Better access, stewardship practices by pharma companies needed for promising new antibiotics: ATMF report

Access to Medicine Foundation (ATMF), based out of Netherlands has recently released its report How can pharma get the few promising drugs in development to patients battling superbugs?. The report is set against the backdrop of an inadequate antibiotic research and development pipeline and looks at what pharmaceutical companies can do to ensure newly-developed drugs reach every patient who needs them. 

Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines. Some estimates suggest that if the trend is not reversed, AMR can lead to 10 million deaths a year by 2050, significant disruption to common surgical and medical interventions as well as a further 24 million people driven into extreme poverty. 

The report took into consideration five late-stage projects that target some of the most severe drug-resistant pathogens. These include candidates being developed by GSK, F2G, Innoviva and Venatorx (gepotidacin, olorofim, zoliflodacin and cefepime-taniborbactam, respectively) as well as Pfizer, with recently approved aztreonam-avibactam (Emblaveo). Out of the five, four projects were antibacterial while one was antifungal. The five selected projects were assessed on elements of their current access and stewardship planning. 

The key findings of the report are as follows: 

One, concrete plans for registration are lacking for almost all low-and middle-income countries (LMIC): Out of 113 LMICs in scope, concrete commitments for registation were only identified in five – China, India, Mexico, South Africa and Thailand. Many of the remaining 108 LMICs in scope face high burdens of diseases targeted by the projects and could benefit from access to them.  

Two, affordability and stewardship in LMICs are largely overlooked: Some of the companies assessed in this report were found to be addressing affordability and stewardship. For example, Pfizer applies specific pricing strategies for aztreonam-avibactam. However, no robust plans for making new products affordable to patients in any LMIC could be identified in the other four case studies in this report. 

Three, paediatric trials prior to market approval hopeful sign: Encouragingly, four of the five companies analysed – GSK, Pfizer, Innoviva and Venatorx – were found to be running or initiating clinical trials that directly target children. 

Four, partnerships help scale efforts, other tools can also be utilised: Small and medium enterprises (SME) rely heavily on partners to help commercialise products and drive global access. The collaboration with the Global Antibiotic Research and Development Partnership is one such example. SMEs also actively seek partnerships directly with large research-based pharmaceutical companies.

Over and above these partnerships and licensing agreements, SMEs and large pharmaceutical companies can also utilise more tools and strategies to advance their access and stewardship plans. An instance cited in the report is the Stewardship and Access Plan (SAP) to support companies in planning ahead for access and stewardship. Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), in collaboration with partners like the Wellcome Trust and the Access to Medicine Foundation, published the SAP Development Guide in 2021.

The report estimated that the selected five projects had the ability to save at least 160,000 lives each year by providing much-needed medicines to treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections and invasive fungal infections if made available on a large scale. 

“We have a small, but effective, arsenal in the race to combat drug resistance. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance,” stated Jayasree K Iyer, chief executive, Access to Medicine Foundation, in a public statement introducing the report. 

It also mentioned that large pharmaceutical companies need to re-enter the antibiotic development space and make their unique expertise on access and commercialisation available.

“Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance on a wider scale,” stated Marijn Verhoef, director of operations and research, Access to Medicine Foundation, in the release note.