Ipsen Biopharmaceuticals, Inc. Announces Five Poster Presentations of Dysport® (abobotulinumtoxinA) Data at the 2017 Annual Meeting of the American Academy of Neurology
Data to be Presented on the Use of Dysport® in
Multiple Therapeutic Areas
BASKING RIDGE, N.J.–(BUSINESS WIRE)–Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN;
ADR: IPSEY) (Ipsen), today announced that five abstracts regarding
Dysport® (abobotulinumtoxinA) data have been accepted for
poster presentations at the annual meeting of the American Academy of
Neurology (AAN) on April 22-28, 2017 in Boston, MA.
“We are proud to showcase this collection of data, highlighting the
use of Dysport® in multiple patient
populations, including children aged two and over with lower limb
spasticity and adults with upper limb spasticity. Two abstracts
specifically look at data about the time to retreatment with Dysport®
– an important consideration for both patients and healthcare
providers,” said David Cox, VP North American Medical, HEOR &
Regulatory Affairs, Ipsen.
Dysport® (abobotulinumtoxinA) and all botulinum toxin
products have a Boxed Warning in the US which states that the effects of
the botulinum toxin may spread from the area of injection to other areas
of the body, causing symptoms similar to those of botulism. Those
symptoms include swallowing and breathing difficulties that can be
life-threatening. Dysport® is contraindicated in patients
with known hypersensitivity to any botulinum toxin preparation or to any
of the components; or in the presence of infection at the proposed
injection site(s); or in patients known to be allergic to cow’s milk
protein. The potency Units of Dysport® are specific to the
preparation and assay method utilized. They are not interchangeable with
other preparations of botulinum toxin products. Please scroll below for
additional Important Safety Information.
The following three posters will be available for viewing during Poster
Session 3 in the Child Neurology section on Tuesday, April 25
between 8:30 am and 7:00 pm ET at the Boston Convention and Exhibition
Center.
Key Presentations in Pediatric Populations:
Dysport® (AbobotulinumtoxinA) injection in
muscles in pediatric patients with lower limb spasticity
- Poster #207
Time to retreatment after abobotulinumtoxinA (Dysport) injections in
children with dynamic equinus foot deformity
- Poster #185
Efficacy and safety of abobotulinumtoxinA (Dysport®)
in children with dynamic equinus foot deformity previously treated with
botulinum toxins
- Poster #191
The following two posters will be available for viewing during Poster
Session 4 in the Neuro-Rehabilitation: Motor Recovery and Spasticity
Treatment section on Wednesday, April 26 between 8:30 am and 7:00 pm
ET at the Boston Convention and Exhibition Center.
Key Presentations in Adult Populations:
Duration of Effect of AbobotulinumtoxinA (Dysport®)
in Adult Patients with Upper Limb Spasticity Post-Stroke or Traumatic
Brain Injury
- Poster #38
Effect of early use of AbobotulinumtoxinA (Dysport®)
after stroke on spasticity progression: first results of a pilot study
- Poster #32
INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is
indicated in the US for the treatment of:
-
Adults with upper limb spasticity, to decrease the severity of
increased muscle tone in elbow flexors, wrist flexors, and finger
flexors - Adults with cervical dystonia
- Lower limb spasticity in pediatric patients 2 years of age and older
The safety and effectiveness of Dysport® injected into upper
limb muscles or proximal muscles of the lower limb for the treatment of
spasticity in pediatric patients has not been established.
Safety and effectiveness in pediatric patients with lower limb
spasticity below 2 years of age have not been evaluated.
Safety and effectiveness in pediatric patients with cervical dystonia or
upper limb spasticity have not been established.
The safety and effectiveness of Dysport® in the treatment of
lower limb spasticity in adult patients has not been demonstrated.
