BIO’s Greg Frank outlines the alarming growth of drug-resistant infections and the steps that need to be taken to combat this rapidly emerging global health threat.
Drug-resistant superbugs are evolving at a rapid pace. In fact, it is estimated that 700,000 people die from drug-resistant infections each year. Without urgent action, that number is expected to exponentially grow to 10 million people dying of that same cause annually by 2050. This is an issue we can no longer ignore.
By treating and preventing infection, antimicrobial medicines have enabled amazing medical advances that may seem routine today — including chemotherapy, complex surgeries, and organ transplants. However, as AMR becomes more prevalent, these procedures may become too risky for patients as existing antibiotics are becoming less and less effective. That’s why the need to develop new ones is so urgent.
Unfortunately, investors and drug companies are reluctant to invest in AMR research because the economics are skewed. Take Achaogen for example, who filed for bankruptcy after being unable to demonstrate a sustainable return to stay viable after year one sales of USD 1 million. Late last year Melinta Therapeutics entered bankruptcy protection while it is restructuring. While the company continues to make its products available during this process, it is yet another sign that there is little return on investment in antibiotic R&D.
As we look globally, the R&D investment landscape for new antimicrobials is also in dire straits, with most drug makers halting their investments in research which are fundamental to bringing a product to the market. The math is simple, it can take over 1 billion USD and over at least ten years to develop a new antimicrobial. Even when a product is in the market, it can take over 20 years to just break even on its R&D investment. This grim reality makes it hard for investors deciding to fund a new antibiotic that might never generate a positive return.
Certain push incentives have catalysed the biotechnology industry to achieve progress in the preclinical stages of new antibiotic development, where the investment levels are encouraging. For example the CARB-X accelerator, a consortium funded by the United States, Wellcome Trust, Germany, the United Kingdom, and the Bill & Melinda Gates Foundation, has supported 50 projects since 2016 – many of them to Alliance members. Furthermore, new rapid infection detection tests are being developed by diagnostics companies -essential tools to prevent AMR by treating infectious more efficiently and tracking resistant strains.
The recently launched AMR Industry Alliance progress report illustrates that private sector is still the biggest investor in AMR related R&D, compared to the USD 500 million per year of the public sector. Current investment levels of this industry group representing 30% of the volume of sales of antimicrobials and 100% of novel on patent products, stood at USD 1.6 billion in 2018. Unfortunately, this investment is inadequate to support the pipeline of antimicrobial medicines we need, especially the costly late stage clinical research to bring them to patients.
Moreover, this investment is at risk precisely when we need it the most. To ensure we have the tools to beat resistant infections, we must build on our progress on push incentives and advance a package of incentives that directly address the market challenges faced by antimicrobial medicines. This package can include reforming reimbursement to better align with the societal value of these products as well as pull incentives that reward successful approval of medicines that meet critical unmet needs.
Without the right package of incentives to spur research and development while ensuring patients can access treatments that are prescribed safely and appropriately, we are setting ourselves up for failure.
As Professor Dame Sally Davies highlights in the report: “close collaborations among governments, the industry, investors, and other funding sources are required to improve antibiotic reimbursement systems and implement much- needed new incentives.” Thus, it is through meaningful engagement between both the public and private sectors that we should explore and pilot new mechanisms and incentives to improve current market conditions with a view to making them more conducive to the development and commercialization of novel solutions to AMR.