Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
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Insights
The submission of a New Drug Application (NDA) for DFD-29 by Journey Medical Corporation represents a pivotal step in the pharmaceutical development process. The successful completion of Phase 3 clinical trials, with DFD-29 meeting all co-primary and secondary endpoints, signifies a robust validation of the drug's efficacy and safety profile. The data indicating statistical superiority over the current standard-of-care and placebo, particularly for the Investigator's Global Assessment and reduction in total inflammatory lesion count, suggests that DFD-29 could potentially disrupt the rosacea treatment market.
From an investment perspective, the approval of DFD-29 has the potential to catalyze a significant growth in Journey Medical's revenue stream. The addressable market, considering the 16 million affected by rosacea in the United States alone, is substantial. The novelty of DFD-29 being the only oral medication to treat both inflammatory lesions and erythema could confer a competitive advantage. However, investors should also consider the regulatory risks involved, as FDA approval is not guaranteed and the competitive landscape, including the entry of generics and other novel therapies.
Rosacea is a chronic skin condition that can significantly affect patients' quality of life and the current treatment landscape includes a variety of topical and systemic therapies. The introduction of DFD-29 as an oral, systemic treatment could represent a significant advancement in the standard of care. The dual efficacy in treating both inflammatory lesions and erythema is particularly noteworthy, as these are two of the most distressing symptoms for patients.
The clinical significance of DFD-29's positive trial results lies in its potential to offer a more comprehensive and convenient treatment option. This could lead to better patient adherence and outcomes. However, long-term safety data will be crucial for assessing the viability of DFD-29 as a chronic therapy, considering the chronic nature of rosacea. The dermatology community will be keenly observing the FDA's review process for insights into the drug's safety profile and its place in therapy.
The market potential for DFD-29 hinges on its unique value proposition as a best-in-class oral medication for rosacea, a market where patients and healthcare providers are constantly seeking better treatment options. The clinical trial data positions DFD-29 favorably against Oracea®, which could lead to a significant shift in prescribing patterns upon approval. Market adoption, however, will depend on factors such as pricing, insurance coverage and marketing strategies employed by Journey Medical.
Understanding the competitive dynamics and patient demographics is essential for forecasting the potential market penetration of DFD-29. The partnership with Dr. Reddy’s Laboratories Ltd. could provide strategic advantages in manufacturing and distribution. Additionally, the impact of DFD-29's entry on the market shares of existing treatments and the response from competitors are critical factors that stakeholders must evaluate. The potential for DFD-29 to expand into international markets would further influence its commercial success.
If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea
NDA submission supported by positive Phase 3 clinical data
SCOTTSDALE, Ariz., Jan. 05, 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, 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 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 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 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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