For Trade and Medical Media Only
• REZZAYO® (rezafungin) is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.2
• The marketing authorisation was based on results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trial and extensive non-clinical development programme.3,4
• This is the first new treatment option for adult patients with invasive candidiasis in the Republic of Ireland for over 15 years.5-9

Dublin, Republic of Ireland, 23 April 2025: Mundipharma today announced that rezafungin is now available in the Republic of Ireland for adult patients with invasive candidiasis following HSE’s reimbursement agreement.1

The authorisation is supported by results from the pivotal ReSTORE Phase III clinical trial which demonstrated statistical non-inferiority* for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. The primary efficacy outcome was global response (confirmed by the Data Review Committee [DRC]) at day 14. Global response was determined from clinical response, mycological response, and radiologic response (for qualifying subjects with invasive candidiasis). Of the 187 patients in the modified intention-to-treat (mITT) population, 59.1% of patients in the rezafungin group (55/93) and 60.6% of patients in the caspofungin group (57/94) had a global response of cure at day 14 (weighted treatment difference −1.1% [95% CI −14.9, 12.7].3 These findings are supported by the STRIVE Phase II clinical trial and an extensive non-clinical development programme.3,4

Rezafungin was generally well tolerated, very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea.2
Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.10,11 It usually affects seriously ill people and those with a weakened immune system, the mortality rate can be 40% or more.12-14 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.15 Over the last 15 years there have been no new treatments and morbidity and mortality rates remain largely the same, indicating the need for alternative treatment options.5-9,16

A new global guideline for the diagnosis and treatment of Candida infections was published in Lancet Infectious Diseases in February 2025. The guideline sets out new standards for managing fungal infections, which affect millions of people worldwide every year, and include the use of all echinocandins including rezafungin.17

Professor Ignacio Martin-Loeches, Consultant in Intensive Care Medicine at St. James’s Hospital, Professor of Intensive Care Medicine at Trinity College Dublin, and internationally renowned researcher with an H-index of 98 and nearly 40,000 citations across more than 600 peer-reviewed publications, said:

"Invasive candidiasis continues to be one of the most serious infectious threats in critical care, associated with alarmingly high mortality rates despite the availability of current antifungal therapies. It primarily affects the most vulnerable patients—those who are critically ill or immunocompromised—and remains difficult to treat effectively.

Over the past 15 years, there have been few therapeutic advances, leaving clinicians with limited options in the face of this life-threatening infection. This reality underscores the urgent need for new antifungal agents. Invasive fungal infections consistently rank among the highest contributors to sepsis-related mortality, yet they receive disproportionately less attention in the development pipeline.

To reverse this trend, we need meaningful collaboration between academia, clinical practice, and the pharmaceutical industry, backed by sustained investment in antimicrobial innovation.

Only through such coordinated efforts can we bring forward the next generation of antifungal treatments, that will strengthen our ability to manage severe infections in the most fragile populations."

“Making rezafungin available in the Republic of Ireland is a culmination of years of developing an additional treatment option for invasive candidiasis patients and underscores our commitment to supporting management of infectious diseases,” said Dr Yuri Martina, Chief Development and Medical Officer at Mundipharma.

*To meet the pre-specified limit of non-inferiority, the upper (for all-cause mortality) and lower (for global
cure) 95% confidence limits for the difference between arms must be within 20%. Both endpoints met the
pre-specified 20% limit, establishing non-inferiority.3

*ENDS*

About invasive candidiasis
Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems.15 Despite a number of available treatments, the mortality rate for patients with invasivecandidiasis is as high as 40%.12-13 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.18

About Rezafungin
Rezafungin is an echinocandin. A Phase III clinical trial has been completed with this treatment for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial).3
In the ReSTORE trial, conducted between October 2018 to August 2021, rezafungin met the primary endpoint for the European Medicines Agency (EMA) Marketing Authorisation Application (MAA) submission of global cure at Day 14 demonstrating statistical non-inferiority for the treatment dosed once-weekly versus caspofungin dosed once-daily, the current standard of care.3 Rezafungin was generally well tolerated, very common adverse reactions include hypokalaemia, pyrexia, and diarrhoea.2

About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com
Commercialisation rights to rezafungin in the United States are licensed to Melinta Therapeutics.

Media contact:
Media.relations@mundipharma.com

References
1. Mundipharma Date in File REF – 20013.
2. REZZAYO® (rezafungin) Summary of product characteristics, Mundipharma 2023
3. Thompson GR, et al. Lancet 2023;401(10370):49–59.
4. Thompson GR, et al. Lancet Infect Dis 2023;24(3):319-328
5. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445.
6. CANCIDAS (formerly Caspofungin MSD) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/cancidas-previously-caspofungin-msd (last accessed April 2025)
7. Vfend (voriconazole) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/vfend (last accessed April 2025
8. Ecalta (anidulafungin) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ecalta (last accessed April 2025)
9. Mycamine (micafungin) EPAR. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/mycamine (last accessed April 2025)
10. Pappas PG, et al. Nat Rev Dis Primers 2018;4:18026.
Job code: IE-RZF-2500043
Date of preparation: April 2025
11. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/candidiasis/?CDC_AAref_Val=https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed April 2025)
12. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56.
13. Bassetti M, et al. Crit Care 2019;23(1):219.
14. Richardson JP, Moyes DL. Adaptive immune responses to Candida albicans infection. Virulence 2015;6(4):327-37
15. Cortegiani A, et al. Cochrane Database Syst Rev 2016;1:CD004920.
16. Ham YY, et al. Future Microbiology 2021;16(1):27–36.
17. Cornely OA, et al. Global guideline for the diagnosis and management of candidiasis: an initiative of the ECMM in cooperation with ISHAM and ASM. The Lancet Infectious Diseases 2025;S1473-3099(24)00749-7.
18. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed April 2025))
Job code: IE-RZF-2500043
Date of preparation: April 2025