Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for VP-102 in Molluscum
Verrica Pharmaceuticals reaffirmed its expectation to resubmit the New Drug Application (NDA) for VP-102, targeting molluscum contagiosum, in Q1 2021. This announcement comes after productive discussions with the FDA addressing prior Chemistry, Manufacturing, and Controls (CMC) issues outlined in a Complete Response Letter received in July. VP-102 is a first-in-class drug-device combination aimed at treating a viral skin disease, currently lacking FDA-approved options. The company is also preparing to complete a Human Factors study by year-end.
- Expected resubmission of NDA for VP-102 in Q1 2021.
- Alignment with FDA on addressing CMC issues.
- Completion of Human Factors study planned by year-end.
- Positive Phase 2 trial results for VP-102 in treating external genital warts.
- Received Complete Response Letter from FDA requesting additional information in July.
- Verrica reaffirms expectation to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021 -
WEST CHESTER, Penn., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) following the Company’s recent Type A meeting to discuss the steps required for resubmission of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).
VP-102 is a first-in-class, proprietary drug-device combination for the treatment of molluscum, a viral skin disease affecting approximately six million people, primarily children, in the United States. There are currently no FDA-approved treatments for molluscum. In July, the Company announced that it had received a Complete Response Letter from the FDA requesting additional Chemistry, Manufacturing and Controls (CMC) information as well as Human Factors validation.
“We are encouraged by our productive discussion with the FDA and the FDA’s written meeting minutes, which reflect alignment on the steps to address the CMC issues raised in the CRL as well as the path forward for resubmission of the NDA and the potential approval of VP-102 to treat patients with molluscum,” said Ted White, President and Chief Executive Officer, Verrica. “In addition, our Human Factors study protocol has been reviewed by the FDA and we are preparing to complete that study by the end of the year. We are pleased to reaffirm our expectation to resubmit the NDA for VP-102 pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021.”
This news follows Verrica’s recent announcement of positive results for VP-102 for the treatment of external genital warts (EGW) in the Phase 2 CARE-1 trial. As previously announced, Verrica intends to request an End-of-Phase 2 meeting with the FDA for VP-102 in EGW in the first quarter of 2021.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. The Company’s late-stage product candidate, VP-102, is a potential first-in-class drug-device combination product containing a topical therapy for the treatment of molluscum contagiosum. 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. The Company is also developing VP-103, its third cantharidin-based product candidate, for the treatment of plantar warts. Verrica submitted an NDA for VP-102 for the treatment of molluscum in September 2019. A Complete Response Letter was received from the FDA regarding the NDA for VP-102 on July 13, 2020. In October 2020, Verrica participated in a Type A meeting with the FDA. Verrica expects to resubmit its New Drug Application for VP-102 for the treatment of molluscum in the first quarter of 2021. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH™. For more information, visit www.verrica.com.
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 expectations regarding the Company’s expectations with regard to its interactions and communications with the FDA, the timing for its resubmission of the NDA for VP-102 in the first quarter of 2021, the potential approval of the NDA for VP-102 following resubmission, the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, and the potential benefits and clinical development plan for VP-102 for the treatment of EGW. 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, uncertainties related to the COVID-19 pandemic and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2019, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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:
A. Brian Davis
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
William Windham
Solebury Trout
646.378.2946
wwindham@troutgroup.com
Media:
Zara Lockshin
Solebury Trout
646.378.2960
zlockshin@troutgroup.com
FAQ
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