DXB says upfront payment marks a milestone in its growth and development. Pic: Getty Images.
Health & Biotech
Special Report: Dimerix is starting to reap the benefits of its licensing deal with Advanz Pharma to commercialise DMX-200 for treatment of rare kidney disease focal segmental glomerulosclerosis (FSGS) with a multi-million dollar upfront payment.
Aussie biotech Dimerix (ASX:DXB) has received the initial upfront payment of €6.5 million ($10.7million) from Advanz Pharma, which it says marks a pivotal milestone in the company’s growth and development.
DXB remains eligible for potential development and sales milestones of up to €132 million ($219 million), plus tiered, escalating, mid-teen to twenty percentage royalties on net sales.
No royalties or similar costs are payable by DXB to third parties, which means that any revenue from Advanz will flow through to pre-tax profit.
DXB announced in October an exclusive license agreement with the multinational pharmaceutical company covering the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
The brand name QYTOVRA has been approved for DMX-200 by the United States Food and Drug Administration (FDA), and may be used as the brand name in some regions.
DXB is currently undertaking its Phase 3 trial titled Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis, or ACTION3 for short.
The pivotal multi-centre, randomised, double-blind, placebo-controlled study is evaluating efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Once the ARB dose is stable, patients will be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo.
The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.
First analysis outcome for the trial is forecast on or around March 15, 2024.
FSGS is a rare condition affecting the kidney’s filtering units, where blood is purified, resulting in permanent kidney damage and eventual organ failure, necessitating either dialysis or a transplant.
It is estimated ~80,000 individuals in the US and ~220,000 worldwide are afflicted by FSGS, making it a substantial market opportunity estimated at billions of dollars for DXB.
DXB has already secured Orphan Drug Designation (ODD) for QYTOVRA in both the United States and Europe for the treatment of FSGS due to the absence of an effective therapy for this condition.
The advantages of ODD encompass a range of development incentives, including seven years of market exclusivity granted by the FDA and 10 years by the EMA if regulatory approval is obtained, exemption from specific application fees, and an expedited regulatory pathway to approval.
DXB and Advanz are establishing a joint steering committee for the development and commercialisation efforts of DMX-200 for FSGS within the Advanz territories.
Any data and regulatory submissions generated by Advanz or DXB may be used by either party for the development and commercialisation of DMX-200 within their designated regions.
Advanz holds the first right to negotiate a licence for the development and commercialisation of DMX-200 in additional medical indications within the licensed territories.
DXB continues its ongoing commitment to explore and advance licensing prospects with potential partners outside of the Advanz-designated regions.
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.
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