The United Nations health body is stingily critical of major pharmaceutical firms, indicating that the pharmaceutical sector has a tendency to see the lack of development of new candidate antimicrobials as someone else’s problem (that is national governments and academia). Over the past few years, big pharmaceutical companies have been slow to develop new medicines, partly due to the long lead times and low profit margins. This is outside of the complexities in terms of finding new, suitable compounds.
WHO has undertaken a review of the current state of clinical development (“Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline”). The report shows that most of the sixty identified antimicrobial products in development are not set to target the most dangerous resistant strains (especially Gram-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli). This is despite WHO having previously outlined the twelve major pathogens of concern, in a 2017 imperative statement.
Ever since their discovery some decades ago, antimicrobial agents particularly antibiotics have saved mankind from the morbidity and mortality of innumerable infectious diseases and/or pathogenic agents even till date. However, due natural resistance; mis-prescribing; over-use; and arguably mis-use (in the case of administering antibiotics to farm animals), many pathogenic organisms have developed resistance to the most common antimicrobials, creating a pressing global need for alternatives.
The WHO report also notes a “worrying gap” in antimicrobial research and development against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1). Here there are just three antibiotics in the pipeline.
A second report (“Antibacterial agents in preclinical development”) finds that of those antimicrobials going through the development pipeline, the research is mostly being driven by small- or medium-sized enterprises and not by the large pharmaceutical companies. This includes big players like AstraZeneca, Novartis, and Sanofi, who have recently stopped developing antibiotics.
Some of the smaller firms have also experienced financing problems, with some being forced to reop programs or to shut down entirely due to insolvency.
Quoted by PharmaceuticalPhorum, the WHO experts state: “In the last couple of years, the majority of the large research-based pharmaceutical companies have exited the field of antibiotic R&D. Despite commitments from the private sector through the AMR Industry Alliance, concrete action is limited.”
The report also notes that many products remain locked in the very early stages of development. This means that the most optimistic scenario is for the first two to five products to become available in about 10 years.
