GARDP maintains relationships with both innovators and generic producers to monitor the product landscape and identify opportunities to enhance drug access. For instance, at the end of 2020, GARDP signed a Memorandum of Understanding (MOU) with Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services Limited (APSL) to explore joint opportunities around delivering access to zoliflodacin, a new treatment for gonorrhoea, in South Africa and Thailand.

GARDP also works with innovative companies and other access organizations to explore how we can combine our expertise to collaborate on accelerating the delivery of access in LMICs. This is the aim of the MOU that GARDP signed with the Clinton Health Access Initiative (CHAI) and Shionogi & Co., Limited related to cefiderocol—an antibiotic for bacterial infections in patients with limited treatment options—in July 2021.
‍
CHAI already has access capabilities developed in the HIV market, while GARDP has extensive expertise in antibiotic development, technical aspects of antimicrobial resistance, and developing solutions to access barriers for the antibiotic market. Together, this puts us in a strong position to work with Shionogi—a Japanese pharmaceutical company whose footprint lies primarily in Asia, Europe, and the US—to bring cefiderocol to patients in a large territory of LMICs in a way that ensures access through appropriate use and minimizes emerging resistance to the drug.

At GARDP, we see cefiderocol as a pathfinder that will help us develop our future approach to access. We have already started to examine criteria—including epidemiology, national health systems, and regulatory pathways—that will determine how we will ensure access to cefiderocol in LMICs. Once a license agreement is signed, we will turn our attention to securing a quality-assured local manufacturer, drug registration, partner engagement, and planning for early introduction and rollout. All of this will enable GARDP to increase our expertise, gather evidence, and build networks around the different aspects of access, so we will be better positioned to deliver new antibiotics to those who need them in the future.

Secure

the ‘antibiotic
facility’: A new model for access

Recent data show that death rates due to AMR are highest in some LMICs. As such, antibiotic resistance is not only a major health problem globally, but also a particularly serious issue for some of the world’s poorest countries. Increasing access to antibiotics would both reduce the burden of AMR in some locations where second-line antibiotics are unavailable and save lives.

SECURE—a collaborative initiative developed by GARDP and the World Health Organization (WHO) with the support of other international organizations—aims to help countries address the silent pandemic of drug-resistant bacterial infections by expanding access to a portfolio of essential antibiotics. Without such an aligned and collaborative global approach, the international community will face increasingly common outbreaks in which antibiotics are ineffective against new strains of resistant bacteria, further exacerbating antibiotic resistance.
‍
SECURE’s antibiotics portfolio will be adapted to individual countries’ needs, with a focus on existing antibiotics that are subject to frequent supply chain interruptions alongside new reserve antibiotics. Participating countries will be able to purchase the antibiotic portfolio at affordable prices through UNICEF or alternative procurement mechanisms.

SECURE will work with each country and local partners to ensure good stewardship, including guideline updates, appropriate use, improved surveillance and diagnostics, and the collection of real-time clinical data. Clinical sites will help deliver post-approval trials to further assess the efficacy of new antibiotics for the most threatening drug-resistant infections.

This pioneering initiative will not only increase access to life-saving drugs, but also make an important contribution towards the development of a new business model for antibiotics and extend the evidence base for the clinical utility of novel antibiotic treatments.

Before scaling up SECURE in every country that would benefit from the initiative, GARDP and its partners will launch a four-year pilot at the end of 2022/beginning of 2023 in participating countries. The pilot phase will serve to demonstrate SECURE’s public health value, test and learn from the model, and implement key activities to ensure pandemic preparedness.