AMR and AMS

Why is antimicrobial resistance (AMR) a global challenge?

Antibiotic resistance is one of the biggest threats to global public health, and it is rising to dangerously high levels in all parts of the world.¹

AMR is limiting the ability of healthcare systems to prevent and treat infections.² If significant action is not taken now, by the year 2050 it is estimated that 10 million lives will be lost globally each year.²

The emergence of antimicrobial resistance threatens current clinical practice across a range of infection types. In 2017, the World Health Organization (WHO) published its list of bacteria for which new antibiotics are urgently needed.³

WHO priority pathogens list for the research and development of new antibiotics³

*Mycobacteria (including Mycobacterium tuberculosis, the cause of human tuberculosis), was not subjected to review for inclusion in this prioritisation exercise as it is already a globally established priority for which innovative new treatments are urgently needed.^3
†Enterobacteriaceae include: Klebsiella pneumonia, Escherichia coli, Enterobacter spp., Serratia spp., Proteus spp., and Providencia spp, Morganella spp.³

Menarini is playing an active role in the fight against AMR

Menarini is providing access to and commercialising antibiotics to address some of these challenging, resistant pathogens, having recently expanded its antibiotic portfolio by launching two antibiotics in two years.

• VABOREM^®(meropenem/vaborbactam), available in the UK since 2019, contains a first-in-class, cyclic boronate β-lactamase inhibitor and offers a directed therapy optimised for the treatment of Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE) infections⁴

• VABOREM^® is indicated for use in adults for the treatment of: complicated urinary tract infection (cUTI) including pyelonephritis; complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP); bacteraemia that occurs in association with, or is suspected to be associated with, any of these previously listed infections; infections due to aerobic Gram-negative organisms in adults with limited treatment options⁴

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Learn more about VABOREM

• QUOFENIX^®(delafloxacin), marketed in the UK since 2020, is the only IV to oral fluoroquinolone monotherapy for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) whilst maintaining activity against Gram-negative bacteria, anaerobes and atypicals⁵

• QUOFENIX^® is indicated for use in adults for the treatment of acute bacterial skin and skin structure (ABSSSI) and community-acquired pneumonia (CAP) when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections⁵

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Learn more about QUOFENIX

As part of our commitment to providing effective and innovative solutions to treat resistant infections, Menarini is also an active partner of AMR ALLIANCE and the AMR Action Fund, along with other leading pharmaceutical companies investing more than $1 billion. This collaboration aims to bring 2 to 4 innovative antibiotics to patients by the end of 2030, bolstering the antibiotics research and development environment with industry resources, knowledge and expertise.

This unique collaborative platform of strategic partners will facilitate the necessary policy reforms to encourage appropriate investment in antibiotic R&D. At the same time, we are engaged at national and international levels in educational scientific meetings and workgroups on antibiotic-resistance.

“Inappropriate use of antimicrobials increases the risk to patients of colonisation and infection with resistant organisms and subsequent transmission to other patients.”⁶

(Public Health England)

In 2015, the WHO set out its global action plan which aims to ensure prevention and treatment of infectious diseases with safe and effective medicines.⁷ As one of its key strategic objectives, the global action plan sets out to improve awareness and understanding of antimicrobial resistance, which includes the adoption of antimicrobial stewardship (AMS) to optimise the use of antimicrobial medicines in human and animal health.⁷

How does stewardship help in the fight against antimicrobial resistance?

With antimicrobial resistance rates increasing worldwide and few new antibiotics being developed, existing antibiotics are becoming a limited resource. It is therefore essential that antibiotics and last-resort antibiotics are reserved for patients who truly need them.⁸

Menarini supports the responsible use of antibiotics through global AMS programmes, including advocating the principles set out by Public Health England based on providing the right antibiotic to the right patient at the right time.

Our medical educational programme “Infection in Focus” (that includes posters, slides and webinars) has been created by Menarini with the purpose of increasing awareness of AMR. We align our activities to best practice as set out in AMS programmes.

Product indications (refer to SmPC for full details):

VABOREM^®(meropenem/vaborbactam) is indicated for use in adults for the treatment of: complicated urinary tract infection (cUTI) including pyelonephritis; complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP); bacteraemia that occurs in association with, or is suspected to be associated with, any of these previously listed infections; infections due to aerobic Gram-negative organisms in adults with limited treatment options.⁴

QUOFENIX^®(delafloxacin) is indicated for the treatment of the following infections in adults: (1) acute bacterial skin and skin structure infections (ABSSSI) (2) community-acquired pneumonia (CAP). Only prescribe when other antibiotics that are commonly recommended for these infections are inappropriate. [Refer to local SmPC for full indication details including risk of prolonged, disabling and potentially irreversible serious adverse drug reactions].¹

References:

1. World Health Organization. Antibiotic resistance. July 2020. Available from: https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance (accessed September 2021).
2. The Review on Antimicrobial Resistance chaired by Jim O’Neill. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. December 2014. Available from: https://wellcomecollection.org/works/rdpck35v (accessed September 2021).
3. World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. February 2017. Available from: https://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf (accessed September 2021).
4. VABOREM^® Summary of Product Characteristics.
5. QUOFENIX^® (tablet and injection) Summary of Product Characteristics.
6. Public Health England. Antimicrobial stewardship: Start smart - then focus. March 2015. Available from: https://www.gov.uk/government/publications/antimicrobial-stewardship-start-smart-then-focus (accessed September 2021).
7. World Health Organization. Global action plan on antimicrobial resistance. January 2016. Available from: https://www.who.int/publications/i/item/9789241509763 (accessed September 2021).
8. World Health Organization. Antimicrobial stewardship programmes in health-care facilities in low- and middle-income countries: a WHO practical toolkit. 2019. Available from: https://apps.who.int/iris/handle/10665/329404 (accessed September 2021).

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to A. Menarini Farmaceutica Internazionale SRL. Phone 0800 085 8678 or email: [email protected]

These medicinal products are subject to additional monitoring.