MUNDIPHARMA

Mundipharma* today announced the acquisition of all assets and rights related to rezafungin globally from Cidara Therapeutics.

This provides Mundipharma with global ownership of rezafungin including ongoing development and distribution. Rezafungin is a novel once-weekly echinocandin indicated for the treatment of invasive candidiasis in adults.¹

Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues.^2,3 It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40%⁴ or more.^5,6 It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays.⁶ 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.^7,8

“This acquisition places Mundipharma in the best position to realise the full potential of rezafungin including its availability and ongoing development. We are committed to ensuring patients affected with invasive candidiasis have access to an additional treatment option to manage this potentially life-threatening condition,” said Marc Princen, Chief Executive Officer at Mundipharma.

Rezafungin received approval by the U.S. Food and Drug Administration (FDA) in March 2023⁹ and the European Commission (EC) in December 2023¹⁰. It has also been authorised for use by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2024¹¹ and the UAE Ministry of Health and Prevention (MOHAP) in March 2024. Rezafungin has been granted Orphan Drug Designation for the treatment of invasive candidiasis in the US¹², EU¹³ and UK.¹⁴ It is currently available to patients in the UK and Germany, and further marketing authorisation applications are subject to accelerated review procedures to support getting this important medicine to patients.

Commercialisation rights to rezafungin in the United States will remain licensed to Melinta Therapeutics.

*Assets and rights acquired by Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies.

*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. Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is 40%⁴ or more.^5,6 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.¹⁵

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.

References:

1. REZZAYO^® Product Information. EPAR Medicine Overview available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed April 2024).
2. Pappas PG, et al. Nat Rev Dis Primers 2018 ;4 :18026.
3. CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed April 2024).
4. Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56.
5. Bassetti M, et al. Crit Care 2019;23(1):219.
6. Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920.
7. Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445.
8. Ham YY, et al. Future Microbiology 2021;16(1):27–36.
9. US Food and Drug Administration approval. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000Approv.pdf (last accessed April 2024)
10. European Medicines Agency approval. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo#ema-inpage-item-assessment-history (last accessed April 2024).
11. UK Medicines and Healthcare Products Regulatory Agency authorisation. Available at: https://www.gov.uk/government/news/rezzayo-approved-to-treat-adult-patients-with-invasive-candidiasis (last accessed April 2024).
12. US Food and Drug Administration. Orphan drug designation notice. Available at: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=507215 (last accessed April 2024)
13. European Commission. Orphan maintenance assesment report. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed April 2024).
14. UK MHRA. Register of orphan medicinal products. Available at: https://www.gov.uk/government/publications/orphan-registered-medicinal-products/orphan-register#rezzayo (last accessed April 2024).
15. Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed April 2024).

Job reference: SciA-RZF-2400003
Date of preparation: April 2024

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