Shionogi secures a BARDA Project BioShield contract worth up to $482 million to support U.S. manufacturing, procurement, and biothreat development of Fetroja (cefiderocol) for difficult-to-treat Gram-negative infections.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
Shionogi & Co., Ltd. announced that its U.S. subsidiary, Shionogi Inc., has been awarded a contract under the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield to support Fetroja (cefiderocol) as a countermeasure against difficult-to-treat Gram-negative infections and high-priority biothreat pathogens. The contract includes initial funding of $119 million, with multi-year options that could bring the total value to up to $482 million.
Contract Supports Manufacturing and Biothreat Preparedness
The funding will support establishment of a U.S. drug product manufacturing site for Fetroja and procurement for national stockpiling. The agreement also advances development of Fetroja for infections caused by high-priority biothreat pathogens, including Burkholderia pseudomallei (melioidosis) and Yersinia pestis (plague).
In addition, Shionogi plans to expand Fetroja’s use in hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in pediatric patients through a supplemental New Drug Application to the U.S. Food and Drug Administration.
Company Commentary
John Keller, Ph.D., Director of the Board and Senior Vice President of the R&D Supervisory Unit at Shionogi, said the contract reflects the company’s longstanding commitment to antibiotic innovation. He noted that Fetroja, described as the first siderophore cephalosporin antibiotic developed in-house, highlights continued collaboration with government and non-governmental partners to advance antimicrobial solutions.
Nathan McCutcheon, MBA, President and CEO of Shionogi Inc., said the BARDA contract supports the company’s broader antimicrobial resistance strategy. He added that the agreement complements continued investment in Fetroja, the acquisition of Qpex Biopharma in 2023, and plans to establish a dedicated antimicrobial research facility in 2025 to expand U.S. operations.
About Fetroja
Fetroja (cefiderocol) is a siderophore cephalosporin antibiotic. In the United States, it is approved for hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. It is marketed in Japan as Fetroja and in Europe as Fetcroja for infections due to aerobic Gram-negative organisms in adults with limited treatment options.
Reference
Shionogi Receives Contract with U.S. Government Through BARDA’s Project BioShield to Enhance National Preparedness for Drug-Resistant Bacterial Threats, 08 April 2026, Shionogi Receives Contract with U.S. Government Through BARDA’s Project BioShield to Enhance National Preparedness for Drug-Resistant Bacterial Threats| Shionogi Inc.
