Verrica Pharmaceuticals Announces that Development Partner Torii Pharmaceutical Files New Drug Application of TO-208 the Treatment of Molluscum Contagiosum in Japan
Verrica Pharmaceuticals announced that its partner Torii Pharmaceutical has submitted a New Drug Application (NDA) for TO-208 to treat Molluscum Contagiosum in Japan. TO-208, marketed as YCANTH® in the U.S., demonstrated superiority to vehicle in Phase 3 clinical studies with Japanese patients aged ≥2 years, showing a safety profile consistent with U.S. studies.
The development addresses an estimated 1.6 million cases of molluscum in Japan, representing a significant unmet medical need. This submission follows Torii's exclusive license agreement with Verrica in March 2021 for development and commercialization in Japan. Notably, VP-102 received U.S. approval in July 2023 and has been marketed as YCANTH® since August 2023.
Verrica Pharmaceuticals ha annunciato che il suo partner Torii Pharmaceutical ha presentato una Nuova Richiesta di Farmaco (NDA) per TO-208 per trattare il Mollusco Contagioso in Giappone. TO-208, commercializzato come YCANTH® negli Stati Uniti, ha dimostrato superiorità rispetto al veicolo negli studi clinici di Fase 3 con pazienti giapponesi di età ≥2 anni, mostrando un profilo di sicurezza coerente con gli studi statunitensi.
Lo sviluppo affronta un stimato 1,6 milioni di casi di mollusco in Giappone, rappresentando un significativo bisogno medico insoddisfatto. Questa presentazione segue l'accordo di licenza esclusiva di Torii con Verrica nel marzo 2021 per lo sviluppo e la commercializzazione in Giappone. È importante notare che VP-102 ha ricevuto l'approvazione negli Stati Uniti nel luglio 2023 ed è stato commercializzato come YCANTH® da agosto 2023.
Verrica Pharmaceuticals anunció que su socio Torii Pharmaceutical ha presentado una Nueva Solicitud de Medicamento (NDA) para TO-208 para tratar el Molusco Contagioso en Japón. TO-208, comercializado como YCANTH® en EE. UU., demostró superioridad frente al vehículo en estudios clínicos de Fase 3 con pacientes japoneses de ≥2 años, mostrando un perfil de seguridad consistente con los estudios estadounidenses.
El desarrollo aborda unos 1.6 millones de casos de molusco en Japón, representando una necesidad médica insatisfecha significativa. Esta presentación sigue al acuerdo de licencia exclusiva de Torii con Verrica en marzo de 2021 para el desarrollo y comercialización en Japón. Cabe destacar que VP-102 recibió aprobación en EE. UU. en julio de 2023 y ha sido comercializado como YCANTH® desde agosto de 2023.
베리카 제약(Verrica Pharmaceuticals)는 파트너사인 토리 제약(Torii Pharmaceutical)이 일본에서 몰루스쿠스 전염증 치료를 위한 TO-208에 대한 신약 신청(NDA)을 제출했다고 발표했습니다. TO-208은 미국에서 YCANTH®로 판매되며, 일본의 2세 이상 환자를 대상으로 한 3상 임상시험에서 대조군보다 우수성을 보였고, 미국 연구와 일치하는 안전성 프로필을 보여주었습니다.
이 개발은 일본 내 160만 건의 몰루스쿠스 사례를 다루며, 이는 상당한 의학적 필요를 충족하지 못하고 있습니다. 이번 신청은 2021년 3월 베리카와의 독점 라이선스 계약을 따른 것입니다. 특히, VP-102는 2023년 7월 미국에서 승인을 받았고, 2023년 8월부터 YCANTH®로 판매되고 있습니다.
Verrica Pharmaceuticals a annoncé que son partenaire Torii Pharmaceutical a soumis une Demande de Nouveau Médicament (NDA) pour TO-208 afin de traiter le Molluscum contagiosum au Japon. TO-208, commercialisé sous le nom de YCANTH® aux États-Unis, a montré une supériorité par rapport au traitement témoin dans des études cliniques de phase 3 avec des patients japonais âgés de ≥2 ans, montrant un profil de sécurité cohérent avec les études américaines.
