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WEST CHESTER, Pa., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced its development and commercialization partner, Torii Pharmaceutical Co. Ltd. (“Torii”), submitted a New Drug Application (“NDA”) of TO-208 (referred to as VP-102 and marketed as YCANTH® in the U.S.) for the treatment of Molluscum Contagiosum (“molluscum”) in Japan.
“Torii continues to be an outstanding partner in advancing TO-208 for the treatment of molluscum, and today’s NDA submission represents the next critical milestone towards bringing to market the first therapeutic for addressing this indication in Japan,” said Jayson Rieger, Ph.D., MBA, President and Chief Executive Officer of Verrica. “With an estimated prevalence of approximately 1.6 million cases, molluscum represents a large and underserved patient population in Japan, and we believe Torii’s therapeutic expertise and commercial infrastructure in dermatology will maximize the opportunity to address this significant unmet need.”
TO-208 is a skin disease treatment drug candidate containing cantharidin as an active ingredient. In the Phase 3 clinical study of TO-208 in patients with molluscum contagiosum (≥2 years old) in Japan, the primary endpoint of efficacy has met superiority to the vehicle. Furthermore, the safety profile of TO-208 in the study was consistent to prior studies in the United States and there were no observed issues of tolerability for the application.
Torii and Verrica executed an exclusive license agreement for the development and commercialization of TO-208 for the treatment of molluscum and common warts in Japan in March 2021.
Verrica received manufacturing and marketing approval of VP-102 to treat molluscum contagiosum in the U.S. in July 2023. Verrica has marketed VP-102 under the brand name YCANTH® in the U.S. since August 2023 and has completed a Phase 2 clinical study of VP-102 for the treatment of common warts and a Phase 2 clinical study of VP-102 for the treatment of external genital warts in the U.S.
About YCANTH® (VP-102)
YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH® is the first and only commercially available product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH® was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH® was a safe and effective therapeutic for the treatment of molluscum. Approximately 228 million lives are eligible to receive YCANTH® covered by insurance. YCANTH® is available to all patients with and without insurance coverage for $25 per treatment, and further financial assistance is available for patients in need. Please visit YCANTHPro.com for additional information.