Mediaroom

AMR life sciences industry 2020 report: Successes and setbacks in fighting superbugs

AMR Industry Alliance reports breakthroughs in the responsible manufacturing of antibiotics and positive steps to improve how patients access and use antibiotics. But its report also highlights concerning levels of research and development (R&D) investment.

Alliance records US1.6B annual investment (in 2018) in antimicrobial resistance (AMR)-relevant R&D. Concerning shortfall is in late stage R&D investment where the amount is likely insufficient to meet global health needs and risks undermining early pipeline investments in R&D and new diagnostics. Investments in AMR related products could increase if governments take action to improve antibiotic reimbursement and implement new incentives.
Alliance takes leadership role in responsible manufacturing of antibiotics, establishing an industry standard for reducing potential environmental risks from antibiotics production two years ahead of schedule.
Next steps include sharing R&D information to support innovation and surveillance data to track resistance, deploying diagnostics and vaccines in support of improved appropriate use and working with health authorities to tackle antibiotic shortages.

16 January 2020, Geneva – AMR Industry Alliance report released today provides a unique snapshot of the life science industry’s collective efforts in delivering on their commitments to tackle the rise of antimicrobial resistance (AMR). Results from the Alliance’s survey of biotech, diagnostics, generic and large research-based biopharmaceutical companies are mixed. Positive results include sustained investment in early R&D and diagnostics for AMR-related products (including antibiotics, antifungals, vaccines) and major strides in responsible manufacturing of antibiotics. Worryingly, low levels of investment for later and more costly stages of R&D for AMR-related products may mean that many promising early-stage compounds will never reach patients unless governments put in place new mechanisms and incentives for antibiotic development.

Taken together, Alliance biotech, generic and large research-based biopharmaceutical companies represent approximately one third of the global antibiotic supply, a significant proportion of antimicrobials in clinical development as well as a major segment of the diagnostic sector working on developing and producing AMR-related products.

Top-line findings for the Research and Science section record confirm that the life sciences industry remains the dominant funder of AMR-relevant R&D with US1.6B invested in 2018. By comparison, the public sector invests ca. US500M annually in AMR-relevant R&D. The Alliance warns that R&D investments are at concerning levels in the most costly later stages of clinical research. This contrasts with a promising biotech pre-clinical pipeline and new rapid infection detection tests being developed by diagnostics companies. Policy action is needed to ensure these compounds reach patients: 74% of companies surveyed for the Alliance report are likely to increase investments in AMR if commercial models improve. Alliance members are eager to find partners in piloting new reimbursement mechanisms and incentives that improve patient access and enable sustainable private investment in the development of new tools to tackle AMR.

Thomas Cueni, Chair of the Alliance, declares: “Our report showcases the diverse range of activities that biotechnology, diagnostics, generics, and large research-based biopharmaceutical companies are undertaking to combat the spread of AMR”. He warns, however, that the findings are “a wake-up call as the reported investment of US1.6B in 2018 in AMR-relevant R&D is likely insufficient to sustain a viable pipeline. Discovering new and effective ways to leverage positive preclinical pipeline results and working together to ensure that late-stage antimicrobial drug discovery and development is better supported are vital”.

Noting the strides the Alliance is making on its manufacturing commitments as well as in securing better access to life-saving antibiotics for patients all over the world, Cueni says: “This demonstrates that working collectively can be a powerful platform for change”. He adds: “There are good reasons to be optimistic about the Alliance’s active and growing engagement with AMR”.

5.7 million people die from treatable bacterial infectious diseases due to lack of access to antibiotics, which far exceeds the estimated annual 700,000 deaths from antibiotic resistant infections. Top-line findings for the Access section highlight how Alliance companies are committed to improving patient access to appropriate, high-quality antibiotics and vaccines along with diagnostics that can help avoid drug-resistant infection or detect and better treat them.

Similarly, results in the Appropriate Use section underline that members are continuing to advance innovative ways to support antimicrobial stewardship. All companies reported taking a wide range of measures to promote appropriate use of antibiotics in order to slow the emergence of resistance, prolong the effectiveness of antimicrobials and improve patient outcomes.

