Verrica Pharmaceuticals Inc. (Verrica) (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 only deficiency listed in the CRL was
related to the deficiencies identified at a general reinspection of
Sterling Pharmaceuticals Services, LLC (Sterling), the contract
manufacturing organization (CMO) that manufactures Verrica’s bulk
solution drug product. Sterling advised Verrica on May 20, 2022
that it received notice that it is on OAI status. Sterling’s OAI
classification resulted from a week-long reinspection of the CMO
conducted by FDA in February 2022. The reinspection was conducted
approximately 90 days after Sterling was originally classified by
the Agency as VAI (Voluntary Action Indicated) on November 17,
2021. Verrica understood that the VAI classification did not
indicate that a reinspection was required.
The CRL did not identify any other deficiencies.
Moreover, none of the issues identified by FDA during the
reinspection were specific to the manufacturing of VP-102.
Additionally, Verrica was informed by the Division that it had
completed its review of Verrica’s NDA and product label, there were
no open questions on the NDA review, and the VP-102 label was ready
to be communicated. However, Verrica has been informed that
internal FDA policy is preventing the Agency from communicating the
label and approving the NDA when a CMO has an unresolved
classification status or is placed on OAI status.
“Based on the successful PAI of VP-102 at
Sterling and our understanding that the Division was ready to
communicate our label, we believe our NDA meets the statutory
standards for approval and that any issues at Sterling do not
impact the manufacturing, quality, efficacy, or safety of VP-102,”
commented Ted White, Verrica’s President and Chief Executive
Officer. “However, we recognize that the Dermatology Division’s
hands may be tied due to the reinspection issues at Sterling and
thank them for their efforts working with us to date.” In addition,
Mr. White noted that “VP-102 is a non-sterile
topical dermatology product that is not systemically absorbed.
It is completely solvent based and has been demonstrated to
have bactericidal and viricidal properties. By comparison, the
observations cited at Sterling which led to its OAI classification
status were predominantly related to its distinct sterile
operations where higher-risk, sterile ophthalmic products are
manufactured by Sterling for, among other distributors, the U.S.
government.”
For additional quality control and oversight at
Sterling, Verrica proactively and responsibly
maintains a Person in the Plant policy
which requires qualified Verrica personnel be
present at Sterling whenever VP-102 is manufactured to
ensure Verrica’s product is in strict compliance with the validated
process and cGMP. In addition, Verrica independently tests the
drug product manufactured at Sterling on two separate occasions at
Alcami Laboratories (Alcami) after manufacturing at Sterling has
been completed. First, the bulk solution is tested by Alcami after
it is packaged into ampules. Then, it is tested again by Alcami
after the ampules are assembled into finished VP-102
applicators.
The FDA previously issued a CRL for Verrica’s
NDA for VP-102 on September 16, 2021, citing, in part, a deficiency
related to the Agency’s general inspection of Sterling; likewise,
not specifically related to the manufacturing of VP-102. Following
the CRL, the FDA classified Sterling as VAI. The Establishment
Inspection Report (EIR) issued on November 17, 2021 in connection
with the VAI specifically stated that (i) FDA would not take or
recommend regulatory or enforcement action against Sterling, (ii)
the VAI classification would not directly negatively impact FDA’s
assessment of any pending marketing application referencing
Sterling, and (iii) approval of an application may depend on a
PAI.
Based on the VAI classification of Sterling and
the statements contained in the EIR, Verrica was led to believe
that any concerns at Sterling had been resolved to FDA’s
satisfaction, and as specifically required in the CRL for approval
of its NDA. Accordingly, Verrica resubmitted its NDA on November
24, 2021, which was accepted.
The NDA submission was 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 a combined 500 subjects
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 at the end of the
trial. VP-102 was well-tolerated in both trials treating nearly
8,000 lesions with bulk solution manufactured at Sterling, with no
serious adverse events reported and a dropout rate of less than two
percent.
Mr. White stated that “Verrica is extremely
disappointed in the Agency’s issuance of the CRL under the totality
of these circumstances. However, as Verrica weighs all its options
to bring the first FDA-approved treatment for molluscum, one of the
largest unmet needs in dermatology, to the market as soon as
possible, it will continue to work collaboratively with the
Agency.” Verrica currently intends to file a Type A meeting request
by the end of this week.
In the meantime, Verrica is working
collaboratively with Sterling and its regulatory and quality
consultants to help Sterling present multiple options to the Agency
to allow Sterling to expeditiously satisfy the majority of the
deficiencies resulting in its OAI classification and which are the
basis for the CRL. Concurrently, Verrica is engaging an additional
CMO to serve as an alternative supplier of VP-102’s bulk
solution.
PBM Capital has expressed its continued support
of the company, and based on these discussions, Verrica is
confident that it will have access to adequate capital to fund
operations through the potential approval of VP-102 for
molluscum.
About VP-102
Verrica’s 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 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,
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,” “look forward,” and similar expressions, and
are based on Verrica’s current beliefs and expectations. These
forward-looking statements include expectations regarding Verrica’s
expectations with regard to requesting a Type A meeting with the
FDA, and 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,
Verrica’s ability to access adequate capital to fund its operations
through the potential approval of VP-102 for molluscum, Sterling’s
ability to expeditiously satisfy the majority of the deficiencies
resulting in its OAI classification, and Verrica’s ability to enter
into a definitive agreement with an additional CMO. 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, 2021 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
Officerinfo@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@soleburytrout.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@soleburytrout.com
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