GARDP and CHAI request proposals to manufacture cefiderocol to treat bacterial infections


3 Aug 2022

GARDP, Shionogi and CHAI are working to accelerate access to cefiderocol, an antibiotic for serious Gram-negative bacterial infections, in low- and middle-income countries (LMICs). This request for proposals (RfP) aims to solicit competitive bids for a contract to manufacture, obtain WHO prequalification, obtain regulatory approval of, and commercialize a cefiderocol 1g lyophilized powder for concentrate for solution for infusion that meets the specifications and indications specified in the RfP.

Antimicrobial resistance (AMR) is a growing global public health threat that causes almost 1.3 million deaths each year. The World Health Organization (WHO) has identified AMR as a leading risk to health and economic development and a barrier to reaching sustainable development goals. The emergence, increased incidence, and rapid dissemination of carbapenem-resistant infections has been identified as a critical concern by the WHO. In 2021, G7 Health Ministers committed to making AMR a key strategic area for action.

Cefiderocol, a siderophore cephalosporin, is a potential treatment option for carbapenem-resistant infections. First approved in 2019, cefiderocol uses a novel mechanism to enable penetration of many types of Gram-negative bacteria. It is approved for use in the United States under the brand name “FETROJA®” and in the European Union under the brand name “FETCROJA®”.

Unlike COVID-19 which raised alarm as it swiftly moved across the globe, AMR is a silent pandemic which has received little public notice while gaining ground in countries and hospitals. Even though the risk from AMR infections continues to increase, only a small number of new antibiotics have been developed in recent years. There is growing demand for antibiotics that target carbapenem-resistant infections, as demonstrated by a soon-to-be-published study of the procurement of antibiotics used for extremely resistant infections in eight countries. This study shows a 6.5% increase in the volume of antibiotics purchased to treat carbapenem-resistant infections, with some countries demonstrating much more rapid growth (e.g., Bangladesh 61.3%, Brazil 28.4%, Mexico 37.8%, Pakistan 29.3%). These eight countries, all of which are included in the territory covered by the cefiderocol license and technology transfer agreement signed by Shionogi and GARDP, procured 3.27 million standard units of these antibiotics in 2021. It is on this basis that GARDP and CHAI anticipate strong demand for cefiderocol—approximately 1 million units per year at launch and for the first few years thereafter.

The goal of this project is to rapidly enable the launch of a quality-assured cefiderocol product that can be affordably priced so that patients in LMICs have access to this treatment option. Together with GARDP, CHAI will support the manufacturing partner in obtaining regulatory approvals and work with regional and national partners to support positioning for appropriate use, forecasting and introduction planning of cefiderocol, including planning for stewardship measures. Related to this RfP, a commercialization support programme to mitigate some of the risks to the supplier associated with the development and launch of this product is under consideration. These include a detailed API and FDF tech package from Shionogi, potential financial support, and CHAI’s work on demand generation.

To initiate the cefiderocol antimicrobial resistance access and stewardship project, CHAI with GARDP’s support will facilitate a competitive selection process to identify manufacturer partner(s). The RfP is open to companies that meet the eligibility criteria and agree to the proposed regulatory filing deadlines and pricing targets. The manufacturer(s) will be chosen via a multi-tiered selection process that involves a written proposal and a potential face-to-face meeting. The first step in this process is to submit a proposal in response to this RfP, with all required documents listed in the instructions, by September 19, 2022 at 5 pm EST. This informational webinar answers questions about the RfP process. Companies are encouraged to submit questions, which CHAI will collect and then respond to in a Q&A document that will be uploaded to CHAI’s website.

For more information, or how to submit a proposal, please refer to the RfP instructions.

Please email cefrfp@clintonhealthaccess.org with any questions.