Shionogi Inc. has been awarded a BARDA Project BioShield contract initially funded at $119 million, with options up to $482 million, to establish US manufacturing for antibiotic Fetroja and expand its use against biothreat pathogens including plague and melioidosis.
According to an official disclosure, Shionogi Inc., the New Jersey-based subsidiary of Shionogi & Co., Ltd., has received a contract through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield for Fetroja (cefiderocol).
The contract addresses difficult-to-treat Gram-negative bacterial infections and high-priority biothreat pathogens. Initial funding is $119 million, with multiyear options bringing the total to $482 million.
The contract requires Shionogi to establish a U.S. drug product manufacturing site for Fetroja, support procurement, advance the antibiotic against Burkholderia pseudomallei and Yersinia pestis, and expand its use for pediatric HABP/VABP via an FDA sNDA. This development matters because antimicrobial resistance and biothreat preparedness are strategic priorities for U.S. national health security.
For pharmaceutical manufacturers, contract logistics providers, and API suppliers, the award signals sustained government demand for reserve antibiotics. Investors should note that establishing domestic production capacity reduces supply chain vulnerability. The contract complements Shionogi’s 2023 acquisition of Qpex Biopharma and its 2025 research facility investment, reinforcing its U.S. expansion strategy.
Shionogi is an Osaka-based pharmaceutical company with a history in antibiotic R&D since the 1950s.
BARDA is a U.S. government agency under HHS focused on medical countermeasures.
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