“Verrica Pharmaceuticals’ Lead Product YCANTH™ Receives New Chemical Entity Status from FDA, Ensuring Five Years of Regulatory Exclusivity”
Verrica Pharmaceuticals Inc. Achieves NCE Status for YCANTH™, Ensuring Five Years of Regulatory Exclusivity
WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a leading dermatology therapeutics company, announced today that its flagship product, YCANTH™, has been granted New Chemical Entity (NCE) Status by the U.S. Food and Drug Administration (FDA). This significant milestone provides YCANTH™ with a minimum of five years of regulatory exclusivity, reinforcing the Company’s patent strategy and underscoring the product’s innovation and value in the dermatology market.
YCANTH™’s NCE Status and Patent Portfolio
“We could not be more pleased to announce YCANTH™ has been granted NCE Status by the FDA,” said Ted White, Verrica’s President and Chief Executive Officer. “Today’s announcement represents the continued execution of our Company’s comprehensive intellectual property strategy to maximize the patent and regulatory protections surrounding YCANTH™. While NCE status will provide YCANTH™ with a minimum of five years of protection, we anticipate our full patent portfolio to provide protection from generic competition for the next decade and potentially beyond.”
The Company’s U.S. patents and pending patent applications related to YCANTH™ are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension. This robust patent portfolio further strengthens Verrica’s position in the dermatology market.
The Importance of the Orange Book Listing
Formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is an FDA publication that provides a list of drugs approved as safe and effective. It serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data. The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled. The inclusion of YCANTH™ in this prestigious list further validates the product’s safety, efficacy, and patent protection.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, YCANTH™ (cantharidin), became the first treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com.
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