Benzinga | Jun 30, 2021 08:03AM EDT

Journey Medical Corporation Enters Into A Definitive Agreement With Dr. Reddy's Laboratories Ltd. To Develop And Commercialize DFD-29 For Treatment Of Rosacea; Financial Details Not Disclosed

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(r) (German equivalent of U.S. marketed Oracea(r)), 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(r) 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."