Global regulatory submissions had been filed resulting in the US
approval of Dysport® in the treatment of Adult
patients with ULS and submission of variations in EU and Rest of the
World countries
Company Website:
http://www.ipsen.com
PARIS -- (Business Wire)
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that The Lancet
Neurology has published online at http://www.thelancet.com/neurology
the detailed results from the Ipsen sponsored phase III randomized study
(NCT01313299) showing the efficacy and safety of Dysport® in
post-stroke or traumatic brain injury patients with upper limb
spasticity. This international phase III registration study led to the
approval of Dysport® for the treatment of ULS in the US by
the FDA on July 16, 2015. In Europe, the upper limb spasticity elements
of the Dysport® SmPC have already been modified in some
countries to include key medical data. Regulatory procedures are still
ongoing in different European and Rest of World countries.
This new study met the primary endpoint (Modified Ashworth Scale, MAS)
and the first secondary endpoint of Physician Global Assessment (PGA) in
patients injected in different upper limb muscle groups (fingers, wrist,
elbow or/and shoulder) according to patient disease presentation as
Dysport® shows muscle tone reduction and clinical benefit. In addition,
efficacy on active movements, spasticity, passive function and ease of
applying splints was demonstrated in a statistically and clinically
significant manner as compared to placebo. Efficacy was observed as
early as one week post-injection and lasted up to 20 weeks in some
patients.
Claude Bertrand, Executive Vice President R&D and Chief Scientific
Officer, Ipsen stated: “The publication of these data in The
Lancet Neurology illustrates the high quality of our study and Ipsen’s
commitment to continue to improve the treatment of patients with
spasticity helping them gain autonomy. It confirms the therapeutic value
of Dysport® in this debilitating condition.”
Professor Jean-Michel Gracies, Neurorehabilitation, Neurology &
Neurophysiology,Chairman of the Department of Physical Medicine
& Rehabilitation, Groupe Hospitalier Albert CHENEVIER - Henri MONDOR
(Créteil, France)stated: “The publication of this study
is great news for the field of neurorehabilitation and botulinum toxin
use. This is the first study that demonstrates substantial improvements
in active range of motion against the injected muscles in the paretic
upper limb, together with expected improvements in tone, spasticity per
se, and both patient-rated and physician-rated clinical improvement
after one injection only. In itself, this study both confirms the
therapeutic value of abobotulinum toxin and shows the practicality and
value of new assessment methods that should be used as primary outcome
in future studies on the product.”
About the Double Blind Phase 3 Study conducted in Adult Upper Limb
spasticity with Dysport®
The Phase III study (NCT01313299) was multi-center, prospective, double
blind, randomized, and placebo-controlled. It was conducted in the U.S.,
France, Italy, Belgium, the Czech Republic, Poland, Slovakia, Russia and
Hungary.
A total of 243 patients from 34 centers were randomized to treatment
with Dysport® 500U (n=80), Dysport® 1000U (n=79)
or placebo (n=79). The purpose of this study was to assess the efficacy
of Dysport® compared to placebo in improving Upper Limb
Spasticity in hemiparetic patients following a stroke or brain trauma.
The new study results published in The Lancet Neurology showed
improvements on muscle tone (MAS) with mean change in MAS score from
baseline at week 4 in the Primary Targeted Muscle Group was –0.3 (SD
0.6) in the placebo group, –1.2 (1.0) in the Dysport® 500 U
group (p<0.0001 vs placebo), and –1.4 (1.1) in the Dysport®
1000 U group (p<0.0001 vs placebo). On the Physician Global Assessment
score, the mean change from baseline at week 4 was 0.6 (SD 1.0) in the
placebo group, 1.4 (1.1) in the Dysport® 500 U group
(p=0.0003 vs placebo), and 1.8 (1.1) in the Dysport® 1000 U
group (p<0.0001 vs placebo). The efficacy of Dysport® was
observed as early as week 1 and persisted up to 20 weeks in some
patients.
