Verrica Pharmaceuticals Provides Regulatory Update on VP-102
June 29 2020 - 4:05PM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for viral
skin diseases requiring medical interventions, today
announced that, on June 24, 2020, the Company received a
letter from the U.S. Food and Drug Administration (FDA)
as part of the FDA’s ongoing review of the Company’s New Drug
Application (NDA) for VP-102 (cantharidin 0.7% topical solution),
Verrica’s lead product candidate for the treatment of molluscum
contagiosum. The letter states that there are deficiencies that
preclude discussion of labeling and post-marketing
requirements/commitments at this time. The letter further states
that the notification does not reflect a final decision on the
information under review. In a letter dated November 26, 2019, the
FDA had assigned a Prescription Drug User Fee Act (“PDUFA”) goal
date of July 13, 2020 for completion of its review of the NDA.
The FDA’s letter does not identify any specific items. But, the
Company notes that information requests from the FDA during the NDA
review have focused on CMC aspects of the drug-device combination.
Verrica’s ability to address these CMC-related requests, however,
was significantly impacted in large part by the COVID-19
pandemic.
The requests include, but are not limited to, a specific request
related to a potential safety issue with the applicator that could
arise if the instructions for use were not properly followed. In
response, the Company incorporated an additional user feature into
the applicator to address that issue. The addition of that user
feature, however, has affected human factors testing as well as
requiring additional supportive stability data on the fully
assembled device incorporating such feature. The Company believes
that both its long-term and registration stability data with the
ampule, and the as-submitted applicator, support significant shelf
life and stability for VP-102.
The Company anticipates interactions with, and additional
communication from, the FDA and intends to work with
the FDA to resolve and address any items as quickly as
possible.
Notwithstanding the pandemic or the CMC-related requests that
have arisen during the review cycle, the Company believes that the
positive results from its two double-blind Phase 3 trials (CAMP-1
and CAMP-2) that evaluated the safety and efficacy of VP-102
compared to placebo in patients two years of age and older
diagnosed with molluscum indicates that VP-102 remains viable for
FDA approval.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing
medications for viral skin diseases requiring medical
interventions. The Company’s late-stage product candidate, VP-102,
is a potential first-in-class topical therapy for the treatment of
molluscum contagiosum. An NDA for VP-102 for the treatment of
molluscum is currently under review by FDA and, if approved, VP-102
will be marketed in the United States under the
conditionally accepted brand name YCANTH™. Verrica intends to
initiate a Phase 3 program of VP-102 for the treatment of common
warts when conditions are appropriate, given the COVID-19 pandemic.
In addition, VP-102 is being evaluated in Phase 2 study for the
treatment of external genital warts. The Company is also developing
VP-103, its second cantharidin-based product candidate, and intends
to launch a Phase 2 study in subjects with plantar warts when
conditions are appropriate. 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 expectations
regarding the potential receipt and timing of the FDA’s approval of
the NDA, the Company’s expectations with regard to its interactions
and communications with the FDA, plans and expectations related to
the PDUFA date, the potential benefits and potential approval and
commercialization of YCANTH™ for the treatment of molluscum, and
the clinical development of product candidates for additional
indications, including common warts, external genital warts and
plantar warts. 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 March 31, 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
Luke Brown Solebury Trout 646.378.2944
lbrown@troutgroup.com
Media:
Joshua R. Mansbach Solebury Trout 646.378.2964
jmansbach@troutgroup.com
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