Journey Medical Corporation Enters into a Definitive Agreement with Dr. Reddy’s Laboratories Ltd. to Develop and Commercialize DFD-29 for the Treatment of Rosacea
Journey Medical Corporation has announced a partnership with Dr. Reddy’s Laboratories Ltd. to conduct two Phase 3 clinical trials for DFD-29, an oral formulation of minocycline aimed at treating rosacea. Journey Medical has acquired global commercialization rights except in specific markets. Previous Phase 2 trials showed DFD-29's efficacy, outperforming the existing treatment, Oraycea®. This collaboration is seen as a significant milestone for Journey Medical, expanding its dermatological footprint.
- Acquisition of global commercialization rights for DFD-29 enhances market position.
- DFD-29 demonstrated superior efficacy compared to existing treatments in Phase 2 trials.
- Dependence on third-party collaboration with Dr. Reddy's for Phase 3 trials.
- Potential risks regarding regulatory approval and market entry timelines.
Journey Medical and Dr. Reddy’s Laboratories Ltd. will conduct two Phase 3 clinical trials to assess the efficacy, safety and tolerability of oral minocycline for regulatory approval
NEW YORK and SCOTTSDALE, Ariz., June 30, 2021 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical”), a partner company of Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced an agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) for the collaborative development and commercialization of the DFD-29 program (Minocycline Modified Release Capsules 40 mg) for the treatment of rosacea. Journey Medical has acquired global commercialization rights including the U.S. and Europe, except that Dr. Reddy’s has retained certain rights to the program in select markets including Brazil, Russia, India and China.
Through this collaboration, the parties will work together to complete the development of DFD-29. Dr. Reddy’s will provide development support including the monitoring of two Phase 3 clinical trials.
A Phase 2 study in Germany was completed which assessed the efficacy, safety and tolerability of DFD-29 for the treatment of inflammatory lesions of rosacea over 16 weeks. DFD-29 demonstrated statistical significance to both placebo and active control, Oraycea® (German equivalent of U.S. marketed Oracea®), on both co-primary endpoints—proportion of subjects with Investigator’s Global Assessment treatment success (grade 0 or 1 with at least a two grade reduction from baseline at week 16) and total inflammatory lesion count reduction from baseline to week 16. Most notably, DFD-29 had approximately double the efficacy when compared against Oraycea® for both co-primary endpoints.
Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “DFD-29 has the potential to be an effective treatment option for those patients who suffer from rosacea. This collaboration with Dr. Reddy’s for the development of DFD-29 marks a meaningful milestone for Journey Medical, allowing us to continue to broaden our footprint in dermatology while expanding our focus to include late-stage development programs that have a strategic fit.”
Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “At Fortress and our partner companies, we always seek opportunities to deliver potential medicines to patients in need. We look forward to working with Dr. Reddy’s to further develop DFD-29 for the treatment of rosacea, which has already seen promising results in Phase 2 clinical trials. The National Rosacea Society estimates 16 million U.S. based patients suffer from rosacea, demonstrating the sizeable market for this opportunity.”
About Rosacea
Rosacea is a chronic, relapsing, diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). Based on research in the British Journal of Dermatology, it is estimated that 415 million people suffer with rosacea worldwide.1 Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent reported 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.
1. Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol 2018 Feb 25. doi: 10.1111/bjd.16481
Oracea® and Oraycea® are a registered trademarks of Galderma Holdings, S.A.
About Journey Medical Corporation
Journey Medical Corporation (“Journey Medical”) is focused on identifying, acquiring and strategically commercializing innovative, differentiated dermatology products through its efficient sales and marketing model. The company currently markets seven products that help treat and heal common skin conditions. The Journey Medical team is comprised of industry experts with extensive experience commercializing some of the most successful prescription dermatology brands. Journey Medical is located in Scottsdale, Arizona and is a partner company of Fortress Biotech, Inc. (NASDAQ: FBIO). For additional information about Journey Medical, visit www.journeymedicalcorp.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.
About Dr. Reddy’s Laboratories Ltd.
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. 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. 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: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. 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. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Company Contacts:
Jaclyn Jaffe and Bill Begien
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com
Investor Relations Contact:
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LifeSci Advisors, LLC
(617) 430-7576
daniel@lifesciadvisors.com
Media Relations Contact:
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6 Degrees
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