Minocycline Hydrochloride

DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks Published data from two Phase 3 clinical trials demonstrated statistical superiority of DFD-29 over both Oracea® (doxycycline) capsules and placebo for IGA treatment success and the reduction of total lesion count, as well as significantly superior reduction in erythema compared to placebo in both studies U.S. FDA approved Emrosi™ (also known as DFD-29) for the treatment of inflammatory lesions of rosacea in adults in November 2024; launch expected in early spring of 2025 SCOTTSDALE, Ariz., March 05, 2025 (GLOBE NEWSWIRE) -- 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 full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea in Rosacea-2 (“MVOR-2”), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg (“DFD-29” or “Emrosi”) for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association - Dermatology (“JAMA Dermatology”). The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. Read the full publication here: JAMA. The FDA approved Emrosi™ for the treatment of inflammatory lesions of rosacea in adults in November 2024. Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical, stated, “Emrosi’s FDA approval last November, supported by these robust and clinically meaningful outcomes, positions it as a potential new treatment paradigm for millions of patients with rosacea. We are thrilled that the positive results of our two Phase 3 clinical trials were published in JAMA Dermatology. This milestone underscores the significance of these findings and reinforces Emrosi’s potential to meaningfully benefit patients when we launch, which we expect will be in early spring.” Subjects in the MVOR-1 and MVOR-2 Phase 3 clinical trials were randomized in a 3:3:2 ratio to treatment with DFD-29, Oracea or placebo once daily for 16 weeks. The primary objective of both studies was to evaluate the safety and efficacy of DFD-29 compared to placebo for the treatment of papulopustular rosacea. The secondary objective was to evaluate the safety and efficacy of DFD-29 compared to Oracea. Both clinical trials achieved the co-primary and all secondary endpoints, which compared the efficacy of DFD-29 to Oracea and placebo for the treatment of rosacea. The proportion of subjects achieving Investigator’s Global Assessment (“IGA”) treatment success in the DFD-29 group was statistically superior to those in Oracea and placebo groups, as well as the reduction in the total inflammatory lesion count from baseline to Week 16. On a secondary endpoint related to erythema (redness) assessment, DFD-29 showed significantly superior reduction in Clinician’s Erythema Assessment (“CEA”) compared to placebo in both clinical trials. There were no major safety issues or serious adverse events related to study products in both MVOR-1 and MVOR-2 trials. The number of treatment emergent adverse events (“TEAEs”) and their severity were similar between the treatment groups. The number of TEAEs related to study products were also similar between the groups. MVOR-1 Results In the DFD-29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.01, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.8 lesions, and the placebo group showed a mean reduction of 12.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001. Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (31.7% vs 13.8%; p-value of 0.006). MVOR-2 Results In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.0 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001. Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (24.5% vs 12.0%; p-value of 0.02). Summary of Co-Primary Endpoint Results from MVOR-1 and MVOR-2 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 www.emrosi.com. About RosaceaRosacea 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 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 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 are without patent protection and/or are, or 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 on 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 Emrosi™ and the successful development, regulatory approval and commercialization of any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and any clinical trials we may initiate for future product candidates 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 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; the substantial doubt expressed about our ability to continue as a going concern; Fortress controls a voting majority of our common stock, which could be detrimental to our other stockholders; 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, 2023, 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 Released March 5, 2025