The mean change from baseline at week 4 in Disability Assessment Scale
(DAS) (passive function) for the principal target of treatment was –0.5
(0.7) in the placebo group (n=79), –0.7 (0.8) in the Dysport®
500 U group (p=0.2560 vs placebo), and –0.7 (0.7) in the Dysport®
1000 U group (p=0.0772 vs placebo). Significantly more patients
receiving Dysport® 1000 U achieved reductions of 1 point or
greater in the DAS for the principal target of treatment at weeks 4 and
12 than in the placebo group. These benefits persisted at week 12
(p=0.0002). In addition, this is the first large study of botulinum
toxin A with a stepwise evaluation of spastic paresis, including active
movements opposing targeted antagonists and spasticity measured by the
Tardieu Scale. Tardieu Scale angles of catch (XV3) improved in finger,
wrist and elbow flexors at week 4; the other Tardieu parameters (range
of passive slow movement (XV1), spasticity angle (X) and spasticity
grade (Y)) improved in some but not all cases at week 4. Active range of
motion improved for movements opposing finger, wrist, and elbow flexors
in the Dysport® 1000 U group and in finger flexors in the 500 U group.
All those improvements in spasticity and function were accompanied by an
improvement in the ease of applying splints by the patient after 4 weeks
in the Dysport® groups compared with the placebo group.
Dysport® was well tolerated at the two doses tested. After
the completion of this double blind study, patients were offered the
option to continue in an open label long-term study where they would
receive additional treatment with Dysport® for a total of 15
months.
About Ipsen
Ipsen is a global specialty-driven biotechnological group with total
sales exceeding €1.2 billion in 2014. Ipsen sells more than 20 drugs in
more than 115 countries, with a direct commercial presence in 30
countries. Ipsen’s ambition is to become a leader in specialty
healthcare solutions for targeted debilitating diseases. Its development
strategy is supported by 3 franchises: neurology, endocrinology and
urology-oncology. Ipsen’s commitment to oncology is exemplified through
its growing portfolio of key therapies improving the care of patients
suffering from prostate cancer, bladder cancer or neuroendocrine tumors.
Ipsen also has a significant presence in primary care. Moreover, the
Group has an active policy of partnerships. Ipsen's R&D is focused on
its innovative and differentiated technological platforms, peptides and
toxins, located in the heart of the leading biotechnological and life
sciences hubs (Les Ulis, France; Slough/Oxford, UK; Cambridge, US). In
2014, R&D expenditure totaled close to €187 million, representing about
15% of Group sales. The Group has more than 4,500 employees worldwide.
Ipsen’s shares are traded on segment A of Euronext Paris (stock code:
IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement
Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has
implemented a Sponsored Level I American Depositary Receipt (ADR)
program, which trade on the over-the-counter market in the United States
under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Ipsen Forward Looking Statements
The forward-looking statements, objectives and targets contained herein
are based on the Group’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 the Group’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 the Group’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
the Group. 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
product 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. The Group must face or might face
competition from generic products 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 the
Group may fail to achieve its objectives and be forced to abandon its
efforts with regards to a product in which it has invested significant
sums. Therefore, the Group cannot be certain that favourable results
obtained during pre-clinical 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 product
concerned. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product 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 health care legislation; global
trends toward health care cost containment; technological advances, new
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Group's ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
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litigation, and/or regulatory actions. The Group also depends on third
parties to develop and market some of its products which could
potentially generate substantial royalties; these partners could behave
in such ways which could cause damage to the Group’s activities and
financial results. The Group 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 the Group’s partners could
generate lower revenues than expected. Such situations could have a
negative impact on the Group’s business, financial position or
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subject to the risk factors outlined in its registration documents filed
with the French Autorité des Marchés Financiers.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150830005014/en/
Contacts:
Ipsen
Media
Didier Véron
Senior
Vice-Président, Public Affairs and Communication
Tel.: +33 (0)1 58
33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Brigitte
Le Guennec
Corporate External Communication Manager
Tel.: +33
(0)1 58 33 51 17
Fax: +33 (0)1 58 33 50 58
E-mail : brigitte.le.guennec@ipsen.com
or
Financial
Community
Stéphane Durant des Aulnois
Vice President,
Investor Relations
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58
33 50 63
E-mail: stephane.durant.des.aulnois@ipsen.com
Source: Ipsen
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