Shionogi & Co., Ltd. Secures U.S. Government Contract via BARDA Project BioShield to Strengthen Preparedness Against Drug-Resistant Bacterial Threats
Shionogi & Co., Ltd. has announced that its U.S.-based subsidiary, Shionogi Inc., has been awarded a significant federal contract under Biomedical Advanced Research and Development Authority’s Project BioShield program. The agreement supports the development, procurement, and domestic manufacturing of Fetroja® (cefiderocol), a novel antibiotic targeting difficult-to-treat Gram-negative bacterial infections, including those considered high-priority biothreats to national health security.
The contract is initially funded at $119 million, with additional multi-year options that could bring the total value up to $482 million. This award reflects the U.S. government’s continued investment in strengthening preparedness against infectious disease threats, particularly those caused by antibiotic-resistant pathogens and organisms that may be used in bioterrorism scenarios.
Fetroja® (cefiderocol) is a siderophore cephalosporin antibiotic, representing a unique class of antibacterial agents designed to overcome resistance mechanisms commonly observed in Gram-negative bacteria. Its mechanism of action leverages bacterial iron transport systems to facilitate drug entry into the pathogen, thereby enhancing its ability to target and eliminate resistant organisms. This innovative approach has positioned Fetroja as an important therapeutic option in the fight against antimicrobial resistance, a growing global health concern.
Through this BARDA contract, Shionogi Inc. will undertake several strategic initiatives aimed at enhancing both national preparedness and the clinical utility of Fetroja. A central component of the agreement is the establishment of a U.S.-based drug product manufacturing facility. This initiative is intended to strengthen domestic production capabilities and ensure a reliable supply of the antibiotic in the event of public health emergencies. By localizing manufacturing, the program also aligns with broader efforts to reduce dependence on global supply chains for critical medical countermeasures.
In addition to manufacturing expansion, the contract includes provisions to support the procurement of Fetroja for national stockpiles, ensuring that the drug is readily available for rapid deployment during emergencies. This is particularly important for addressing outbreaks involving highly resistant bacterial infections or pathogens classified as high-risk biothreat agents.
The agreement also supports the advancement of Fetroja for additional clinical indications, including infections caused by high-priority pathogens such as Burkholderia pseudomallei and Yersinia pestis. These organisms are associated with serious diseases—melioidosis and plague, respectively—and are considered potential biological threats due to their severity and potential for rapid spread. Expanding Fetroja’s utility against these pathogens could significantly enhance the United States’ biodefense capabilities.
Another key component of the contract involves the planned expansion of Fetroja’s use in pediatric populations. Shionogi intends to pursue a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration to extend the indication of Fetroja for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in children. This effort underscores the importance of ensuring that effective antimicrobial therapies are available across all age groups, particularly in critical care settings where resistant infections can have severe consequences.
John Keller, Ph.D., Director of the Board and Senior Vice President of the R&D Supervisory Unit at Shionogi, highlighted the company’s longstanding commitment to antibiotic innovation. He noted that since the 1950s, Shionogi has been actively engaged in researching and developing new antibacterial therapies, often in collaboration with global partners. According to Keller, Fetroja represents a culmination of the company’s in-house innovation capabilities and serves as a testament to its dedication to addressing unmet medical needs in infectious diseases.
Keller also emphasized that the BARDA contract reflects Shionogi’s ongoing collaboration with government and non-governmental organizations to advance public health objectives. By working closely with agencies like BARDA, the company aims to accelerate the development and availability of critical medical countermeasures that can be deployed in response to emerging health threats.
Nathan McCutcheon, MBA, President and CEO of Shionogi Inc., echoed these sentiments and highlighted the company’s broader strategy in combating antimicrobial resistance. He pointed to continued investments in Fetroja since its introduction in 2020, as well as the acquisition of Qpex Biopharma, Inc. in 2023, as key components of Shionogi’s efforts to expand its antimicrobial portfolio. The company has also committed additional resources to establish a new research facility dedicated to advancing antimicrobial research and development, further reinforcing its leadership in this critical area.
McCutcheon noted that the BARDA contract complements Shionogi’s existing collaborations with the U.S. government and enables the company to accelerate its expansion efforts within the United States. By scaling up manufacturing, advancing clinical development, and enhancing supply readiness, Shionogi aims to play a central role in strengthening the nation’s ability to respond to infectious disease threats.
The funding for this initiative is provided through the U.S. Department of Health and Human Services, specifically under the Administration for Strategic Preparedness and Response, with BARDA serving as the contracting authority. Project BioShield, under which this contract was awarded, is a federal program designed to accelerate the research, development, procurement, and availability of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats.
Fetroja is already approved in the United States for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Japan, the drug is marketed under the Fetroja brand for infections caused by carbapenem-resistant strains, while in Europe it is available under the name Fetcroja® for adult patients with limited treatment options for aerobic Gram-negative infections.
The continued development and expansion of Fetroja’s indications reflect the urgent need for new antibiotics capable of addressing resistant pathogens. Antimicrobial resistance remains one of the most pressing global health challenges, with increasing numbers of infections becoming difficult or impossible to treat with existing therapies. Innovative drugs like cefiderocol are therefore critical components of the global response to this threat.
Overall, the BARDA contract represents a significant advancement for Shionogi and its efforts to combat antimicrobial resistance while enhancing national health security. By integrating manufacturing expansion, clinical development, and strategic collaboration, the initiative aims to ensure that effective treatments like Fetroja are available when and where they are needed most.
About Shionogi in Infectious Disease
Over the past 70 years, Shionogi has discovered and commercialized six 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 and technology transfer 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 many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries.
Shionogi’s ongoing efforts to address current and emerging health threats include a U.S.-based drug discovery laboratory in the U.S. with Qpex Biopharma, Inc., a Shionogi Group Company. Through Qpex, we are advancing a robust portfolio of potential best-in-class, clinical-stage antimicrobial compounds. Learn more about the Qpex lab here.
Shionogi ranked #2 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 & 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, CNS disorders and cardiovascular diseases. 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.
About Cefiderocol
In the U.S., cefiderocol is commercially available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. 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.
In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.
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