Dimerix and Amicus Therapeutics partner to commercialise kidney disease treatment DMX-200 in the US
Drug developer Dimerix (ASX: DXB) and US biopharmaceuticals company Amicus Therapeutics have entered into an exclusive US licence agreement for the commercialisation of Dimerix’s lead candidate DMX-200.
The drug is under development in a pivotal Phase 3 study known as ACTION3 for the treatment of rare-but-fatal kidney disease focal segmental glomerulosclerosis (FSGS).
Under the terms of the agreement, Dimerix will continue to fund and execute ACTION3 and Amicus will be responsible for the submission and maintenance of a regulatory dossier in the US as well as the cost of all commercialisation activities.
Exclusive rights
Dimerix will retain all rights to commercialise DMX-200 in territories other than those already exclusively licensed, while Amicus will retain exclusivity to develop the drug for other indications in the US market.
Amicus will pay Dimerix US$30 million upfront as consideration.
Dimerix will also be eligible to receive milestone payments totalling as much as US$560m for achievements including US regulatory approval and first sale, with up to US$40m available for any future indications the company makes.
The two companies will also form a joint steering committee to align the development and commercialisation of DMX-200 in FSGS in the US.
Beneficial partnership
Dimerix chief executive officer Dr Nina Webster said she looked forward to the mutually-beneficial partnership.
“We are delighted to partner with Amicus in the US—the team has a remarkable history of delivering rare disease medicines to those in need and their expertise and resources will be crucial to help achieve our mutual objective of commercialising this innovative treatment,” she said.
“We are grateful to our dedicated Dimerix team, the 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.”
Rare kidney disorder
FSGS is a kidney disorder characterised by progressive sclerosis (scarring) in parts of the glomeruli—the kidney’s filtering units.
The sclerosis leads to high levels of protein in urine, progressive loss of kidney function and often end-stage renal disease.
FSGS is understood to have an inflammatory component, with monocyte and macrophage activation contributing to glomerular injury.
No approved treatments
More than 40,000 adults and children in the US live with FSGS and, with no currently approved treatments, management relies on non-specific immunosuppressive and supportive therapies.
For patients with progressive or treatment-resistant FSGS, the average time from diagnosis to end-stage kidney disease can be as short as five years.
For those who undergo kidney transplant surgery, disease recurrence can occur in up to 60% of cases, underscoring the urgent need for new and disease-modifying treatments.