Program Includes Establishing Pharmaceutical Manufacturing in the U.S., Procurement and Development of Treatment for Infections Caused by Biothreat Pathogens
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that Shionogi Inc., a New Jersey-based subsidiary of Shionogi, has been awarded a contract through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield related to Fetroja® (cefiderocol) as a critical countermeasure against difficult-to-treat Gram-negative bacterial infections and pathogens that present a high-priority biothreat to national health security. The contract is initially funded at $119 million with multiyear options for a total of up to $482 million.
The contract will bolster the U.S. government’s ability to respond to national health security threats and strengthen domestic manufacturing capabilities and supply readiness by funding Shionogi Inc. to:
- Establish a U.S. drug product manufacturing site for Fetroja.
- Support procurement of Fetroja.
- Advance Fetroja for the treatment of infections caused by high priority biothreat pathogens, including Burkholderia pseudomallei (melioidosis) and Yersinia pestis (plague).
- Expand the utility of Fetroja for HABP/VABP in pediatric patients with a U.S. Food and Drug Administration (FDA) Supplemental New Drug Application (sNDA).
“Since the 1950s, Shionogi has been researching, developing and partnering to deliver innovative antibiotics to patients worldwide,” said John Keller, Ph.D., Director of the Board, Senior Vice President, R&D Supervisory Unit, Shionogi. “Fetroja, the world’s first siderophore cephalosporin antibiotic, is a prime example of our in-house innovation and this contract is a continuation of the way we collaborate with global government and non-governmental organizations to drive innovation.”
“Shionogi is proud of our ongoing commitment to combating antimicrobial resistance, as shown by the continued investment in Fetroja since its introduction 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,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. “This contract complements our existing work with the U.S. government and enables us to advance our ongoing expansion efforts in the U.S. at greater pace and scale.”
This project has been funded with Federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004.
BARDA’s Project BioShield accelerates the research, development, procurement and availability of effective medical countermeasures against chemical, biological, radiological and nuclear (CBRN) agents.
In the U.S. Fetroja is approved by the FDA for the treatment of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Japan cefiderocol is commercially available under the brand name Fetroja® for various infections caused by strains resistant to carbapenem antibiotics. In Europe cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. See Fetroja U.S. full indications and important safety information below in the About Cefiderocol section.
For Full U.S. Prescribing Information for Fetroja® (cefiderocol), including approved indications and safety information, please visit Fetroja Prescribing Information.
