Cefiderocol has been approved by the US Food and Drug Administration and by the European Medicines Agency, and is included on the WHO Model List of Essential Medicines. Until now, this antibiotic has been available in only a few high-income countries, and it has not been available at all in low- and middle-income countries (LMICs). On the basis of a first-of-its-kind license agreement with Shionogi, a collaboration agreement with Shionogi and CHAI, and a manufacturing sublicense agreement with Orchid Pharma, GARDP and partners aim to forge new pathways and build sustainable networks so that cefiderocol—and, in the future, other antibiotics like it—can reach people in need.  

Under the agreement with Shionogi, GARDP will be able to manufacture and commercialize cefiderocol through sub-licensees in almost 70% of countries worldwide (135 countries), most of which tend to have delayed access (if any) to novel antibiotics. The license territory includes all low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. The manufacturing sublicense agreement with Orchid Pharma Ltd (Orchid) has important access, environmental, & stewardship provisions, to help keep the product affordable for patients and health systems in low-resource settings.  

By improving efficiencies in forecasting, procurement and supply, SECURE aims to improve decision-making, reduce shortages and identify priorities for local manufacturing. SECURE has also developed a forecasting and economic model to illustrate the benefits of pooling demand, stockpiling, supplier guarantees and country subsidies, all of which can help to incentivize suppliers.  

Also, improvements in supply security, demand predictability, availability and affordability of these antibiotics will help to expand access in a sustainable, equitable and appropriate way.  

SECURE is the first dedicated initiative to expand access to a portfolio of essential antibiotics in LMICs. This goes beyond access to single products.