- Dimerix (ASX:DXB) receives an initial upfront payment of €6.5 million (A$10.7 million) from Advanz Pharma
- As part of the agreement, Advanz has been granted rights to market DMX-200 for FSGS within the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand
- This single phase 3 trial in FSGS patients incorporates two interim analysis points aimed at capturing evidence related to proteinuria and kidney function (eGFR slope) throughout the study
- The objective is to gather sufficient data to support marketing approval
- DXB shares last traded at 17 cents
Biopharma company Dimerix (ASX:DXB) has received an initial upfront payment of €6.5 million (A$10.7 million) as part of its licensing agreement with Advanz Pharma.
Under the agreement, Advanz has been granted the rights to market DMX-200 for FSGS within the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand.
Dimerix will retain full commercial control over DMX-200 outside of Advanz’s designated territories, as well as all other potential applications worldwide.
Dimerix may receive development and sales milestone payments of up to €132 million (AU$219 million), in addition to tiered, increasing royalties ranging from the mid-teens to 20 per cent on the net sales of DMX-200 if it achieves successful commercialisation.
The phase three study, ACTION3, is a pivotal, multicenter, randomised, double-blind, placebo-controlled study of the effectiveness and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). After the ARB dose is stabilised, patients will be randomly assigned to receive either DMX200 (120 mg capsule twice daily) or placebo.
This phase 3 trial in FSGS patients will include two interim analysis points to gather evidence related to proteinuria and kidney function. The objective is to collect sufficient data to support marketing approval.
DXB shares last traded at 17 cents.