Dimerix soars on $230m licensing deal with ADVANZ PHARMA for DMX-200 into rare kidney disease
Health & Biotech
Health & Biotech
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Dimerix shares surged more than 100% after announcing it will receive $230m in upfront and milestone payments following a licensing deal with ADVANZ PHARMA to commercialise DMX-200 for treatment of rare kidney disease focal segmental glomerulosclerosis (FSGS).
Aussie biotech Dimerix (ASX:DXB) is currently undertaking its Phase 3 trial, known as ACTION3, into its lead drug DMX-200, with the first analysis outcome forecast on or around March 15, 2024.
The exclusive license agreement with multinational pharmaceutical company ADVANZ covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
DXB retains all rights to commercialise the drug outside of these territories.
The US Food and Drug Administration (FDA) last month granted DXB conditional approval for the brand name QYTOVRA.
DXB says it will continue to fund and execute the global ACTION3 trial 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 the rights, DXB will receive an upfront payment of €6.5 million (~AU$10.8 million) within 30 days, plus potential development, and commercialisation milestones of up to €132 million (AU$219 million).
Furthermore, DXB is eligible to receive tiered, escalating, mid-teen to twenty percentage royalties on net sales of DMX-200 if successfully commercialised.
FSGS is a rare disease attacking the kidney’s filtering units, where blood is cleaned, causing irreversible scarring which leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation.
Around 80,000 people suffer from FSGS in the US and around 220,000 worldwide, making it a potential billion-dollar market opportunity for DXB.
DXB has already received Orphan Drug Designation (ODD) for QYTOVRA in both the US and Europe for FSGS because there is no effective treatment for the disease.
The benefits of ODD include various development incentives including seven years (FDA) and 10 years (EMA) of market exclusivity if regulatory approval is received, exemption from certain application fees, and a fast-tracked regulatory pathway to approval.
DXB and Advanz will form a joint steering committee to align development and commercialisation of DMX-200 in FSGS in the territories.
Any data and regulatory filings generated by ADVANZ or DXB 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.
DXB says it continues to pursue and progress licensing opportunities with potential partners outside the ADVANZ territories.
ADVANZ CEO Steffen Wagner says the company is looking forward to 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,” Wagner says.
“We are committed to bringing innovative rare disease medicines to market which serve a high unmet patient need.”
DXB CEO and managing director Dr Nina Webster says 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,” she says.
Nephrologist Jonathan Barratt, Leicester University’s Mayer Professor of Renal Medicine ánd co-chair of the UK Glomerulonephritis clinical study group has also welcomed the 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,” he says.
“Dimerix’s 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.”
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.