Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults
Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced the approval of REZZAYO (rezafungin acetate) in the European Union (EU) for the treatment of invasive candidiasis in adults. The approval is based on the positive results from the pivotal ReSTORE Phase III clinical trial, supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
The approval of REZZAYO (rezafungin acetate) by the European Commission represents a significant advancement in the treatment of invasive candidiasis, a condition with high morbidity and mortality rates. The drug's non-inferiority to the existing standard of care, demonstrated in the ReSTORE Phase III clinical trial, suggests that it could become an integral part of the therapeutic arsenal against this severe infection. The potential for once-weekly dosing, as opposed to the daily regimen required by caspofungin, may offer improved adherence and patient outcomes.
From a medical research perspective, the approval also underscores the importance of continuous innovation in antifungal treatments, given the limited advancements over the past decade and a half. The Orphan Drug Designation granted to rezafungin signals the drug's potential in addressing a significant unmet medical need, which could lead to market exclusivity benefits and financial incentives for Cidara Therapeutics.
The financial implications of the European Medicines Agency's approval of REZZAYO are considerable for Cidara Therapeutics. The immediate milestone payment of approximately $11.14 million from Mundipharma enhances Cidara's cash flow. Furthermore, the partnership agreement, including potential payments totaling up to approximately $470 million and tiered double-digit royalties on net sales, could substantially contribute to the company's revenue streams.
Investors should note the significance of the EU market in terms of revenue potential for new pharmaceutical products. The approval not only diversifies Cidara's market presence but also validates the company's research and development capabilities. However, investors should also consider the costs associated with commercialization and the competitive landscape of antifungal drugs when evaluating the long-term financial impact.
The antifungal drug market has been relatively stagnant in terms of new entrants and the approval of rezafungin could disrupt this trend. Rezafungin's once-weekly dosing regimen could provide a competitive advantage over existing treatments that require daily dosing, potentially leading to increased adoption by healthcare providers. The impact on the market could be further amplified by the high burden of invasive candidiasis on healthcare systems, which may drive demand for more effective and convenient treatments.
Additionally, Cidara's strategic partnership with Mundipharma for commercial rights outside the U.S. and Japan exemplifies the trend of biotech companies leveraging collaborations to maximize global market penetration and manage commercialization risks. The success of rezafungin in the EU could serve as a bellwether for its potential uptake in other international markets.
12/22/2023 - 07:30 AM
Approval based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program. REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval. SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. These findings are supported by the positive results of the STRIVE Phase II clinical trial and an extensive nonclinical development program.
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.
Professor Oliver Cornely, Head of the European Excellence Centre for Medical Mycology at the University Hospital Cologne, Germany, and Data Review Committee member in the Phase III ReSTORE trial, said, “There has been a significant global unmet need for treating people with invasive candidiasis. Today’s announcement by the European Commission marks an important moment that could enable the healthcare professional community to manage invasive candidiasis patients in a different way using a new treatment option. ”
Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara, said, “We welcome the European approval, which makes this treatment option available to patients in Europe alongside patients in the United States following the FDA’s approval earlier this year. This is a great step forward on our journey to help patients with serious Candida infections across the globe. ”
Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU.
Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.
Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union (EU) approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma. Under the licensing agreement, Cidara remains eligible to receive additional potential payments of up to approximately $470 million upon achievement of development and regulatory milestones planned over the next several years, as well as double-digit royalties in the teens on tiers of annual net sales.
About invasive candidiasis 40% . IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.
About REZZAYO ® (rezafungin for injection)
REZZAYO (rezafungin for injection) is a novel once-weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The structure and properties of REZZAYO are specifically designed to improve upon a clinically validated mechanism.
INDICATIONS AND USE
REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
IMPORTANT SAFETY INFORMATION
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.
REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
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 the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.com.
About Cidara Therapeutics ® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO ® www.cidara.com .
Forward-Looking Statements , and the likelihood that rezafungin will be prescribed by physicians in the EU or approved for reimbursement by member state authorities. 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. 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.
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What is the latest announcement from Cidara Therapeutics, Inc.?
Cidara Therapeutics, Inc. (Nasdaq: CDTX) announced the approval of REZZAYO (rezafungin acetate) in the European Union (EU) for the treatment of invasive candidiasis in adults.
What is the basis for the approval of REZZAYO in the EU?
The approval is based on the positive results from the pivotal ReSTORE Phase III clinical trial, supported by the STRIVE Phase II clinical trials and an extensive nonclinical development program.
What payment is Cidara entitled to receive for the European Medicines Agency (EMA) approval?
Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
What is the significance of the approval of REZZAYO for the treatment of invasive candidiasis?
REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis, addressing a significant global unmet need.
Who has commercial rights to rezafungin outside the U.S. and Japan?
Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.
