Ipsen updates on QM-1114 regulatory process
PARIS, FRANCE, 3 October 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today 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).
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,300 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com
Dysport®, Ipsen’s botulinum toxin type A, is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm. It was initially developed for the treatment of movement disorders such as cervical dystonia, blepharospasm, hemifacial spasms and spasticity affecting the upper and/or lower limbs in adults and children aged 2 years or older. Dysport® has marketing authorizations in more than 90 countries worldwide. The product is currently referred to as Dysport® for medical and aesthetic markets, and as Azzalure® in aesthetic indications in the E.U.
Alluzience®, Ipsen’s botulinum toxin type A is a neuromuscular blocking toxin in liquid formulation, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at maximum frown in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.
About QM-1114 (relabotulinumtoxinA)
QM-1114, is an investigational liquid formulation botulinum toxin A (supported by READY-1 / READY-2 / READY-3 / READY-4 Phase III trials sponsored by Galderma), seeking registration for the improvement of both glabellar and lateral canthal lines in adult patients.
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