Journey Medical Corporation Enters into an Exclusive License Agreement with Maruho Co., Ltd. for Qbrexza® in South Korea and Other Asian Nations
September 06 2023 - 8:00AM
Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or
“the Company”), a commercial-stage pharmaceutical company that
primarily focuses on the selling and marketing of U.S. Food and
Drug Administration (“FDA”) approved prescription pharmaceutical
products for the treatment of dermatological conditions, today
announced it has entered into an exclusive license agreement (the
“Agreement”) with Maruho Co., Ltd. (“Maruho”), a Japanese company
specializing in dermatology and also Journey’s exclusive licensing
partner that developed and is commercializing Qbrexza
(Rapifort
®) in Japan. Pursuant to the terms of the
Agreement, Journey Medical granted Maruho an exclusive license to
develop and commercialize Qbrexza® (Rapifort® / DRM04 /
glycopyrronium tosylate hydrate) for the treatment of
hyperhidrosis, in South Korea, Taiwan, Hong Kong, Macau, Thailand,
Indonesia, Malaysia, Philippines, Singapore, Vietnam, Brunei,
Cambodia, Myanmar and Laos (the “Territory”).
Under the terms of the Agreement, Journey
Medical will receive a $19 million nonrefundable upfront payment.
Maruho is responsible for all development and commercialization
costs for the program throughout the Territory. Additionally, in
conjunction with the new license grant, Journey Medical and Maruho
have also entered into an amendment of their existing license
agreement that grants Maruho exclusive rights to Qbrexza (Rapifort)
in Japan (the “Amendment”). The Amendment contains modifications
that reduce certain royalty and milestone obligations payable to
Journey, among other changes to certain economic sharing
obligations. Under the Amendment, Journey is still eligible to
receive certain milestones payments, totaling up to $45
million.
Claude Maraoui, Journey Medical’s Co-Founder,
President and Chief Executive Officer, said, “As Journey Medical
continues to expand its out-licensing efforts globally, we are
delighted to work with Maruho to further expand the reach of
Qbrexza (Rapifort) to address the unmet need of patients suffering
from hyperhidrosis in the expanded territories. Maruho has
successfully commercialized Qbrexza (Rapifort) in Japan, bolstering
our confidence in Maruho’s ability to bring this novel product to
the broader region. We look forward to making this innovative,
effective and well-tolerated product more accessible to patients
who suffer from hyperhidrosis.”
According to the International Hyperhidrosis Society, nearly 5%
of the world’s population suffers from hyperhidrosis.
About Journey Medical
CorporationJourney Medical Corporation (Nasdaq: DERM)
(“Journey Medical”) is a commercial-stage pharmaceutical company
that primarily focuses on the selling and marketing of U.S. Food
and Drug Administration-approved prescription pharmaceutical
products for the treatment of dermatological conditions through its
efficient sales and marketing model. The company currently markets
eight branded and three generic products that help treat and heal
common skin conditions. The Journey Medical team comprises industry
experts with extensive experience in developing and commercializing
some of dermatology’s most successful prescription brands. Journey
Medical is located in Scottsdale, Arizona and was founded by
Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common
stock is registered under the Securities Exchange Act of 1934, as
amended, and it files periodic reports with the U.S. Securities and
Exchange Commission (“SEC”). For additional information about
Journey Medical, visit www.journeymedicalcorp.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
As used below and throughout this press release, the words “the
Company”, “we”, “us” and “our” may refer to Journey Medical. Such
statements include, but are not limited to, any statements relating
to our growth strategy and product development programs and any
other statements that are not historical facts. The words
“anticipate,” “believe,” “estimate,” “may,” “expect,” “will,”
“could,” “project,” “intend” and similar expressions are generally
intended to identify forward-looking statements. Forward-looking
statements are based on management’s current expectations and are
subject to risks and uncertainties that could negatively affect our
business, operating results, financial condition and stock price.
Factors that could cause actual results to differ materially from
those currently anticipated include: the fact that our products and
product candidates are subject to time and cost intensive
regulation and clinical testing and as a result, may never be
successfully developed or commercialized; a substantial portion of
our sales derive from products that may become subject to
third-party generic competition, the introduction of new competitor
products, or an increase in market share of existing competitor
products, any of which could have a significant adverse impact on
our operating income; we operate in a heavily regulated industry,
and we cannot predict the impact that any future legislation or
administrative or executive action may have on our operations; our
revenue is dependent mainly upon sales of our dermatology products
and any setback relating to the sale of such products could impair
our operating results; competition could limit our products’
commercial opportunity and profitability, including competition
from manufacturers of generic versions of our products; the risk
that our products do not achieve broad market acceptance, including
by government and third-party payors; our reliance third parties
for several aspects of our operations; our dependence on our
ability to identify, develop, and acquire or in-license products
and integrate them into our operations, at which we may be
unsuccessful; the success of any of our licensing arrangements
including with our exclusive licensing partner and any resulting
revenue from such arrangements; the dependence of the success of
our business, including our ability to finance our company and
generate additional revenue, on the successful development and
regulatory approval of the DFD-29 product candidate and any future
product candidates that we may develop, in-license or acquire;
clinical drug development is very expensive, time consuming, and
uncertain and our clinical trials may fail to adequately
demonstrate the safety and efficacy of our current or any future
product candidates; our competitors could develop and commercialize
products similar or identical to ours; risks related to the
protection of our intellectual property and our potential inability
to maintain sufficient patent protection for our technology and
products; our business and operations would suffer in the event of
computer system failures, cyber-attacks, or deficiencies in our or
our third parties’ cybersecurity; the substantial doubt about our
ability to continue as a going concern; the effects of major public
health issues, epidemics or pandemics on our product revenues and
any future clinical trials; our potential need to raise additional
capital; Fortress controls a voting majority of our common stock,
which could be detrimental to our other shareholders; as well as
other risks described in Part I, Item 1A, “Risk Factors,” in our
Annual Report on Form 10-K for the year ended December 31, 2022,
subsequent Reports on Form 10-Q, and our other filings we make with
the SEC. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as may be required by
law, and we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contact:Jaclyn Jaffe
(781) 652-4500ir@jmcderm.com
Media Relations Contact:Tony
Plohoros6 Degrees(908)
591-2839tplohoros@6degreespr.com
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