Verrica Pharmaceuticals Announces Amendment to Company’s Collaboration and License Agreement with Torii Pharmaceutical Co. Ltd. to Fund Global Pivotal Phase 3 Clinical Trial to Study YCANTH® for the Treatment of Common Warts
Verrica Pharmaceuticals announced an amendment to its collaboration with Torii Pharmaceutical to jointly conduct a global pivotal Phase 3 clinical trial for YCANTH® in treating common warts, expected to start in the first half of 2025. The cost will be equally shared, with Torii funding Verrica's portion through future payment offsets. Verrica highlighted the significant commercial prospects for YCANTH, given the 22 million common wart patients in the U.S. alone and no FDA-approved treatments. Torii will also make an $8 million milestone payment to Verrica upon the first patient dosing in Japan. The trial's initiation depends on feedback from the FDA and Japan's PMDA.
- Global pivotal Phase 3 clinical trial for YCANTH® to address a large unmet need in dermatology.
- Equal cost-sharing with Torii, minimizing impact on Verrica's finances.
- Potential multibillion-dollar commercial opportunity for YCANTH® in the U.S. and E.U.
- Torii to make an $8 million milestone payment upon first patient dosing in Japan.
- Successful Phase 2 COVE-1 trial showing 51% complete clearance of warts.
- Phase 3 trial initiation subject to FDA and PMDA feedback, introducing regulatory uncertainty.
- Financial dependency on future offset payments from Torii, which are not immediate.
Insights
The amendment to the collaboration and license agreement between Verrica Pharmaceuticals and Torii Pharmaceutical to jointly fund and conduct a global pivotal Phase 3 clinical trial for YCANTH in the treatment of common warts is strategically significant for both companies. Splitting the Phase 3 trial costs reduces financial risk for Verrica, which is a positive factor given its existing cash position. The structure of the funding, where Torii offsets Verrica’s costs against future payments, is innovative and reduces immediate cash outflow, which is critical for a smaller biotech firm. The
Potential Drawbacks: The trial's success isn't guaranteed and feedback from regulatory bodies like the FDA and PMDA could delay or alter the trial's design, impacting timelines and costs. Additionally, the amendment hinges on Torii’s future sales and regulatory milestones in Japan, which adds an element of uncertainty.
Short-Term Implications: Short-term, this news may lead to a positive response from the market due to the reduced financial burden on Verrica and the potential for milestone payments. It also demonstrates active management and tangible progress in advancing YCANTH.
Long-Term Implications: If successful, the Phase 3 trial could open significant revenue streams from both U.S. and E.U. markets, with common warts representing a
From a medical research perspective, the global pivotal Phase 3 trial for YCANTH represents a critical step in addressing a significant unmet need in dermatology. The Phase 2 COVE-1 trial showed promising results, with
Clinical Relevance: The prevalence of common warts and the lack of FDA-approved treatments make this a high-stakes trial. The potential for YCANTH to fill this therapeutic gap is significant, especially given the overlap with the pediatric population, which represents
Regulatory Considerations: Regulatory feedback will be crucial. Positive data could expedite approval processes not just in the U.S., but also open doors in the E.U. and other markets. The collaboration with Torii adds credibility and resources, potentially smoothing the regulatory pathway.
Patient Impact: If approved, YCANTH could drastically improve treatment options for common warts, offering a targeted solution where none currently exists. This could lead to better patient outcomes and reduced healthcare costs associated with ineffective treatments.
The market potential for YCANTH in the treatment of common warts is substantial. With an estimated 22 million affected individuals in the U.S. and a similar patient population in the E.U., the commercial opportunity is significant. The lack of FDA-approved treatments creates a unique market entry point for YCANTH, which Verrica estimates as a
Market Synergies: Verrica’s existing marketing infrastructure for YCANTH, used for molluscum contagiosum, could be leveraged for the common warts indication, leading to cost efficiencies and stronger market penetration. Synergies in promotion and distribution channels can expedite YCANTH's market adoption.
Competitive Landscape: The absence of direct FDA-approved competitors places YCANTH in a favorable position upon approval. However, potential competition from off-label treatments and natural remedies exists, which the company must navigate through robust clinical efficacy and strategic marketing.
Investor Considerations: For retail investors, this amendment represents a strategic move that could significantly enhance Verrica's market position and revenue streams. However, the trial's success and regulatory approval are important and investors should be prepared for the inherent risks associated with clinical trials.
