Dimerix (ASX: DXB), an Australian drug developer, has entered into an exclusive US licensing agreement with Amicus Therapeutics for the commercialization of Dimerix’s lead candidate, DMX-200. This drug is currently in a pivotal Phase 3 study, ACTION3, for the treatment of focal segmental glomerulosclerosis (FSGS), a rare and often fatal kidney disease.
Under the agreement, Dimerix will continue to fund and execute the ACTION3 study, while Amicus will handle regulatory submissions and commercialization in the US. Dimerix retains rights to commercialize DMX-200 outside the licensed territories, and Amicus holds exclusivity for developing the drug for other indications within the US market. Amicus will make an upfront payment of US$30 million to Dimerix.
Dimerix is also eligible for milestone payments totaling up to US$560 million, contingent on achievements such as US regulatory approval and first sale, with an additional US$40 million potentially available for future indications. The companies will establish a joint steering committee to coordinate the development and commercialization efforts for DMX-200 in FSGS within the US. With over 40,000 individuals in the US affected by FSGS, and no approved treatments currently available, this collaboration addresses a critical unmet need.
