Aussie biotech secures licensing deal to commercialise rare disease therapy

Biotech News: An Australian biotech company has clinched an exclusive licensing agreement for its rare disease therapy. Melbourne-based Dimerix revealed a substantial windfall of $230 million in upfront and milestone payments resulting from the collaboration with UK-based pharmaceutical company, Advanz Pharma. This alliance is set to drive the commercialisation of DMX-200, a promising treatment for focal segmental glomerulosclerosis (FSGS), a rare form of kidney disease.

Dimerix is currently undertaking its Phase 3 trial (ACTION3) into its lead drug DMX-200, with the first analysis of the outcomes anticipated in March 2024. The exclusive license agreement inked with Advanz Pharma encompasses Australia, New Zealand, Europe, UK, Switzerland and Canada. Notably, Dimerix retains unbridled rights to commercialise the drug beyond these defined territories.

The collaboration delineates that while Dimerix will maintain funding and execution of the global ACTION3 trial, Advanz will spearhead the submission and maintenance of the regulatory dossier within the licensed territories, in addition to overseeing all sales and marketing initiatives.

FSGS, a rare disease affecting the kidney’s vital filtering units, has dire consequences as it causes irreparable scarring, leading to chronic kidney disease and eventual organ failure. The disease impacts approximately 80,000 individuals in the US and a staggering 220,000 worldwide, presenting a potential billion-dollar market opportunity for Dimerix.

In the wake of this monumental partnership, Advanz CEO Steffen Wagner expressed enthusiasm about commercialising DXB-200.

“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,” Mr Wagner said. “We are committed to bringing innovative rare disease medicines to market which serve a high unmet patient need.”

Dimerix’s CEO and Managing Director, Dr Nina Webster, emphasised the significance of Advanz’s expertise and resources in advancing their shared goal.

“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,” Dr Webster commented.

Prominent nephrologist, Professor Jonathan Barratt, from Leicester University and co-chair of the UK Glomerulonephritis clinical study group, also welcomed this pivotal licensing deal.

“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,” Professor Barratt said.

While the US Food and Drug Administration (FDA) granted Dimerix conditional approval for DMX-200 (brand name Qytovra) last month, Dimerix and Advanz are set to form a collaborative steering committee to align their efforts in commercialising the novel therapy. Additionally, Advanz retains the right of first offer to negotiate further licenses for DMX-200 in any additional indications within the licensed territories, while Dimerix continues to actively explore licensing prospects with potential partners outside of the Advanz designated regions.

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