Shots:
- Dimerix has granted Amicus exclusive US rights to develop & market DMX-200 for all indications, incl. focal segmental glomerulosclerosis (FSGS), with Amicus handling regulatory filings, dossier maintenance, & marketing in the US
- Dimerix will get $30M cash upfront, ~$75M on FDA approval, $35M on 1st sale, ~$40M for future indications & ~$410M in sales milestones, plus tiered royalties on net sales (low teens to low twenties %); they will also form a joint steering committee to align US development & marketing of DMX-200 for FSGS
- Dimerix will fund & execute the P-III (ACTION3) trial, with full enrollment expected by end-2025. A blinded interim analysis is planned after finalization of revised EPs in the protocol & FDA agreementÂ
Ref: Globenewswire | Image: Amicus Therapeutics & Dimerix
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