WEST CHESTER, Pa. - Verrica Pharmaceuticals Inc. (NASDAQ: NASDAQ:VRCA), a company specializing in dermatology therapeutics, 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 designation secures a minimum of five years of market exclusivity for the drug, which is listed in the FDA's Orange Book.
YCANTH™, which targets skin diseases needing medical treatment, received FDA approval on July 21, 2023, for treating molluscum contagiosum in adults and children over two years old. The viral skin infection affects roughly 6 million individuals in the U.S., predominantly children. Verrica's product is also under development for other skin conditions, including common and external genital warts.
The NCE status is a critical component of Verrica's strategy to protect its product from generic competition. The company's President and CEO, Ted White, expressed satisfaction with the FDA's decision, highlighting its importance to the company's intellectual property strategy. According to White, the current patent portfolio for YCANTH™ could extend protection against generics well into the next decade.
The Orange Book, formally known as the Approved Drug Products with Therapeutic Equivalence Evaluations, is a resource for information on drug marketing availability, bioequivalence, and patent and exclusivity data. It also includes listings of patents that cover approved drugs and approved methods of their use.
Verrica is further developing VP-103, another cantharidin-based product candidate, for plantar warts treatment. Additionally, the company has a licensing agreement to develop and commercialize VP-315 for non-melanoma skin cancers, including basal cell and squamous cell carcinoma.
This article is based on a press release statement from Verrica Pharmaceuticals Inc.
InvestingPro Insights
Amid the promising news of YCANTH™ gaining NCE status, Verrica Pharmaceuticals Inc. (NASDAQ: VRCA) presents a mixed financial canvas, according to InvestingPro data. With a market capitalization of $214.64 million, the company's financial health and growth prospects are areas of interest for investors. Notably, Verrica holds more cash than debt on its balance sheet, which could provide a cushion as it ramps up the commercialization of its newly approved drug. However, the company is not without its challenges, as it is quickly burning through cash and has not been profitable over the last twelve months as of Q1 2023.
Analysts have their eyes on Verrica's sales growth in the current year, which could be pivotal for the company's trajectory. Still, the company’s stock price movements remain quite volatile, which may concern some investors. Further, Verrica is trading at a high Price / Book multiple of 10.86 as of the last twelve months, indicating a premium valuation compared to its book value.
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