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Shionogi secures BARDA contract for cefiderocol for resistant infections, bioterror threats
Chris Dall, MA
Today at 9:51 a.m.
Antimicrobial Stewardship
Bioterrorism
The contract, awarded through the Biomedical Advanced Research and Development Authority (BARDA), seeks to establish a US manufacturing site for the antibiotic cefiderocol and support procurement of the drug. It will also help fund development of cefiderocol to respond to high-priority bacterial biothreats. The contract has multiyear options that could bring the total up to $482 million.
Cefiderocol, marketed under the brand name Fetroja, is a siderophore cephalosporin antibiotic with a novel method of penetrating the tough outer membrane of gram-negative bacteria and an ability to overcome resistance mechanisms used by bacteria to evade antibiotics. Approved by the US Food and Drug Administration (FDA) for treating complicated urinary tract infections and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in adults, cefiderocol has become a valued option for difficult-to-treat, multidrug-resistant infections.
The move is the latest among several efforts by the Trump administration to boost US manufacturing of pharmaceuticals. An executive order issued in May 2025 directing the FDA to ease obstacles for drug manufacturers to establish or expand domestic production facilities. In February 2026, the FDA launched a pilot program that aims to speed up construction and review of US drug manufacturing facilities.
Gareth Morgan, MBA, associate corporate officer at Shionogi and president of Shionogi subsidiary Qpex Biopharma, said Shionogi will work with a third party to establish a US manufacturing site.
“We’re going to maintain a heavy commitment to onshoring and making sure it goes well,” Morgan told CIDRAP News.
Defense against bioterror threats
BARDA’s Project Bioshield, which works to accelerate research, development, and procurement of medical countermeasures against bioterror threats, is also interested in developing cefiderocol as an effective treatment for infections caused by Yersinia pestis, the bacterium that causes plague, and Burkholderia pseudomallei, which causes melioidosis. Both pathogens occur naturally in certain parts of the world and have the potential to be used as weapons in a biological attack.
“The US government wants to be prepared should there be some use of these biothreat pathogens,” Morgan said.
The contract will also cover development work to expand the use of cefiderocol in children with HABP/VABP.
“We’ve completed a number of pediatric studies and will submit them to the FDA for a supplemental NDA [new drug application] to include pediatric use in the label,” Morgan said.
Shionogi secures BARDA contract for cefiderocol for resistant infections, bioterror threats
Chris Dall, MA
Today at 9:51 a.m.
Antimicrobial Stewardship
Bioterrorism
Japanese drugmaker Shionogi announced yesterday that its US subsidiary has received a $119 million contract from the US government to bolster the nation’s ability to respond to drug-resistant infections and national health security threats.The contract, awarded through the Biomedical Advanced Research and Development Authority (BARDA), seeks to establish a US manufacturing site for the antibiotic cefiderocol and support procurement of the drug. It will also help fund development of cefiderocol to respond to high-priority bacterial biothreats. The contract has multiyear options that could bring the total up to $482 million.
Cefiderocol, marketed under the brand name Fetroja, is a siderophore cephalosporin antibiotic with a novel method of penetrating the tough outer membrane of gram-negative bacteria and an ability to overcome resistance mechanisms used by bacteria to evade antibiotics. Approved by the US Food and Drug Administration (FDA) for treating complicated urinary tract infections and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in adults, cefiderocol has become a valued option for difficult-to-treat, multidrug-resistant infections.
The move is the latest among several efforts by the Trump administration to boost US manufacturing of pharmaceuticals. An executive order issued in May 2025 directing the FDA to ease obstacles for drug manufacturers to establish or expand domestic production facilities. In February 2026, the FDA launched a pilot program that aims to speed up construction and review of US drug manufacturing facilities.
Gareth Morgan, MBA, associate corporate officer at Shionogi and president of Shionogi subsidiary Qpex Biopharma, said Shionogi will work with a third party to establish a US manufacturing site.
“We’re going to maintain a heavy commitment to onshoring and making sure it goes well,” Morgan told CIDRAP News.
Defense against bioterror threats
BARDA’s Project Bioshield, which works to accelerate research, development, and procurement of medical countermeasures against bioterror threats, is also interested in developing cefiderocol as an effective treatment for infections caused by Yersinia pestis, the bacterium that causes plague, and Burkholderia pseudomallei, which causes melioidosis. Both pathogens occur naturally in certain parts of the world and have the potential to be used as weapons in a biological attack.
“The US government wants to be prepared should there be some use of these biothreat pathogens,” Morgan said.
The contract will also cover development work to expand the use of cefiderocol in children with HABP/VABP.
“We’ve completed a number of pediatric studies and will submit them to the FDA for a supplemental NDA [new drug application] to include pediatric use in the label,” Morgan said.