Amicus secures exclusive U.S. rights to DMX-200 for FSGS treatment, with significant financial incentives for Dimerix.
Quiver AI Summary
Dimerix Limited has granted Amicus Therapeutics exclusive rights to commercialize its drug candidate DMX-200 in the U.S. for Focal Segmental Glomerulosclerosis (FSGS), a serious kidney disease that currently lacks FDA-approved treatments. The agreement follows Dimerix's successful alignment with the FDA on using proteinuria as the primary endpoint for DMX-200's approval, as part of the pivotal Phase 3 ACTION3 trial. Dimerix will receive an upfront payment of $30 million, with the potential for up to $560 million in success-based milestone payments and tiered royalties on U.S. sales. Dimerix will continue to manage the clinical trial, while Amicus will handle regulatory submissions and commercialization costs. This partnership aims to leverage Amicus's expertise in developing treatments for rare diseases, benefiting patients with FSGS.
Potential Positives
- Dimerix has entered a significant licensing agreement with Amicus Therapeutics, allowing for the commercialization of its Phase 3 drug candidate DMX-200 in the U.S., which can enhance the company's market presence.
- The agreement includes an upfront payment of US$30 million and potential milestone payments totaling up to US$560 million, signaling strong financial prospects for Dimerix.
- DMX-200 is currently in a pivotal Phase 3 trial with positive interim results, positioning the product to potentially fill a critical therapeutic gap in the treatment of FSGS, a rare kidney disease.
- Dimerix retains the commercialization rights outside the U.S., allowing the company to maintain strategic control over its product in other markets while leveraging Amicus's resources in the U.S.
Potential Negatives
- Dimerix retains all commercialization rights outside the U.S., indicating it may not benefit as much from the U.S. market's potential compared to Amicus.
- Amicus has exclusive rights to develop DMX-200 for future indications in the U.S., limiting Dimerix's control over the product's overall future potential in the market.
- Dimerix relies heavily on the success of the Phase 3 trial for milestone payments, which may not be guaranteed.
FAQ
What is DMX-200 and its significance?
DMX-200 is a drug candidate under development for treating Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disease with no FDA-approved therapies.
What agreement was made between Dimerix and Amicus?
Dimerix and Amicus entered an exclusive agreement for Amicus to commercialize DMX-200 in the U.S., receiving an upfront payment and potential milestone payments.
What are the results from the ACTION3 trial?
The ACTION3 trial has shown positive interim results, indicating that DMX-200 is more effective than placebo in reducing proteinuria without safety concerns.
What are the potential financial implications for Dimerix?
Dimerix could receive up to US$560 million in success-based milestone payments and tiered royalties on DMX-200 net sales in the U.S.
How does FSGS impact patients?
FSGS leads to progressive kidney damage and has a poor prognosis, with an average time from diagnosis to end-stage kidney disease as short as five years.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Amicus licenses exclusive U.S. rights to commercialize DMX-200 for the treatment
of Focal Segmental Glomerulosclerosis (FSGS)
DMX-200 is in a pivotal Phase 3 trial for FSGS, a rare and fatal kidney disease
with no FDA-approved therapies
Dimerix successfully completed Type C meeting with the FDA in March 2025,
aligning on proteinuria as the primary endpoint for approval
Dimerix to receive US$30 million (~AU$48 million) upfront payment,
up to US$560 million (~AU$892 million) for success-based milestone payments,
in addition to tiered royalties on DMX-200 net U.S. sales
MELBOURNE, Australia and PRINCETON, N.J., April 30, 2025 (GLOBE NEWSWIRE) -- Dimerix Limited (ASX: DXB, “Dimerix”) and Amicus Therapeutics (Nasdaq: FOLD, “Amicus”) today announced that the two companies have entered into an exclusive license agreement for the commercialization of Dimerix’ Phase 3 drug candidate DMX-200 for all indications, including FSGS, in the United States (U.S.). Dimerix retains all rights to commercialize DMX-200 in all territories other than those already exclusively licensed.
DMX-200 is a small molecule inhibitor of the chemokine receptor 2 (CCR2) under development in a pivotal Phase 3 study, ACTION3, for the treatment of Focal Segmental Glomerulosclerosis (FSGS) kidney disease. In early 2024, Dimerix reported positive interim results from the ACTION3 trial in FSGS showing DMX-200 was performing better than placebo in reducing proteinuria with no safety concerns to date. Full enrollment of ACTION3 is expected by year-end 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.
“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. 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.,” said Bradley Campbell, President and Chief Executive Officer, Amicus Therapeutics. “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.”
