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Journey Medical Corporation Announces U.S. FDA Approval of Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea Journey Medical to host investor conference call on Monday

Key Takeaway: Journey Medical Corporation announced FDA approval for Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. The approval follows successful Phase 3 clinical trials demonstrating its superiority over the current standard treatment. With a focused marketing team ready for the launch, Journey Medical anticipates Emrosi to become a leading oral treatment option in the dermatological market. A conference call is scheduled for November 4, 2024, to discuss the approval details.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval of Emrosi represents a significant milestone for Journey Medical.
  • Emrosi has shown great efficacy and tolerability in clinical trials.
  • The launch of Emrosi aims to establish a new standard of care for rosacea treatments.

Full Press Release Details

Journey Medical Corporation Announces U.S. FDA
Approval of Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea
Journey Medical to host investor conference
call on Monday, November 4, 2024, at 8:30 a.m. E.T.
AZ - November 4, 2024 - Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical"), a commercial-stage
pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration ("FDA")-approved
prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi
(Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions
of rosacea in adults. Emrosi was developed in collaboration with Dr. Reddy's Laboratories Ltd.
Claude Maraoui, Co-Founder, President, and
Chief Executive Officer of Journey Medical, said, "With approval from the FDA, Journey Medical is proud to deliver Emrosi, a
unique treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a diffilut to treat skin
condition and based on the favorable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral
medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to
establish Emrosi as a new standard of care in the treatment of rosacea. Journey Medical is committed to bringing cutting-edge
innovation to patients with dermatological conditions and the healthcare professionals who treat them."
The approval of Emrosi is supported by positive
data from Journey Medical's two Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials met all co-primary
and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues. Emrosi demonstrated statistically
significant 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 total inflammatory lesion count in both studies.
Journey Medical is completing the manufacturing
of Emrosi for the U.S. market and anticipates that initial supply will be available late in the first quarter or early in the second quarter
of 2025. Journey Medical intends to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization. In line with
the approved label, Journey Medical will execute a launch strategy to drive Emrosi toward becoming a new oral standard of care for adult
Srinivas Sidgiddi, M.D., Vice President, Research
& Development at Journey Medical, added, "Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and
we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this
important approval milestone."
Conference Call and Replay Information
Journey Medical management will host a conference
call to review the FDA approval on Monday, November 4, 2024, at 8:30 a.m. Eastern Time.
To listen to the conference call, interested parties
within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 for international callers. All callers should dial in approximately
10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register
for the conference call online by clicking the following link: https://dpregister.com/sreg/10193869/fdcd4e50be. Please note that
registered participants will receive their dial-in number upon registration.
A replay of the conference call will be available
shortly after the call concludes for approximately two weeks, and can be accessed by dialing 1-877-344-7529 (domestic) or 1-412-317-0088
(international), and providing the replay access code: 8833884. Participants will be required to state their name and company upon registering
Important Safety Information
Indication: EMROSI is indicated for the
treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported
by 1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI
should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis,
serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS)
syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI
immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent
discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs.
Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about
driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue
EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately
if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class
antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes,
thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during
the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform
periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For full prescribing information, please visit
Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like
inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it
is estimated that rosacea affects well over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently
seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than
90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had
caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder
had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition.
About Journey Medical Corporation
Journey 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 Statements
This 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 commercialization of our recently approved
product, EmrosiTM, 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

Frequently Asked Questions

What is Emrosi approved for by the FDA?

Emrosi is approved for treating inflammatory lesions of rosacea in adults.

When will Emrosi be available in the U.S. market?

Emrosi's initial supply is expected to be available in late Q1 or early Q2 of 2025.

What significant results did Emrosi show in trials?

Emrosi showed statistically significant superiority over standard treatments in clinical trials.

Who collaborated in the development of Emrosi?

Emrosi was developed in partnership with Dr. Reddy's Laboratories Ltd.

When is the conference call about Emrosi approval scheduled?

The conference call is set for November 4, 2024, at 8:30 a.m. E.T.

Last updated: Nov 4, 2024