Manufacturing accounts for a small proportion of all antibiotic emissions to the environment but poorly controlled discharges can lead to active residues in the immediate surroundings of production sites that may increase the risk of AMR developing. In the Manufacturing section, the Alliance reports that members are two years ahead of schedule in establishing an industry standard (framework) and predicted no-effect concentrations for reducing the potential environmental risks from antibiotic production. The Alliance has set out a common framework for responsible antibiotic manufacturing. So far, the findings show that over 80% of participating companies’ antibiotics manufacturing facilities meet or partially meet the framework’s requirements and have shared these with more than 400 suppliers. The Alliance will continue to reach out to other manufacturers to join its ranks or commit to implementing this new industry standard so as to ensure the continued supply and responsible manufacturing of antibiotics.

The Alliance outlines how members and the broader life science industry can contribute further in future. This includes accelerating sharing R&D information and surveillance data. The Alliance proposes areas where new or deeper partnerships with governments, patients and providers are required (such as for R&D) as well as plans to strengthen local healthcare and laboratory capabilities for the effective diagnosis and treatment of drug-resistant infections.

Alliance members hope that this report will encourage others in the life science sector to join their ranks and that their proposals for next steps can encourage greater collaboration in combatting the spread of AMR. The Alliance will host a high-level meeting to discuss these findings with the AMR global health community in early March 2020.

For more information, please contact:

Magdalena Babinska

m.babinska@AMRindustryAlliance.org
+41 79 309 4998

Acumen public affairs
abigail@acumen-publicaffairs.com
+32 475 41 09 76

Kate O’Regan
Medicines for Europe
koregan@medicinesforeurope.com
+32 2 2392019

Unjela Kaleem
IFPMA
u.kaleem@ifpma.org
+41 22 338 32 00

Andrew Segerman
Biotechnology Innovation Organization (BIO)
asegerman@bio.org
+1 202 747 1281

Jon Dobson
AdvaMed
jdobson@advamed.org
+1 202 434 7272

About the AMR Industry Alliance

The AMR Industry Alliance was formed in 2017. With approximately 100 life sciences companies and trade associations, it represents nearly one third of the volume of sales and the majority of all novel products. Members have committed to report on activities they are undertaking in the areas of research & science, access to antibiotics and appropriate use of these, as well as responsible environmental manufacturing to tackle the rapid spread of antimicrobial resistance. If AMR remains unchecked, the annual death toll could climb from 700,000 each year to 10 million by 2050 and the economic impacts could be on par with those of the 2008 financial crisis. The AMR Industry Alliance ensures that signatories collectively deliver on the specific commitments made in the Industry Declaration on AMR and the Roadmap and measures progress made in the fight against antimicrobial resistance.

AMR Industry Alliance 2020 Progress Report

AMR Industry Alliance 2020 Executive Summary

AMR Industry Alliance Case Studies

About SustainAbility

The report was compiled by SustainAbility, a consultancy and think tank enabling business to lead on the sustainability agenda.

www.sustainability.com

date 16/01/2020

There are encouraging results in the pre-clinical pipeline of biotechnology firms, and new rapid detection tests are also being developed by diagnostics companies. Our industry is on the cutting-edge of science and innovation and as we look to protect society from multi-drug resistant superbugs, we’ll need every tool available to us. These positive developments appear to be in line with reported increases in levels of investment in the diagnostics and biotechnology sectors.

Biotechs: Gregory Frank, Director of Infectious Disease Policy at Biotechnology Innovation Organisation (BIO)

All over the world, the overuse and misuse of antibiotics are rapidly accelerating the pace at which antimicrobial resistance develops and spreads. There is an urgent need to preserve existing and new antibiotics by developing and implementing more robust user guidelines; this in turn depends on broader access to, and use of, diagnostics and surveillance tools. Donors and governments will need to provide greater support in appropriate prescribing practices in countries, communities, and hospitals, with particular emphasis on making the right tools available and accessible in low-resource settings.

