Medexus Pharmaceuticals announced that the company recently entered into a third amendment to its February 2021 exclusive license agreement with medac GmbH relating to commercialization of treosulfan in the United States. Among other things, the third amendment extends the agreed outside date for FDA approval to reflect the current status of the FDA regulatory review process, and provides that, if and when the FDA accepts medac's resubmission of its New Drug Application for treosulfan, the parties will then negotiate in good faith any adjustments to the value of unpaid regulatory and sales-based milestone payments as may be appropriate in the then-prevailing circumstances. Medexus continues to expect that it will take medac a period extending into first half calendar year 2024 to collect and submit the information requested by the FDA and obtain FDA acceptance of medac's treosulfan NDA resubmission.

The parties will then have a specified negotiation period to agree to a further amendment with respect to any adjustments to the milestone payments. Medexus will have no obligation to make any milestone payments before the effective date of the further amendment (if any).