BARDA awards Paratek up to $285 million to develop anthrax treatment
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The Biomedical Advanced Research and Development Authority, or BARDA, awarded Paratek Pharmaceuticals a contract worth up to $285 million to develop and test omadacycline — marketed as Nuzyra — for the treatment of pulmonary anthrax, the company announced.
“Saving lives after an anthrax attack on our nation means not only having FDA-approved antibiotics readily available to treat anthrax infections but also having products available to combat drug-resistant infections,” BARDA director and U.S. Deputy Assistant Secretary for Preparedness Rick Bright, PhD, said in a news release.
BARDA is responsible for preparing the U.S. for public health emergencies by supporting novel antibacterial product development. With the Paratek contract, BARDA said it hopes to procure up to 10,000 courses of pulmonary anthrax treatment to stockpile in the event of a bioterrorism attack.
The contract was awarded under Project BioShield, a program created by BARDA to “accelerate the research, development, purchase, and availability of effective medical products against chemical, biological, radiological, or nuclear agents,” according to the release.
“We are pleased that BARDA has identified and validated the important role Paratek and Nuzyra will play in supporting the biomedical preparedness of our country, saving lives and protecting our country,” Paratek CEO Evan Loh, MD, told Healio.
Omadacycline is a broad-spectrum, once-daily oral and IV tetracycline antibiotic. The FDA approved it in 2018 for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections.
Under the contract from BARDA, Paratek will receive about $59 million in funding to develop omadacycline as a treatment for pulmonary anthrax. This funding would also secure an initial 2,500 treatment courses for the stockpile. Further funding will be provided at two separate times. In April 2020, about $77 million is scheduled for existing FDA premarket requirements and approximately $20 million is scheduled for June 2020 for manufacturing-related requirements.
The company could also receive an additional $13 million of milestone-based funding to further develop Nuzrya for the prophylaxis of anthrax. Up to $115 million is available for three additional purchases of the drug for the stockpile.
“Paratek is preparing to file its Emergency Use Authorization (EUA) with the U.S. FDA,” Loh said. “An EUA allows the United States government to use and procure a product not yet approved for a biothreat indication in an emergency situation. Purchase of the first 2,500 treatment courses of Nuzyra will begin upon acceptance of the EUA, which we expect to happen in the first half of 2020.” – by Marley Ghizzone
Disclosures: Bright reports no relevant financial disclosures. Loh is the CEO of Paratek.