IMPORTANT SAFETY INFORMATION
Warning: Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of Dysport®
and all botulinum toxin products may spread from the area
of injection to produce symptoms consistent with botulinum toxin
effects. These may include asthenia, generalized muscle weakness,
diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria,
urinary incontinence, and breathing difficulties. These symptoms have
been reported hours to weeks after injection. Swallowing and breathing
difficulties can be life threatening and there have been reports of
death. The risk of symptoms is probably greatest in children treated for
spasticity, but symptoms can also occur in adults treated for spasticity
and other conditions, particularly in those patients who have underlying
conditions that would predispose them to these symptoms. In unapproved
uses, including upper limb spasticity in children, and in approved
indications, cases of spread of effect have been reported at doses
comparable to lower than the maximum recommended total dose.
Contraindications
Dysport® is contraindicated in patients with known
hypersensitivity to any botulinum toxin preparation or to any of the
components; or in the presence of infection at the proposed injection
site(s); or in patients known to be allergic to cow’s milk protein.
Warnings and Precautions
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of Dysport® are specific to the preparation
and assay method utilized. They are not interchangeable with other
preparations of botulinum toxin products, and, therefore, units of
biological activity of Dysport® cannot be compared to or
converted into units of any other botulinum toxin products assessed with
any other specific assay method.
Dysphagia and Breathing Difficulties
Treatment with Dysport® and other botulinum toxin products
can result in swallowing or breathing difficulties. Patients with
pre-existing swallowing or breathing difficulties may be more
susceptible to these complications. In most cases, this is a consequence
of weakening of muscles in the area of injection that are involved in
breathing or swallowing. When distant side effects occur, additional
respiratory muscles may be involved (see Boxed Warning). Deaths as a
complication of severe dysphagia have been reported after treatment with
botulinum toxin. Dysphagia may persist for several weeks, and require
use of a feeding tube to maintain adequate nutrition and hydration.
Aspiration may result from severe dysphagia and is a particular risk
when treating patients in whom swallowing or respiratory function is
already compromised. Patients treated with botulinum toxin may require
immediate medical attention should they develop problems with
swallowing, speech, or respiratory disorders. These reactions can occur
within hours to weeks after injection with botulinum toxin.
Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic
lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia
gravis or Lambert-Eaton syndrome) should be monitored particularly
closely when given botulinum toxin. Patients with neuromuscular
disorders may be at increased risk of clinically significant effects
including severe dysphagia and respiratory compromise from typical doses
of Dysport®.
Human Albumin
This product contains albumin, a derivative of human blood. Based on
effective donor screening and product manufacturing processes, it
carries an extremely remote risk for transmission of viral diseases. A
theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD)
also is considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been reported for albumin.
Intradermal Immune Reaction
The possibility of an immune reaction when injected intradermally is
unknown. The safety of Dysport® for the treatment of
hyperhidrosis has not been established. Dysport® is approved
only for intramuscular injection.
Adverse Reactions
Most common adverse reactions (≥2% and greater than placebo in either
Dysport® group) in adults with upper limb spasticity
for Dysport® 500 Units, Dysport® 1000 Units, and
Placebo, respectively, were: nasopharyngitis (4%, 1%, 1%), urinary tract
infection (3%, 1%, 2%), muscular weakness (2%, 4%, 1%), musculoskeletal
pain (3%, 2%, 2%), dizziness (3%, 1%, 1%), fall (2%, 3%, 2%), and
depression (2%, 3%, 1%).
Most common adverse reactions (≥5% and greater than placebo) in
adults with cervical dystonia for Dysport® 500 Units and
Placebo, respectively, were: muscular weakness (16%, 4%), dysphagia
(15%, 4%), dry mouth (13%, 7%), injection site discomfort (13%, 8%),
fatigue (12%, 10%), headache (11%, 9%), musculoskeletal pain (7%, 3%),
dysphonia (6%, 2%), injection site pain (5%, 4%), and eye disorders (7%,
2%).
Most common adverse reactions (≥10% in any group and greater than
placebo) in pediatric patients with lower limb spasticity for
Dysport® 10 Units/kg, 15 Units/kg, 20 Units/kg, or 30
Units/kg; and Placebo, respectively, were: upper respiratory tract
infection (9%, 20%, 5%, 10%, 13%), nasopharyngitis (9%, 12%,16%, 10%,
5%), influenza (0%, 10%, 14%, 3%, 8%), pharyngitis (5%, 0%,11%, 3%, 8%),
cough (7%, 6%, 14%, 10%, 6%), and pyrexia (7%, 12%, 8%, 7%, 5%).
