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Highlights
- Dimerix inks US licensing deal with Amicus for kidney drug DMX-200
- Agreement includes up to US$560 million in milestone payments
- Addresses urgent need for treatment in rare kidney disease FSGS
Australian biotech company Dimerix (ASX:DXB) has announced a strategic licensing deal with US-based Amicus Therapeutics (NASDAQ:FOLD) to commercialise its lead drug candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis (FSGS)—a rare and often life-threatening kidney disease.
The exclusive agreement grants Amicus the commercialisation rights for DMX-200 in the United States, where the drug is currently undergoing a pivotal Phase 3 clinical trial, known as ACTION3. This study is focused on assessing the safety and efficacy of DMX-200 in patients suffering from FSGS, a condition that currently lacks any FDA-approved therapies.
As part of the deal, Amicus will make an upfront payment of US$30 million to Dimerix. In addition to this, Dimerix stands to receive up to US$560 million in milestone payments linked to key regulatory and commercial achievements. These include US regulatory approval and first commercial sale milestones, along with up to US$40 million for any new indications pursued in the future.
Dimerix will retain full rights to commercialise the therapy outside the territories currently licensed and maintain control over ongoing development through the ACTION3 trial. Meanwhile, Amicus will oversee all US-based regulatory submissions and bear the costs associated with bringing the product to market.
This collaboration reflects the growing significance of the healthcare sector within the S&P/ASX 200, especially as innovative therapies targeting rare diseases gain momentum.
FSGS is a progressive kidney disorder that leads to scarring in the kidney’s filtering units, causing protein loss, declining kidney function, and often end-stage renal disease. With over 40,000 patients affected in the US and no approved treatments currently available, the urgency for novel therapies like DMX-200 cannot be overstated. For patients with severe or resistant forms of the disease, the average time to kidney failure can be as short as five years.
The new alliance between Dimerix and Amicus will also see the formation of a joint steering committee, guiding development and commercialisation strategies to ensure timely progress.
This move aligns with broader investor interest in innovative biotech firms within the Australian market, including those found among ASX dividend stocks, as the sector demonstrates long-term potential and strategic global collaborations.
By joining forces with Amicus, Dimerix reinforces its commitment to advancing transformative therapies and addressing critical unmet needs in rare disease treatment.
