Special Report: Dimerix has received the initial payment of ¥300 million (A$3.2 million) in line with its recently announced licence agreement with Japanese FUSO Pharmaceutical Industries Ltd in Japan for its phase III clinical asset in kidney disease DMX-200.
Dimerix (ASX:DXB) said it had received the initial payment for its licence agreement with FUSO for development and commercialisation of its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease.
Under the deal, FUSO has been granted exclusive rights to commercialise DMX-200 for FSGS in Japan. Dimerix may become eligible to receive:
Dimerix said all trial sites have been identified in Japan with progress being made towards opening those sites to support recruitment in Q1 2025. Under the licensing deal FUSO remains responsible for all clinical trial costs in Japan.
Dimerix said no royalties or similar costs were payable by Dimerix to third parties, which means that any revenue from FUSO will flow through to pre-tax profit for the company.
The ACTION3 phase III trial is a randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Planned blinded interim data collection is anticipated in August 2025, following 35 weeks of dosing of the first 144 patients.
FSGS attacks the kidneys and results in irreversible scarring, leading to permanent kidney damage and eventually end-stage kidney failure, requiring dialysis or transplantation.
The disease impacts both adults and children as young as two years old, with no drugs currently approved specifically for its treatment worldwide, significantly restricting available options and affecting overall prognosis.
Consequently, DMX-200 has been granted Orphan Drug Designation in the US and Europe, as well as the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK.
Dimerix now has three partners across multiple territories, providing strong support for advancing and commercialising DMX-200 as a potential new treatment for FSGS.
Dimerix announced a licensing deal in October 2023 with Advanz Pharma covering the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
The company also announced a licensing deal with Taiba in May 2024 for several Middle Eastern countries including the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
Dimerix said that, collectively, the licensing deals provide up to ~AU$458 million in upfront payments and potential milestone payments, plus royalties on net sales.
The company retains all rights to commercialise DMX-200 in all territories other than those covered by the Fuso, Advanz Pharma and Taiba licence agreements.
Dimerix added it continues to focus on licensing opportunities with potential partners in territories other than those covered by the FUSO, Advanz Pharma and Taiba licence agreements, including the major markets of the US and China.
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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