Drug Interactions
Co-administration of Dysport® and aminoglycosides or other
agents interfering with neuromuscular transmission (e.g., curare-like
agents), or muscle relaxants, should be observed closely because the
effect of botulinum toxin may be potentiated. Use of anticholinergic
drugs after administration of Dysport® may potentiate
systemic anticholinergic effects such as blurred vision. The effect of
administering different botulinum neurotoxins at the same time or within
several months of each other is unknown. Excessive weakness may be
exacerbated by another administration of botulinum toxin prior to the
resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle
relaxant before or after administration of Dysport®.
Use in Pregnancy
Based on animal data Dysport® may cause fetal harm. There are
no adequate and well-controlled studies in pregnant women. Dysport®
should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
Pediatric Use
Based on animal data Dysport® may cause atrophy of injected
and adjacent muscles; decreased bone growth, length, and mineral
content; delayed sexual maturation; and decreased fertility.
Geriatric Use
In general, elderly patients should be observed to evaluate their
tolerability of Dysport®, due to the greater frequency of
concomitant disease and other drug therapy.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact
Ipsen at 1-855-463-5127. You may also report SUSPECTED ADVERSE REACTIONS
to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Full Prescribing Information for Dysport®
available here
and, for more information, visit www.dysport.com.
About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global
specialty-driven pharmaceutical group. The US head office is located in
Basking Ridge, New Jersey. Ipsen Biopharmaceuticals Canada, Inc. is an
integrated business unit within North America and has its head office
located in Mississauga, Ontario. Ipsen Bioscience, Inc., the Ipsen US
research and development center focused on peptide research in oncology
and endocrinology, is located in Cambridge, Massachusetts. At Ipsen
Bioscience, we focus on creating a highly cooperative and passionate R&D
organization through partnerships, innovation, and continuous learning
to effectively deliver new treatments for patients. At Ipsen, we focus
our resources, investments, and energy on discovering, developing, and
commercializing new therapeutic options for oncologic, neurologic, and
endocrine diseases. For more information on Ipsen in North America,
please visit www.ipsenus.com
or www.ipsen.ca.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical group with total sales
close to €1.6 billion in 2016. Ipsen sells more than 20 drugs in more
than 115 countries, with a direct commercial presence in more than 30
countries. Ipsen’s ambition is to become a leader in specialty
healthcare solutions for targeted debilitating diseases. Its fields of
expertise cover oncology, neurosciences and endocrinology (adult &
pediatric). Ipsen’s commitment to oncology is exemplified through its
growing portfolio of key therapies improving the care of patients
suffering from prostate cancer, neuro-endocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a significant presence
in consumer healthcare. 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/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2016,
R&D expenditures exceeded €200 million. The Group has more than 4,900
employees worldwide. Ipsen’s shares are traded on segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150) and are 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 trades on the over-the-counter market in
the United States under the symbol IPSEY. For more information on Ipsen,
visit www.ipsen.com.
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 favorable 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
international economies and sovereign risk; dependence on the
effectiveness of the Group’s patents and other protections for
innovative products; and the exposure to litigation, including patent
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
fulfill 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
performance. The Group 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. The Group’s business is
subject to the risk factors outlined in its registration documents filed
with the French Autorité des Marchés Financiers.
Dysport® (abobotulinumtoxinA) for injection, for
intramuscular use 300- and 500-Unit vials
DYSPORT is a registered trademark of Ipsen Biopharm Limited.
© 2017 Ipsen Biopharmaceuticals, Inc.
March 2017 DYS-US-001735
Contacts
Ipsen Biopharmaceuticals, Inc. (North America)
Media:
W2O
Group
Dawn Sciortino, 646-380-3500
dsciortino@w2ogroup.com
or
Centron
PR
Katie Zied, 646-722-8807
kzied@centronpr.com
