Ipsen updates on QM-1114 regulatory process
03 Octobre 2023 - 6:00PM
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 €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
About DysportDysport®, 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 MarksVice President, Investor Relations+44
(0)7584 349 193 |
Nicolas BoglerSenior Manager, Investor
Relations+33 6 52 19 98 92 |
Media |
|
Amy
WolfVP, Head of Corporate Brand Strategy &
Communications+41 79 576 07 23 |
Ioana PiscociuSenior
ManagerGlobal Media Relations+33 6 69 09 12 96 |
Ipsen’s
forward-looking
statementsThe forward-looking
statements, objectives and targets contained herein are based on
Ipsen’s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that
may cause actual results, performance or events to differ
materially from those anticipated herein. All of the above risks
could affect Ipsen’s future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic
conditions based on the information available today. Use of the
words ‘believes’, ‘anticipates’ and ‘expects’ and similar
expressions are intended to identify forward-looking statements,
including Ipsen’s expectations regarding future events, including
regulatory filings and determinations. Moreover, the targets
described in this document were prepared without taking into
account external-growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by Ipsen.
These targets depend on conditions or facts likely to happen in the
future, and not exclusively on historical data. Actual results may
depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
medicine in early development phase or clinical trial may end up
never being launched on the market or reaching its commercial
targets, notably for regulatory or competition reasons. Ipsen must
face or might face competition from generic 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 significant sums. Therefore,
Ipsen cannot be certain that favorable results obtained during
preclinical trials will be confirmed subsequently during clinical
trials, or that the results of clinical trials will be sufficient
to demonstrate the safe and effective nature of the medicine
concerned. There can be no guarantees a medicine will receive the
necessary regulatory approvals or that the medicine will prove to
be commercially successful. If underlying assumptions prove
inaccurate or risks or uncertainties materialize, actual results
may differ materially from those set forth in the forward-looking
statements. Other risks and uncertainties include but are not
limited to, general industry conditions and competition; general
economic factors, including interest rate and currency exchange
rate fluctuations; the impact of pharmaceutical industry regulation
and healthcare legislation; global trends toward healthcare cost
containment; technological advances, new medicine and patents
attained by competitors; challenges inherent in new-medicine
development, including obtaining regulatory approval; Ipsen's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of Ipsen’s patents and other protections for
innovative medicines; and the exposure to litigation, including
patent litigation, and/or regulatory actions. Ipsen also depends on
third parties to develop and market some of its medicines which
could potentially generate substantial royalties; these partners
could behave in such ways which could cause damage to Ipsen’s
activities and financial results. Ipsen cannot be certain that its
partners will fulfil their obligations. It might be unable to
obtain any benefit from those agreements. A default by any of
Ipsen’s partners could generate lower revenues than expected. Such
situations could have a negative impact on Ipsen’s business,
financial position or performance. Ipsen expressly disclaims any
obligation or undertaking to update or revise any forward-looking
statements, targets or estimates contained in this press release to
reflect any change in events, conditions, assumptions or
circumstances on which any such statements are based, unless so
required by applicable law. Ipsen’s business is subject to the risk
factors outlined in its registration documents filed with the
French Autorité des Marchés Financiers. The risks and
uncertainties set out are not exhaustive and the reader is advised
to refer to Ipsen’s latest Universal Registration Document,
available on ipsen.com.
- Ipsen PR_QM-1114_03102023
Ipsen (EU:IPN)
Graphique Historique de l'Action
De Juin 2024 à Juil 2024
Ipsen (EU:IPN)
Graphique Historique de l'Action
De Juil 2023 à Juil 2024