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. Cefiderocol was approved by the US Food and Drug Administration in 2019, and by the European Medicines Agency in 2020, and it was recently added to WHO’s Model List of Essential Medicines. Normally, when Reserve 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.
The innovative partnership between GARDP, Shionogi & Co., Ltd. (Shionogi) and the Clinton Health Access Initiative (CHAI) aim to change that.
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 “fools” the bacteria by binding to iron and getting actively transported into bacterial cells via 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 and Enterobacterales.
GARDP’s role in accelerating access to cefiderocol.
Working with CHAI and Shionogi, GARDP has entered into a license and technology transfer agreement to support 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 that normally face delayed access to newer antibiotics.
GARDP subsequently entered into a sublicense agreement with India-based Orchid Pharma Ltd (Orchid) to manufacture cefiderocol at its plant in Chenai, in India. 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. This delay has dire consequences given that the number of serious, life-threatening, infections caused by carbapenem-resistant bacteria that require newer antibiotics for optimal treatment, has been steadily 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 create a supply chain 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.
COMPLETed
2024 – GARDP’s sublicensee, Orchid, successfully synthesized cefiderocol API (Active Pharmaceutical Ingredient) at laboratory scale.
Ongoing
2025 to 2027 – Construction of dedicated active pharmaceutical ingredient (API) and drug product facilities for cefiderocol by Orchid.
Resources
Statement on Brazil’s draft National Action Plan for Antimicrobial Resistance
Read more
GARDP welcomes first-ever WHO list of antibiotics to be prioritized for paediatric development
Read more