Verrica Pharmaceuticals Announces Exclusive Licensing Agreement With Torii Pharmaceutical Co., Ltd. To Develop and Commercial...
March 17 2021 - 7:00AM
Verrica Pharmaceuticals Inc. (Verrica) (NASDAQ: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, announced today that it
has entered into a License Agreement with Torii Pharmaceutical Co.,
Ltd. (Torii) granting Torii an exclusive license to develop and
commercialize Verrica’s product candidates for the treatment of
molluscum contagiosum and common warts in Japan, including
Verrica’s lead product candidate VP-102, which is currently under
U.S. Food and Drug Administration (FDA) review for the treatment of
molluscum, with a PDUFA goal date of June 23, 2021.
“We are pleased to partner with Torii and expand
VP-102, which could potentially be the first product approved in
the United States to treat molluscum, to global markets. The
prevalence of molluscum contagiosum alone in Japan was
approximately 1.6 million cases in 2017,” said Ted White, Verrica’s
President and Chief Executive Officer. “We believe Torii has the
expertise and commercial infrastructure to develop and
commercialize VP-102 in Japan and successfully bring VP-102 to
patients with molluscum and common warts. We look forward to
embarking on this partnership.”
“We are excited to partner with Verrica and add
VP-102 to Torii’s growing portfolio of products to treat
dermatologic skin diseases with significant unmet need,” said
Goichi Matsuda, Torii’s Representative Director, President and
Chief Executive Officer. “VP-102 has the potential to alleviate the
burden of molluscum and common warts for patients in Japan. We look
forward to partnering with Verrica and developing VP-102 for the
Japanese market.”
In August 2020 Verrica entered into an Option
Agreement with Torii granting Torii an exclusive option to acquire
an exclusive license to develop and commercialize Verrica’s product
candidates for the treatment of molluscum and common warts in
Japan, including VP-102. Torii exercised its option to acquire the
exclusive license on March 2, 2021. Under the terms of the License
Agreement, Torii will make an up-front payment of $11.5 million and
up to an additional $58 million in aggregate payments contingent on
achievement of specified development, regulatory, and sales
milestones, in addition to tiered transfer price payments for
supply of product in the percentage range of the mid-30s to the
mid-40s of net sales. Torii is responsible for all development
activities and costs in support of obtaining regulatory approval in
Japan.
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 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 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 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, the clinical development of Verrica’s
VP-102 for additional indications and Verrica’s other product
candidates, and the potential payments and benefits to Verrica of
the license agreement with Torii. 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@soleburytrout.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@soleburytrout.com
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