WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced that its partner Torii Pharmaceutical Co. Ltd., now a subsidiary of Shionogi & Co., Ltd., has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for YCANTH® (TO-208) to treat molluscum contagiosum. The decision marks the first approval of the therapy outside the United States and triggers a $10 million milestone payment to Verrica.
“This approval enables individuals in Japan who contract molluscum to access a safe and effective therapy,” said Jayson Rieger, PhD, MBA, Verrica’s president and CEO. “The milestone payment provides meaningful non-dilutive capital to support our U.S. commercial activities as we work to establish YCANTH as the standard of care.”
Verrica retains global rights to YCANTH for all indications outside Japan and is preparing for additional international expansion. The company also plans to partner with Torii on a global Phase 3 program evaluating the therapy for common warts, with first patient dosing in the U.S. expected by year-end 2025.
YCANTH, a cantharidin-based drug-device combination applied via single-use applicator, is already FDA-approved for molluscum contagiosum in patients as young as two. In Japan, Torii’s Phase 3 trial demonstrated statistically significant lesion clearance compared to placebo, with the treatment well tolerated.
Molluscum contagiosum is a highly contagious viral skin disease that primarily affects children. In the U.S., an estimated six million people are impacted annually. Verrica notes that about 225 million Americans have insurance coverage for YCANTH, with most commercially insured patients paying $25 per treatment visit.
The Japanese approval represents both a financial boost for Verrica and a step forward in making molluscum treatment accessible worldwide.
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