Antimicrobial resistance (AMR) happens when microbes such as bacteria, viruses and fungi change over time and stop responding to medicine. Their failure to respond makes it harder to treat infections, potentially resulting in spread, serious illness or death.

In today’s AMR drug discovery sector, pharmaceutical companies find it challenging to profit from new innovative drugs because, rightfully, hospitals reserve these drugs for only advanced cases. As a result, the current approach reduces the financial incentive to make these drugs, contributing to global concern about AMR infections and their impact.

Legal guidance on AMR returns

On 27 April, the Pasteur Act, which deals with AMR and is sold as a bipartisan legislation to combat superbugs, was reintroduced into the US Senate. A core focus, this time around, is to jumpstart antibiotic development with a new payment model for novel treatments alongside improving how existing antibiotics are prescribed.

The bill would establish a subscription-style model where the government enters into contracts with antibiotic developers, paying upfront for access to however much or little of the treatment patients need. Under the bill, antibiotics would be sold based on their value to public health rather than enough volume to recoup development costs. A similar model was adopted by the UK National Health Service on a pilot scale, and with talks ongoing to potentially expand it.

Reason for reintroduction

The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) recognize AMR as one of the world’s most urgent public health threats. “The reintroduction of Pasteur reflects the increasing urgency of – and attention to – the crisis of AMR,” says Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO).

Antibacterial-resistant infections played a role in five million global deaths in 2019, the United Nations said in its 2023 report, “Bracing for Superbugs”, and superbugs are on track to kill ten million people annually by 2050 if there is no course correction soon.  

“This legislation is one of the most impactful solutions to bring forward much-needed innovation within the antimicrobial research and development (R&D) ecosystem and help save lives from superbug infections,” Wheeler continues. “The AMR threat is here, and we are unfortunately seeing that truth more than ever, as a nation and as a world,” Wheeler adds.

The Pasteur Act

The Pasteur Act is intended to increase public health preparedness by bringing novel antibiotics to the US and improving appropriate use across the healthcare system. “If passed, this legislation will encourage desperately needed innovation in a frequently underfunded category,” says Gareth Morgan, senior vice president, Global Portfolio Management and AMR Policy, Shionogi.

If introduced, the Act strives to help align market incentives with innovation by creating a new alternative payment model for antimicrobials, targeting the most threatening infections.

The proposed Act would also, Wheeler continues, “provide much-needed reinvigoration of the antimicrobial pipeline while enabling a business model centred around the appropriate use of these medicines”.

Under this model, the government would enter into contracts with developers to pay for the availability of novel antimicrobials that meet unmet needs. “By establishing subscription-style contracts, the Pasteur Act would address the market failure in the antimicrobial resistance space and increase public health preparedness by keeping novel antibiotics on the market and improving appropriate use across the healthcare system,” Morgan details.

Under these contracts, payments are decoupled from the volume of antimicrobials used, so innovators can earn a more reliable return on their investment (ROI), while clinicians can focus on prescribing these novel products appropriately based on patient needs.

Adequate financial incentives?

The sponsors of the Pasteur Act have consulted experts to ensure it will provide sufficient financial incentives to address the issue. Based on modelling by AMR experts, the contract values in the recently introduced Pasteur Act, contracts between $750 million to $3 billion, “are within the appropriate range for an effective antimicrobial pull incentive”, says Wheeler.

“Making this investment will help ensure clinicians have the therapeutic tools they need to treat life-threatening bacteria and fungi, diminishing the patient and economic impact of AMR infections,” Wheeler adds.

Upfront funding for the Pasteur Act is also a meaningful initial investment to begin achieving policy objectives as a first step toward the amount of funding ultimately required to ensure an ongoing sustainable and robust antimicrobial R&D pipeline.

“Importantly, the initial investment would also signal that the US government is committed to providing a sustainable and impactful solution to drive much-needed R&D to address AMR,” Wheeler continues.

Passing the Pasteur Act

Feedback to date is promising, but there have been no updates since the bill was introduced in late April. “Bipartisan support has been building steadily; the hearing on 27 April demonstrated unanimity of support for the need for action,” emphasises John Rex, chief medical officer and director at F2G and former expert-in-residence at the London-based Wellcome Trust.

Earlier in 2023, over 230 organisations representing healthcare providers, patient groups, and the pharmaceutical and diagnostic industries sent a letter to Congress supporting the bill and called for action on the legislation later in the year. “We are seeing more momentum to address the superbug crisis than ever before,” says Wheeler.

Impact on the pharmaceutical industry

At least 18 major pharmaceutical companies were involved in antimicrobial development in the 1980s, Wheeler says, before emphasising that by 2019, it was down to just three. Ultimately, Rex affirms that the bill “evens the economic playing field for antibiotic developers”.

“It is small biotech companies that drive most of the innovation today and take on enormous financial risk, with many going under after gaining US Food and Drug Administration (FDA) approval for their treatment,” says Wheeler.

The approach brings the hope that it will not only sustain the few companies still actively working on new antibiotics to address AMR but also motivate others to reinvest in antibiotic R&D. “Reinvestment will also motivate talented researchers to work on new and innovative antibiotics, stemming the current ‘brain drain’ to other therapeutic areas,” Morgan details.

If introduced, the legislation seeks to help repair the broken antimicrobial ecosystem and restore confidence in developers’ ability to remain financially viable while bringing forward novel, life-saving antimicrobials to patients.

“AMR will only get worse if we don’t act now,” Morgan highlights. “Passing [the Pasteur Act] will establish the US as a leader on this issue and could motivate other countries to introduce similar legislation,” Morgan concludes.

Source: pharmaceutical-technology.com