Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
05 Januar 2024 - 2:30PM
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 that the Company has submitted a New Drug Application
(“NDA”) to the FDA seeking approval for DFD-29 (Minocycline
Hydrochloride Modified Release Capsules, 40 mg) for the treatment
of inflammatory lesions and erythema of rosacea in adults. DFD-29
is being developed in collaboration with Dr. Reddy’s Laboratories
Ltd.
“This NDA submission is a significant milestone
for Journey Medical and we look forward to collaborating with the
FDA during its review to bring DFD-29, a potentially
differentiated, best-in-class oral rosacea treatment, one step
closer to patients. Based on the data seen in our pivotal trials,
DFD-29 could fundamentally improve the treatment paradigm for
patients suffering from both inflammatory lesions and erythema
(redness) from rosacea,” said Claude Maraoui, Co-Founder, President
and Chief Executive Officer of Journey Medical.
The NDA submission is supported by positive data
from Journey Medical’s two DFD-29 Phase 3 clinical trials for the
treatment of rosacea. The Phase 3 clinical trials achieved all
co-primary and secondary endpoints, and subjects completed the
16-week treatment with no significant safety issues. DFD-29
demonstrated statistical superiority over both the current
standard-of-care treatment, Oracea® 40 mg capsules, and placebo for
Investigator’s Global Assessment treatment success as well as the
reduction in the total inflammatory lesion count in both studies.
On a secondary endpoint related to erythema (redness) assessment,
DFD-29 showed statistically significant reduction in Clinician’s
Erythema Assessment (CEA) compared to placebo in both clinical
trials.
Rosacea, which affects approximately 16 million
people in the United States according to the National Rosacea
Society, is a long-term, inflammatory skin condition that causes
small, red, pus-filled bumps, redness and visible blood vessels in
the face. DFD-29 has the potential to become the only oral,
systemic therapy to address both inflammatory lesions and erythema
(redness) from rosacea, as demonstrated in the clinical trials.
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 FDA
-approved prescription pharmaceutical products for the treatment of
dermatological conditions through its efficient sales and marketing
model. The company currently markets eight branded and two 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,” “potential” 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 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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