Kidney disease-focused biotech Dimerix announced a US licensing deal for DMX-200! And this could be the best deal of all!

Dimerix has been targeting a US licensing deal for DMX-200 and the dreams are now a reality as of this morning! The company already had licensing deals with 2 companies for other jurisdictions, but not for the US (or China) which were and are larger opportunities. But this morning, it unveiled the deal to shareholders – a deal that will bring it A$48m upfront and up to A$892m in milestone payments, plus royalties.

Recap of Dimerix (ASX:DXB) and DMX-200

Dimerix is a clinical-stage ASX biotech focused on kidney disease. Its flagship drug DMX-200 is in Phase 3 for FSGS, a kidney disease that attacks the kidney’s filtering units where the blood is cleaned (called the glomeruli). This causes irreversible scarring and leading to permanent kidney damage and eventual end-stage kidney failure, requiring dialysis or a replacement.

FSGS is a major market with approximately 220,000 diagnosed sufferers worldwide, about 80,000 of which are in the US. Dimerix has estimated that the biggest 7 markets alone are worth US$3bn per annum – Japan, China, the EU, UK and USA.

Dimerix is now in Phase 3 with DMX-200 for FSGS (ACTION3). If successful in this study, the company is expected to gain approval in the US and EU. ACTION3 is currently being conducted at over several dozen clinical sites in several countries including Australia, New Zealand, Taiwan, Hong Kong, France, Denmark, the UK, Spain, Argentina, Brazil, and the US. It is ultimately planned to take place at 170+ sites and across 286 patients. If all stays on schedule, investors should expect the next set of results in August 2025.

All the while, Dimerix has prepared for commercialisation, licensing DMX-200 for FSGS. Prior to the US licensing deal, the company had two deals. The first was with Advanz Pharma for the UK, EU, Switzerland, Canada and New Zealand; and the second was with Taiba in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq. In all these markets, the licensee has exclusive jurisdictional rights with DMX-200, but only for FSGS.

A US licensing deal for DMX-200

Dimerix has a deal that its biggest to date and could be the biggest of all, not just the money it will received but by securing its partner for such a large market. Dimerix has partnered with NASDAQ-listed Amicus Therapeutics for Amicus to have exclusive licensing rights for the US.

Amicus will pay US$30m upfront which is A$48m at current exchange rates. It will pay milestone payments amounting to US$560m or A$892m in addition to tiered royalties (low-teens to low-twenties according to Dimerix) on net sales.

This includes up to US$75m/A$119m until FDA approval, US$35m/A$56m on the first sale and sales milestones of up to US$410m/A$653m. DXB is eligible to get up to US$40m/A$64m in milestone payments for potential future indications.

Amicus CEO Bradley Campbell hailed the deal to his company’s investors.

“Amicus is thrilled to enter into this collaboration with Dimerix to bring DMX-200 to patients in the U.S., and we are incredibly impressed by their achievements to date,’ he said.

‘We look forward to leveraging our regulatory, commercial, medical, and advocacy capabilities to bring this potentially transformative treatment to people living with FSGS in the U.S.

‘This licensing agreement represents a major step forward in our strategy to strengthen our portfolio and fully aligns with our mission to develop and deliver transformative medicines for people living with rare diseases’.

Amicus is paying for this with cash on hand. Dimerix will continue to fund and execute the study, but Amicus will be responsible for submission and maintenance of the regulatory dossier and the costs of commercialisation activities. Unlike the last 2 deals, Amicus has also gained exclusive rights to develop DMX-200 in other future indications in the USA.

Conclusion

Dimerix is well set up for commercialisation. It still needs to pass its clinical trials, but there is reason to be optimistic because the data to date has been unanimously positive.

And if the trial is successful, the company is well-positioned in several markets with exclusive licensing deals. The US is arguably DXB’s most important, and the Amicus deal sets up the company for that market.

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