Verrica Pharmaceuticals Announces Receipt of Final FDA Minutes Following Type A Meeting Regarding Resubmission of the NDA for...
November 17 2020 - 7:30AM
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 DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@troutgroup.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@troutgroup.com
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