Dimerix banks upfront US$30m payment in US pharma licensing deal for kidney drug

Dimerix has received a US$30m (~$48m) upfront payment from Amicus Therapeutics under a US licensing deal for its phase III candidate in rare kidney disease.

Dimerix receives initial payment for DMX-200 under US licensing deal. Pic via Getty Images.

• Dimerix receives upfront payment of US$30 million for US licensing deal of DMX-200

• Company eligible for further potential development milestones of up to US$560 million plus tiered royalties

• Fourth license deal executed for phase III clinical asset in kidney disease DMX-200, that could bring in up to AU$1.4 billion

 

Special Report: Dimerix has received the upfront payment of US$30 million (~A$48m) from Amicus Therapeutics after signing an exclusive licensing agreement with the Nasdaq-listed biotech to commercialise its lead drug candidate DMX-200 in the US.

Dimerix (ASX:DXB) announced last week it had signed it’s fourth licensing deal for DMX-200 in focal segmental glomerulosclerosis (FSGS), for which the company is undertaking its ACTION3 phase III trial.

Amicus has exclusively licensed the asset for the United States, and additionally too the exclusive rights to develop DMX-200 in other future indications in the world’s largest healthcare market.

The next potential milestone payment from the US licensing deal is based on positive data from Dimerix’s ACTION3 trial.

Dimerix said it was eligible for further potential development milestones of up to US$560 million (~A$892m) for success-based milestone payments, in addition to tiered royalties on DMX-200 net US sales.

Targeting rare kidney disease

FSGS causes progressive kidney scarring that can lead to end-stage kidney failure, requiring dialysis or transplant.

The disease affects both adults and children as young as two, with no approved treatments currently available.

As a result, DMX-200 has received orphan drug designation in the US and Europe, and the equivalent innovative licensing and access pathway (ILAP) status in the UK.

DXB-200 is a small molecule of the chemokine receptor 2 (CCR2) inhibitor.

The phase III study is titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis, or ACTION3 for short.

It is a pivotal phase III, multi-centre, 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).

Once the ARB dose is stable, patients will be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo.

The single-phase III trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.

In early 2024 Dimerix reported positive interim results from the trial showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date.

Full enrolment in the ACTION3 study is expected by the end of 2025 with a further blinded interim analysis planned once the revised primary and secondary endpoints are pre-specified in the protocol and agreed upon with the FDA.

In a Type C meeting held in March 2025, Dimerix said it had successfully aligned with the FDA on using proteinuria as an appropriate primary endpoint to support traditional marketing approval for DMX-200.

Four licensing deals for DMX-200

Dimerix now has four high quality partners across multiple territories, providing strong support for Dimerix in advancing and commercialising DMX-200 as a potential new treatment for FSGS.

Collectively across all licences, Dimerix said it may become eligible for up to A$1.4 billion in total upfront payments and potential milestone payments, plus royalties on net sales. Over $60 million has already come in upfront payments.

In January of this year, Dimerix announced it had secured a deal to develop and commercialise DMX-200 in Japan to treat FSGS with Fuso Pharmaceutical Industries Pty Ltd in January.

In October 2023, Dimerix inked a licensing deal 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.

In May 2024, Dimerix announced a licensing agreement with Taiba covering multiple Middle Eastern countries, including the UAE, Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

Dimerix retains full commercialisation rights for DMX-200 in all regions not covered by the Amicus, Fuso, Advanz Pharma, and Taiba agreements.

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.

Originally published as Dimerix banks upfront US$30m payment in US pharma licensing deal for kidney drug