Verrica Pharmaceuticals Announces that YCANTH™ Receives New Chemical Entity Status and Orange Book Listing from the FDA

Rhea-AI Summary

Verrica Pharmaceuticals Inc. announced that their lead product, YCANTH™, has received New Chemical Entity (NCE) Status and a listing in the Orange Book from the FDA, providing a minimum of five years of regulatory exclusivity. The Company's patents related to YCANTH™ are projected to expire between 2034 and 2041, with potential protection from generic competition for over a decade.

Insights

Pharmaceutical Patent Attorney

The conferment of New Chemical Entity (NCE) status to YCANTH™ by the FDA is a significant milestone for Verrica Pharmaceuticals, essentially serving as a moat against generic competition. This exclusivity period can be a strategic advantage, especially in the highly competitive dermatology market. The extended protection until 2034, with the possibility of further extensions, allows Verrica to potentially recoup its investment in R&D and marketing without immediate pressure from generics. However, it's important to note that while NCE status is beneficial, it is not absolute. The company must continue to innovate and maintain its market position against branded competitors and be prepared for eventual generic entry post-exclusivity.

Financial Analyst

From a financial perspective, the announcement of NCE status and the extended patent protection timeline for YCANTH™ should be received positively by investors. The exclusivity until at least 2034 provides a clearer revenue projection for the company's lead product. This visibility can lead to increased investor confidence and potentially a higher stock valuation. However, investors should monitor the company's pipeline and sales performance of YCANTH™ closely, as the true financial impact will depend on the product's market uptake and the company's ability to manage operational costs effectively during the exclusivity period.

Market Research Analyst

Understanding the dermatology market dynamics is important when evaluating the impact of Verrica's announcement. The dermatology therapeutics sector is driven by innovation and the introduction of new treatments. YCANTH™'s NCE status indicates a recognition of its novelty and potential competitive edge. Market research would focus on assessing the demand for such a product, the size of the addressable market and the competitive landscape. The company's strategy to maximize patent and regulatory protections suggests a strong commitment to securing a significant market share. However, the real test will be in the execution of commercialization strategies and the ability to meet market expectations in terms of efficacy, safety and cost-effectiveness.

NCE status provides a minimum of five years of regulatory exclusivity

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

WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.

“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™ and further underscores the product’s innovation and intrinsic value in the dermatology market. 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.”

Formally described 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 and also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data.¹ The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled.

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.

Forward-Looking Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “anticipate”, and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include the Company’s expectations with regard to the length of time for which YCANTH will not face competition from generic products and patent expiration dates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2023, and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

Terry Kohler 
Chief Financial Officer 
tkohler@verrica.com

Kevin Gardner 
LifeSci Advisors 
kgardner@lifesciadvisors.com

Chris Calabrese 
LifeSci Advisors 
ccalabrese@lifesciadvisors.com

¹ _{https://www.fda.gov/media/143766/download}

FAQ

What is the significance of YCANTH™ receiving NCE Status?

YCANTH™ receiving NCE Status means it will have a minimum of five years of regulatory exclusivity, providing protection from generic competition.

What is the Orange Book listing mentioned in the press release?

The Orange Book is an FDA publication that lists approved drugs, patents, and regulatory exclusivities. It serves as a resource for drug information and availability.

How long are Verrica's patents related to YCANTH™ projected to last?

Verrica's patents related to YCANTH™ are projected to expire between 2034 and 2041, with potential protection from generic competition for over a decade.