Dimerix and Amicus Therapeutics Announce Exclusive License Agreement for DMX-200 in the United States
Dimerix and Amicus Therapeutics have formed an exclusive license agreement for DMX-200 in the United States. The deal focuses on treating Focal Segmental Glomerulosclerosis (FSGS), a rare and fatal kidney disease with no FDA-approved therapies.
Key financial terms include:
- US$30 million upfront payment to Dimerix
- Up to US$560 million in success-based milestone payments
- Tiered royalties on U.S. sales from low-teens to low-twenties percentages
DMX-200 is currently in a pivotal Phase 3 trial called ACTION3, with positive interim results showing better performance than placebo in reducing proteinuria. The FDA has aligned on proteinuria as the primary endpoint for marketing approval. Full trial enrollment is expected by year-end 2025. Amicus will handle U.S. regulatory submissions and commercialization, while Dimerix retains rights in other territories.
Dimerix e Amicus Therapeutics hanno stipulato un accordo di licenza esclusiva per DMX-200 negli Stati Uniti. L'accordo riguarda il trattamento della Glomerulosclerosi Segmentaria e Focale (FSGS), una malattia renale rara e letale per la quale non esistono terapie approvate dalla FDA.
I termini finanziari principali includono:
- Pagamento anticipato di 30 milioni di dollari a Dimerix
- Fino a 560 milioni di dollari in pagamenti milestone legati al successo
- Royalties a scaglioni sulle vendite negli USA, che vanno da percentuali basse a percentuali medio-basse
DMX-200 è attualmente in una fase 3 cruciale chiamata ACTION3, con risultati intermedi positivi che mostrano una migliore riduzione della proteinuria rispetto al placebo. La FDA ha concordato che la proteinuria sarà l'endpoint primario per l'approvazione commerciale. Il completamento delle iscrizioni al trial è previsto entro la fine del 2025. Amicus gestirà le autorizzazioni regolatorie e la commercializzazione negli Stati Uniti, mentre Dimerix manterrà i diritti in altri territori.
Dimerix y Amicus Therapeutics han establecido un acuerdo exclusivo de licencia para DMX-200 en Estados Unidos. El acuerdo se centra en el tratamiento de la Glomeruloesclerosis Segmentaria y Focal (FSGS), una enfermedad renal rara y fatal sin terapias aprobadas por la FDA.
Los términos financieros clave incluyen:
- Pago inicial de 30 millones de dólares a Dimerix
- Hasta 560 millones de dólares en pagos por hitos basados en el éxito
- Regalías escalonadas sobre las ventas en EE. UU., desde porcentajes bajos hasta bajos veinte por ciento
DMX-200 está actualmente en un ensayo pivotal de fase 3 llamado ACTION3, con resultados intermedios positivos que muestran un mejor desempeño que el placebo en la reducción de la proteinuria. La FDA ha acordado que la proteinuria será el criterio principal para la aprobación comercial. Se espera que la inscripción completa del ensayo finalice a finales de 2025. Amicus se encargará de las presentaciones regulatorias y la comercialización en EE. UU., mientras que Dimerix mantiene los derechos en otros territorios.
Dimerix와 Amicus Therapeutics는 미국 내 DMX-200에 대한 독점 라이선스 계약을 체결했습니다. 이 계약은 FDA 승인 치료제가 없는 희귀하고 치명적인 신장 질환인 국소 분절 사구체 경화증(FSGS) 치료에 중점을 둡니다.
주요 재무 조건은 다음과 같습니다:
- Dimerix에 대한 3,000만 달러 선불 지급
- 성공에 따른 최대 5억 6,000만 달러의 마일스톤 지급
- 미국 내 판매에 대한 낮은 10%대에서 낮은 20%대까지의 단계별 로열티
DMX-200은 현재 ACTION3라는 중요한 3상 시험 중이며, 중간 결과에서 단백뇨 감소 면에서 위약보다 우수한 성과를 보였습니다. FDA는 마케팅 승인 주요 평가 기준으로 단백뇨를 승인했습니다. 전체 시험 등록은 2025년 말까지 완료될 예정입니다. Amicus는 미국 내 규제 제출과 상업화를 담당하며, Dimerix는 다른 지역에서 권리를 유지합니다.
Dimerix et Amicus Therapeutics ont conclu un accord de licence exclusive pour DMX-200 aux États-Unis. Cet accord porte sur le traitement de la Glomérulosclérose segmentaire et focale (FSGS), une maladie rénale rare et mortelle sans thérapies approuvées par la FDA.
Les principaux termes financiers comprennent :
- Un paiement initial de 30 millions de dollars à Dimerix
- Jusqu'à 560 millions de dollars en paiements d'étapes basés sur le succès
- Des redevances échelonnées sur les ventes aux États-Unis allant de faibles pourcentages en dizaines à un peu plus de vingt pour cent
DMX-200 est actuellement en phase 3 pivot appelée ACTION3, avec des résultats intermédiaires positifs montrant une meilleure réduction de la protéinurie par rapport au placebo. La FDA a validé la protéinurie comme critère principal pour l'approbation commerciale. Le recrutement complet de l'essai est attendu d'ici la fin 2025. Amicus prendra en charge les soumissions réglementaires et la commercialisation aux États-Unis, tandis que Dimerix conserve les droits dans d'autres territoires.
