- Treatment with Dysport® at the doses of
10U/kg/leg and 15U/kg/leg statistically significantly improved muscle
tone (primary endpoint) in hemiplegic and diplegic cerebral palsy
children with lower limb spasticity
- Treatment with Dysport® at the dose of
1500U statistically significantly improved muscle tone (primary
endpoint) in adult patients with lower limb spasticity
- Safety profile consistent with known safety profile of Dysport®
in these indications
Company Website:
http://www.ipsen.com
PARIS -- (Business Wire)
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced topline results for
two double-blind phase III studies of Dysport®
(abobotulinumtoxinA) in Pediatric Lower Limb (PLL) spasticity in
children with cerebral palsy and in Adult Lower Limb (ALL) spasticity in
patients who had experienced a stroke or traumatic brain injury.
In the PLL phase III study, conducted in children with hemiparetic or
diplegic cerebral palsy, treatment with Dysport® showed a
statistically significant response versus placebo in the improvement of
muscle tone, as measured by the Modified Ashworth Scale (MAS; primary
endpoint), and a statistically significant overall benefit versus
placebo, as measured by the Physician Global Assessment (PGA; first
secondary endpoint).
In the ALL phase III study, conducted in hemiparetic patients who had
experienced a stroke or traumatic brain injury, treatment with Dysport®
at the dose of 1500U showed a statistically significant response versus
placebo in the improvement of muscle tone, as measured by the Modified
Ashworth Scale (MAS; primary endpoint). An overall benefit (measured by
the Physician Global Assessment (PGA); first secondary endpoint) versus
placebo was observed but did not reach statistical significance
according to the pre-specified statistical analysis.
Other spasticity and functional outcome results are currently being
analyzed. The safety profile observed in the studies was consistent with
the known safety profile of Dysport® in these indications.
Comprehensive results from these double-blind studies will be disclosed
in the next few months at major international congresses. Ipsen will
share these results with key regulatory agencies this year.
Claude Bertrand, Executive Vice-President Research & Development and
Chief Scientific Officer of Ipsen commented: “We believe these
results should meet the expectations of physicians by potentially
providing a new alternative for treating adults and children suffering
from lower limb spasticity. This unique data is a testimony to Ipsen’s
growing scientific leadership in the field of toxins. We are grateful to
the clinicians, caregivers, patients and their families who were
involved in this study.”
Pr. Mauricio Delgado, Principal Investigator of the PLL study stated:
“This is the largest pediatric double-blind placebo controlled study
demonstrating that Dysport® is an effective and
safe treatment for spasticity in children with Cerebral Palsy. Unlike
previous studies, this study was designed to demonstrate efficacy
through a variety of outcome measures that are of direct relevance to
the patient and their family. The study brought together an
international and multidisciplinary group of investigators including
pediatric neurologists, physiatrists, orthopedic surgeons and physical
therapists who got the benefit of using standardized clinical
assessments having a positive impact on their clinical practice.”
Pr. Jean Michel Gracies, Principal Investigator of the ALL study stated:
“This global double-blind phase III study provides evidence that
Dysport® demonstrates high benefit in adults
with stroke or traumatic brain injury causing lower limb spasticity.
This study also reveals that it was possible to achieve highly
productive collaboration with a very large number of investigators from
several countries and health systems. In addition, it must be stressed
that this study involved multidisciplinary teams including physical and
occupational therapists, particularly involved in patient assessment.
These important results reinforce the positioning of Dysport® as
an excellent treatment for patients with spastic paresis.”
About the studies
The Phase III study conducted in children with cerebral palsy included
235 patients and was multicentric, prospective, double blind,
randomized, and placebo-controlled. It was conducted in the USA, France,
Turkey, Poland, Mexico and Chile. The purpose of this study in children
was to assess the efficacy and safety of Dysport® compared to
placebo in improving lower limb spasticity in hemiparetic or diplegic
cerebral palsy patients.
The phase III study in adults suffering from lower limb spasticity
included 388 patients and was international, multicentric, prospective,
double blind, randomized and placebo-controlled. It was conducted in the
USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia
and Hungary. The purpose of this study was to assess the efficacy and
safety of Dysport® compared to placebo in improving lower
limb spasticity in hemiparetic adult patients who had experienced a
stroke or a traumatic brain injury.
The primary endpoint for both studies was the improvement of muscle tone
in the treated lower limb measured by the Modified Ashworth Scale (MAS).
Patients were offered to continue in an open label long-term study
wherein they will be receiving additional Dysport® treatment
cycles within a total of 15 months.
About the Modified Ashworth Scale (MAS)
The MAS is the reference clinical scale to assess muscle tone in
clinical trials in patients with spasticity. It allows categorizing the
severity of spasticity by evaluating resistance to passive movement. It
ranges from 0 (=no increase in tone) to 4 (=affected limb rigid in
flexion or extension).
About the Physician Global Assessment (PGA)
The PGA is an outcome measure used to assess the overall clinical
benefit for the patient. It is a 9-point scale that ranges from -4
(markedly worse) to +4 (markedly better).
About Dysport®
Dysport® is an injectable form of botulinum toxin type A
(BTX-A), which is isolated and purified from Clostridium BTX-A bacteria.
It is supplied as a lyophilized powder.
Dysport® was first registered for the treatment of
blepharospasm and hemifacial spasm in the United Kingdom in 1990, and is
licensed in 82 countries for various indications including:
blepharospasm, adult upper and lower limb spasticity, hemifacial spasm,
spasmodic torticollis (ST) (previously referred to as cervical
dystonia), pediatric lower limb spasticity due to cerebral palsy (CP),
axillary hyperhidrosis, and glabellar lines.
Dysport® is approved for the treatment of upper limb
spasticity and pediatric lower limb spasticity in many international
markets, but not in the United States (US). Dysport® is also
approved for the treatment of adult lower limb spasticity in some
European countries, but not in the United States (US). Dysport®’s
only approved therapeutic indication in the United States (US) is for
the treatment of adults with cervical dystonia (referred to spasmodic
torticollis in other markets). As such, data from studies in adults and
children with lower limb spasticity are of an investigational use of
Dysport® in the USA.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.2 billion in 2013. 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 uro-oncology. 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. In
2013, R&D expenditure totaled close to €260 million, representing more
than 21% of Group sales. Moreover, Ipsen also has a significant presence
in primary care. The Group has close to 4,600 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
products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approval; the
Group's ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
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effectiveness of the Group’s patents and other protections for
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contained in this press release to reflect any change in events,
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with the French Autorité des Marchés Financiers.
Contacts:
For further information:
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
Investor Relations
Director
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
E-mail:
stephane.durant.des.aulnois@ipsen.com
or
Thomas
Peny-Coblentz, CFA
Investor Relations Deputy Director
Tel.:
+33 (0)1 58 33 56 36
Fax: +33 (0)1 58 33 50 63
E-mail:thomas.peny-coblentz@ipsen.com
Source: Ipsen
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