Dimerix Limited (ASX: DXB) has entered into a significant development and license agreement with FUSO Pharmaceutical Industries Limited, granting FUSO exclusive rights to DMX-200, Dimerix's Phase 3 drug candidate for focal segmental glomerulosclerosis (FSGS), in Japan. This agreement represents a major step forward in addressing FSGS, a rare kidney disease with limited treatment options.
Financial and Development Terms
Under the terms of the agreement, Dimerix will receive an upfront payment of ¥300 million within 40 days and an additional ¥400 million upon the initiation of clinical trial sites in Q1 2025. Furthermore, Dimerix is eligible to receive up to ¥9.8 billion in milestone payments, along with royalties ranging from 15% to 20% on net sales in Japan. FUSO will be responsible for all development costs, regulatory submissions, and commercialization efforts within Japan, while Dimerix retains all rights outside the licensed territory.
Strategic Alignment and Global Impact
The global Phase 3 ACTION3 study for DMX-200, which is funded and executed by Dimerix outside of Japan, will be strategically aligned with FUSO's activities through a Joint Steering Committee. Data generated from FUSO's activities in Japan will support Dimerix's broader global commercialization strategies. This collaborative approach aims to expedite the availability of DMX-200 to patients worldwide.
DMX-200 and FSGS
DMX-200 is a novel therapy being developed for FSGS, a rare and serious kidney disease that can lead to end-stage renal failure. Currently, treatment options for FSGS are limited, highlighting the significant unmet medical need. The Phase 3 ACTION3 study is designed to evaluate the efficacy and safety of DMX-200 in patients with FSGS. The agreement with FUSO will facilitate the development and potential commercialization of DMX-200 in Japan, offering hope for patients with this debilitating condition.
The agreement includes standard terms and termination clauses. Dimerix continues to explore additional licensing opportunities in the USA and Mainland China.
