MUNDIPHARMA
24.4.2024 22:02:28 CEST | Business Wire | Press release
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:
- REZZAYO® Product Information. EPAR Medicine Overview available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed April 2024).
- Pappas PG, et al. Nat Rev Dis Primers 2018 ;4 :18026.
- CDC. Invasive candidiasis. Available at: https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html (last accessed April 2024).
- Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56.
- Bassetti M, et al. Crit Care 2019;23(1):219.
- Cortegiani A, et al. Cochrane Database Syst Rev 2016;2016:Cd004920.
- Bassetti M, et al. J Antimicrob Chemother 2018; 73 Suppl 1: i14–i25 doi:10.1093/jac/dkx445.
- Ham YY, et al. Future Microbiology 2021;16(1):27–36.
- US Food and Drug Administration approval. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217417Orig1s000Approv.pdf (last accessed April 2024)
- 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).
- 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).
- 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)
- European Commission. Orphan maintenance assesment report. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rezzayo (last accessed April 2024).
- 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).
- 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240424542362/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 15:45:00 CET | Press release
Global conservation and philanthropic leader to spearhead REV Ocean's next chapter, connecting world-class science with international collaboration and ocean protection REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, fundi
Holder Partners Launches Strategic Communications Practice and Appoints Ali Ponte as Director and Practice Lead29.10.2026 15:15:00 CET | Press release
The new practice connects strategic communications and stakeholder engagement with Holder Partners’ capabilities in investigations, disputes, cybersecurity, due diligence and risk advisory. Holder Partners, a multidisciplinary consulting and advisory firm, today announced the launch of its Strategic Communications practice and the appointment of Ali Ponte as Director and Practice Lead. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027701219/en/ Ali Ponte, Director and Practice Lead of Holder Partners’ Strategic Communications practice. The practice advises leading companies and institutions, their boards, senior executives and counsel on communications, reputation and stakeholder considerations in complex matters and periods of significant change or opportunity. Each engagement is tailored to the client’s objectives and, where relevant, draws on Holder Partners’ broader advisory capabilities. Its strategic counsel, infor
Accertify Formalizes Partner Ecosystem as Fraud, Payments, and Chargebacks Converge Into a Single Risk Surface29.10.2026 15:00:00 CET | Press release
New partner program brings payment providers, orchestrators, commerce platforms, and consultancies together around the industry's largest fraud data community Accertify, a leading fraud decisioning provider whose Predictive Yes Platform helps merchants say yes to more good customers, more revenue, and more growth, today announced the launch of the Accertify Partner Program, a formalized partnership ecosystem connecting payment providers, orchestrators, commerce platforms, and consultancies to Accertify’s network-powered fraud intelligence. Partners can join through two tracks. The Referral track lets partners make a single introduction while Accertify handles the sale, implementation, and support. The Reseller track lets partners sell Accertify on their own contract and own the client relationship and margin. Partners that integrate with Accertify follow a defined certification path, so clients get a tested, supported connection from day one. Every client a partner brings joins a conso
Draslovka to Acquire ex-Natron Energy Battery IP, Completing a Vertically Integrated Western Sodium-Ion Value Chain29.10.2026 14:30:00 CET | Press release
Acquisition gives Draslovka control of former Natron Energy IP portfolio spanning sodium-ion materials, cells and complete battery systems. Deal combines acquired IP with Draslovka’s existing chemistry and European cathode-material capabilities, bringing key parts of the sodium-ion value chain together within one Western-aligned group and its partners. The IP acquisition strengthens Draslovka’s position across the emerging Western sodium-ion battery value chain. Technology targets applications where safety, high power, long cycle life and performance across a wide temperature range are critical, including data centers, grid storage, defense, industrial fleets, telecoms, rail and aviation. The acquired IP will substantively boost Draslovka’s technology offering, a portfolio of transformative and protected innovations for specific industries. Draslovka’s US-based subsidiary, COVORO MINING SOLUTIONS LLC (Covoro), the operator of one of the largest solid sodium cyanide plants in the world,
Veracode Finds First Meaningful Gain in AI Code Security Since 2025 as Average Pass Rate Hits 62%29.10.2026 14:27:00 CET | Press release
October 2026 Study: Anthropic’s Claude Opus 5.5 and OpenAI’s GPT-6-Sol Jointly Lead at a Record 73%, Breaking the Previous High of 68% Veracode, the global leader in application risk management, today announced a jump from 56 percent to 62 percent in overall AI-generated code security, alongside a drop in vulnerabilities from 44 percent to 38 percent — the most significant improvement since the GenAI Code Security Report series began in July 2025. Anthropic's Claude Opus 5.5 and OpenAI's GPT-6-Sol co-lead the rankings at 73 percent, surpassing the previous high of 68 percent set by GPT-5.5 in July 2026. “We’ve been analysing code generated by multiple LLMs for more than a year. Until now, we have not seen a marked improvement in AI code security, despite consistently near-perfect functionality,” said Chris Wysopal, Co-founder & Chief Security Evangelist at Veracode. “This is the first time since running our study that we’ve been able to report a meaningful move on the security dial. Te
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom