A new agreement is poised to accelerate antibiotic access for tens of thousands of patients in regions with the highest rates of antimicrobial resistance (AMR). The Global Antibiotic Research & Development Partnership (GARDP) and India-based Orchid Pharma have signed a sublicense agreement to manufacture cefiderocol, an antibiotic to treat certain Gram-negative infections.

This agreement is a critical step in an ambitious project by Japan-based Shionogi & Co., GARDP, and the Clinton Health Access Initiative (CHAI) that aims to provide access to cefiderocol in a number of predominantly low- and middle- income countries.  

The project represents a new model for bridging global gaps in equitable access to important antibiotics. Even though populations in low- and middle-income countries face a high burden of death from drug-resistant bacterial infections, their access to antibiotics with activity against resistant bacteria is usually delayed by more than a decade. That situation may worsen given that the number of serious, potentially life-threatening, infections due to carbapenem-resistant bacteria has been growing across multiple regions, including South Asia and Latin America. By addressing barriers that have historically limited the availability of important antibiotics in low- and middle-income countries, this innovative project aims to accelerate appropriate access for an affordable, quality-assured antibiotic to treat drug-resistant Gram-negative infections.  

The signing of the manufacturing sublicense agreement builds on the license agreement between Shionogi and GARDP and on the collaboration agreement between Shionogi, GARDP, and CHAI, both of which were signed in June 2022.

Based on these agreements, CHAI will facilitate the technology transfer process between Shionogi and Orchid, and Shionogi will convey essential information for the manufacture of cefiderocol to Orchid, thus accelerating Orchid’s ability to manufacture the product and reducing costs that might otherwise be passed on to patients.