Dimerix and Amicus Therapeutics have entered into an exclusive license agreement granting Amicus the rights to commercialize DMX-200 in the United States for all indications, including Focal Segmental Glomerulosclerosis (FSGS). DMX-200, currently in a Phase 3 trial named ACTION3, is being developed to treat FSGS, a rare kidney disease. Interim results from the study showed promising reductions in proteinuria with no significant safety issues. Dimerix retains commercialization rights in other regions and will continue leading the ACTION3 trial. Amicus will oversee U.S. regulatory submissions and commercial operations, and both companies will collaborate through a joint steering committee to coordinate development and commercialization efforts.
Under the agreement, Dimerix will receive a $30 million upfront payment and is eligible for up to $560 million in development, regulatory, and commercial milestone payments, along with tiered royalties on U.S. sales. Dr. Nina Webster, CEO and Managing Director of Dimerix, commented on the partnership, “I’m grateful to the dedicated Dimerix team, trial participants, and investigators for their continued commitment to developing a new therapy for patients with FSGS who currently have a poor prognosis and very limited treatment options.” FSGS affects an estimated 40,000 individuals in the U.S., and the collaboration aims to address the significant need for new treatment options for this serious kidney condition.
