Melinta Therapeutics and Cidara Therapeutics Announce Licensing Agreement to Commercialize Rezafungin in the U.S.

Melinta Therapeutics, LLC and Cidara Therapeutics announced that they have entered into a License Agreement to facilitate a strategic partnership to commercialize rezafungin, a novel, once-weekly echinocandin antifungal in the United States (U.S.). Cidara is developing rezafungin for the treatment of candidemia and invasive candidiasis in adults, as well as for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation.

The partnership follows Cidara’s submission of a New Drug Application (NDA) for rezafungin for the treatment of candidemia and invasive candidiasis, for which no new therapies have been approved in over a decade. The U.S. Food and Drug Administration (FDA) has previously granted Qualified Infectious Disease Product (QIDP) designation to rezafungin for injection which confers priority review of the NDA. Additionally, the treatment indication has orphan drug designation. Cidara expects to be assigned a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2023, if the NDA is accepted for review following application validation. Under the terms of the Agreement, Cidara will continue to lead the ongoing global Phase 3 ReSPECT prophylaxis study, as well as the regulatory activities for the approval of rezafungin in both the treatment and prophylaxis indications. The NDA will be transferred to Melinta at the time points as specified in the Agreement.

“The addition of rezafungin expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy. By leveraging our expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization of rezafungin and ensure patient access to this life-saving medicine in the U.S.” said Christine Ann Miller, President and Chief Executive Officer, Melinta Therapeutics. “We will continue to aggressively pursue portfolio expansion that aligns with our mission of providing innovative therapies for acute and life-threatening illnesses.”

“With its existing U.S. commercial infrastructure and significant experience in commercializing infectious disease products, including once-weekly antibiotics, Melinta is ideally positioned to bring rezafungin to the U.S. market and patients in need,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.