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European Medicines Agency Grants Orphan Medicinal Product Designation for SCYNEXIS’ Innovative Antifungal Ibrexafungerp for the Indication of Invasive Candidiasis
Orphan medicinal product designation will provide at least 10 years of market exclusivity in the EU for ibrexafungerp for invasive candidiasis. SCYNEXIS
About this update from Scynexis, Inc.
[{"type":"text","content":"Orphan medicinal product designation will provide at least 10 years of market exclusivity in the EU for ibrexafungerp for invasive candidiasis. SCYNEXIS recently was awarded a new patent in the U.S. and obtained allowance of an additional European patent application, expanding lifecycle protection to 2038. JERSEY CITY, N.J., Dec. 15, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation to ibrexafungerp for the indication of invasive candidiasis (IC). “Our vision for ibrexafungerp is to build a global antifungal franchise for community and hospital infections by leveraging the versatility and potency of our unique systemic antifungal agent to benefit patients,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Ibrexafungerp benefits from lengthy regulatory and patent exclusivities in the U.S. and around the world. The 10 years of market exclusivity in the EU based on orphan medicinal product designation builds on those exclusivities as we work to expand the approved indications for our groundbreaking therapy to help patients around the world fight these serious and sometimes deadly fungal infections.” David Angulo, M.D., Chief Medical Officer of SCYNEXIS added, \"EMA’s granting of orphan product designation for invasive candidiasis underscores the unmet need and the agency’s assessment of the potential for ibrexafungerp to provide a significant treatment benefit to patients suffering from this life-threatening disease. This orphan designation is timely, as we recently announced the initiation of a global, Phase 3 study of ibrexafungerp as a much-needed oral step-down therapy for the treatment of invasive candidiasis.” Announced in December, the MARIO global Phase 3 multi-center, randomized, double-blind study of two treatment regimens will evaluate oral ibrexafungerp as a step-down treatment in patients suffering from invasive candidiasis compared to oral fluconazole. Additionally, SCYNEXIS recently was awarded a new patent in the U.S. and obtained allowance of an additional European patent application, expanding lifecycle protection for ibrexafungerp. In September,...