BASKING RIDGE, N.J., February 9, 2017 – Ipsen Biopharmaceuticals, Inc., an affiliate of
Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that three poster presentations
about Dysport®(abobotulinumtoxinA) will be presented at the annual meeting of the Association
of Academic Physiatrists (AAP) being held in Las Vegas, NV, February 7-11, 2017.
“We are excited to participate in this meeting and to share data regarding abobotulinumtoxinA,”
said David Cox, VP NA Medical & Regulatory Affairs, Ipsen. “Physiatrists play an important role
in patients’ overall management plans, and we are looking forward to working together to
support the care of children struggling with lower limb spasticity.”
Dysport®(abobotulinumtoxinA) and all botulinum toxin products have a Boxed Warning 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 resence 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 see below for additional Important Safety Information.
The following posters are available for viewing at the Poster Gallery Reception on Friday,
February 10, 2017 between 4:30 PM – 6:00 PM (PST) in the Oceanside Ballroom on Level 2 of
the Mandalay Bay South Convention Center:
- Dysport®(AbobotulinumtoxinA) injection in muscles in pediatric patients with lower limb
spasticity- Poster #803
- Efficacy of repeat abobotulinumtoxinA (Dysport®) injections in improving gait in children
with dynamic equinus foot due to cerebral palsy- Poster #804
- Efficacy and safety of abobotulinumtoxinA in children with dynamic equinus foot
deformity previously treated with botulinum toxins- Poster #901
INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is indicated 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 exceeding €1.4 billion in
2015. 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 neuro-endocrine tumors, prostate cancer, bladder cancer and renal cancer. 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/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditures
neared €193 million. The Group has more than 4,600 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 dotm8q9wub2y8.cloudfront.net.
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 forwardlooking 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.
Media:
Priya Sharma-Joshi
Senior Communications Manager
Tel: 908-275-6508
E-mail: priya.sharma-joshi@ipsen.com
Katie Zied
Centron PR
Tel: 646-722-8807
E-mail: kzied@centronpr.com
Dysport is a registered trademark of Ipsen Biopharm Ltd.
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© 2017 Ipsen Biopharmaceuticals, Inc.
February 2017 DYS-US-001559