“We are delighted to partner with Amicus in the United States. The Amicus team has a remarkable history of successfully delivering rare disease medicines to those in need. Their expertise and resources will be crucial to help achieve our mutual objective of commercializing this innovative treatment,” said Dr. Nina Webster, CEO and Managing Director of Dimerix. “I’m grateful to the dedicated Dimerix team, trial participants, and investigators for their continued commitment to developing a new therapy for patients with FSGS who currently have a poor prognosis and very limited treatment options.”
Dimerix will continue to fund and execute the ACTION3 study, and Amicus will be responsible for submission and maintenance of the regulatory dossier in the United States, as well as all costs of commercialization activities. Additionally, Amicus will have the exclusive rights to develop DMX-200 in other future indications in the United States. Amicus and Dimerix will form a Joint Steering Committee to align the development and commercialization of DMX-200 in FSGS in U.S. The agreement otherwise contains terms common for an arrangement of this kind.
In exchange for these rights, Dimerix will receive a US$30 million (~AU$48 million) upfront payment. The next potential milestone payment is based on positive data from the Phase 3 trial in FSGS. In total, Dimerix is eligible to receive potential success-based development and regulatory milestone payments of up to US$75 million (~AU$119 million) until FDA approval of DMX-200 in FSGS, US$35 million (~AU$56 million) on first sale, commercial sales milestone payments of up to US$410 million (AU$653 million), and tiered royalties from the low-teens to low-twenties percentages of DMX-200 net sales in the U.S. In addition, Dimerix is eligible to receive up to US$40 million (~AU$64 million) in milestone payments for potential future indications. The upfront payment from Amicus will be funded with cash on hand. All contracted financial terms are denominated in U.S. dollars.
Evercore Partners International LLP is acting as exclusive financial advisor to Dimerix, and Cooleys LLP is serving as Dimerix legal advisor. Wilson Sonsini Goodrich & Rosati is serving as Amicus legal advisor.
Authorized for lodgment with ASX by the Board of Dimerix.
About ACTION3 Phase 3 Study
The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a pivotal (Phase 3), multi-center, randomized, 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 randomized to receive either DMX-200 (120 mg capsule twice daily) or placebo.
The single Phase 3 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. Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785).
About DMX-200
DMX-200 is a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker, the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to Orphan Drug Designation granted by the FDA in the United States.
About FSGS
FSGS is a rare, serious kidney disorder characterized by progressive scarring (sclerosis) in parts of the glomeruli—the kidney’s filtering units. This scarring leads to proteinuria, progressive loss of kidney function, and often end-stage renal disease. FSGS is increasingly understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury. In the United States, more than 40,000 people are estimated to be living with FSGS, including both adults and children. There are no therapies specifically approved for FSGS in the U.S., and management relies on non-specific immunosuppressive and supportive therapies. In patients with progressive or treatment-resistant FSGS, the average time from diagnosis to end-stage kidney disease can be as short as five years. Even among those who undergo kidney transplantation, disease recurrence occurs in up to 60% of cases, underscoring the urgent need for new, disease-modifying treatments.
About Dimerix Limited
Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including kidney diseases. Dimerix is currently focused on developing its proprietary Phase 3 product candidate DMX-200, for Focal Segmental Glomerulosclerosis (FSGS) kidney disease, and is also developing DMX-700 for respiratory disease. DMX-200 and DMX-700 were both identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities. For more information, please visit the company’s website at
www.dimerix.com
and follow on
X
and
LinkedIn
.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the company’s website at
www.amicusrx.com
, and follow on
X
and
LinkedIn
.
Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to: the Amicus collaboration and license agreement with Dimerix of DMX-200, the timing of Phase 3 clinical trial evaluating DMX-200; the likelihood of success of such clinical trial; the prospects for FDA approval of DMX-200 for FSGS or other indications; the estimated prevalence of FSGS; the achievement of any milestone and timing of any payments associated with milestones and the success of any efforts to commercialize DMX-200, including any projections of future financial performance or payments. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
DIMERIX CONTACTS:
Dr. Nina Webster
Dimerix Limited
Chief Executive Officer & Managing Director
Tel: +61 1300 813 321
E: [email protected]
Rudi Michelson
Monsoon Communications
Tel: +61 3 9620 3333
Mob: +61 (0)411 402 737
E: [email protected]
AMICUS CONTACTS:
Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
[email protected]
+1 (609) 662-3809
Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Affairs and Communications
[email protected]
+1 (609) 662-5079
FOLD-G
