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).
ENDS
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative
medicines in Oncology, Rare Disease and Neuroscience. With total sales of EUR3.0bn
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 (https://www.ipsen.com)
About Dysport
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.
For further information:
Contacts
Investors
Craig Marks Nicolas Bogler
Vice President, Investor Relations Senior Manager, Investor Relations
+44 (0)7584 349 193 +33 6 52 19 98 92
Media
Amy Wolf Ioana Piscociu
VP, Head of Corporate Brand Strategy Senior Manager
& Communications Global Media Relations
+41 79 576 07 23 +33 6 69 09 12 96
Ipsen's forward-looking statements
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medicine that might translate into a loss of market share. Furthermore, the
research and development process involves several stages each of which involves
the substantial risk that Ipsen may fail to achieve its objectives and be forced
to abandon its efforts with regards to a medicine in which it has invested
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obtained during preclinical trials will be confirmed subsequently during
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be no guarantees a medicine will receive the necessary regulatory approvals or
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assumptions prove inaccurate or risks or uncertainties materialize, actual
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litigation, and/or regulatory actions. Ipsen also depends on third parties to
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Ipsen's latest Universal Registration Document, available on ipsen.com
(https://www.ipsen.com).
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