Ipsen announced that its partner Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114), noting certain deficiencies related to chemical, manufacturing and controls (CMC) processes. Furthermore, on 28 September 2023, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision on arbitration proceedings that Galderma initiated against Ipsen. This dispute was initiated in July 2021 following a difference of opinion on the regulatory submission strategy for QM-1114 related to the potency-assay testing method used in the release of commercial batches of QM-1114 in the United States, Canada and Australia.

The result of this arbitration is that any regulatory applications for QM-1114 in the partnership territories submitted by Galderma shall be assigned to Ipsen as the owner of the intellectual property and marketing authorization of QM-1114. Galderma remains responsible for development, regulatory filing strategy, manufacturing and commercialization. As such, the Tribunal declared that Galderma has the right to decide on QM-1114?s regulatory strategy.

On 27 July 2023, Ipsen confirmed that it had notified Galderma of its decision to terminate the Parties? joint R&D collaboration entered into in July 2014 related to the parties? respective neurotoxin programs, including the development of IPN10200 (longer-acting neurotoxin).