Dimerix Signs Exclusive License Agreement with Advanz to Commercialize Investigational FSGS Treatment

Rare Daily Staff

Advanz Pharma has entered into an exclusive license agreement with Dimerix to commercialize its late-stage candidate DMX-200 for the treatment of focal segmental glomerulosclerosis kidney disease, following regulatory approval in the European Economic Area, the United Kingdom, Switzerland, Canada, Australia, and New Zealand.

In exchange for these rights, Dimerix will receive an upfront payment of $6.9 million (€6.5 million), plus potential development and commercialization milestones of up to $140 million (€132 million). In addition, Dimerix is eligible to receive tiered, escalating, mid-teen to twenty percentage royalties on net sales of DMX-200 if successfully commercialized.

Advanz will leverage its specialty, hospital, and rare disease expertise and commercial platform to register and effectively promote the product and offer greater patient access. Dimerix retains all rights to commercialize DMX-200 outside of these territories. DMX-200 is currently in global phase 3 clinical development in FSGS, which Dimerix will continue to fund, and Advanz will be responsible for submission and maintenance of the regulatory dossier in the licensed territories, as well as all sales and marketing activities.

“Advanz’s expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of commercializing this novel treatment, and this partnership recognizes the decade of work by our dedicated team, consultants, trial participants, and investigators in the developing a new therapy for patients with FSGS,” said Nina Webster, CEO and managing director of Dimerix.

Focal segmental glomerulosclerosis (FSGS) is a rare disease that attacks the kidney’s filtering units, where blood is cleaned, causing irreversible scarring. This leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation. The average time from a diagnosis of FSGS to the onset of complete kidney failure is only five years and it affects both adults and children as young as two years old. For those who are fortunate enough to receive a kidney transplant, approximately 60% will get re-occurring FSGS in the transplanted kidney. At this time, there are no drugs specifically approved for FSGS anywhere in the world, so the treatment options and prognosis are limited.

DMX-200 is the adjunct therapy of 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. In 2020, Dimerix completed two phase 2 studies: one in FSGS and one in diabetic kidney disease. No significant adverse safety events were reported in any trial, and all studies resulted in encouraging data that could provide meaningful clinical outcomes for patients with kidney disease. DMX-200 is currently in development in the global ACTION3 phase 3 clinical trial in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker. The study has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function during the trial, aimed at generating sufficient evidence to support marketing approval. Dimerix has received Orphan Drug designation for DMX 200 in both the United States and Europe for FSGS.

Photo: Nina Webster, CEO and managing director of Dimerix