The discovery and introduction of antibiotics in the 1940s transformed modern medicine and enabled tremendous progress in health care and life expectancy. Today, this progress is being threatened by a health crisis on the rise: antimicrobial resistance (AMR). AMR affects at least 3 million Americans and results in 48,000 U.S. deaths annually. The World Bank Group’s 2017 report on drug-resistant infections estimates that unless action is taken, AMR globally could take 10 million lives annually by 2050, a higher toll than from cancer. If we fail to address the crisis, many modern medical advances that depend on antibiotics—such as routine surgery, cancer therapy and treatment of chronic disease—may be jeopardized.
AMR is a natural process that occurs when microorganisms such as bacteria, viruses, fungi and parasites change in ways that make the microorganisms resistant to the medications used to cure the infection. This means the more we use medicines, the more resistance we create. Unfortunately, the current treatments were not developed to treat these resistant strains and the pipeline of new antimicrobials needed to stem the tide of AMR has been on the decline. A robust pipeline of new antimicrobial medicines is critical to ensure that treatments can keep pace with evolving pathogens and continue to fight infections.
To avoid turning back the progress made, biopharmaceutical researchers are working to develop new and effective treatments to combat AMR. These medicines represent more than antibiotics and include innovative, non-traditional antibacterial treatments such as bacteriophage products, live therapeutic products and monoclonal antibodies. A new report released today from PhRMA finds that there are nearly 90 medicines in development against drug-resistant infections.
Now more than ever, we need a robust and diverse pipeline of treatments to manage the growing threat of AMR and ensure more medicines enter the market. Unfortunately, several obstacles including the time needed to research and develop new treatments and lack of incentives stand in the way of needed innovation.
Developing new medicines is a long, complex and risky process taking anywhere from 10 to 15 years and costing on average $2.6 billion for a single medicine. Among antibiotics, this process is fraught by even more risk. Developing new antimicrobial medicines can take anywhere from 10-20.5 years and $568-$700 million to develop a single new medicine. In fact, among investigational medicines in preclinical development for existing classes of antibiotics just one in 15 will ultimately be approved and reach patients. And among new classes of antibiotics these odds are even slimmer with just one in 30 ultimately obtaining U.S. Food and Drug Administration (FDA) approval.
The challenge with antimicrobial medicines is that in order to slow and control continued antimicrobial resistance, newer medicines are frequently only used in a limited set of circumstances. Moreover, the U.S. reimbursement system also reinforces misguided incentives which discourage use of new antimicrobials when they are appropriate and favor older medicines that have been around for decades but may be less effective in meeting current AMR threats. Collectively, these challenges make it harder for biopharmaceutical research companies to recoup the substantial costs of R&D.
To address the challenges of early and late-stage clinical development and to overcome the market’s failure to drive innovation for new antimicrobial medicines, innovative partnerships and initiatives within and between the public and private sectors have evolved. The biopharmaceutical industry in particular is taking action through the AMR Action Fund. This fund aims to bring two to four new antimicrobials to market by 2030, focusing on innovative medicines that address the highest priority public health needs. This industry-driven effort will also work to drive comprehensive policy reforms that are needed to advance new reimbursement methodologies and create incentives that enable appropriate patient access, creating a sustainable ecosystem for antimicrobial R&D and commercialization.
The fund will also provide technical support to emerging companies, giving them access to the deep expertise and resources of large biopharmaceutical companies to strengthen and accelerate the development of novel antimicrobial medicines.
This issue is further being underscored by a chorus of voices in the biopharmaceutical industry outside of PhRMA, including the World Health Organization which recently spotlighted the insufficient number of medicines in the pipeline to address the growing threat of AMR.
As we look to the future, PhRMA and our members support bolstering pandemic preparedness and health care resiliency to make sure our country, and American patients, are stronger, healthier and better prepared for the next public health emergency. While recent policy changes have enhanced the research ecosystem and have sought to provide support and incentives for researchers to develop new antimicrobial medicines, additional policy reforms are still needed to create a more sustainable environment for antimicrobial R&D and commercialization and ensure a robust pipeline for future treatments.
The current challenge with the AMR pipeline is an example of what can happen when there are insufficient market dynamics to incentivize innovation. Potential changes to the innovation ecosystem could further have a significant detrimental impact on the ability to research and develop new and needed treatments. Those new treatments could be the ones we need to address the next pandemic, or the next superbug. It is crucial to create and strengthen an ecosystem where innovation can flourish rather than fail.
To learn more about medicines in development against drug-resistant infections as well as resources on the role of the innovation ecosystem in overcoming the misaligned incentives that plague the development of medicines to combat AMR, click here.