Journey Medical Corporation (NASDAQ: DERM) (“Journey Medical”), a
commercial-stage pharmaceutical company that focuses on the
development and commercialization of pharmaceutical products for
the treatment of dermatological conditions, today announced that
the company entered into a definitive agreement with VYNE
Therapeutics, Inc. (“VYNE”) to acquire its Molecule Stabilizing
Technology (“MST”)™ franchise for an upfront payment of $20.0
million and an additional $5.0 million on the one (1)-year
anniversary of the closing. The agreement also provides for
contingent net sales milestone payments. The first year that annual
net sales reach each of $100 million, $200 million, $300 million,
$400 million and $500 million, a one-time payment of $10 million,
$20 million, $30 million, $40 million and $50 million,
respectively, will be paid in that year only, per product, totaling
up to $450.0 million. The franchise includes two FDA-approved
products (AMZEEQ® and ZILXI®), and a development-stage dermatology
program (FCD105) along with the MST proprietary platform. The
transaction closed simultaneously with signing.
These proprietary foam-based products optimize
the topical delivery of minocycline, an active pharmaceutical
ingredient that was previously available only in oral form.
Approved by the U.S. Food and Drug Administration (“FDA”) nearly 50
years ago, minocycline is a well-established molecule that has been
prescribed, in oral formulation, over 30 million times in the past
decade.
AMZEEQ (minocycline) topical foam, 4%, is the
first and only topical formulation of minocycline to be approved by
the FDA for the treatment of inflammatory lesions of non-nodular
moderate to severe acne vulgaris in adults and children 9 years and
older. According to the American Academy of Dermatology (“AAD”),
acne is the most common skin condition in the United States,
affecting up to 50 million Americans annually.
Approved by the FDA in May 2020, ZILXI
(minocycline) topical foam, 1.5%, is the first and only topical
minocycline treatment for inflammatory lesions due to rosacea in
adults. Rosacea is a common skin disease that affects 16 million
Americans, according to AAD. Market research shows that over 70% of
patients with rosacea are seeking better alternatives to current
treatments.
AMZEEQ and ZILXI generated approximately $4
million in net sales in the U.S. in the third quarter of 2021.
Claude Maraoui, Journey Medical’s President and
Chief Executive Officer, said, “This accretive acquisition
complements our existing dermatology portfolio, allowing us to
leverage our existing infrastructure and seasoned dermatology sales
force while continuing to drive our net sales growth. We are
excited to expand our dermatologic footprint with AMZEEQ and ZILXI,
two unique topical products that complement our seven currently
marketed prescription-based products, including QBREXZA® and three
prescription acne products. Additionally, our development stage
product candidate, DFD-29, is being evaluated in a Phase 3 clinical
program for the treatment of inflammatory lesions of rosacea. We
look forward to bringing AMZEEQ and ZILXI to patients in need,
while further demonstrating our commitment to dermatology.”
In conjunction with today’s announcement of its
closing on the asset purchase, Journey Medical has expanded its
credit agreement with East West Bank to $30.0 million.
“We are pleased to have the support of East West
Bank, which helps fuel our continued growth by enabling us to
strategically acquire additional dermatology assets while providing
operating funds as we market our robust portfolio of FDA-approved
products,” added Mr. Maraoui.
About Journey Medical
CorporationJourney Medical Corporation (NASDAQ: DERM)
(“Journey Medical”) is focused on identifying, acquiring,
developing and strategically commercializing innovative,
differentiated dermatology products through its efficient sales and
marketing model. The company currently markets seven products that
help treat and heal common skin conditions. The Journey Medical
team is comprised of industry experts with extensive experience
commercializing some of the most successful prescription
dermatology brands. Journey Medical is located in Scottsdale,
Arizona and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).
