Verrica Pharmaceuticals Announces Litigation Settlement with Dormer Laboratories, Inc.
Verrica Pharmaceuticals (Nasdaq: VRCA) announced a settlement with Dormer Laboratories, resulting in Dormer halting sales of cantharidin-containing products in the U.S. Verrica's FDA-approved YCANTH is now the sole commercially available cantharidin therapy for molluscum contagiosum, a skin disease. CEO Ted White emphasized the importance of FDA approval for patient safety and indicated increased market usage for YCANTH as a result. The settlement underscores Verrica's commitment to preventing the distribution of non-FDA approved cantharidin products in the U.S.
- Dormer Labs discontinued all cantharidin-containing product sales in the U.S.
- YCANTH is now the only FDA-approved, commercially available cantharidin therapy for molluscum contagiosum.
- The settlement may lead to increased patient usage and market share for YCANTH.
- None.
Insights
The settlement between Verrica Pharmaceuticals and Dormer Laboratories signifies a pivotal legal development. This agreement essentially removes Dormer Labs from the U.S. market for cantharidin-containing products, which were previously non-FDA approved. Verrica's aggressive legal stance versus unauthorized competition emphasizes their commitment to patient safety and regulatory compliance. This successful litigation highlights the importance of intellectual property and regulatory adherence in the pharmaceutical industry.
From a legal perspective, the settlement could set a precedent, potentially deterring other companies from attempting to bypass FDA regulations. Such moves reinforce the value of regulatory approval and patent protections, ensuring a level playing field and upholding the integrity of the market.
The litigation settlement is a notable financial event for Verrica Pharmaceuticals. By removing Dormer Labs' non-FDA approved products from the U.S. market, Verrica effectively eliminates a major competitor. This shift is likely to lead to increased market share for their FDA-approved YCANTH, as it is now the sole cantharidin therapy available.
In the short term, this could lead to higher revenue and an improved financial outlook for Verrica. Investors should monitor upcoming financial reports for positive revenue impacts. However, it's important to consider the costs associated with the legal action, though these are likely outweighed by the long-term financial gains from increased market exclusivity and heightened brand trust.
This settlement reshapes the competitive landscape of the dermatological treatments market, specifically for molluscum contagiosum. By eliminating non-FDA approved products, Verrica's YCANTH now has a unique market position, likely improving its adoption among dermatologists and patients.
The increased market exclusivity can enhance Verrica's pricing power, contributing positively to their profit margins. It's also important to note that the eradication of non-compliant products may bolster overall patient trust in pharmaceutical treatments, translating into better patient outcomes and potentially higher long-term product loyalty for YCANTH.
However, investors should remain aware of potential market entry by new competitors in the future, which could impact Verrica’s market position.
- Dormer Labs has discontinued the sale of all cantharidin-containing products into the United States
- YCANTH is the only commercially available, FDA approved therapy for molluscum contagiosum and is clinically proven to be safe and effective
WEST CHESTER, Pa., July 01, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced the settlement of litigation with Dormer Laboratories, Inc. (“Dormer Labs”). As part of the settlement, Dormer Labs has discontinued the sale of all cantharidin-containing products into the United States, including Dormer brands Cantharone (Liquid) and Cantharone Plus.
“We are pleased to announce the expeditious settlement with Dormer Labs, which Verrica believes was the largest supplier of non-FDA approved cantharidin-containing products into the U.S. market,” said Ted White, Verrica’s President and Chief Executive Officer. “This settlement should send a clear message that Verrica will remain vigilant in its efforts to identify and stop any drug manufacturer or distributor that seeks to market, sell or distribute non-FDA approved cantharidin in the United States. We believe that this settlement will result in greater patient usage of the FDA-approved YCANTH.”
We remain vigilant regarding any U.S. based pharmacies or outsourcing facilities improperly compounding cantharidin without adhering to the requirements and parameters established by the FDA. Patient safety is imperative, and compounded cantharidin is not only unapproved, but it can be harmful to patients due to its lack of stability and inconsistent concentration. YCANTH is the only commercially available cantharidin therapy for the treatment of molluscum contagiosum that the FDA has found to be safe and effective,” White added.
About YCANTH® (VP-102)
YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only commercially available product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapy for the treatment of molluscum. Approximately 228 million lives are eligible to receive YCANTH covered by insurance. YCANTH is available to all patients with and without insurance coverage for between
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.
YCANTH should only be administered by a trained healthcare professional. YCANTH is not for home use.
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 also 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 impact of the settlement on patient usage of YCANTH and the Company’s intention to continue efforts to identify and stop manufacturer and distributors of non-FDA approved cantharidin. 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, Verrica’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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
FAQ
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