The Global Antibiotic Research & Development Partnership (GARDP) today announced a major step in its efforts to bridge global gaps in access to innovative, critically needed antibiotics.
Under a sublicense agreement with GARDP, India-based Orchid Pharma will manufacture cefiderocol, an antibiotic for difficult-to-treat, gram-negative bacterial infections developed by Japanese drugmaker Shionogi. The agreement will enable Orchid to produce the drug cheaper and make it available in low- and middle-income countries (LMICs), many of which are confronting rising rates of antimicrobial resistance (AMR) with a limited arsenal of antibiotics.
The agreement builds on a partnership between GARDP, Shionogi, and the Clinton Health Initiative (CHAI) announced last year, under which Shionogi agreed to grant GARDP the license for cefiderocol. CHAI will work with Shionogi to transfer technology and convey essential manufacturing information to Orchid and other sublicensees to help reduce manufacturing costs, which will make the drug more affordable—pending local authorization or national regulatory approval—for the 135 LMICs that don't currently have access to it.
"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," Takuko Sawada, director and vice chairperson of Shionogi's board, said in a company press release.
Reducing the access gap
Cefiderocol was approved by the US Food and Drug Administration in 2019 and the European Medicines Agency in 2020 and is on the World Health Organization Model List of Essential Medicines. It's considered an important weapon against carbapenem- and multidrug-resistant infections, but to date has only been commercially available in high-income countries.
"Access is one of the least talked about issues in the global AMR crisis," said GARDP executive director Manica Balasegaram, MRCP, MSc. "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."
Access is one of the least talked about issues in the global AMR crisis.