenous (IV) tetracycline to treat community-acquired pneumonia caused by bacteria, including drug-resistant strains.
Using Project BioShield authorities and funding, BARDA awarded a contract to Paratek in December 2019, potentially totaling up to $285 million over 10 years, for the late-stage development needed to achieve regulatory approval of the drug for post-exposure prophylaxis after anthrax exposure and to treat lung infections caused by inhaling anthrax spores. The contract also supports post-marketing requirements of the drug for bacterial pneumonia and enables federal procurement of NUZYRA.
Focusing on emergency uses of products that are FDA-approved for common medical needs reduces development and preparedness costs for taxpayers and simplifies logistics during emergency responses. In addition, an important element of emergency response is having effective antibiotics available to treat secondary bacterial infections, particularly multidrug- resistant bacterial infections, which can complicate a public health emergency response.
The contract is part of BARDA’s Antibacterials Program which has supported 28 advanced research and development public-private partnerships with industry, ranging from small biotechnology firms to global pharmaceutical companies.
This award is just one component of BARDA’s Chemical, Biological, Radiological, and Nuclear (CBRN) medical countermeasures portfolio. Visit the CBRN portfolio to learn more about efforts to expand the development pipeline and accelerate the progression of products that combat the rising global health threat of antibiotic-resistant infections.