Dimerix (ASX: DXB) and Japan's FUSO Pharmaceutical Industries have entered into an exclusive development and license agreement for the development and commercialisation of Dimerix’ Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan.
Dimerix retains all rights to commercialise DMX-200 in all territories other than those covered by the FUSO, Advanz Pharma2 and Taiba license agreements. DMX-200 is currently in global Phase 3 clinical development, with a blinded interim analysis anticipated in August 2025.5
Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients outside of Japan, and FUSO will be responsible for all development costs, submission and maintenance of the regulatory dossier with the PMDA, as well as all sales and marketing activities in Japan.
In exchange for these rights, Dimerix will receive a payment of A$3.1 million within 40 days of executing the agreement, A$4.1 million1) on initiation of the first clinical trial site which is anticipated in Q1 2025, plus potential development and commercialisation milestones of up to A$100 million.
In addition, Dimerix is eligible to receive royalties of between fifteen to twenty percent on net sales of DMX-200 if successfully commercialised (all contracted financial terms are denominated in Japanese Yen).
“We are delighted to partner with FUSO for the commercialisation of DMX-200 in Japan," Dr Nina Webster, CEO and Managing Director of Dimerix, said.
"FUSO brings a wealth of experience in pharmaceutical development and sales and marketing across Japan, and with a proven record in sales and marketing products for patients with renal disease. This partnership reflects a confidence not only in the significant potential for DMX-200 in FSGS patients but also in Dimerix’ capabilities in the development of DMX-200. FUSO’s expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of developing and commercialising DMX-200 and bringing hope to those patients desperately in need of treatment options.”
Dimerix and FUSO will form a Joint Steering Committee to align the development and commercialisation of DMX-200 in FSGS in Japan. Any data and regulatory filings generated by FUSO may be used by Dimerix for the development and commercialization of DMX-200 outside of the territory. FUSO also has a right to negotiate a license to develop and commercialize DMX-200 in any additional indications in the licensed territory that Dimerix may achieve for the compound. The agreement otherwise contains terms common for an arrangement of this kind, including termination provisions that, amongst other matters, allows for FUSO to terminate on 180 days' notice.
Dimerix continues to pursue and progress licensing opportunities with potential partners outside the licensed territories, including in the United States of America and Mainland China.