Medexus Pharmaceuticals, recognized as a prominent specialty pharmaceutical company with a robust North American presence and an expanding range of unique treatments for rare disorders, recently declared that it has reached a fourth amendment to its exclusive licensing agreement from February 2021 with medac. This agreement pertains to the marketing of treosulfan in the United States.
Under the revised regulatory milestone arrangement, payments will be made in the following installments:
– One-sixth of the complete amount by June 30, 2025;
– One-third of the complete sum by October 1, 2025;
– The remaining half by January 1, 2026.
For the minimum regulatory milestone total, this schedule will lead to payments of US$ 2.5 million, US$ 5 million, and US$ 7.5 million.
Medexus is allowed, if necessary, to delay a segment of the first installment (any portion exceeding US$ 3.25 million) for up to 90 days, the second installment for 120 days, and the final installment for 30 days, with any deferred sums accruing interest at a rate of 9.0% per year.
“We are delighted to have clarified the remaining contractual targets in our agreement and reached terms that rightly uphold this product’s value,” stated Ken d’Entremont, CEO of Medexus. “We continue to be hopeful for a US FDA approval by no later than January 30, 2025. We anticipate that the lower threshold milestone levels are more probable based on the projected product labeling. If granted, we maintain confidence that the annual revenue from this product in the United States might surpass US$ 100 million within five years post-launch, greatly enhancing our growth prospects.”
“Finalizing the beneficial payment terms of this amendment further boosts our financial standing,” added Brendon Buschman, Medexus’s CFO. “This framework enables us to direct existing funds towards the launch of treosulfan in the U.S., providing the option to defer 83% of the entire milestone figure until the end of January 2026. This approach allows funding flexibility through cash reserves, operational earnings, additional financing, or any option best suited to our strategic goals at the time.”
This fourth revision also updates the target date for US FDA endorsement to align with the present stage of the US FDA review process. Additionally, linked to this fourth change, Medexus agreed to cease a prior concession made by medac regarding Rasuvo’s supply cost and, should Medexus enact the proposed temporary deferral, to a slight upswing in the per-unit pricing of that product.