Cidara’s U.S. Commercial Partner, Melinta Therapeutics, has Initiated Commercial Launch of REZZAYO™
EMA Regulatory Decision for Rezafungin Expected by Year End 2023
SAN DIEGO, July 31, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing therapeutics designed to save lives and improve the standard of care for patients facing serious diseases, today announced an update on REZZAYO™ (rezafungin for injection) which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. Earlier today, Cidara’s U.S. partner, Melinta Therapeutics, announced the commercial launch of REZZAYO.
“The U.S. launch of REZZAYO recently announced by our partner Melinta is very important for the many patients in need of treatment for deadly fungal infections,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We look forward to expanding the reach of rezafungin for patients across the world starting in Europe with the upcoming EMA decision and subsequently in Japan where we are currently evaluating potential commercial partnerships. The expected milestone payments and royalties from our current partnerships for rezafungin will further support our Cloudbreak® drug-Fc conjugate (DFC) programs, for which we will provide an update at an upcoming R&D Day event.”
The total potential transaction value of the Melinta License Agreement is $460.0 million, including a $30.0 million upfront payment and up to $430.0 million in regulatory and commercial milestones. In addition, Cidara is eligible to receive tiered royalties on U.S. sales in the low double digits to mid-teens. As of June 30, 2023, Cidara has received the $30.0 million up-front payment and a $20.0 million regulatory milestone payment for U.S. FDA approval.
The European Medicines Agency (EMA) accepted the marketing authorization application (MAA) for rezafungin in August 2022 with Cidara’s EU partner, Mundipharma, and it is currently under review, with a decision timeline on track for year-end 2023. Cidara retains the rights to rezafungin in Japan, and the company is currently evaluating potential commercial partnership opportunities in that country.
About REZZAYO™ (rezafungin for injection)
INDICATIONS AND USE
REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data.
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
REZZAYO™ is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
Warnings and Precautions
Infusion-related Reactions: REZZAYO™ may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion.
Photosensitivity: REZZAYO™ may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO™. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO™ therapy.
Most common adverse reactions (incidence 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.
Please see full Prescribing Information for REZZAYO™ (rezafungin for injection), available at www.rezzayo.com.
About Cidara Therapeutics
Cidara is developing therapeutics designed to improve the standard of care for patients facing serious diseases. The company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including drug-Fc conjugates (DFCs) from its proprietary Cloudbreak® platform targeting oncologic and viral diseases. In addition, Cidara recently received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. 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,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether REZZAYO will be prescribed by physicians in the U.S. or reimbursed by public or private payors, whether rezafungin will be approved for commercialization in the EU, and whether we will be able to license the rights to rezafungin in Japan.. 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 preclinical 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 CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 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.