Dimerix secures deal to commercialise DMX-200 for treatment of rare kidney disease
Drug development company Dimerix (ASX: DXB) has secured a licencing deal with Advanz Pharma Corp for the commercialisation of Dimerix’s Phase 3 drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease.
The agreement will give Advanz exclusive rights to register and market the drug in the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand following regulatory approval.
Dimerix will retain all rights to commercialise DMX-200 outside of these territories.
Under the terms of the deal, Dimerix will receive an upfront payment of $10.8 million within the first month and milestone payments of up to $219 million, plus tiered royalties of up to 20% on net sales of the drug.
Dimerix and Advanz will form a steering committee to align the development and commercialisation of DMX-200 and any data and regulatory filings may be used by either party for development and commercialisation purposes in their respective territories.
Advanz has a right of first offer to negotiate a licence to develop and commercialise DMX-200 in any additional indications in the licenced territories.
Dimerix chief executive officer Dr Nina Webster said the company was pleased to be working with Advanz.
“The Advanz team has a proven record in developing and commercialising medicines in areas with no approved therapies and high unmet needs… their expertise and resources will be invaluable to advancing our shared goal of commercialising this novel treatment,” she said.
“This partnership recognises a decade of work achieved by our team, as well as consultants, trial participants and investigators in developing a new therapy for patients with FSGS.”
Focal segmental glomerulosclerosis is a rare condition which attacks the kidney’s filtering units where blood is cleaned (called the ‘glomeruli’) and causes irreversible scarring.
This can lead to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation.
The average time from FSGS diagnosis to the onset of kidney failure is five years, and it can affect adults and children as young as two years old.
Research shows that of those patients who receive a kidney transplant, approximately 60% will experience a re-occurrence of FSGS in the transplanted organ.
There are currently limited treatment options for FSGS and Dimerix said there remains a significant unmet need for efficacious therapies.
Billion dollar market
FSGS represents a billion-dollar plus market, with the number of US patients tallying over 80,000 and worldwide figures hitting around 220,000.
The illness has a global compound annual growth rate of 8% and more than 5400 new cases are diagnosed in the US each year.
Dimerix has received Orphan Drug Designation in the US and Europe for DMX-200 to treat FSGS.
DMX-200 is currently in global Phase 3 clinical development, with the first analysis outcome expected in early 2024.