Journey is registered under the Securities Exchange Act of 1934, as
amended, and 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 and Section
21E of the Securities Exchange Act of 1934, as amended. As used
below and throughout this press release, the words “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. 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: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; uncertainties
relating to preclinical and clinical testing; risks relating to the
timing of starting and completing clinical trials; our dependence
on third-party suppliers; risks relating to the COVID-19 outbreak
and its potential impact on our employees’ and consultants’ ability
to complete work in a timely manner and on our ability to obtain
additional financing on favorable terms or at all; our ability to
attract, integrate and retain key personnel; the early stage of
products under development; our need for substantial additional
funds; government regulation; patent and intellectual property
matters; competition; as well as other risks described in our SEC
filings. 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. The information contained herein is
intended to be reviewed in its totality, and any stipulations,
conditions or provisos that apply to a given piece of information
in one part of this press release should be read as applying
mutatis mutandis to every other instance of such information
appearing herein.
AMZEEQ and ZILXI Important Safety
Information
Indications
AMZEEQ® (minocycline) topical foam, 4% is for
the treatment of pimples and red bumps (non-nodular inflammatory
lesions) that happen with moderate to severe acne in patients 9
years age and older. It is not known if AMZEEQ is safe and
effective in children under 9 years of age.
ZILXI™ (minocycline) topical foam, 1.5% is for
the treatment of adults with pimples and bumps caused by a
condition called rosacea. It is not known if ZILXI is safe and
effective in children.
AMZEEQ and ZILXI are both topical forms of the
antibiotic minocycline and are available by prescription only.
ZILXI and AMZEEQ are for use on skin only (topical use). AMZEEQ and
ZILXI are not for use in the mouth, eyes or vagina.
AMZEEQ and ZILXI should not be used for the
treatment of infections.
Important Safety
Information
AMZEEQ and ZILXI should not be used in people
who are allergic to AMZEEQ and ZILXI, or any tetracycline medicine.
Use of AMZEEQ and ZILXI should be stopped right away if a rash or
other allergic symptom occurs.
AMZEEQ and ZILXI should not be used in women who
are pregnant, may become pregnant or are nursing. If a woman
becomes pregnant while using AMZEEQ and ZILXI, she should talk to
her doctor. Tetracycline medicine when taken by mouth during
pregnancy, infancy and/or childhood up to the age of 8 years may
permanently discolor teeth (yellow-gray-brown) and may slow the
growth of bones.
AMZEEQ and ZILXI are flammable and fire, flame,
and smoking must be avoided when applying and right after applying
AMZEEQ and ZILXI.
People should protect their skin from the sun
while using AMZEEQ and ZILXI and avoid sunlight or artificial
sunlight such as sunlamps or tanning beds. Use of AMZEEQ and ZILXI
should be stopped if skin is sunburned.
When taken by mouth, minocycline may cause
feelings of lightheadedness, dizziness or spinning. People should
not drive or operate dangerous machinery if they have these
symptoms.
AMZEEQ and ZILXI are both topical foams that
contain minocycline, a tetracycline medicine. They are not taken by
mouth. However, tetracyclines, when taken by mouth (capsules or
tablets), may cause serious side effects, including: diarrhea,
including watery or bloody stools; loss of appetite; tiredness;
yellowing of the skin or eyes; bleeding more easily than normal;
confusion; sleepiness; vision changes, including blurred vision,
double vision, or permanent vision loss; unusual headaches; fever;
rash; joint pain; body weakness; discoloration or darkening of the
skin, scars, teeth, or gums. People should call their doctor right
away if these side effects occur.
The most common side effect of AMZEEQ is
headache. The most common side effect of ZILXI is diarrhea.
These are not all of the possible side effects
for AMZEEQ and ZILXI. People should contact their doctor for
medical advice about side effects and be sure to tell their doctor
about all of their medical conditions and medicines they take
before using AMZEEQ and ZILXI.
People are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for
AMZEEQ and ZILXI.
Company Contacts:Jaclyn Jaffe
and Bill Begien(781) 652-4500ir@jmcderm.com
Media Relations Contact:Tony
Plohoros6 Degrees(908)
591-2839tplohoros@6degreespr.com
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