Shionogi & Co., Ltd. and the Global Antibiotic Research and Development Partnership (GARDP) have announced the signature of a license and technology transfer agreement and, with the Clinton Health Access Initiative (CHAI), a collaboration agreement, that aim to significantly transform the landscape of access to antibiotics for countries around the world.
The agreements will provide access to cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections, which may be resistant to other antibiotic treatments. Cefiderocol was recently added to the World Health Organization (WHO) Model List of Essential Medicines and targets a number of Gram-negative WHO priority pathogens. It was approved by the European Medicines Agency in 2020 and, separately, by the U.S. Food and Drug Administration in 2019.
This is the first license agreement for an antibiotic to treat serious bacterial infections between a pharmaceutical company and a non-profit organization driven by public health priorities. Under this agreement, GARDP will manufacture and commercialize cefiderocol through sub-licensees in a large range of countries that have delayed access (if any) to newer antibiotics. The license territory includes all low-income countries, most lower middle- and upper middle-income countries, and select high-income countries (135 countries total, almost 70% of countries worldwide). It includes a significant proportion of the world
