The primary goal of Working to Fight AMR is closing the gap between the increasing number of drug-resistant infections and production of new antimicrobials.
A new coalition of biotechnology stakeholders has formed to promote development of new antibiotics to fight antimicrobial resistance.
The Centers for Disease Control and Prevention estimates more than 2 million Americans experience a drug-resistant infection annually, with at least 23,000 deaths. A new estimate from the Washington University School of Medicine in St. Louis puts the annual death toll as high as 162,000.
Working to Fight AMR launched in August to close the gap in the pharmacological arms race between deadly microbes and antibiotic treatments, the new coalition's director told HealthLeaders last week.
"Many procedures are only possible because of the ability to treat infection, including cancer therapies, transplantation, complex surgeries, and Cesarean sections. Unfortunately, our use of antimicrobials has prompted an evolutionary response, and we are now in a phase where we are behind the curve. Resistance is increasing, and we are not producing enough new drugs to keep pace," said Greg Frank, PhD, director of Working to Fight AMR, and director of infectious disease at the Biotechnology Innovation Organization in Washington, DC.
Several biotechnology industry leaders have joined the new coalition:
- Aleks Engel, PhD, director of the REPAIR Impact Fund at Novo Holdings
- Julie Louise Gerberding, MD, MPH, former director of the Centers for Disease Control and Prevention and executive vice president and chief patient officer at Merck
- Eric Kimble, chief commercial officer at Entasis Therapeutics
- Werner Lanthaler, PhD, CEO at Evotec
- Evan Loh, MD, CEO at Paratek Pharmaceuticals and chairman of the Antimicrobials Working Group
- Ruben Tommasi, PhD, chief scientific officer at Entasis Therapeutics
- Zachary Zimmerman, PhD, CEO at Forge Therapeutics
Broken antibiotics pipeline
The economics of antibiotics development is dysfunctional, Frank says.
"When someone develops a brand new, innovative antibiotic, the product will be reserved for the worst of all cases only when no other treatments work. You do not want to use these products indiscriminately because every time you use a product, new resistance develops. This makes it hard for industry to generate a return on investment. What we have been seeing over the past two decades is an exodus of the large pharmaceutical companies from developing antibiotics. And many of the small biotechs that are developing these products are struggling to raise the capital that they need."
The recent bankruptcy of South San Francisco, California-based Achaogen illustrates the economic problem.
Achaogen developed plazomicin, an innovative antibiotic with infection and antiterrorism applications that received government approval in 2018. The company filed for bankruptcy protection in April.
"They received approval for their antibiotic last summer and filed for bankruptcy earlier this year because they could not survive in the market given how little their antibiotic was used. They are not the only company that is in trouble. There are several other biotechs that have recent approvals that are also experiencing similar commercial challenges," Frank says.
Antibiotics are losing the antimicrobial arms race, he says. "We have a pipeline of very few products relative to the need to keep pace with resistance. There are only about 43 antimicrobials under development right now. Only a handful of those will actually reach patients given the trials and tribulations of clinical development. That is not nearly enough to stay ahead of antimicrobial resistance."
Antimicrobial policy prescriptions
Working to Fight AMR is calling for two federal policy initiatives:
1. Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act: Introduced by Sens. Bob Casey and Johnny Isakson, this bill aims to address some of the reimbursement challenges for new antibiotics, which are more expensive than most established antibiotics, Frank says.
"It creates a separate payment for qualifying innovative antimicrobials outside of bundled payments, so the hospital is made whole regardless of whether these innovative antibiotics are used. In their clinical decision-making, it will allow the people in charge of an antibiotics stewardship program at a hospital to prescribe antibiotics based on whatever they think is best for the patient rather than the cost."
2. Pull incentive: Working to Fight AMR is advocating for new financial incentives in antibiotics development.
"The new incentives would aim to provide some level of substantial financial reward to a company that develops an innovative antimicrobial that meets an urgent unmet public health need. This would be reserved for the best-of-the-best products to provide sustainable return on investment. You don't want these products to be used widely. You want to find a way to generate a return on investment that is not driven by utilization of the product," Frank says.
One of these "pull incentive" concepts is a market entry reward, where regularly installed payments would be given to a company for a period of years after approval of an antibiotic. The payments would be linked to obligations to make sure that the antibiotic is accessible, used appropriately, and produced through a stable supply chain.
"By creating a reward, it pulls products through the pipeline," Frank says.
Christopher Cheney is the CMO editor at HealthLeaders.
KEY TAKEAWAYS
As many as 162,000 American die annually because of drug-resistant infections.
Currently, the economics of developing antibiotics is problematic because new drugs are used sparingly to avoid spurring antimicrobial resistance.
Working to Fight AMR supports the DISARM Act, federal legislation that includes reforming Medicare reimbursement for antibiotics.