Shionogi sets sights on US antibiotic plant with $119M from BARDA
Japan’s Shionogi is joining the spate of drugmakers to announce manufacturing commitments in the U.S. since last year, albeit under slightly different circumstances than many of its peers.
The Osaka-headquartered company on Wednesday unveiled a new contract through the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) to bolster the domestic supply of Fetroja (cefiderocol) and potentially expand the antibiotic’s purview to tackle “high biothreat pathogens” like plague and melioidosis.
Fetroja won its first U.S. green light back in 2019 as a treatment for complicated urinary tract infections, following that up a year later with a second FDA nod in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP and VABP).
In its April 8 announcement, Shionogi noted that the deal positions Fetroja as a “critical countermeasure” against those difficult-to-treat infections, plus other biological threats to U.S. national health security.
BARDA, part of HHS’ Administration for Strategic Preparedness and Response (ASPR), has funded the contract with an initial $119 million, although “multiyear options” could ultimately net Shionogi up to $482 million if exercised, the company said.
With that cash, Shionogi says it will establish a dedicated U.S. manufacturing site for Fetroja, with the funding also expected to help support the med’s procurement. The company did not elaborate on expected capacity or a potential location for the upcoming production plant.
At the same time, the drugmaker will hunker down to advance development of Fetroja to treat infections caused by “high priority biothreat pathogens” like melioidosis (Burkholderia pseudomallei) and plague (Yersinia pestis), plus Shionogi will seek an FDA expansion to treat HABP and VABP in pediatric patients.
“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,” Nathan McCutcheon, president and CEO of Shionogi Inc., Shionogi’s U.S. subsidiary, said in a statement.
“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,” McCutcheon added.
Shionogi notes that it has discovered and brought six novel antibiotics to market over a 70-year span.
The Fetroja contract falls under BARDA’s Project BioShield, which aims to accelerate R&D, procurement and availability of medical countermeasures meant to tackle chemical, biological, radiological and nuclear agents.
Apart from the antibiotic focus on display in its Shionogi tie-up, BARDA has laid out several major prophylactic supply pacts in recent years.
Beyond deals for U.S. supplies of COVID-19 vaccines—plus therapeutics and diagnostics—during the pandemic, BARDA has helped shore up American stockpiles of vaccines for smallpox and mpox through Bavarian Nordic, and the agency has engaged with GSK, Sanofi and CSL to shore up inventories of bird flu shots, too.
More recently, Cidara Therapeutics snagged a BARDA award worth up to $339 million in October to support domestic manufacturing for its experimental non-vaccine flu preventive, CD388, and help establish an “initial commercial supply chain” for the asset. Since then, the biotech has been bought out by Merck for $9.2 billion.
The National Defense Authorization Act establishes statutory requirements around security, software control, data sovereignty, qualification and scale in relation to the use of Additive Manufacturing by the US Department of Defense (Courtesy US House of Representatives) 
