The AMR Innovation Challenge

01

Our world faces a silent, slow-moving global threat that kills around 700,000 people each year due to the uncontrolled rise of superbugs resistant to antibiotics. These superbugs can affect anyone, of any age, in any country. AMR is a universal issue that impacts us all – we are all at risk.

This looming global crisis has the potential to be as large or even larger than COVID-19 in terms of deaths and economic costs.

 

AMR undermines every aspect of modern medicine

We rely on the availability of effective antibiotics to be able to do everything from wisdom tooth extractions to organ transplantation to cancer chemotherapy.

Superbugs could set medicine back to the 19th century, before the discovery of penicillin, when simple infections could kill.

Now is the time for action

Though AMR is a long-established and slow-moving threat, it is no less dangerous than the COVID-19 pandemic impacting the world today.

As we’ve seen with COVID-19, we are all still vulnerable to infectious diseases – and, as we scramble to find treatments and vaccines for COVID-19, we see the huge economic and public health costs from a lack of preparedness. Ultimately, being prepared is more cost-effective in the long run.

Whereas the new coronavirus was not known until early January 2020, AMR is a threat we know. It is here now and only increasing. We know the priority pathogens for which there is an urgent need for new treatments, and AMR has been on the political agenda for years.

AMR is a predictable and preventable crisis. We have a critical opportunity to get ahead of it.We must not waste it.

02

Next-generation antibiotics are vital for humanity, but – right now – there are not enough of these valuable tools in development

Given the nature of resistance, we will always need new antibiotics. However, drug resistant bacteria are developing faster than new antibiotics can reach the market.

And today, there are too few antibiotics in clinical development to meet current and anticipated needs, according to a recent assessment by the Pew Charitable Trusts. Most of these compounds are being developed by small biotechnology companies.

A Breakdown of the Issue:
1

There is no viable antibiotic market
Developing antibiotics is a long, complex and risky process, and many in development fail along the way. Once new antibiotics are approved, they are used sparingly to preserve effectiveness and slow the development of further resistance. While this makes sense for public health, it doesn’t support the level of investment needed to maintain a robust antibiotic pipeline. What’s more, despite the huge societal costs of AMR, our health care systems do not recognize the value of new antibiotics.

2

Late-stage investment is limited
Without a viable antibiotic market, biotech companies developing new antibiotics are unable to find financing for clinical development, meaning important antibiotics may never overcome the “valley of death” to reach the patients who need them. Recent initiatives that provide funding for early-stage research have contributed to improving the pre-clinical antibacterial treatment pipeline. However, without support and investment in the more complex, expensive later stages of development, these compounds will wither on the vine.

3

The fragile antibiotic pipeline is close to collapse
There are few new antibiotics in clinical development. In recent years, a number of antibiotic-focused biotechs have declared bankruptcy or exited this space, despite having successfully developed new antibiotics, due to the lack of commercial sustainability, resulting in the loss of valuable expertise and resources.

We must take action now to respond to a pressing global public health crisis and create a sustainable antibiotic market.
03

Market-based policy reforms are urgently needed to drive sustainable investments in antibiotic R&D

There is broad agreement that market-based policy reforms, including reimbursement reform and new pull incentives, are needed to create market conditions that enable sustainable investment in antibiotic R&D.

Decisive government action is needed to revitalize the antibiotics market to ensure the antibiotic pipeline meets the needs of patients.

No single action is going to solve this problem

Policymakers across the globe must enact market-based reforms to create an environment where antibiotic R&D can flourish for decades to come.

A number of different solutions have been discussed that have the potential to drive additional R&D investment. These should be worked up further and implemented or tried out by governments in different countries. There isn’t a single solution that will work everywhere around the world.

Market entry rewards, subscription models, and other novel incentives, which provide a certain level of economic return based on the value a new antibiotic brings not the volume used, could help drive innovation.

Reforms to the way antibiotics are reimbursed and valued, reflecting the unique characteristics of antibiotics, are needed to enable appropriate access and stabilize the economics of antibiotic R&D.

04

Putting the necessary policy reforms in place will take time

Until then, it is up to all of us – public and private sector combined – to take action now to sustain the current pipeline of effective new antibiotics to safeguard our future.

The pharmaceutical industry is stepping up with nearly US$1 billion to bridge the gap and respond to the AMR threat. The Fund aims to bring 2-4 new antibiotics to market this decade that will save patient lives. The AMR Action Fund will bridge innovative candidates in the pipeline through the most challenging later stages of drug development, ultimately providing governments time to make the necessary policy reforms to enable a sustainable antibiotic pipeline.

To make this work, all stakeholders must come together to unleash innovation
The AMR Action Fund expects to invest more than US$1 billion with the support of future partners, such as:
1
Development banks
2
Philanthropic organizations
3
Multilaterals and strategic partners
4
Other impact funds

Forming this broad alliance of industry and non-industry stakeholders will allow us to work together to respond to a pressing global public health crisis and encourage governments to create market conditions that enable sustainable investment in the pipeline.