Verrica Pharmaceuticals Announces FDA Filing Acceptance of Resubmitted New Drug Application for VP-102 for the Treatment of M...
February 17 2021 - 7:30AM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced that its
resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7%
Topical Solution), a proprietary topical therapy for the treatment
of molluscum contagiosum (molluscum), has been accepted for filing
by the U.S. Food and Drug Administration (FDA). The Prescription
Drug User Fee Act (PDUFA) goal date assigned by the FDA for this
NDA is June 23, 2021.
Verrica previously submitted an NDA for VP-102 for the treatment
of molluscum in September 2019. As previously announced, the FDA
issued a Complete Response Letter requesting additional Chemistry,
Manufacturing and Controls (CMC) information as well as Human
Factors validation in July 2020. Verrica resubmitted the NDA for
VP-102 for the treatment of molluscum on December 23, 2020.
“This is an exciting time for Verrica as we work with the FDA to
continue to move VP-102 through the regulatory process,” said Ted
White, President and Chief Executive Officer, Verrica. “We believe
that VP-102 is well-positioned to become the first FDA-approved
product for the treatment of molluscum and could potentially bring
relief to the millions of children diagnosed with this highly
contagious disease.”
The NDA is based on positive results from two identical Phase 3
randomized, double-blind, multicenter clinical 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. In both trials, a clinically and statistically
significant number of patients treated with VP-102 met the primary
endpoint of complete clearance of all treatable molluscum
lesions.
VP-102 was well-tolerated in both trials, with no serious
adverse events reported in VP-102-treated subjects.
About VP-102
Verricaʼs lead product candidate, VP-102, is a proprietary
drug-device combination product that contains a GMP-controlled
formulation of cantharidin (0.7% w/v) delivered via a single-use
applicator that allows for precise topical dosing and targeted
administration. VP-102 is currently under U.S. Food and Drug
Administration (FDA) review and could potentially be the first
product approved by the FDA to treat molluscum contagiosum ― a
common, highly contagious skin disease that affects an estimated
six million people in the United States, primarily children. If
approved, VP-102 will be marketed in the United States under the
conditionally accepted brand name YCANTH™. 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.
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a
highly contagious viral skin disease that affects approximately six
million people — primarily children — in the United States.
Molluscum is caused by a pox virus that produces distinctive
raised, skin-toned-to-pink-colored lesions that can cause pain,
inflammation, itching and bacterial infection. It is easily
transmitted through direct skin-to-skin contact or through fomites
(objects that carry the disease like toys, towels or wet surfaces)
and can spread to other parts of the body or to other people,
including siblings. The lesions can be found on most areas of the
body and may carry substantial social stigma. Without treatment,
molluscum can last for an average of 13 months, and in some cases,
up to several years.
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing
medications for skin diseases requiring medical interventions.
Verrica’s late-stage product candidate, VP-102, is in development
to treat molluscum contagiosum (molluscum), common warts and
external genital warts, three of the largest unmet needs in medical
dermatology. Verrica is also developing VP-103, its second
cantharidin-based product candidate, for the treatment of plantar
warts. The Company has also entered a worldwide license agreement
with Lytix Biopharma AS to develop and commercialize LTX-315 for
dermatologic oncology conditions. 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 the potential
approval of the NDA for VP-102 and the potential benefits and
potential commercialization of VP-102 for the treatment of
molluscum, if approved. 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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