Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States

Core Points - Dimerix Limited has entered into an exclusive licensing agreement with Amicus Therapeutics for the commercialization of DMX-200 in the U.S. for the treatment of Focal Segmental Glomerulosclerosis (FSGS) [1][3] - DMX-200 is currently in a pivotal Phase 3 trial, ACTION3, which has shown positive interim results in reducing proteinuria without safety concerns [2][6] - Dimerix will receive an upfront payment of US$30 million and could earn up to US$560 million in success-based milestone payments, along with tiered royalties on net U.S. sales of DMX-200 [1][4] Company Overview - Dimerix is a clinical-stage biopharmaceutical company focused on developing treatments for inflammatory diseases, including kidney diseases, with DMX-200 as its lead candidate for FSGS [10] - Amicus Therapeutics is a biotechnology company dedicated to developing novel medicines for rare diseases, emphasizing patient-focused approaches [11] Financial Terms - The licensing agreement includes potential milestone payments of up to US$75 million until FDA approval, US$35 million upon first sale, and up to US$410 million in commercial sales milestone payments [4] - Dimerix is also eligible for up to US$40 million in milestone payments for future indications of DMX-200 [4] Clinical Development - The ACTION3 study is a multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of DMX-200 in patients with FSGS [6][7] - The trial includes interim analysis points to assess proteinuria and kidney function, aiming to generate evidence for marketing approval [7] Market Context - FSGS is a rare and serious kidney disorder affecting over 40,000 people in the U.S., with no FDA-approved therapies currently available [9] - The disease is characterized by progressive scarring in the kidney's filtering units, leading to significant health complications and a high need for new treatments [9]