Dr. Najy Alsayed MD, M.Sc., MBA
Global Therapeutic Area Head – Infectious Diseases, Menarini
A leading expert voices highly cautious optimism over the very few steps taken today that could help tackle the threat to patients’ lives and their medical care from antimicrobial resistance (AMR).
With AMR contributing to millions of deaths and costing the global economy billions of dollars, Dr Najy Alsayed, Head of Infectious Diseases in 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, Dr Alsayed says they continue to diligently work with authorities over implementing tailored effective solutions, should the political awareness be translated into decisions and decisive actions.
AMR threat
Menarini, a mid-sized European pharmaceutical company focusing on oncology, cardiovascular and respiratory and infectious diseases, sees three major elements to the AMR threat: (1) life-threatening clinical impact; (2) associated with rising healthcare costs; (3) while threatening the present and 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, Dr Alsayed 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.
the action taken through the designated Orphan Medicine EU-Legislation has led to significantly
improved patient access, a more dynamic pipeline and investments, boosting the sustainable availability of orphan medicines for patients with rare diseases.
Broken model
Dr Alsayed indicates that at present we have a ‘broken model’ as we strive to develop and bring to the clinicians and patients novel antibiotics to support our fight against the accelerating AMR threat. This is because the current model is driven by an approach of largely restrictive, rather than appropriate, use and availability of novel antibiotics to clinicians and patients.
This has resulted in a lack of commercial viability in a large number of countries. Indeed, of the 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.
Lessons can be learned from how the orphan diseases crisis has been successfully addressed over the past 25 years. Facing similar barriers to novel antibiotics, with poor patient access, challenging commercial viability and sustainability, alongside lack of investment attractiveness, the action taken through the designated Orphan Medicine EU-Legislation has led to significantly improved patient access, a more dynamic pipeline and investments, boosting the sustainable availability of 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, acknowledging 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 Menarini having a portfolio of novel antibiotics and collaborating with biotech companies, he believes that through the collaborative efforts and partnerships between governments and EU policymakers, pharmaceutical companies, patient associations and other AMR key stakeholders, decisive solutions will emerge to address both the current broken market and patient access failures.
This article contains partnered content provided by Menarini.
