Cefiderocol.
Expanding cefiderocol access to 70% of the globe.
GARDP is working with partners to expand access to cefiderocol, an antibiotic that is active against a number of drug-resistant bacteria on the World Health Organization (WHO) priority pathogens list. Normally, when antibiotics like cefiderocol are first developed, it can take more than a decade before people in low- and middle-income countries (LMICs) get access to them, if at all. This innovative partnership aims to change that. Cefiderocol was recently added to WHO’s Model List of Essential Medicines.
It was approved by the European Medicines Agency in 2020 and, separately, by the US Food and Drug Administration in 2019.
What is cefiderocol and how does it work?
Cefiderocol is a siderophore cephalosporin antibiotic with an innovative mechanism of action against Gram-negative pathogens. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters.
Data from multinational surveillance studies demonstrate potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia.
GARDP’s role in accelerating access to cefiderocol.
Working with the Clinton Health Access Initiative (CHAI), Shionogi & Co., Ltd. (Shionogi) and GARDP have entered into a license and technology transfer agreement, supporting wider access to cefiderocol. This is the first such license agreement for an antibiotic to treat serious bacterial infections between a pharmaceutical company and a non-profit organization. Under this agreement, GARDP has the rights to manufacture and commercialize cefiderocol through sub-licensees in 135 countries with delayed access (if any) to newer antibiotics.
GARDP subsequently entered into a sublicense agreement with India-based Orchid Pharma Ltd (Orchid) to manufacture cefiderocol. This agreement has important access, environmental, and stewardship provisions, to help keep the product affordable for patients and health systems in low-resource settings.
The potential impact
The cefiderocol project represents a new model for bridging global access gaps for important antibiotics. Even though populations in LMICs face high mortality from drug-resistant bacterial infections, their access to new antibiotics 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, this innovative project aims to accelerate appropriate access to an affordable, quality-assured antibiotic for those who need it most.
Where does the project stand?
Until now, cefiderocol has been available in only a few high-income countries. Landmark licensing agreements are changing this, with more countries set to gain access to this important Reserve antibiotic over the coming years.
With GARDP’s support, efforts are underway to establish manufacturing capacity in India through Orchid in order to increase production and supply for LMICs. GARDP is also working to support sustainable introduction of cefiderocol in specific countries, providing technical support for registrations, stewardship and clinical use.
Key milestones
Signed
2022 – Shionogi, GARDP and CHAI announced landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in up to 135 countries.
Signed
2023 – GARDP and Orchid signed a sublicense agreement for manufacturing. It is a critical step in increasing access in LMICs, pending local authorization or national regulatory approval.
Succeeded
2024 – GARDP’s sublicensee, Orchid, successfully synthesized cefiderocol API (Active Pharmaceutical Ingredient) at laboratory scale.
Ongoing
2025 to 2027 – Construction of dedicated API and drug product facilities for cefiderocol by Orchid.
Resources
Statement on Brazil’s draft National Action Plan for Antimicrobial Resistance
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GARDP welcomes first-ever WHO list of antibiotics to be prioritized for paediatric development
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