Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
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Insights
The acceptance of Journey Medical's NDA by the FDA for DFD-29 represents a pivotal step for the company, potentially expanding its portfolio in the dermatological market. The drug's unique proposition to address both inflammatory lesions and erythema could position it as a differentiated product. It's important to note that the rosacea treatment market is competitive, with several topical and systemic therapies available. However, if DFD-29's claims of superiority over current standard-of-care and placebo are substantiated, it could capture a significant market share.
Investors should monitor the progress of DFD-29 closely as the PDUFA date approaches. Approval could lead to an increase in Journey Medical's revenue streams and potentially enhance its market cap. Conversely, any setbacks in the approval process could have a negative impact on stock performance. In assessing the potential market impact, it is also essential to consider the prevalence of rosacea, which affects millions worldwide and the demand for more effective treatments.
The reported efficacy of DFD-29 in achieving all co-primary and secondary endpoints in Phase 3 clinical trials is significant. The comparison to Oracea® and placebo suggests that DFD-29 could offer a superior treatment profile, which is critical for medical professionals seeking more effective treatment modalities for rosacea. The lack of significant safety issues is also a positive indicator, as it may facilitate a smoother FDA review process.
From a research perspective, the statistical significance in reducing erythema is particularly noteworthy, as this is a challenging symptom to manage. The potential approval of DFD-29 could also set a new standard in rosacea treatment, encouraging further innovation in the field. Stakeholders in the pharmaceutical industry should consider the long-term implications of such advancements, including the potential for Journey Medical to leverage its research capabilities for future drug development.
Assuming FDA approval, DFD-29's market entry timing will be crucial. The company's ability to market the drug effectively and secure favorable reimbursement from insurers will be key determinants of its commercial success. Additionally, the positioning of DFD-29 as the only oral medication for both inflammatory lesions and erythema could give it a competitive edge in physician prescribing habits.
It's also essential to evaluate the potential for DFD-29 to disrupt current treatment algorithms. If physicians adopt it as a first-line therapy, the impact on Journey Medical's business could be substantial. The broader implications for the dermatological pharmaceutical industry include potential pricing pressures on existing treatments and a shift in research focus towards addressing multiple symptoms of dermatological conditions in single formulations.
Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024
SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- 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 Rosacea
Rosacea 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 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 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) 652-4500
ir@jmcderm.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
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