The Presentations Span Multiple Disease Areas Including Adult and Pediatric Lower Limb Spasticity, Adult Upper Limb Spasticity, and Adult Cervical Dystonia
BASKING RIDGE, N.J., October 19, 2016 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that seventeen abstracts were chosen for poster presentations during the annual meeting of the American Academy of Physical Medicine & Rehabilitation (AAPM&R) being held in New Orleans, LA, October 20 – 23, 2016.
“The poster presentations at this year’s AAPM&R Annual Assembly Meeting
demonstrate our continued commitment in the fields of spasticity and neuroscience,”
said Cynthia Schwalm, EVP, North America Commercial Operations, Ipsen.
“We are particularly excited that these data will be shared with the
physical medicine and rehabilitation community.”
The following posters are available for viewing on October 21 and October 22 between
8:00 AM – 5:00 PM (CDT) at the Ernest N. Morial Convention Center, Exhibit Hall B, Level 1.
Key Presentations in Pediatric Populations:
- Safety and Tolerability of abobotulinumtoxinA (Dysport) In Children (2-17 Years) With Lower Limb Spasticity Due to Cerebral Palsy: A Pooled Analysis of 8 Clinical Trials
- Abstract #485
- A Review of the Health-Related Quality of Life in Pediatric Patients with Cerebral Palsy and Associated Spasticity
- Abstract #478
- Economic Burden of Pediatric Spasticity in Cerebral Palsy: A Review of the Literature
- Abstract #479
- Key Presentations in Adult Populations:
Improvement of Spasticity, Active Movements and Active Function After Repeated Injections of abobotulinumtoxinA (Dysport) in Adults with Spastic Paresis in The Upper Limb: Results of A Phase III Open-Label Extension Study
- Abstract #308
- Improvement of Spasticity Following abobotulinumtoxinA (Dysport®)
Injections in Shoulder Muscles in Hemiparetic Patients with Upper Limb
Spasticity – Sub-Analysis of a Prospective,
Long-Term, Open-Label Study with Single and Repeated Injection Cycles
- Abstract #292
- Efficacy and Safety of Repeated abobotulinumtoxinA Injections in Adults
with Lower Limb Spasticity
- Abstract #288
- Budget Impact Analysis of Botulinum Toxin a Therapy for Adult Upper Limb Spasticity in The United States
- Abstract #496
- Efficacy and Safety of A 2 mL Dilution of abobotulinumtoxinA Compared with Placebo in Adult Patients with Cervical Dystonia
- Abstract #290
- Is There a Correlation Between Tremor and Other Symptoms of Cervical
Dystonia? An Analysis of Data from The Ongoing INTEREST IN CD2 Study
- Abstract #187
- abobotulinumtoxinA Injection Patterns in Patients with Cervical Dystonia
from The ANCHOR-CD Registry Study
- Abstract #296
- Spasticity Diagnosis Rates in Post-Stroke Adult Patients Among Commercially and Medicare Insured Populations
- Abstract #208
- Treatment Characteristics of Post-Stroke Adults Diagnosed with Spasticity Among Commercially
and Medicare Insured Populations
- Abstract #205
- Geographic Differences in the Characteristics of Cervical Dystonia Patients
- Abstract # 498
- Baseline Characteristics of Cervical Dystonia Subjects in Observational Routine-Practice Studies Are Different to Those from Randomized Controlled Trials
- Abstract #182
- Relationship Between abobotulinumtoxinA Injections into Shoulder Muscles and PatientCentered Primary Goal Selection and Achievement: Sub-Analyses from the Upper Limb International Spasticity (ULIS)-II Study
- Abstract #313
- Systematic Literature Review of abobotulinumtoxinA in Randomized, Controlled Clinical Trials for Adult Lower Limb Spasticity
- Abstract #203
- Integrated Upper Limb Spasticity Management Including Botulinum Toxin A on Patient-Centered Goal Attainment: Methodology for ULIS-III and Initial
- Abstract #373-C
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 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.
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 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.
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
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
Please see Full Prescribing Information for Dysport® available here and, for more information, visit
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 prostate cancer, bladder cancer and 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/Paris-Saclay, France; Slough/Oxford, UK; Cambridge, US). In 2015, R&D expenditure totaled close to €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 eligible to the “Service de Règlement Différé”(“SRD”). The Group is partof 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.
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 Vice-President, Public Affairs and Communication
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
Brigitte Le Guennec
Corporate External Communication Manager
Tel.: +33 (0)1 58 33 51 17
Fax: +33 (0)1 58 33 50 58
Vice President – Investor Relations
Tel.: +44 () 1753 627721
Côme de la Tour du Pin
Investor Relations Executive
Tel.: +33 (0)1 58 33 53 31
Dysport® is a registered trademark of Ipsen Biopharm Ltd.
© 2016 Ipsen Biopharmaceuticals, Inc.
October 2016 DYS-US-001270
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