Japan’s Shionogi & Co. has joined a spate of drug makers announcing U.S. manufacturing commitments since last year, although the situation is a little different than many of its peers.
The Osaka-based company on Wednesday announced a new agreement through the U.S. Biomedical Advanced Research and Development Authority (BARDA) aimed at boosting the domestic supply of Fetroya (cefiderocol) and potentially expanding the antibiotic’s coverage to combat “high biothreat pathogens” such as plague and scabies.
Fetroja first received the U.S. green light in 2019 for the treatment of complicated urinary tract infections, and a year later received a second FDA approval for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP and VABP).
In an April 8 announcement, Shionogi noted that the agreement positions Fetroha as a “critical countermeasure” against these hard-to-treat infectious diseases, as well as other biological threats to U.S. national health security.
BARDA, part of HHS’s Office of Strategic Preparedness and Response (ASPR), initially funded the contract for $119 million, but Shionogi could ultimately earn up to $482 million if a “multi-year option” is exercised, the company said.
Shionogi & Co. has said it will use the cash to establish a dedicated manufacturing facility for Fetroya in the United States, and the funds are also expected to help support drug procurement. The company did not elaborate on expected production capacity or potential locations for future production plants.
At the same time, the drugmaker is committed to advancing the development of Fetroya to treat infections caused by “high-priority biothreat pathogens” such as melioidosis (Burkholderia pseudomallei) and plague (Yersinia pestis), and in addition, Shionogi will seek FDA expansion for the treatment of HABP and VABP in pediatric patients.
“Shionogi is proud of our continued commitment to the fight against antimicrobial resistance, as demonstrated by our continued investments since introducing Fetroja in 2020, expanding our portfolio with the acquisition of Qpex Biopharma, Inc. in 2023, and further investing in Qpex to establish a new research facility dedicated to advancing antimicrobial research and development in 2025,” the statement said.
McCutcheon added, “This agreement complements our existing efforts with the U.S. government and will enable us to move forward with our ongoing expansion efforts in the U.S. at greater pace and scale.”
Shionogi & Co. says it has discovered and brought six new antibiotics to market over 70 years.
The Fetroha contract is part of BARDA’s Project BioShield, which aims to accelerate the research, development, procurement, and availability of medical countermeasures to combat chemical, biological, radiological, and nuclear materials.
Apart from the antibiotics exhibition focus in partnership with Shionogi & Co., BARDA has entered into several major preventive drug supply agreements in recent years.
During the pandemic, in addition to deals for the supply of COVID-19 vaccines and therapeutics and diagnostics in the United States, BARDA has helped strengthen the U.S. stockpile of smallpox and smallpox vaccines through Bavarian Nordic, and the agency is also working with GSK, Sanofi, and CSL to strengthen stocks of avian influenza vaccinations.
Most recently, Cidara Therapeutics won a BARDA award worth up to $339 million in October to support domestic manufacturing of experimental CD388, a non-vaccine influenza prevention drug, and to help establish a “first commercial supply chain” for this asset. The biotech has since been acquired by Merck for $9.2 billion.
