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With AMR contributing to millions of deaths and costing the global economy billions of dollars, Najy Alsayed, Head of Infectious Diseases at Menarini emphasises the urgency in fighting the AMR threat, where microorganisms develop resistance to antimicrobial medicines. While warning that the model to produce novel antibiotics is broken, we continue to work with authorities on implementing potential solutions, should the political awareness be translated into decisive actions.

AMR threat

Menarini is a mid-sized European pharmaceutical company focusing on oncology, cardiovascular and respiratory and infectious diseases. Alsayed sees three major elements to the AMR threat: life-threatening clinical impact; associated rising healthcare costs; and a threat to the future progress of modern medicine.

Pointing to a 2019 paper in The Lancet which showed 4.95 million annual AMR deaths globally (a figure which could rise to 38.5 million by 2050), he adds: “We must take decisive actions to curb this accelerating threat.”

Healthcare-associated costs of USD66 billion a year are projected to rise to USD1.2 trillion by 2050, but he is particularly concerned about the impact on patients. In one example, he fears that half of organ transplant patients will be affected by an AMR-related infection due to their immunocompromised systems, and 30–40% of these patients will die as a result.

Broken model

At present, he believes there is a “broken model” against tackling AMR, with constraints on the availability of novel antibiotics to clinicians and patients. Of 16 antibiotics approved in the last decade, only two are available in high-income countries, with access further limited in low and middle-income countries.

“That access is constrained because of the failure of the current model,” says Alsayed, pointing to development costs and little investment, meaning novel antibiotics are becoming not commercially viable in many countries and to the patients who need them the most, even in countries where these antibiotics have already been launched.

Lessons can be learned from how the orphan diseases crisis has been successfully addressed over the past 25 years. Facing similar challenges to novel antibiotics, with poor patient access, commercial viability and sustainability — alongside lack of investments attractivity — the action taken, through the designated Orphan Medicine EU-Legislation, has led to significantly improved patient access, pipeline and investments, boosting orphan medicines for patients with rare diseases.

Emerging solution

Another positive step comes from the Italian reserved antibiotics model, announced during the G7 meeting in June 2024. It acknowledged the “significant and accelerating threat of AMR and the need for novel antibiotics.” Under this, Italian policymakers and government created an antibiotic patient access model through which novel antibiotics will be “evaluated, priced and reimbursed” and “patient access will be facilitated accordingly.”

He also highlighted that RDTs (rapid diagnostic tests) are important in ensuring novel antibiotics are promptly and appropriately delivered to patients. With pharmaceutical companies like Menarini collaborating with biotech companies, he believes that through the collaborative efforts and partnerships — alongside governments and EU policymakers, pharma industry, patient associations and other key AMR stakeholders — decisive solutions will emerge to address both the current broken model and patient access failures.

Antimicrobial resistance threatens treatment progress and the lives of cancer patients

A cancer advocacy group warns that data relating to antimicrobial infections (AMI) in cancer patients is being under-recorded in hospitals across Europe.

Cancer Patients Europe (CPE) believes the risk posed by antimicrobial resistance (AMR) in cancer care is being overlooked and that the cause of death in cancer sufferers often fails to reflect the fact that an antibiotic resistant-related infection killed them rather than their underlying condition.

Infection risk

��CPE’s CEO Antonella Cardone says: “AMR is a priority for us because it is significantly impacting cancer patients; data shows that 50% of all cancer deaths are due to antibiotic-resistant infections, which could not be treated.”

She adds: “We cannot ignore this, and the situation is worsening to the point that, as cancer treatments impact the immune system of individuals, there is the risk that soon the use of traditional cancer treatments like chemotherapy will be compromised���� due to the infection risk.”

CPE — a pan-European patient organisation with 70 members from 29 countries and working on research, advocacy and delivering a united voice for the cancer community in Europe — highlights further data suggesting that cancer patients are up to three times more at risk of developing an infection compared to patients without cancer.

