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September 4, 2019

Cidara and Mundipharma sign rezafungin drug development deal

US-based biotech Cidara Therapeutics has partnered with UK-based Mundipharma in a deal valued at more than $568m to develop and commercialise its anti-fungal drug rezafungin.

US-based biotech Cidara Therapeutics has partnered with UK-based Mundipharma in a deal valued at more than $568m to develop and commercialise its anti-fungal drug rezafungin.

Rezafungin is a once-weekly echinocandin intended to provide first-line treatment of candidemia and invasive candidiasis. It is also being developed to prevent invasive fungal infections in patients receiving allogeneic blood and marrow transplantation.

The drug obtained qualified infectious disease product (QIDP), fast track and orphan drug designations from the US Food and Drug Administration (FDA) in candidemia and invasive candidiasis indications.

Rezafungin, which recently completed a Phase II clinical trial called STRIVE B, has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure. It allows for once-weekly IV therapy for inpatient and outpatient use.

Under the terms of the deal, Mundipharma will gain exclusive licence to commercialise the drug outside the US and Japan, where Cidara retains the rights.

Mundipharma president and CEO Alberto Martinez said: “With our proven commercial excellence, we are confident that we will maximise the potential of this differentiated and innovative asset.

“Rezafungin will be a significant addition to our pipeline that integrates well with our overall portfolio and sales force capabilities.”

As part of the deal, Mundipharma will make an upfront payment of $30m to Cidara, along with a $9m equity investment.

Cidara will additionally gain $42m in near-term funding for Phase III ReSTORE and ReSPECT trials that will assess the drug to treat and prevent fungal infections.

The company is also eligible for development, regulatory and commercial milestone payments.

It will continue to be responsible for the ongoing Phase III development programmes, while Mundipharma will provide support.

Cidara Therapeutics president and CEO Jeffrey Stein said: “Through this partnership, both companies fully commit to advancing rezafungin and helping to save the lives of patients who are highly vulnerable to these deadly infections.”

The partners may choose to explore other indications or formulations of rezafungin in the future.

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