Combating AMR With Antibiotic Development Incentives
Jennifer Quinn, head of Global Value & Access, Debiopharm, offers insights on pull incentives and how they look to get more antibiotics to market.
There are a number of issues associated with antibiotic development including, the lifespan of antibiotics’ effectiveness, the time it takes to develop new therapies, and reimbursement. This last issue can be especially problematic because it involves revenue and the ability for companies to recoup their development funding and make a profit for their efforts. It has been estimated it takes 10-15 years, and over 1 billion dollars to get an antibiotic from development to market. Wrapped inside this process is finding a novel compound, getting the investigational therapy through clinical trials, and the regulatory approval.
And revenue for antibiotics is limited. According to a research report published last year by Spherical Insights & Consulting, the global antibiotics market size was valued at $48.2 billion in 2023.1 To compare, the successful cancer therapy, Keytruda, made 20.93 billion in 2022.2 And this does not even compare to the COVID-19 vaccines. Sales for the Pfizer/BioNTech vaccine have been more than $80 billion.3
Another challenge is the size of the companies that are developing these therapies. In recent years, this has mostly been the domain of smaller biopharmaceutical companies and start-ups looking to develop such therapies with the hopes the therapy or the company itself will be acquired by larger, well-established pharmaceutical companies. And with regards to the large pharmaceutical companies, there has been some who are developing antibiotics, but not the type of large scale push to develop antibiotics because of the lack of incentives, due to the aforementioned revenue projections.
One large example of a potential pull incentive is the Pasteur Act, which is a prospective bill in Congress that authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs, provides $6 billion in appropriations for activities under the bill, and contains other related provisions.4
The challenge is this bill has been in Congress for 4 years and while there has been a building momentum driving the bill towards the end goal of becoming a law, it still is in a holding pattern.
“I believe, and Debiopharm believes, that pull incentives are the way forward, and AMR-specific antibiotic reimbursement pathways are the best way to go; however, they are very few in place,” said Jennifer Quinn, head of Global Value & Access, Debiopharm. “The ones that are in place are not finalized; and then, a lot of countries just don't—at the moment—seem to have any plans for them. So I think, as an industry, we can't just wait for that to happen; we can't rely on that happening. We have to try and work in the environment we have.”
Quinn is actively working on this significant subject, and she presented at the recent World AMR Congress. Her company is a privately-owned, Swiss-based, biopharmaceutical company working on treatments to cure cancer and treat infectious diseases. They are actively developing antimicrobial compounds for potential commercialization.
For example, Debiopharm is developing microbiome-sparing pathogen-specific FabI inhibitors, a new class of antibiotics with novel mechanism of action. Afabicin is the most advanced FabI inhibitor in the pipeline, and inhibits the fatty acid synthesis in staphylococci by targeting the Fabl enzyme.
Quinn acknowledges the differences in payer formulas in Europe and the US; however, she does see the positive aspects of pull incentives overall and the influence they can have on the development market. She cites the National Institutes of Health and Care Excellence (NICE), the payer body for England, Northern Ireland, and Wales as an example.
“I think the pull incentives that exist, like the one with NICE I think that has given manufacturers a glimmer of hope that things are going to move, and there will be pathways. So I think that's been extremely helpful, because I think we all know that there aren't that many companies out there making antibiotics, because they're not really commercially viable, and most pharmaceutical companies answer to their shareholders,” Quinn said. “I think any sort of tangible move in the market that's saying if you develop these, you will have a return on investment; you will get a certain price. It might not be such a battle.”