Diagnostics: Cecilia Ferreyra, AMR Medical Officer, FIND

Advancing the diagnostics pipeline is a crucial element of industry solutions and responses to AMR, helping to improve patient health in countries all around the world. The report records a vibrant pipeline for new rapid infection detection tests that are being developed by diagnostics companies. In Vitro Diagnostic manufacturers of the Alliance have demonstrated how development and effective deployment of diagnostics tests and technologies enable early identification of resistant infections optimizing clinical use of antimicrobials for patients while generating quality surveillance data to monitor AMR-related trends on national and global levels.

Diagnostics: Susan Van Meter, Executive Director at AdvaMedDx

The actions of the Alliance are driving positive change across all sectors, including the generics industry. The Alliance is engaged in efforts to collaborate with local health authorities and policy makers to explore and support initiatives that will strengthen sustainability of the antimicrobial product market, improve supply chain security, and reduce drug shortages for AMR-relevant products. We will be looking at initiatives that could include improvements to contracting practices and incentives for investing in responsible manufacturing and continuity of supply.

Generics: Alba Tiley, Sustainability Director at Centrient Pharmaceuticals

We need to be mindful not to abuse the new drugs currently in development. To that end, investment in solutions that promote prevention, including vaccines, and appropriate use, including diagnostics, is needed at a level commensurate with the investments in revitalizing the antibiotics pipeline. The Alliance should be applauded for its work to move the needle on antibiotic reimbursement and for its continued support for investment in R&D in challenging circumstances.

Kevin Outterson, Founding Executive Director, CARB-X

Members of the AMR Industry Alliance are firmly committed to minimizing antibiotic residues in manufacturing discharges by improving environmental and wastewater management systems. Having established the Common Antibiotic Manufacturing Framework in 2018, 83% of Alliance antibiotic manufacturing company members report that they had assessed all of their own antibiotics manufacturing sites against the common framework. Medicines for Europe has signed up to the manufacturing framework and associated predicted no-effect concentrations used to determine discharge targets as a condition of membership for all our generic company members that manufacture and supply antibiotics.

Koen Laenen, Medicines for Europe, Regulatory Affairs and Quality Manager

The Alliance’s manufacturing framework and discharge targets mark a significant step forward in reducing antibiotic impacts in the environment. These initiatives, developed considering current scientific understanding, are already having an impact. However, there is still work to do to ensure full adherence to the framework within this timeframe. Alliance members must continue to refine and update the framework and targets as new scientific knowledge becomes available; and should work to encourage non-member manufacturers to adopt the new standards.

Manufacturing: Alistair Boxall, Professor of Environmental Science, University of York

In this second biennial report, Alliance members provide detailed survey data that give a valuable snapshot of industry progress on AMR and show some encouraging areas of progress and innovation.

Finding ways to accelerate R&D investment, expand access to quality-assured antimicrobials and vaccines, and promote novel diagnostic tools and technologies as a means of cutting unnecessary use is of utmost importance. On these fronts, governments, industry, and other stakeholders must work together, pulling out all the stops to put in place more effective regulations, improve market mechanisms and incentive systems, leverage existing stewardship and prevention strategies, and further strengthen public-private partnerships. I look to the AMR Industry Alliance to play its part at the forefront of these efforts.

Professor Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance and co-convener of the UN Interagency Coordination Group on AMR

Our report showcases the diverse range of activities that biotechnology, diagnostics, generics, and large research-based biopharmaceutical companies are undertaking to combat the spread of AMR. However, the reported investment of US1.6B in 2018 in AMR-relevant R&D is likely insufficient to sustain a viable pipeline. Discovering new and effective ways to leverage positive preclinical pipeline results and working together to ensure that late-stage antimicrobial drug discovery and development is better supported are vital.

R&D Pharma: Thomas Cueni, Director General of IFPMA

While the overuse of antibiotics makes headlines as an emerging global threat, the high death toll from the lack of access to antibiotics is a public health crisis today. Why is this so? The culprits are numerous, ranging from supply chain storage, transportation, and oversight issues to in-country regulatory hurdles, poor medical facilities, lack of local manufacturing, and high patient co-pays. Overcoming these barriers will take concerted action from governments, pharmaceutical companies, healthcare institutions, and international public health bodies.

Ramanan Laxminarayan, founder and director of the Center for Disease Dynamics, Economics & Policy CDDEP