Agreement to accelerate access to antibiotics for serious bacterial 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 India-based Orchid Pharma Ltd 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, 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, pending local authorization or national regulatory approval.

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. 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.

Manica Balasegaram, Executive Director of GARDP said: “Access is one of the least talked about issues in the global AMR crisis. This is not just a global market failure but also a public health failure,” said Manica Balasegaram, Executive Director of GARDP. “We can effectively offset the burden of antibiotic resistance by reducing the access gap between high- and lower-income countries so that the right antibiotics are affordable and available for appropriate use. We are proud to work with Orchid to help make this a reality for cefiderocol, and we hope that this project can help pave the way for access to additional antibiotics in the future.”

Manish Dhanuka, Managing Director of Orchid Pharma, one of the world’s leading manufacturers of cephalosporin antibiotics “We are proud to work with Shionogi, GARDP, and CHAI to provide a global solution to access an important antibiotic for areas of need. Our decades-long expertise in cephalosporins will be advantageous in manufacturing affordable and quality-assured cefiderocol. This will address the unmet needs of patients across low- and middle-income countries where antimicrobial resistance is spreading.”

Takuko Sawada, Director and Vice Chairperson of the Board, Shionogi & Co. Ltd said: “Our work goes beyond researching and developing innovative new medicines to address significant unmet medical needs. We are also focused on developing sustainable programmes, including the critically important agreements with GARDP and CHAI, that focus on significant public health priorities, including access to and appropriate use of antibiotics. We welcome Orchid to this programme and are confident that together we will continue to make strides toward increasing access to medications for people living in low and middle-income countries.”