M/s. Orchid Pharma Limited has entered into a manufacturing sublicense agreement with Global Antibiotic Research & Development Partnership (GARDP) to manufacture Cefiderocol- an antibiotic to treat certain Gram-negative infections. 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 Orchid Pharma Ltd. (Orchid) 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 Shionogi & Co. Ltd. (Shionogi), 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. Launched in June 2022, 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. The licensing agreement signed between Shionogi and GARDP in June 2022 enables GARDP to make cefiderocol available in 135 countries (70% of countries worldwide, including those with the highest AMR burden), none of which currently has access. Cefiderocol was approved by the US Food and Drug Administration in 2019 and the European Medicines Agency in 2020, and it is on the World Health Organization (WHO) Model List of Essential Medicines.

Orchid was selected following a rigorous vetting process led by CHAI with GARDP. The manufacturing sublicense agreement has important access, environmental, and stewardship provisions, including cost-plus pricing, with a commitment to lower the costs based on volumes to help keep the product affordable for patients and health systems in low-resource settings. The sublicense access plan, constituting a part of the sublicense agreement, also stipulates that Orchid will submit the product to the WHO medicines prequalification (PQ) programme.

Products listed with WHO PQ are eligible for a collaborative procedure for accelerated registration that reduces the time for national regulatory approvals to 90 days in participating countries. In March 2023, WHO PQ invited manufacturers of cefiderocol to submit expressions of interest, marking the first instance that WHO PQ opened eligibility to products that treat bacterial infections other than tuberculosis. 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. In the spirit of transparency and knowledge sharing, and as a baseline for similar agreements in the future, the license agreement and manufacturing sublicense agreement have been published online.