ADVANZ PHARMA and Dimerix enter into an Exclusive License Agreement to commercialise DMX-200 in Europe, Canada, Australia, and New Zealand

ADVANZ PHARMA Corp. Limited, a UK headquartered global pharmaceutical company with a strategic focus on speciality, hospital and rare disease medicines in Europe, Canada, and Australia, 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’ Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease, following regulatory approval. Dimerix retains all rights to commercialise DMX-200 outside of these territories. DMX-200 is currently in global Phase 3 clinical development.

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 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 percentage royalties on net sales of DMX-200 if successfully commercialised (all contracted financial terms are denominated in Euros).

Steffen Wagner, CEO, ADVANZ PHARMA, said, “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.”

Dimerix and ADVANZ will form a Joint Steering Committee to align the development and commercialisation of DMX-200 in FSGS in the territories. Any data and regulatory filings generated by ADVANZ or Dimerix may be used by either party for the development and commercialization of DMX-200 in their respective territories. ADVANZ has a right of first offer to negotiate a license to develop and commercialize DMX-200 in any additional indications in the licensed territories.

Dimerix continues to pursue and progress licensing opportunities with potential partners outside the ADVANZ territories.

CEO & Managing Director of Dimerix, Dr Nina Webster, said, “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.”

Professor Jonathan Barratt, Nephrologist, Mayer Professor of Renal Medicine: University of Leicester, Co-Chair UK Glomerulonephritis Clinical Study Group, said, “With limited treatment options currently available and many patients who do not adequately respond to existing treatment regimes, there remains a significant unmet need for efficacious FSGS therapies Dimerix’ and ADVANZ’s commitment to DMX-200 brings us closer to the first potential treatment specifically for FSGS designed to improve the lives of those suffering from the disease”.