Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
18 3월 2024 - 9:30PM
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, announced
today that the FDA has accepted the Company’s New Drug Application
(“NDA”) for DFD-29 (Minocycline Hydrochloride Modified Release
Capsules, 40 mg) for the treatment of inflammatory lesions and
erythema of rosacea in adults. The FDA has set a Prescription Drug
User Fee Act (“PDUFA”) goal date of November 4, 2024.
“We are pleased that the FDA has set a PDUFA
date of November 4, 2024 for DFD-29 and we look forward to
collaborating with the agency throughout the review process in
order to bring this unique treatment option to patients suffering
from rosacea,” said Claude Maraoui, Co-Founder, President and Chief
Executive Officer of Journey Medical. “If approved, we believe that
DFD-29 will be the only oral medication to address both
inflammatory lesions and erythema (redness) from rosacea, and will
be a preferred treatment option by physicians and their patients to
address the condition.”
Srinivas Sidgiddi, M.D., Vice President,
Research & Development at Journey Medical, added, “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 statistically
significant superiority over both the current standard-of-care
treatment, Oracea® 40 mg capsules, and placebo for Investigator’s
Global Assessment (IGA) treatment success as well as the reduction
in the total inflammatory lesion count in both studies. For the
secondary endpoint evaluating erythema (redness) associated with
rosacea, DFD-29 showed a statistically significant reduction in
Clinician’s Erythema Assessment (CEA) compared to placebo in both
clinical trials.”
About RosaceaRosacea is a
long-term, inflammatory skin condition that causes small, red,
pus-filled bumps, redness and visible blood vessels in the face.
The disorder affects approximately 16 million people in the United
States according to the National Rosacea Society.
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 seven 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
Journey Medical (NASDAQ:DERM)
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