Press release published on SHIONOGI website on June 14, 2022
Shionogi & Co., Ltd. (Shionogi) and the Global Antibiotic Research and Development Partnership (GARDP) have today announced the execution 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. Please refer to the detailed U.S. indications and Important Safety Information for cefiderocol found below.
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’s population living in areas most affected by antibiotic resistance.“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,” stated Takuko Sawada, Director and Executive Vice President, Senior Vice President of Integrated Disease Care Division, Shionogi & Co., Ltd.Antibiotic resistance is a growing public health emergency.
A recent study found that antibiotic resistance caused nearly 1.3 million deaths worldwide in 2019 – almost double previous estimates.“Too often, antibiotic resistance is presented as a problem for the future,” said Manica Balasegaram, Executive Director of GARDP. “In fact, 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.
Thanks to essential support from our funding partners, and in collaboration with Shionogi and CHAI, GARDP is accelerating global access now, so that doctors and patients who urgently need antibiotics can get them. Antibiotic development and delivery go hand-in-hand in GARDP’s efforts to fight antibiotic resistance.
”Getting cefiderocol to patients in need will require overcoming a number of technical, legal, regulatory and economic barriers. Shionogi and GARDP will collaborate with CHAI, which has expertise working with the public and private sectors to reshape markets and introduce medicines in countries around the world.“Appropriate diagnosis and treatment of bacterial infections, which would include access to innovative medications like cefiderocol, can improve the treatment of life-threatening infections,” stated David Ripin, Chief Science Officer and Executive Vice President of Infectious Diseases at CHAI. “CHAI is excited to be a part of this partnership that will ensure that this innovative antibiotic is affordable and available to patients when and where they need it.
”The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programs that ensure appropriate use. These provisions are especially important to avoid fueling resistance to cefiderocol.According to Kamini Walia, Senior Scientist and Program Officer of AMR at the Indian Council of Medical Research, “New therapeutic options are urgently needed for treating highly resistant infections in Indian patients. Making cefiderocol available to appropriate Indian patients earlier than it was expected to hit Indian markets will be immensely beneficial in treating patients. However, there is need to practice strict stewardship around use of this drug to prevent its misuse and overuse.”
India is one of the many countries that may benefit from the license and collaboration agreements.This project has a broader purpose to pave the way for antibiotic access more generally. Shionogi and GARDP have agreed to publish their innovative license agreement, which may serve as a new baseline for similar agreements in the future. The license and collaboration agreements also offer a dynamic and promising collaborative approach to antibiotic access. By bringing together key actors from the private and non-profit sectors, this project may help overcome barriers so that cefiderocol reaches patients in need.
Cefiderocol for injection is the first and only siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections. It has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. 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, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.
Cefiderocol has also demonstrated in vitro activity against certain bacteria that contain problematic resistant enzymes such as ESBLs, AmpC, and serine- and metallo-carbapenemases. Data from multinational surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii complex, P. aeruginosa, Enterobacterales and S. maltophilia. The clinical significance of the in vitro data is unknown. Cefiderocol has no clinically relevant in vitro activity against most Gram-positive bacteria and anaerobic bacteria.
Click here for Full U.S. Prescribing Information for Fetroja® (cefiderocol).