LOS ANGELES — Superbugs, and our dwindling arsenal of drugs that can successfully combat them, are a serious public health concern. The private sector, however, is largely unwilling to take on the financial risk of developing new drugs that could help. Those treatments bring little if any profit.
But what if U.S. policymakers upended the incentive structure for developing new therapies? What if, for instance, drug makers were granted additional exclusivity in certain situations?
Increasingly, the idea of rethinking models for antibiotic development is animating industry leaders and policy wonks eager to find new tools to combat superbugs.
“We’re in a time of growing nationalism, but this is a global problem,” said former Food and Drug Administration Commissioner Dr. Margaret Hamburg, who was part of a panel discussion on the issue earlier this week at the Milken Institute Global Conference. “This will require global coordination, and strategic thinking and action.”
The market for combating superbugs, in theory, is substantial. In the U.S. alone, some 2 million people are infected with antibiotic-resistant strains of bacteria annually, and 23,000 people die. Globally, about 700,000 people die each year thanks to antimicrobial resistance, according to a UN committee report. By 2030, the authors believe superbugs may kill up to 10 million people each year.
Yet companies continue to bow out of the antimicrobial field.
“It’s a market failure that companies aren’t investing in antimicrobial resistance,” said Gates Foundation CEO Sue Desmond-Hellmann, who spoke on the issue at the conference.
The traditional drug development pathway doesn’t seem to be sufficient. Take the case of Achaogen, a San Francisco biotech that won one of the first antibiotic approvals in decades last year. Despite its novelty, plazomicin (Zemdri) generated sales less than $1 million; Achaogen filed for bankruptcy just a few weeks ago.
The financial challenges underline one of the ironies around antibiotics: Although they’re sorely needed, they will only be most effective if they’re used sparingly — for the most critical of cases.
“We want biotechs and pharma to create new products, but we don’t want them to sell any,” said Peter Jackson, executive director of the AMR Center, a U.K.-based accelerator to help develop new antibiotics and diagnostics.
Finding new ways to spark enthusiasm — and investment — in tackling these ever-evolving pathogens is still very nascent. But experts agree that it’ll involve a public-private partnership: Government entities, investors, and the industry will have to work together to find better treatments.
The key is to approach the issue of incentivizing biopharma with more ambition, said Amitabh Chandra, director of health policy research at the Harvard Kennedy School of Government.
Companies typically get five years of market exclusivity if they develop a new chemical entity. If a drug treats a rare disorder, however, they’ll get seven. Such incentives could be written into law to help in the case of global public health crises, like antimicrobial resistance.
If a company develops a gene drive to eradicate malaria, Chandra said, saving 500,000 people who might otherwise have died from the disease, give it 30 years of exclusivity on the technology — not just five.
“You need imagination on that scale to reduce the burden of disease,” Chandra said.
Jackson suggested that transferable market exclusivity vouchers may be another tool to incentivize biopharma to reenter the antimicrobial market. That is, if a company develops an effective antibiotic or antifungal drug that can indeed tackle superbugs, give it bonus exclusivity years — but allow it to transfer that to a different, and potentially more profitable, drug in its pipeline.
Chandra suggested, too, that the stipulations for doling out extra market exclusivity could be created in advance by regulators. If a drug reduces overall spending by a predetermined amount, for instance, the market exclusivity could be extended a year. If it improves symptoms of a disease by a certain percentage, perhaps the exclusivity could be extended even more.
The idea, according to the Harvard economist, is that rewarding companies for their drug’s overall efficacy, and broader impact on global health, might allow them to ultimately profit enough that they’ll want to invest in the initial research and development in the first place.
One thing that the experts agree on: Antimicrobial resistance isn’t a problem that industry can tackle alone.
“This really needs a societal approach. It has to be at the top of political agendas,” said Dr. Peter Piot, director of global health at the London School of Hygiene and Tropical Medicine. “It’s a threat to our survival. It’s as simple as that.”