Verrica Pharmaceuticals Inc. announced the successful completion of the technology transfer of bulk solution manufacturing to Piramal Pharma Solutions. The technology transfer includes the completion of the registration batch material, which has been placed on stability, and the manufacture of three process validation batches of bulk solution.
“We are pleased to have completed the technology transfer of bulk solution manufacturing for VP-102 to Piramal Pharma Solutions,” said Ted White, Verrica’s President and Chief Executive Officer. “Based on our communications with FDA, we believe that the successful tech transfer of bulk solution manufacturing to Piramal will be well-received by FDA and completes a substantial requirement toward the resubmission of our NDA for VP-102 for the treatment of molluscum in the first quarter of 2023. We would like to thank Piramal Pharma Solutions, and their entire staff at the Sellersville, PA location, who have been true partners in this tech transfer process. We appreciate their dedication to making this tech transfer process a success.”
Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, Piramal Pharma Ltd. said, “This collaboration with Verrica is an excellent example of how Piramal’s capabilities support our ultimate objective of reducing the burden of disease on patients. We believe that this program represents the start of a long and mutually beneficial relationship that will address the needs of dermatological patients for years to come.”
About VP-102
Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Upon resubmission of the NDA for VP-102, Verrica intends to seek conditional approval to market VP-102 in the United States under the brand name YCANTH™. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.
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