BASKING RIDGE, N.J., October 26, 2016 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen
(Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that three abstracts were chosen for
poster presentations during the annual meeting of the Child Neurology Society (CNS) being held in
Vancouver, BC, October 26 – 29, 2016.
“Following the recent FDA approval of Dysport®
for the treatment of lower limb spasticity in children two years of age and older, we are
proud to present related data at this year’s Child Neurology Society Annual Meeting,” said Cynthia Schwalm, EVP, North America Commercial Operations, Ipsen. “Our understanding of the needs of children with cerebral palsy keeps us at the leading edge of therapy development, with a
single-minded focus on supporting the CP community with the highest standards of care possible,
now and in the future.”
The following posters are available for viewing on October 27 between 12:30 PM – 2:00 PM (PDT)
and 4:30 PM – 6:00 PM (PDT) and on October 28 between 7:00 AM and 8:15 AM (PDT) at the
Vancouver Convention Center.
Data Presentations in Pediatric Populations:
- Safety of abobotulinumtoxinA (Dysport) in Children Aged 2-17 Years Old with
Lower Limb Spasticity Due to Cerebral Palsy: Data from Clinical Trials and Pharmacovigilance Reporting
- Poster #131
- Efficacy and safety of abobotulinumtoxinA (Dysport®) in children with
dynamic equinus foot deformity previously treated with botulinum toxins
- Poster #126
- A Review of the Health-Related Quality of Life in Pediatric Patients
with Cerebral Palsy and Associated Spasticity
- Poster #132
Indications and Important Safety Information
Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:
- Adults with upper limb spasticity, to decrease the severity of increased muscle tone
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.
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 (e.g., 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®.
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
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.
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%).
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.
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.
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-FDA1088 or www.fda.gov/medwatch.
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.
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 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.
For further information:
Vice President, North America, Communications
Senior Communications Manager
Dysport®is a registered trademark of Ipsen Biopharm Ltd.
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© 2016 Ipsen Biopharmaceuticals, Inc.
October 2016 DYS-US-001283