BASKING RIDGE, N.J., September 14, 2017 – Ipsen Biopharmaceuticals, Inc., an affiliate of
Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that five abstracts regarding
abobotulinumtoxinA data have been accepted for three oral presentations and two poster
presentations at the annual meeting of the American Academy of Cerebral Palsy and
Developmental Medicine (AACPDM) on September 13-16, 2017 in Montreal, Canada.
“The data being presented at AACPDM bring to life the efficacy and safety, as well as the
potential benefit that abobotulinumtoxinA may bring to children aged 2 and older with lower limb
spasticity,” said David Cox, VP North American Medical, HEOR & Regulatory Affairs, Ipsen.
“A recent retrospective study of a managed Medicaid database analyzed the epidemiology,
treatment patterns, resource utilization and associated costs of children with Cerebral Palsy. As
the only botulinum toxin manufacturer in the U.S. with an approval for pediatric patients (aged 2
and older) with lower limb spasticity, we are excited to contribute to data that helps the medical
community better understand the role of abobotulinumtoxinA in helping these patients.”
Dysport®is currently the only FDA-approved botulinum toxin for the treatment of lower limb
spasticity in children ages two and older.
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 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.
Oral Presentations: September 15, 2017
10:35-10:42 AM
Safety Profile of AbobotulinumtoxinA for Lower Limb Spasticity in
Preschool Aged Children (2-5 Years) Compared With Older Children:
Pooled Analysis of Controlled Clinical Trials
10:51-10:58 AM
Efficacy and Safety of AbobotulinumtoxinA in Children with
Dynamic Equinus Foot Deformity Previously Treated with Botulinum
Toxins
11:39-11:46 AM
Time To Retreatment After Abobotulinumtoxina Injections In
Children With Dynamic Equinus Foot Deformity
Poster Presentations: September 14, 2017
6:00-7:00 PM
AbobotulinumtoxinA Injection in Muscles Outside the
Gastrocnemius-Soleus Complex in Pediatric Patients With Lower
Limb Spasticity.
6:00-7:00 PM
Development of a pediatric upper limb spasticity home exercise
program for use in a Phase III study of abobotulinumtoxinA
INDICATIONS
Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:
- Spasticity in adult patients
- 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.
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. Hypersensitivity reactions including anaphylaxis have been reported.
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 and Transmission of Viral Diseases
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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for
transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of
transmission would also be considered extremely remote. No cases of transmission of viral
diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in
other licensed products.
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 either Dysport® group) in
adults with lower limb spasticity for Dysport® 1000 Units, Dysport® 1500 Units, and Placebo,
respectively, were: falls (9%, 6%, 3%), muscular weakness (2%,7%, 3%), pain in extremity(6%,
6%, 2%). Muscular weakness was reported more frequently in women (10%) treated with 1500
units of Dysport compared to men (5%).
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. Subjects aged 65 years
and over who were treated with DYSPORT® for lower limb spasticity reported a greater
percentage of fall and asthenia as compared to those younger (10% versus 6% and 4% versus
2%, respectively).
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 Dysport® Full Prescribing Information including Boxed Warning and Medication
Guide.
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 biopharmaceutical group focused on innovation and specialty
care. The group develops and commercializes innovative medicines in three key therapeutic
areas – Oncology, Neurosciences and Rare Diseases. Its commitment to oncology is
exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine
tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales close to €1.6 billion in 2016, Ipsen sells more
than 20 drugs in over 115 countries, with a direct commercial presence in more than 30
countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms
located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France;
Oxford, UK; Cambridge, US). The Group has about 5,100 employees worldwide. Ipsen is listed
in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American
Depositary Receipt program (ADR: 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.
For further information:
Marisol Peron
Vice President, North American
Internal & External Communications
Tel: 908-275-6330
E-mail: marisol.peron@ipsen.com
Katie Zied
CentronPR
Tel: 646-722-8807
E-mail: kzied@centronpr.com
Dysport®(abobotulinumtoxinA) for injection, for intramuscular use 300- and 500-Unit vials
DYSPORT is a registered trademark of Ipsen Biopharm Limited.
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© 2017 Ipsen Biopharmaceuticals, Inc.
September 2017 DYS-US-002202
