WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced this week an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. This collaboration marks a critical step towards launching a global pivotal Phase 3 clinical trial for YCANTH®, an innovative treatment aimed at common warts.
The amended agreement underscores the deepening partnership between Verrica and Torii Pharmaceutical, building on their successful collaboration on YCANTH for molluscum contagiosum. “This advancement into a global Phase 3 clinical trial for common warts signifies our commitment to addressing this widespread dermatological challenge,” stated Ted White, President and CEO of Verrica Pharmaceuticals. He highlighted the potential of this trial to pave the way for regulatory approval and subsequent marketing authorizations in the U.S., Japan, and potentially the European Union.
The original agreement, forged in March 2021, granted Torii an exclusive license to develop and commercialize Verrica’s product candidates, including YCANTH, for the treatment of molluscum contagiosum and common warts in Japan. The amendment introduces a cost-sharing arrangement for the forthcoming global trial, with Torii covering Verrica’s expenses as an advance against future milestone payments and sales royalties in Japan. Furthermore, upon the first patient being dosed in Japan, Verrica is set to receive a milestone payment of $8 million from Torii.
The initiation of the global study is contingent upon feedback from regulatory bodies, including the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), concerning the trial’s design.
With common warts affecting approximately 22 million patients in the U.S. alone, and the absence of FDA-approved therapies, Verrica identifies this condition as representing a substantial commercial opportunity, potentially worth billions. The prevalence among children, who constitute about half of those seeking treatment, emphasizes the urgent need for a safe and effective solution. Success in developing, approving, and commercializing YCANTH for common warts could establish significant synergies with Verrica’s marketing efforts for molluscum contagiosum, leveraging overlaps in target demographics.
The ambitious venture by Verrica and Torii not only highlights the potential of collaborative efforts in expediting the development of medical treatments but also signals a hopeful future for millions suffering from common warts worldwide. With the European market viewed as equally promising as the U.S., the global impact of YCANTH, if successful, could be monumental, offering relief to a vast, underserved patient population.
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