Le développement répond à un 1,6 million de cas estimés de molluscum au Japon, représentant un besoin médical non satisfait important. Cette soumission fait suite à l'accord de licence exclusive de Torii avec Verrica en mars 2021 pour le développement et la commercialisation au Japon. Il est à noter que VP-102 a reçu l'approbation aux États-Unis en juillet 2023 et est commercialisé sous le nom de YCANTH® depuis août 2023.
Verrica Pharmaceuticals gab bekannt, dass sein Partner Torii Pharmaceutical einen Antrag auf Zulassung eines neuen Arzneimittels (NDA) für TO-208 zur Behandlung von Molluscum contagiosum in Japan gestellt hat. TO-208, der in den USA als YCANTH® vermarktet wird, zeigte in Phase-3-Studien mit japanischen Patienten im Alter von ≥2 Jahren eine Überlegenheit gegenüber dem Placebo und wies ein Sicherheitsprofil auf, das mit den US-Studien übereinstimmte.
Die Entwicklung befasst sich mit geschätzten 1,6 Millionen Fällen von Molluscum in Japan und stellt einen erheblichen ungedeckten medizinischen Bedarf dar. Diese Einreichung folgt dem Exklusivvertragsabschluss zwischen Torii und Verrica im März 2021 zur Entwicklung und Vermarktung in Japan. Bemerkenswert ist, dass VP-102 im Juli 2023 in den USA genehmigt wurde und seit August 2023 als YCANTH® vermarktet wird.
- Successful submission of NDA in Japan, expanding market reach
- Phase 3 clinical study met primary endpoint showing superiority to vehicle
- Large target market with 1.6 million potential cases in Japan
- Consistent safety profile with U.S. studies
- None.
Insights
WEST CHESTER, Pa., Dec. 06, 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 its development and commercialization partner, Torii Pharmaceutical Co. Ltd. (“Torii”), submitted a New Drug Application (“NDA”) of TO-208 (referred to as VP-102 and marketed as YCANTH® in the U.S.) for the treatment of Molluscum Contagiosum (“molluscum”) in Japan.
“Torii continues to be an outstanding partner in advancing TO-208 for the treatment of molluscum, and today’s NDA submission represents the next critical milestone towards bringing to market the first therapeutic for addressing this indication in Japan,” said Jayson Rieger, Ph.D., MBA, President and Chief Executive Officer of Verrica. “With an estimated prevalence of approximately 1.6 million cases, molluscum represents a large and underserved patient population in Japan, and we believe Torii’s therapeutic expertise and commercial infrastructure in dermatology will maximize the opportunity to address this significant unmet need.”
TO-208 is a skin disease treatment drug candidate containing cantharidin as an active ingredient. In the Phase 3 clinical study of TO-208 in patients with molluscum contagiosum (≥2 years old) in Japan, the primary endpoint of efficacy has met superiority to the vehicle. Furthermore, the safety profile of TO-208 in the study was consistent to prior studies in the United States and there were no observed issues of tolerability for the application.
Torii and Verrica executed an exclusive license agreement for the development and commercialization of TO-208 for the treatment of molluscum and common warts in Japan in March 2021.
Verrica received manufacturing and marketing approval of VP-102 to treat molluscum contagiosum in the U.S. in July 2023. Verrica has marketed VP-102 under the brand name YCANTH® in the U.S. since August 2023 and has completed a Phase 2 clinical study of VP-102 for the treatment of common warts and a Phase 2 clinical study of VP-102 for the treatment of external genital warts in the U.S.
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 therapeutic 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
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. Verrica’s product YCANTH® (VP-102) (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. 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.
Forward-Looking Statements
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 statements about Verrica’s expectations with regard to the clinical development and potential commercialization of TO-208 for the treatment of molluscum in Japan, Torri’s ability to maximize the opportunity in Japan, the clinical development of YCANTH (VP-102) for additional indications, and the benefits of Verrica’s product candidates, including YCANTH (VP-102). 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 risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering 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 September 30, 2024 and other filings Verrica makes with the SEC. 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.
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FAQ
What is the status of TO-208 (VRCA) drug application in Japan?
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