Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
September 20 2021 - 4:05PM
Verrica Pharmaceuticals Inc. (the “Company”) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced that the
U.S. Food and Drug Administration (FDA) has issued a Complete
Response Letter (CRL) regarding its New Drug Application (NDA) for
VP-102 for the treatment of molluscum contagiosum (molluscum). The
Company had previously disclosed that the FDA extended the
Prescription Drug User Fee Act (PDUFA) goal date for the NDA by
three months to September 23, 2021 to allow the Agency additional
time to review information submitted by the Company in response to
comments from the Agency regarding the Company’s human factors
study.
According to the CRL, the FDA has identified deficiencies at a
facility of a contract manufacturing organization (CMO), which are
not specifically related to the manufacturing of VP-102 but instead
raise general quality issues at the facility. At no time prior to
the CRL was the Company notified by the FDA of any deficiencies at
the CMO related specifically to the manufacturing of VP-102 or that
their general investigation of the facility would have any
impact on the Company’s NDA. More importantly, the FDA did not
identify any clinical, safety or product specific Chemistry,
Manufacturing, and Controls (CMC) deficiencies related to
VP-102.
The Company understands from the CMO that it has
implemented corrective actions to address the Agency’s concerns and
the CMO has advised Verrica that it is expecting
a satisfactory resolution of the facility's identified
deficiencies from the FDA within the next 30 business days.
During this timeframe, the Company will engage with the Agency to
demonstrate that the Company’s good manufacturing practices,
controls and processes ensure that any deficiencies at the CMO do
not impact the efficacy, safety or quality of VP-102.
“We remain confident that we have a path forward for VP-102 as a
potential treatment option for molluscum, a highly contagious viral
skin disease affecting approximately six million people in the
United States - primarily children - for which there are currently
no FDA-approved treatments,” said Ted White, Verrica’s President
and Chief Executive Officer.
About Molluscum Contagiosum (Molluscum)
Molluscum is 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 VP-102Verricaʼs 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. A Complete Response
Letter was received from the FDA regarding the NDA for VP-102
on September 17, 2021. 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 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, 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 interactions
with the FDA, including the FDA’s potential favorable response, and
the timing of such response to the CMO’s corrective actions, 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,
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:
Terry KohlerChief Financial
Officer484.453.3296info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@soleburytrout.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@soleburytrout.com
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