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Highlights

  • Dimerix receives $30 million upfront and may earn up to $560 million in development and sales milestones.

  • Amicus secures exclusive U.S. rights to DMX-200, a promising Phase 3 treatment for rare kidney disease FSGS.

  • Dimerix retains ex-U.S. rights and will earn tiered royalties on U.S. sales.

Australian biotech firm Dimerix Limited (ASX:DXB) has signed a landmark licensing agreement with Amicus Therapeutics (Nasdaq:FOLD), granting the U.S.-based rare disease specialist exclusive rights to commercialize Dimerix’s Phase 3 kidney drug candidate DMX-200 in the United States.

The deal, which centers on the treatment of Focal Segmental Glomerulosclerosis (FSGS) – a rare and serious kidney disorder currently without any FDA-approved therapies – could be worth up to $590 million for Dimerix. The agreement includes a $30 million upfront payment, with additional milestone payments of up to $560 million tied to regulatory, clinical, and commercial achievements.

Dimerix will also receive tiered royalties ranging from the low-teens to low-twenties on U.S. net sales of DMX-200.

DMX-200, a CCR2 antagonist, is currently in a pivotal Phase 3 trial known as ACTION3, with full enrollment expected by late 2025. Interim results released in early 2024 showed statistically significant reductions in proteinuria — a key indicator of kidney damage — compared to placebo.

FSGS, affecting around 40,000 people in the U.S., is known for its progressive damage to kidney filtering units, often leading to end-stage renal failure. With no current standard of care, DMX-200’s potential approval would represent a major therapeutic advancement.

While Amicus will handle regulatory submissions and commercialization in the U.S., Dimerix retains full rights to the drug outside the U.S., opening additional partnership or commercialization opportunities in other markets.

The agreement marks a strategic expansion for Amicus into nephrology, complementing its existing rare disease portfolio. “This partnership brings together Dimerix’s innovation and Amicus’s proven commercial capabilities in rare disease,” said company executives in a joint statement.