MORRISTOWN, N.J.–(BUSINESS WIRE)–Melinta Therapeutics, LLC (“Melinta”) and Cidara Therapeutics (“Cidara”) today announced that they have entered into a License Agreement (the “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.
About Melinta Therapeutics
Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes six commercial-stage products: Baxdela® (delafloxacin), Kimyrsa® (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), TOPROL-XL® (metoprolol succinate) and Vabomere® (meropenem and vaborbactam).
With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. For additional information, including product and respective important safety information, please visit our website.
Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. Rezafungin has not been approved for commercial use in any market. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara has completed a Phase 3 clinical trial with rezafungin for the treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and is currently conducting a second Phase 3 clinical trial of rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial). Rezafungin has been designated a Qualified Infectious Disease Product (QIDP) with Fast Track status by the FDA, and has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in both the U.S. and EU.
About Cidara Therapeutics
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak ® platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to our expectations that the ReSTORE trial data will support an NDA submission in the U.S. and similar marketing authorization submissions in other countries; the potential timing of such submissions; and the likelihood that rezafungin, if approved, will be prescribed by physicians or included in formularies or treatment guidelines. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of rezafungin development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.