WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical interventions, announced it has entered into an Option Agreement with Torii Pharmaceutical Co., Ltd. (Torii) granting Torii an exclusive option to acquire an exclusive license to develop and commercialize Verrica’s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including VP-102.
“We are extremely pleased to take this initial step of entering into an option agreement with Torii, as we seek to address the global burden of molluscum by creating an opportunity for VP-102 to be available for people in Japan who are affected by this viral skin disease,” said Ted White, Verrica’s President and Chief Executive Officer.
“Torii is an ideal partner, as they have an established position in the Japanese dermatology market, and have the resources and infrastructure to develop and commercialize VP-102 and any other cantharidin-based product candidates we seek to develop to treat molluscum or common warts. We look forward to working with Torii as they evaluate the option to exclusively license VP-102 in Japan.”
Under the terms of the Option Agreement, Torii will pay Verrica USD $500,000 to secure the exclusive option. Torii may exercise the option to obtain exclusive license rights until the later of six months after the effective date of the Option Agreement, or ten business days after the Company notifies Torii that the FDA has accepted for filing the Company’s resubmission of the NDA for VP-102.
If Torii exercises the option, the license agreement would provide for Torii to make an up-front payment of $11.5 million, up to an additional $58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, and tiered transfer price payments for supply of product in the percentage range of the mid-30s to the mid-40s of net sales. Torii would be responsible for all development activities and costs in support of obtaining regulatory approval in Japan.
Two double-blind Phase 3 trials (CAMP-1 and CAMP-2), which evaluated VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum, have demonstrated favorable safety, efficacy and tolerability.
Specific results from the CAMP-1 and CAMP-2 studies showed that 46 and 54 percent, respectively, of subjects treated with VP-102 achieved complete clearance of all baseline and new molluscum lesions at the end of the trials (Day 84), versus 18 and 13 percent, respectively, of subjects in the vehicle groups (p<0.0001).
There were no serious adverse events reported in VP-102-treated subjects, and most adverse events reported in subjects receiving VP-102 were local skin reactions and mild to moderate in severity.
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