Australian biopharmaceutical company Dimerix and Amicus Therapeutics have signed an agreement for the US commercialisation of the former’s Phase III drug candidate DMX-200.
The drug will be marketed for all indications, including the rare kidney disease focal segmental glomerulosclerosis (FSGS).
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Dimerix retains the drug’s commercialisation rights in all territories, excluding the already licensed areas.
Amicus will gain exclusive development rights to the drug for other potential future indications in the country.
The companies will establish a joint steering committee to coordinate development and commercialisation strategies for DMX-200 in FSGS treatment in the US market.
In return for these rights, Dimerix will obtain an upfront payment of $30m from Amicus, with the potential for additional milestone payments based on the success of the Phase III trial for treating FSGS.
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By GlobalDataThe upfront payment will be made by Amicus with cash on hand.
Dimerix could receive up to $75m in development and regulatory milestone payments until US Food and Drug Administration (FDA) approval is gained, $35m upon first sales and commercial sales milestone payments up to $410m, along with tiered royalties on net sales in the country.
The company may also receive up to $40m for potential future indications.
Evercore Partners International is serving as Dimerix’s exclusive financial advisor. Cooleys is the legal advisor.
Amicus’ legal advice is provided by Wilson Sonsini Goodrich & Rosati.
Amicus Therapeutics CEO and president Bradley Campbell stated: “Amicus is thrilled to enter into this collaboration with Dimerix to bring DMX-200 to patients in the US, and we are incredibly impressed by their achievements to date.
“We look forward to leveraging our regulatory, commercial, medical and advocacy capabilities to bring this potentially transformative treatment to people living with FSGS in the US.”
A chemokine receptor 2 inhibitor, DMX-200 has shown promising interim outcomes in the ongoing pivotal Phase III ACTION3 trial.
Dimerix will fund and manage the trial, while Amicus will handle the regulatory dossier submission and maintenance in the US, along with all commercialisation expenses.
The drug is protected by patents until 2032, and these may extend to 2042 with further applications, including an orphan drug designation by the US regulator.
