- Paratek Pharmaceutical on Wednesday said it won a U.S. government contract worth as much as $285 million to develop its Nuzyra medicine for anthrax.
- The five-year contract may be extended out through 10 years, and includes initial funding of $59 million to explore the antibiotic's effectiveness as a treatment for pulmonary anthrax. The agreement also sets out an option for the government to acquire 2,500 courses of Nuzyra for the Strategic National Stockpile.
- Potential other payments include $77 million to help address post-marketing requirements related to Nuzyra's initial approval, $13 million to develop the drug for prevention of anthrax and $115 million for further purchases of the treatment for the stockpile.
The award extends the potential market for Nuzyra, approved in 2018 to treat pneumonia and acute skin infections. The Strategic National Stockpile is part of a program administered by the Department of Health and Human Services to safeguard the U.S. against biological threats.
Nuzyra, a once daily oral and intravenous treatment, has shown promise against certain biothreat pathogens in animal testing, company CEO Evan Loh said in a Dec. 18 statement.
Paratek estimated that it would need funding to meet Food and Drug Administration post-marketing requirements that kick in in April, and for manufacturing requirements starting in June. Potential purchases of the antibiotic could reach to as much as 10,000 courses for the stockpile, the company said.
The contract flows from the Biomedical Advanced Research and Development Authority, whose Project BioShield program is designed to encourage development of treatments that can address chemical, biological, radiological or nuclear threats.
Congress authorized the program in 2004, in part as a response to the Sept. 11 attacks and anthrax mailings in 2001.
BARDA also recently funded manufacturing of Merck & Co.'s experimental Ebola vaccine to help combat an outbreak of the virus in the Democratic Republic of the Congo.