OSAKA, Japan–(BUSINESS WIRE)–Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a $36.9 million procurement option, under Project BioShield funding, from its April 2026 contract with Shionogi Inc., a New Jersey-based subsidiary of Shionogi, to procure 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 order exercises the first of several procurement and related options under the contract, with initial funding of $119 million and multiyear options for a total of up to $482 million. Other projects under the contract include establishing a U.S. drug product manufacturing site for Fetroja, advancing Fetroja for the treatment of infections caused by high-priority biothreat pathogens and expanding the utility of Fetroja for HABP/VABP in pediatric patients through a U.S. Food and Drug Administration (FDA) Supplemental New Drug Application (sNDA).
This project has been supported in whole or in part 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.
Fetroja is approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis and HABP/VABP caused by certain susceptible Gram-negative bacteria.
For full Prescribing Information for Fetroja, including approved indications and Important Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf.
About Shionogi in Infectious Disease
For more than 60 years, Shionogi has discovered and commercialized novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus.
As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and Global Antibiotic Research and Development Partnership (GARDP) have a license agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (CHAI) that aim to transform the landscape of access to antibiotics in most low-, lower middle- and upper middle-income countries, and select high-income countries.
Shionogi ranked second among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide.
About Shionogi Inc.
Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company. Since 1878, Shionogi has been developing new treatments to improve patients’ lives worldwide. Today in North America, our portfolio of FDA approved products includes an antibiotic for serious infections caused by susceptible Gram-negative bacteria, an oral antiviral for post-exposure prophylaxis of COVID-19 and a therapy for amyotrophic lateral sclerosis (ALS). Our pipeline programs include investigational treatments across infectious disease, rare disease and additional high‑need therapeutic areas. Together with our subsidiaries Qpex Biopharma Inc. and Shionogi Canada Inc., we are continuing to innovate for patients in the U.S. and worldwide. Learn more at shionogi.com.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, and CNS disorders. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.
Forward-Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Contacts
Media Contacts:
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Japan: https://www.shionogi.com/global/en/contact.html
Europe: [email protected]
