Shionogi has teamed up with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) to improve global access to antibiotics.
Shionogi and GARDP have completed a license and technology transfer agreement – and a collaboration agreement with CHAI – to provide access to cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections, which may be resistant to other antibiotic treatments.
After approval by the US Food and Drug Administration (FDA) in 2019 and subsequent approval by the European Medicines Agency (EMA) in 2020, cefiderocol was recently added to the World Health Organization (WHO) Model List of Essential Medicines.
WHO has cited antibiotic resistance as one of the biggest threats to global health, with new resistance mechanisms threatening the ability to treat common infections and diseases.
GARDP’s executive director, Manica Balasegaram, said: “Resistant bacterial infections are already costing lives and taking a heavy toll on health systems around the world. We can change that by supporting accelerated access to antibiotics in regions with the highest burden of resistance – that is, where antibiotic access is often neglected, and should be prioritized.”
Under the agreement, GARDP will manufacture and commercialize cefiderocol through sub-licenses in a large number of countries that struggle with delayed access to new antibiotics, with the license territory including 135 countries in total.
“Shionogi is proud to work on such an innovative license agreement with GARDP and CHAI to accelerate antibiotic access. Shionogi is committed to ensuring that cefiderocol is accessible worldwide as a potential treatment option for certain highly resistant Gram-negative infections,” said Takuko Sawada, director and executive vice president, senior vice president of Integrated Disease Division, Shionogi.
Shionogi and GARDP will work with CHAI, which has expertise working with the public and private sectors to reshape markets and introduce medicines in countries around the world, to help overcome a number of technical, legal, regulatory and economic barriers in getting cefiderocol to patients.
The appropriate use of cefiderocol will be ensured by provisions included in the collaboration to coordinate with ministries of health and other experts to strengthen hospital-based stewardship programmes.
The license deal between Shionogi and GARDP is the first involving an antibiotic to treat serious bacterial infections between a pharmaceutical company and a non-profit organization driven by public health priorities.
Shionogi and GARDP will publish their license agreement to help create a new baseline for similar deals in the future.