Shionogi secures USD482M BARDA contract for US antibiotic manufacturing

USA—Osaka-based pharmaceutical company Shionogi has announced a significant government partnership that sets it apart from other drugmakers investing in domestic production.

Through a new contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA), the company will strengthen American supplies of Fetroja (cefiderocol) and explore new uses for this powerful antibiotic against dangerous pathogens.

Building domestic capacity

Shionogi made the announcement on April 8, positioning Fetroja as a critical tool against serious infections that resist standard treatments.

The U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR) approved the deal, providing an initial investment of USD 119 million.

The contract includes multiyear options that could ultimately deliver up to USD 482 million if exercised, enabling Shionogi to establish a dedicated manufacturing facility in the United States.

While the company did not specify the location or production capacity of the planned facility, the funding will also support the procurement of the antibiotic.

This investment reflects broader efforts to bolster domestic pharmaceutical manufacturing following increased demand for medical countermeasures.

Expanding Fetroja’s arsenal

Shionogi first gained FDA approval for Fetroja in 2019 as a treatment for complicated urinary tract infections.

The following year, the agency greenlit the antibiotic for two additional uses: hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, conditions that frequently affect critically ill patients.

Beyond expanding current manufacturing capacity, Shionogi will now pursue development of Fetroja to combat infections caused by serious biological threats.

These include plague and melioidosis, rare but potentially devastating infections that pose biosecurity concerns.

Simultaneously, the company plans to seek FDA approval for pediatric use in treating hospital-acquired and ventilator-associated pneumonia, broadening the drug’s therapeutic reach.

A track record in antimicrobials

Nathan McCutcheon, president and CEO of Shionogi’s U.S. subsidiary, emphasized the company’s long-standing commitment to fighting antimicrobial resistance.

Shionogi has discovered and brought six novel antibiotics to market over seven decades.

The company reinforced this commitment through its 2023 acquisition of Qpex Biopharma and plans to establish a dedicated research facility for antimicrobial development in 2025.

McCutcheon stated that the BARDA contract accelerates Shionogi’s expansion efforts in the United States while complementing existing government collaborations.

Part of a broader defense strategy

The agreement operates under BARDA’s Project BioShield, an initiative designed to accelerate research, development, procurement, and distribution of medical countermeasures against chemical, biological, radiological, and nuclear threats.

BARDA has pursued comparable supply agreements in recent years beyond antibiotics.

These include partnerships with Bavarian Nordic for smallpox and mpox vaccines and collaborations with GSK, Sanofi, and CSL for pandemic influenza vaccines.

In October 2025, biotech company Cidara Therapeutics secured a BARDA award worth up to USD 339 million to manufacture its experimental non-vaccine flu preventive, CD388. Merck subsequently acquired Cidara for USD 9.2 billion.