Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
December 23 2020 - 4:01PM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced that it
has resubmitted the New Drug Application (NDA) for VP-102 for the
treatment of molluscum contagiosum (molluscum) to the U.S. Food and
Drug Administration (FDA). The NDA for VP-102 was resubmitted based
on the outcome and final minutes of a Type A meeting with the FDA,
which was conducted to obtain clarity on the Complete Response
Letter (CRL) issued by the FDA in July 2020.
“We are pleased that we were able to expeditiously provide a
comprehensive resubmission of the NDA focused on the Chemistry,
Manufacturing and Controls (CMC) information as well as Human
Factors validation identified by the FDA in its Complete Response
Letter,” said Ted White, President and Chief Executive Officer,
Verrica. “We look forward to working with the FDA through the
review process, and if approved, bringing VP-102 to patients as the
first FDA-approved treatment option for molluscum.”
About VP-102
Verricaʼs lead product candidate, VP-102, is a proprietary
drug-device combination 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 its
interactions and communications with the FDA, the potential
approval of the NDA for VP-102 following resubmission 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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