Dimerix Ltd (ASX:DXB, OTC:SBMJF) has flagged that its US commercial licensing agreement for DMX-200 remains intact following BioMarin Pharmaceutical’s move to acquire Dimerix’s US partner Amicus Therapeutics in an all-cash transaction valuing Amicus’ equity at about US$4.8 billion (about AU$7.25 billion).
If the transaction completes, BioMarin would assume Amicus’ rights and obligations under the existing Dimerix US commercial licensing agreement, which would remain in force. Until completion, Amicus and Dimerix continue joint planning for DMX-200 in the US.
“We are pleased to see such strong commercial interest in the rare disease space. BioMarin is a patient-focused multi-national rare disease company with a proven track record of navigating rare disease commercialisation," Dimerix CEO and managing director, Dr Nina Webster said.
"BioMarin have experience with global approvals, reimbursement strategies, in-house manufacturing, and have a strong and diverse rare disease portfolio. This transaction is fantastic news for patients with rare diseases, including FSGS, who currently have a poor prognosis and very limited treatment options. Collectively, we could deliver potential new life-changing therapies to patients faster and more efficiently. We look forward to collaborating with the BioMarin team in due course on the ongoing development and commercialisation of DMX-200.”
Milestones and royalties
Under the current US commercial licensing agreement, Dimerix remains eligible for up to US$590 million in upfront, development and sales milestone payments, plus tiered low-teen to low-twenties royalties on net sales.
This includes US$30 million received on execution in May 2025, up to US$75 million in development milestones, US$35 million on first commercial sale, up to US$410 million in sales milestones and US$40 million linked to potential future indications.
- Received US$30 million (~AU$48 million) on execution in May 2025
- Up to US$75 million (~AU$119 million3) in potential development milestones
- US$35 million (~AU$56 million3) on first sale of DMX-200
- Up to $410 million (~AU$653 million3) in potential sales milestones
- US$40 million (~AU$64 million3) in potential future indications milestone
- Tiered low-teen to low-twenties royalties on net sales
Ex-US licensing remains unchanged
Licensing arrangements outside the US are unchanged, including agreements with Advanz Pharma, Taiba and Fuso.
Across its 4 licensing deals, Dimerix has secured potential upfront and milestone payments totalling about AU$1.4 billion, in addition to royalties, with more than AU$65 million received to date.
DMX-200 and the Phase 3 ACTION3 trial
Dimerix’s lead asset DMX-200 is being assessed in the ACTION3 pivotal Phase 3 trial, a multi-centre, randomised, double-blind, placebo-controlled study in patients with focal segmental glomerulosclerosis (FSGS) who are on a stable dose of an angiotensin II receptor blocker (ARB).
After stabilisation on the ARB, participants are randomised to receive DMX-200 120 mg twice daily or placebo over a two-year treatment period. The trial is designed to evaluate reductions in proteinuria and changes in kidney function (eGFR slope) to support potential regulatory approval.
Disease context: FSGS
FSGS is a rare and serious kidney disease characterised by progressive scarring of the kidney’s filtering units, leading to proteinuria and declining kidney function.
More than 40,000 people are estimated to be living with FSGS in the US, and there are currently no therapies specifically approved for the condition.
Disease progression can be rapid, with some patients reaching end-stage kidney disease within five years of diagnosis, and recurrence after kidney transplant reported in up to 60% of cases.