Dimerix und Amicus Therapeutics haben eine exklusive Lizenzvereinbarung für DMX-200 in den Vereinigten Staaten geschlossen. Der Vertrag konzentriert sich auf die Behandlung der Fokal segmentalen Glomerulosklerose (FSGS), einer seltenen und tödlichen Nierenerkrankung ohne von der FDA zugelassene Therapien.
Wichtige finanzielle Bedingungen umfassen:
- Eine Vorauszahlung von 30 Millionen US-Dollar an Dimerix
- Bis zu 560 Millionen US-Dollar an erfolgsabhängigen Meilensteinzahlungen
- Gestaffelte Lizenzgebühren auf US-Verkäufe von niedrigen bis mittleren zwanziger Prozenten
DMX-200 befindet sich derzeit in einer entscheidenden Phase-3-Studie namens ACTION3, mit positiven Zwischenergebnissen, die eine bessere Wirksamkeit als Placebo bei der Reduzierung der Proteinurie zeigen. Die FDA hat Proteinurie als primären Endpunkt für die Marktzulassung festgelegt. Die vollständige Einschreibung der Studie wird bis Ende 2025 erwartet. Amicus wird die US-Zulassungsanträge und die Vermarktung übernehmen, während Dimerix die Rechte in anderen Regionen behält.
- Secured $30M upfront payment from Amicus, strengthening immediate cash position
- Potential milestone payments up to $560M plus tiered royalties from low-teens to low-twenties
- Positive interim Phase 3 results showing DMX-200 outperforming placebo
- FDA alignment on proteinuria as primary endpoint for marketing approval
- Retains commercialization rights for all territories outside US
- No safety concerns reported in Phase 3 trial to date
- Partnership with established rare disease company Amicus for US commercialization
- Phase 3 trial not yet fully enrolled, completion expected by end-2025
- Additional blinded interim analysis still needed
- No current FDA-approved therapies for FSGS indicates regulatory uncertainty
- Development and trial costs continue to be funded by Dimerix
Insights
Dimerix-Amicus $30M upfront deal unlocks potential $560M milestone payments, creating substantial value for both companies in untapped FSGS market.
The licensing agreement between Dimerix and Amicus represents a transformative development for both companies. Dimerix receives an immediate
The milestone structure reveals strategic priorities:
For Amicus, this agreement strategically expands their rare disease portfolio into nephrology. With approximately 40,000 FSGS patients in the U.S. and no FDA-approved therapies, DMX-200 addresses a significant unmet medical need. The March 2025 FDA alignment on proteinuria as a primary endpoint substantially derisks the regulatory pathway.
The deal's timing follows positive interim results but precedes full enrollment (expected by year-end 2025), balancing risk and value optimization. Dimerix retains rights outside the U.S., preserving significant global commercial opportunity while leveraging Amicus's established U.S. commercial infrastructure for optimal market access.
DMX-200 shows promising efficacy for FSGS with favorable FDA regulatory alignment; could become first approved therapy for this devastating kidney disease.
The development of DMX-200 for FSGS represents a potential breakthrough for a devastating kidney disorder with extremely limited treatment options. FSGS patients currently face rapid disease progression, with advancement to end-stage renal disease often occurring within five years of diagnosis. Even kidney transplantation offers limited benefit, with disease recurrence in up to
DMX-200's mechanism as a CCR2 antagonist directly addresses the inflammatory component of FSGS pathophysiology. Current management relies on non-specific immunosuppressants with substantial side effects and limited efficacy. DMX-200 is administered alongside angiotensin II receptor blockers (ARBs), building upon existing standard of care rather than replacing it.
The positive interim results from ACTION3 showing superior proteinuria reduction versus placebo provide encouraging evidence of efficacy. The FDA's agreement on proteinuria as an appropriate primary endpoint for traditional approval represents a crucial regulatory milestone that significantly streamlines the path to market.
If approved, DMX-200 would become the first FDA-approved therapy specifically for FSGS, establishing a new standard of care for these patients. The patent protection extending to 2032 (with potential extension to 2042) and Orphan Drug Designation provide substantial market exclusivity. The Amicus partnership ensures that if successful, this therapy will have the commercial support needed to effectively reach the approximately 40,000 U.S. patients living with this condition.
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
up to US
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
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
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: investor@dimerix.com
Rudi Michelson
Monsoon Communications
Tel: +61 3 9620 3333
Mob: +61 (0)411 402 737
E: rudim@monsoon.com.au
AMICUS CONTACTS:
Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
+1 (609) 662-3809
Media:
Amicus Therapeutics
Diana Moore
Head of Global Corporate Affairs and Communications
dmoore@amicusrx.com
+1 (609) 662-5079
FOLD-G
FAQ
What is the value of Amicus (FOLD) and Dimerix license deal for DMX-200?
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