Advanz Pharma and Dimerix (ASX:DXB) have announced they have entered into an exclusive license agreement for the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand for the commercialisation of Dimerix’s Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease.
Dimerix said it retains all rights to commercialise DMX-200 outside of these territories. DMX-200 is currently in global Phase 3 clinical development, in which the first analysis outcome is expected in March 2024.
Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients, and ADVANZ will be responsible for the submission and maintenance of the regulatory dossier in the licensed territories, as well as all sales and marketing activities.
In exchange for these rights, Dimerix will receive an upfront payment of €6.5 million within 30 days, plus potential development and commercialisation milestones of up to €132 million. In addition, Dimerix is eligible to receive tiered, escalating, mid-teen to twenty per cent royalties on net sales of DMX-200 if successfully commercialised.
“We are excited to announce this partnership with Dimerix, which is fully in line with our strategy to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. We are committed to bring innovative rare disease medicines to market which serve a high unmet patient need.” said Steffen Wagner, the CEO of Advanz Pharma.
“We are delighted to be partnering with Advanz in Europe, UK, Australia, New Zealand and Canada. The Advanz team has a proven record in developing and commercialising medicines in areas with no approved therapies and high unmet needs. Advanz's expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of commercialising this novel treatment, and this partnership recognises the decade of work by our dedicated team, consultants, trial participants, and investigators in the developing a new therapy for patients with FSGS.” said Dr Nina Webster, CEO and managing director of Dimerix.