Dimerix inks lucrative US licensing deal for phase III drug candidate

Dimerix has entered an exclusive licensing deal with Amicus Therapeutics to commercialise its phase III drug candidate DMX-200 in the US.

Dimerix has entered an exclusive licensing deal for DMX-200 in the US. Pic viaGetty Images.

• Dimerix enters exclusive licence deal with Amicus Therapeutics to commercialise phase III drug candidate DMX-200 in US

• Deal is for focal segmental glomerulosclerosis and other future indications

• Dimerix to receive US$30 million upfront payment with significant success-based milestone payments

• This is the fourth licensing deal entered into by Dimerix, collectively worth up to AU$1.4 billion

 

Special Report:  Dimerix has achieved a major milestone on inking an exclusive licensing agreement with Nasdaq-listed Amicus Therapeutics to commercialise its lead drug candidate DMX-200 in the US.

Dimerix (ASX:DXB) said the licensing deal was for DMX-200 in focal segmental glomerulosclerosis (FSGS), for which the company is undertaking its ACTION3 phase III trial.

Additionally, Amicus has exclusive rights to develop DMX-200 in other future indications in the world’s largest healthcare market.

In exchange for these rights Dimerix will receive a US$30 million (~A$48m) upfront payment.

The next potential milestone payment is based on positive data from its ACTION3 trial. In total, Dimerix is eligible to receive potential success-based development and regulatory milestone payments of:

• Up to US$75m (~A$119m) until FDA approval of DMX-200 in FSGS;
• US$35m (~A$56m) on first sale;
• Commercial sales milestone payments of up to US$410m (~A$653m);
• Tiered royalties from the low-teens to low-twenties percentages of DMX-200 net sales in the US; and
• Up to US$40m (~A$64m) in milestone payments for potential future indications.

Dimerix said it would continue to fund and execute the ACTION3 study, and Amicus was responsible for submission and maintenance of the regulatory dossier in the US, as well as all costs of commercialisation activities.

The two companies plan to form a joint steering committee to align the development and commercialisation of DMX-200 in FSGS in the US.

Promising much-needed treatment for rare disease

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 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.

DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2). The ACTION3 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).

In early 2024 Dimerix reported positive interim results from the ACTION3 trial showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date.

Full enrolment of ACTION3 is expected by the end of 2025. An additional blinded interim analysis is planned once the revised primary and secondary endpoints have been pre-specified in the protocol and agreed with the FDA.

In a March 2025 Type C meeting, Dimerix successfully aligned with the FDA on proteinuria as an appropriate primary endpoint for traditional marketing approval for DMX-200.

Fourth licensing deal for DMX-200

The licensing deal with Amicus in the US is the fourth for DMX-200, bringing in over U$60 million in upfront payments alone. In January of this year, Dimerix announced a deal to develop and commercialise DMX-200 in Japan to treat FSGS with Fuso Pharmaceutical Industries Pty Ltd in January.

In October 2023, the company 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.

Its licensing deal with Taiba was announced in May 2024 for several Middle Eastern countries including the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

The company retains all rights to commercialise DMX-200 in all territories other than those covered by the Amicus, Fuso, Advanz Pharma and Taiba licensing agreements.

Amicus ‘impressed’ by Dimerix achievements

Amicus president and CEO Bradley Campbell said the company was thrilled to enter a collaboration with Dimerix to bring DMX-200 to patients in the US.

“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 US.

“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.”

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 inks lucrative US licensing deal for phase III drug candidate