While focus is on the global deaths from COVID-19 crossing the six lakh mark, we have lost seven lakh people to antimicrobial resistance (AMR) each year, which is why more than 20 biopharmaceutical companies recently announced the launch of the AMR Action Fund that aims to bring two to four new antibiotics to patients by 2030. Silas Holland, Interim Director – External Affairs, AMR Action Fund explains to Viveka Roychowdhury how the collaboration will support small biotech firms involved with promising antibiotic R&D as well as with governments, not lobbying for specific legislative changes but participating in the broader debate about AMR and the need to support sustainable investment in antibiotic R&D

Research on new antibiotics does not get funding as the market is limited due antibiotic stewardship programmes to prevent overuse as well as increasing patient awareness on the harms of self-medication. In fact, most of the 20 bio-pharma companies that are partnering with the AMR Action Fund to put up this new investment of $1 billion have abandoned or contracted out their antibiotic research programmes for this reason. How will the Fund address this issue?

We know that collaboration will be critical to address the global AMR crisis. The AMR Action Fund investors include both companies that continue to invest in antibiotic R&D (e.g., MSD, Pfizer, GSK) and those that do not – including some that were once active in this space but exited due to the market challenges (e.g., Lilly, Novartis).

Many of the exciting and innovative products in the antibiotic pipeline are being developed by small biotech companies. So, this is where the AMR Action Fund will focus its investment. However, because developing antibiotics is a long, complex and expensive process and there is no viable market for new antibiotics, many of those small companies struggle to secure the necessary funding to cover the challenging later stages of 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.

With the AMR Action Fund, the pharma industry is stepping up to support these biotechs with funding and expertise to strengthen and accelerate antibiotic R&D. Nevertheless, in order to ensure that we have a sustainable market in the long-term, policymakers need to take action too, by enacting market-based reforms that create an environment where antibiotic R&D can flourish. We believe that by bringing together a broad alliance of industry and non-industry stakeholders, including philanthropies, development banks and multi-lateral organisations, the AMR Action Fund can help encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline. These policy reforms will address the underlying market challenges for antibiotics that led to the larger companies exiting antibiotic R&D and bankruptcies of the antibiotic-focused biotechs.

The AMR Action Fund aims to bring two to four new antibiotics to patients by 2030. The Fund is expected to be operational during the fourth quarter of 2020. What are the milestones to the 2030 goal? Does the Fund already have a few candidates, in terms of companies or investigational candidates, in their sights? What is the expected financial commitment per biopharma partner?

The AMR Action Fund is a true collective industry initiative, bringing together more than 20 innovative pharma companies of different sizes from around the world. Companies voluntarily set their investment level and committed up to $100 million. Beyond funding, the AMR Action Fund will also provide technical support to portfolio companies, giving them access to the deep expertise and resources of large pharma companies, to strengthen and accelerate antibiotic development. This “in-kind” support is in addition to the cash investments already raised.

The AMR Action Fund will invest in smaller biotech companies focused on developing novel antibiotics that address the highest priority public health needs (based on WHO and US CDC lists of priority pathogens), make a significant difference in clinical practice and save lives. Our investments will be guided by an independent Scientific Advisory Board, comprising world-class experts. More information on the investment process will be available once the Fund becomes operational during the fourth quarter of 2020 (expected).

You mentioned that the AMR Action Fund intends to work with governments to ensure there is a sustainable pipeline of new antibiotics. Could you give us more details on what will this possibly entail?

The AMR Action Fund will bring together a broad alliance of industry and non-industry stakeholders, including philanthropies, development banks and multi-lateral organisations, and help encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline. The AMR Fund will not lobby for specific legislative changes, but will participate in the broader debate about AMR and the need to support sustainable investment in antibiotic R&D.

What role does the new AMR Action Fund envisage for countries like India in terms of research and development of new antibiotics, and in terms of long-term policy solutions to build a sustainable antibiotic pipeline?

The AMR Action Fund is open to making investments in biotechs in any country, including India. If an India-based biotech has a product that meets the AMR Action Fund’s criteria and is recommended for investment by the Scientific Advisory Board, it will be considered for investment.

All countries have a role to play in supporting appropriate access and innovation for novel antibiotics – and there is no one-size-fits-all solution. The AMR Action Fund would be happy to work with all relevant stakeholders to determine the appropriate long-term policy solutions in India.

AMR levels are expected to rise due to over/misuse of antibiotics, both by doctors as well as potential patients during the COVID-19 pandemic. How will the launch of the AMR Action Fund address the issue that having new antibiotics may not be the only solutions to address future infections?

The AMR Action Fund takes the issue of responsible use seriously, and is committed to ensure that the novel antibiotics it invests in are used appropriately. Through its investments and capability platform, the AMR Action Fund will ensure that company activities are aligned with the appropriate use goals. However, even with appropriate use, bacteria will continue to evolve and develop resistance to antibiotics. Staying ahead of this growing threat requires ongoing innovation and a functioning innovation ecosystem. It is the focus of the AMR Action Fund to address this problem, beginning to rebuild the global antibiotic pipeline while working across the ecosystem to support long-lasting solutions.