Mundipharma has acquired 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.
Invasive candidiasis, is a severe, life-threatening infection of the bloodstream and/or deep/visceral tissues. It affects seriously ill people, especially those with a weakened immune system and the mortality rate can be 40% or more.
It can place a large burden on the healthcare system, with the potential for extended treatment regimens and long hospital stays. 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.
“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 2023 and the European Commission (EC) in December 2023. It has also been authorised for use by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2024 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 US, EU and UK. 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.
