Dimerix (ASX:DXB) and Amicus Therapeutics entered into an exclusive license agreement for the commercialization of Dimerix's drug candidate DMX-200 in the US, according to a Thursday Australian bourse filing.
DMX-200 is a small-molecule inhibitor of the chemokine receptor 2, currently undergoing a phase-three study for the treatment of focal segmental glomerulosclerosis kidney disease (FSGS), for which there is no approved treatment in the US.
Dimerix will receive an upfront payment of $30 million, and it will be eligible to receive potential success-based development and regulatory milestone payments of up to $75 million until the approval of DMX-200 for the treatment of FSGS by the US Food and Drug Administration.
It will also be eligible to receive $35 million on first sale, commercial sales milestone payments of up to $410 million, tiered royalties of up to low-twenties percentages of DMX 200 net sales in the US, and up to $40 million in milestone payments for potential future indications.
Full enrollment for the study is expected by the end of the current year. Dimerix will continue to fund and execute the study, while Amicus will be responsible for the submission and maintenance of the regulatory dossier in the US, as well as all costs of commercialization activities.
Amicus and Dimerix will form a committee to align the development and commercialization of DMX-200 for the treatment of FSGS in the US. Amicus will also have the exclusive rights to develop DMX-200 in other future indications in the US.
Its shares surged 43% in early trading on Thursday, reaching their highest point since late 2020.
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