Shionogi gains $36.9 million U.S. order for Fetroja
KEY POINTS
- Shionogi secures $36.9 million after U.S. government exercises cefiderocol procurement option
- BARDA Project BioShield contract includes options for U.S. manufacturing, pathogen-focused development and pediatric label expansion
- Initial funding totals $119 million, with potential contract value rising to $482 million
The BARDA Project BioShield contract also covers U.S. manufacturing, priority-pathogen development and potential pediatric label expansion for cefiderocol. Photo by Pavel Danilyuk on Pexels
Pavel Danilyuk
Shionogi & Co. said on August 28 that the U.S. government had exercised a procurement option for cefiderocol, a treatment for Gram-negative bacterial infections, under a contract through the Biomedical Advanced Research and Development Authority’s Project BioShield program.
The exercised option will bring $36.9 million to the Shionogi group. Cefiderocol is sold in the United States under the brand name Fetroja.
Shionogi signed the contract with the U.S. government on April 8 as part of Project BioShield, a U.S. Department of Health and Human Services program designed to accelerate the research, development, procurement and supply of medical countermeasures against chemical, biological, radiological and nuclear threats.
Under the agreement, Shionogi initially received $119 million in funding. The contract includes multiple related options, including the establishment of a U.S. pharmaceutical manufacturing site for cefiderocol, development targeting infections caused by high-priority pathogens considered biological threats, and a supplemental new drug application to the U.S. Food and Drug Administration to expand the drug’s label for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in pediatric patients.
If those options advance, total funding under the contract could reach as much as $482 million, the company said.
Shionogi said the impact of the procurement option on its consolidated earnings for the fiscal year ending March 2027 would be minimal.
Cefiderocol is marketed in the United States for adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative bacteria, as well as hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug is also sold in multiple markets including Japan, Europe and Taiwan.
Shionogi is also working with the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative to prepare for broader patient access to cefiderocol in low- and middle-income countries and upper-middle-income countries, the company said. Antimicrobial resistance is a major public health concern globally, and the company said an estimated 1.14 million people died worldwide in 2021 from AMR.
