Half a century after helping oversee the launch of amoxicillin, one of the world’s most widely used antibiotics, Bill Burns came out of retirement to support an initiative to develop urgently needed alternatives. .
While Covid-19 has shed light on the threat posed by the new viruses, Burns is equally concerned about the underlying “silent pandemic” of antimicrobial resistance.
As chairman of the billion-dollar AMR Action Fund – which supports companies conducting late-stage experimental drug trials – he is expected to approve the first in a series of grants to fund testing next year. companies on new experimental antibiotics.
But the pharmaceutical industry veteran is concerned the fund’s efforts to provide those “push incentives” may not be enough. Many pharmaceutical groups have pulled out of the field, and several nascent biotech companies that have developed new drugs in recent years have stumbled or failed due to low revenues.
“You have a broken business model,” says Burns. “Venture capital has very little interest in supporting biotechnology companies developing antibiotics. “
However, there is a growing international dynamic to develop parallel “pull incentives” provided by governments and health systems, which would provide greater financial return to developers whose drugs gain approval.
To remain effective for as long as possible, antibiotics must be narrowly targeted: made affordable to all patients who need them, but with their administration otherwise strictly limited to avoid excessive and inappropriate use which can lead to resistance.
This requires “decoupling” the reward paid to drug developers from the income derived directly from their sales, which has encouraged over-prescribing. Instead, attention turns to a model close to insurance, with companies paying lump sums or “premiums” to compensate them for the development and storage of drugs in the hope that they will be available. but rarely used.
“We all agree that we need to rethink how this market works,” says Hubertus von Baumbach, director of German pharmaceutical group Boehringer Ingelheim and president of the European Federation of Pharmaceutical Industries and Associations. “Our systems are not designed to recognize the safety net put in place by these new antibiotics. We’re hanging on to old systems that don’t care about prevention. “
His own business has no developing antibiotics. However, its animal health division has observed the dangers of livestock developing drug resistance, which also threatens humans. He contributed $ 50 million to the AMR Action Fund, supplemented by a similar amount from his corporate foundation. “There is no doubt that in 10 to 15 years, RAM will be a huge burden on society,” said von Baumbach.
Longer term, he hopes Boehringer Ingelheim can apply his expertise in immuno-oncology drugs – the science of harnessing a patient’s immune system to fight tumors – to fight bacterial infections. But, for now, his attention is focused on efforts to boost the incentives available in Germany, as well as across the EU and among the G7 group of wealthy industrialized countries.
there are still discrepancies on the scale of rewards required and the structure they should adopt. The pharmaceutical industry has advocated for “transferable exclusivity vouchers,” for example, which would allow them to extend patent exclusivity and revenues on other drugs as a reward for antibiotic development.
Meanwhile, recent regulatory changes in Germany – which will take over the G7 presidency next year – mean more expensive innovative antibiotics to treat the most troubling infections should be able to be approved more easily. Previous regulations prioritized the use of cheaper, existing – and sometimes less well-targeted – generic drugs.
New approaches are also being tested in Sweden. A program now offers a guaranteed annual lump sum payment to producers of antibiotics regardless of the amount prescribed.
In the UK, the National Institute for Health and Care Excellence, the drug watchdog, is expected to reveal early next year the results of its pilot program offering significant additional incentives for two new antibiotics. Likewise, in the United States, there is growing political support for legislation to support even larger rewards,
And, early next year, the European Commission will announce the outcome of a call for tenders for new approaches to antibiotic development and supply, as well as the outcome of consultations on new financial incentives.
During Britain’s G7 presidency this year, Dame Sally Davies, the former chief medical officer, pushed for wider recognition of the importance of both antimicrobial resistance and new financial mechanisms to help deal with it with new drugs. She also cited essential preventive measures – from developing vaccines to stricter use of existing drugs and cracking down on counterfeits.
“We were very successful in declarations and for the first time we engaged the finance and health ministers,” she said. “But it turns out to be difficult. We have to go as far as possible and we always work until the last moment before handing over to Germany.