In one of the largest licensing deals in the Australian biotechnology industry, Dimerix (ASX:DXB) has signed an exclusive US licence agreement with Amicus Therapeutics to commercialise its kidney disease drug candidate DMX-200.
DMX-200 is in a pivotal Phase 3 trial for Focal Segmental Glomerulosclerosis (FSGS), a rare and fatal kidney disease with no approved therapies anywhere in the world.
Under its agreement with Amicus, Dimerix will receive an upfront US$30 million payment, up to US$560 million for success-based milestone payments, and tiered royalties on DMX‑200 net US sales.
Dimerix said the agreement with Amicus is the fourth licensing deal executed for DMX-200. Collectively, the four deals are valued at up to AU$1.4 billion in total upfront and potential milestone fees, in addition to royalties on net sales. Across all four licences, Dimerix will have received over AU$60 million in upfront payments.
The first licensing deal was announced in October 2023 with Advanz Pharma for the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand. The second was announced in May 2024 with Taiba Rare for the United Arab Emirates, Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq. The third was announced in January 2025, with Fuso Pharmaceutical Industries for Japan.
DMX-200 is the only therapy in Phase 3 trials for FSGS.
Dimerix CEO and managing director Dr Nina Webster, “It really is worth reminding ourselves that we are invested in a company that is at the forefront of delivering a new potential treatment for this rare type of kidney disease. Dimerix and our partners share the goal of delivering transformational medicines to improve the lives of patients living with rare disease.
"Coupled with our announcement last Monday confirming the US FDA’s acceptance of proteinuria as a primary endpoint for DMX-200 marketing approval in the United States, this puts us in a far stronger position to deliver our exciting drug candidate to FSGS patients who currently have limited treatment options. With significant potential value remaining across other unlicensed territories, we continue to pursue and progress those opportunities, including in Mainland China.”