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Medexus and medac Conclude Negotiations to Amend US Treosulfan Agreement, Setting Regulatory Milestone Amounts and Payment Schedule
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - December 2, 2024) - Medexus Pharmaceuti...
About this update from Medexus Pharmaceuticals Inc.
[{"type":"text","content":"Medexus and medac Conclude Negotiations to Amend US Treosulfan Agreement, Setting Regulatory Milestone Amounts and Payment ScheduleToronto, Ontario and Chicago, Illinois--(Newsfile Corp. - December 2, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that the company recently entered into a fourth amendment to its February 2021 exclusive license agreement with medac relating to commercialization of treosulfan in the United States.Among other things, the fourth amendment adjusts the unpaid regulatory milestone payments under the US treosulfan agreement. Upon an FDA approval of treosulfan, Medexus would repay a US$2.5 million credit received from medac in September 2021 and would pay a regulatory milestone amount to medac, based on the language of the product label approved by the FDA, of either US$15 million, or US$20 million if the product label includes non-inferiority but not clinical superiority, or US$45 million if the product label includes clinical superiority. This regulatory milestone amount would be paid in installments as follows:one-sixth of the total amount by June 30, 2025,one-third of the total amount by October 1, 2025, andthe remaining amount (50% of the total) by January 1, 2026.For the lowest regulatory milestone amount, this installment schedule would result in payments of US$2.5 million, US$5 million, and US$7.5 million.Medexus would be entitled to temporarily defer a portion of the first installment (to the extent, if any, exceeding US$3.25 million) for up to 90 days, the second installment for up to 120 days, and the third installment for up to 30 days, with any deferred amount accruing interest at an interest rate of 9.0% per annum.\"We are pleased to have achieved clarity on the remaining contractual milestones under our agreement and arrived at terms that appropriately reflect the value we see in this product,\" commented Ken d'Entremont, Chief Executive Officer of Medexus. \"We remain optimistic about the prospect of FDA approval no later than January 30, 2025, and we view the lower milestone amounts as the more likely outcome based on the expected labeling of the product. If approved, we continue to believe annual product-level revenue in the United States has the potential to exceed US$100 million within five years after commercial launch, providing a significant uptick ...