AMR data capture

��Cardone and leading oncologists fear that such high levels of infection risk could undermine innovations such as CAR T-cell therapy and other immunotherapies. An additional concern is a lack of capture of AMR as a cause of death; when an oncology patient suffers an AMR-related death, the cause is still often recorded as cancer-related.

“This is because when people enter the hospital or a treatment pathway, they enter as cancer patients. When they die, the death is recorded as cancer rather than considering that the reason that caused the death in the end was the infection,” she adds.

“We strongly believe that if this alarming data were shown in hospital records, there would be greater attention to the topic of AMR and to the urgent need to take decisive actions by policymakers.”

Emotional burden

��There is also an overlooked AMR-associated emotional burden impacting patients and families as they go through their challenging cancer treatment journey. “The risk of an infection puts a huge psychological burden on patients and families because they then tend to isolate themselves,” she says. “They avoid going to work or having a social life, but this is a vicious circle because people become depressed, which aggravates the entire situation.”

To help address this, we want more attention to be given to the prevention of infections, identifying novel effective antibiotics, as well as making them accessible to all those patients who need them most.

Biotech investment aims to tackle global AMR threat crisis

Policymakers have been warned that a USD1 billion fund to support development of new antibiotics is only a ‘temporary stopgap’ while urgently awaiting more robust market solutions to take place.

A groundbreaking fund is helping support smaller biotech firms in the race to develop antibiotics to combat antimicrobial resistance (AMR).

Funding for AMR solutions

The AMR Action Fund is investing USD1 billion in companies that are developing urgently needed antibiotics targeting bacteria and fungi that the World Health Organization has deemed a priority because of the significant morbidity and mortality they bring.

However, CEO Henry Skinner warns that the fund is only “a partial and temporary stopgap” to the problem and is “buying time” for policymakers to deliver more permanent market solutions.

Developing promising antibiotics

��With AMR being one of the world’s leading health challenges, new antibiotics are desperately needed to treat superbugs. However, due to a lack of return on investment, investors have abandoned this area, and the pipeline of treatments is almost dry.

He explains: “Our focus is on supporting companies that are developing the most promising antibiotics in terms of potential public health benefit while raising the attention and informing policymakers on the need to change how antibiotics are valued so that upon the expiration of the Fund, other investors will support innovation to address the accelerating AMR challenge. Our goal is to support these companies, so they can obtain approval for two to four new antibiotics by 2030.”

Raising financial investment

Under the current system, a drug’s value is determined by its sales volume. That model works well in other therapeutic areas, but it is not the case with antibiotics.

“Antibiotics are not big money-makers,” Skinner continues. “They deliver incredible value to society, cure infections and enable a wide range of modern medical procedures like surgery, chemotherapy and organ transplants. While that’s good for public health, this critical contribution is not reflected in terms of patients’ access, which limits antibiotics’ clinical contribution and commercial potential, with investors fleeing to more financially rewarding and commercially viable areas.”

It is, he adds, a broken market that makes it exceedingly difficult for small and mid-size biotechnology companies to raise the necessary financing to advance antibiotics development.

Proper policies

Figures¹ show how investors favour other areas. For example, between 2011–20, venture capital funding for US oncology companies totalled USD26.5 billion, but only USD1.6 billion for antibiotics. He warns: “Investors will continue to avoid antibiotics until policymakers enact meaningful policies that incentivise investment into antibiotic R&D, reward successful innovation and reflect the true value-contribution of antibiotics.”

While the AMR Action Fund is investing in promising companies until policymakers enact market solutions, that will not continue forever. Acknowledging that the UK and Italy are exceptions, Skinner states there must be longer-term solutions with “proper policies in place to make a real difference,” leading to the development of novel antibiotics.

This article contains partnered content provided by Menarini.

1. Biotechnology Innovation Organization. 2022. The State of Innovation in Antibacterial Therapeutics.