Global pivotal Phase 3 clinical trial would be conducted jointly by Verrica and Torii Pharmaceutical; trial expected to begin in the 1st half of 2025
Amendment should benefit both parties from a cost and time to market standpoint; funding structure is expected to have a minimal impact on Verrica’s cash position
Common warts is one of the largest and most underserved patient populations in medical dermatology with a prevalence of ~22M in the U.S. and no FDA approved products; Verrica believes common warts represents a multibillion-dollar commercial opportunity; patient opportunity for common warts in the E.U. is believed to be at least equivalent to the U.S.
WEST CHESTER, Pa., May 15, 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 it has entered into an amendment to its existing licensing agreement with Torii Pharmaceutical Co. Ltd. (Torii), to jointly conduct a global pivotal Phase 3 clinical trial of YCANTH® for the treatment of common warts.
“We are pleased to announce this significant amendment to our license agreement with Torii Pharmaceutical to advance YCANTH into a global pivotal Phase 3 clinical trial for the treatment of common warts,” said Ted White, President and Chief Executive Officer of Verrica Pharmaceuticals. “Torii has been an outstanding partner in the development of YCANTH for molluscum contagiosum, and we look forward to our continued collaboration to progress YCANTH through a pivotal global Phase 3 clinical trial for common warts, which represents the single largest and most underserved patient population in all of dermatology. If positive, the data from this global Phase 3 clinical trial would not only potentially allow Verrica to submit a sNDA in the U.S. seeking FDA approval for the use of YCANTH for the treatment of common warts, but may also be utilized by Verrica to seek future marketing authorizations in territories outside the U.S. and Japan, including potentially within the European Union.”
In March 2021, Verrica and Torii Pharmaceutical entered into an agreement granting Torii an exclusive license to develop and commercialize Verrica’s product candidates for the treatment of molluscum contagiosum and common warts in Japan, including YCANTH (TO-208 in Japan). The terms of the amendment would enable the two parties to equally split the cost of the global Phase 3 clinical trial in common warts, with Torii funding Verrica’s portion of the costs as an offset to Torii’s future payment obligations to Verrica based on regulatory milestones and sales of YCANTH for molluscum contagiosum and common warts in Japan. In addition, Torii would make a milestone payment of
With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes represents a multibillion-dollar commercial opportunity. In the United States, approximately
COVE-1 Phase 2 Data in Common Warts
Verrica has previously announced positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts. COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed that
About YCANTH (formerly 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 currently approved by the FDA to treat molluscum in adult and pediatric patients 2 years of age and older, a common, highly contagious viral skin disease that affects an estimated six million people in the United States, primarily children. Please visit YCANTHPro.com for additional information.
In addition, Verrica has successfully completed a Phase 2 clinical trial of VP-102 for the treatment of common warts and a Phase 2 clinical trial 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.
Important Safety Information
CONTRAINDICATIONS:
None.
WARNINGS AND PRECAUTIONS:
- YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes. If YCANTH gets in eyes, flush eyes with water for at least 15 minutes.
- Local Skin Reactions: Reactions at the application site may occur, including vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin. If YCANTH contacts any unintended surface, or healthy skin, immediately remove. If severe local skin reactions occur, remove prior to the recommended 24 hours after treatment.
- YCANTH is flammable, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed.
ADVERSE REACTIONS:
The most common (incidence ≥
DRUG INTERACTIONS:
No studies evaluating the drug interaction potential of cantharidin have been conducted.
USE IN SPECIFIC POPULATIONS:
Pregnancy: There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug.
Lactation: Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.
OVERDOSAGE:
Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis.
Please see accompanying full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-VERRICA (1-877-837-7422), or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Local skin reactions are expected and should be reported if they are severe.
About Common Warts
Common warts (verruca vulgaris) are skin growths caused by a contagious viral skin infection, most commonly on the fingers or hands. The human papilloma virus (HPV), the causative agent in common warts, is transmitted by touch. The virus enters the skin and causes skin growths by inducing the skin cells to multiply rapidly. Common warts are benign, but treatment is recommended to prevent the spread of infection and relieve the patient’s physical and psychological discomfort.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH (cantharidin), is the first and only commercially available 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. 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,” 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 clinical development and potential regulatory approval of and commercialization of YCANTH™ for the treatment of common warts in the United States and Japan, including Verrica’s expectations regarding the timing of the initiation of a Phase 3 clinical trial of YCANTH™ (VP-102) for the treatment of common warts, and the potential to seek marketing authorizations outside of the United States and Japan. 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
FAQ
What is Verrica's latest announcement regarding YCANTH®?
When is the Phase 3 clinical trial for YCANTH® expected to begin?
How will the cost of the Phase 3 trial for YCANTH® be shared?
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What milestone payment will Verrica receive from Torii?
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