Saol sales team to promote Dysport® for select approved therapeutic indications
in U.S. hospitals
BASKING RIDGE, N.J., June 30, 2017 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen SA
(Euronext: IPN; ADR: IPSEY) (Ipsen), today announced that it has entered into an exclusive,
three-year agreement with Saol Therapeutics Inc. to promote Dysport® (abobotulinumtoxinA) for
injection for approved therapeutic indications in adult spasticity and pediatric lower
limb spasticity in the United States.
“By adding the Saol team’s extensive experience with physicians in the hospital setting to our
existing efforts, we are able to educate more U.S. healthcare professionals on Dysport®,” said
Cynthia Schwalm, President, North American Commercial Operations, Ipsen. “As the only
botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower
limbs, and also for the treatment of lower limb spasticity in children ages two and older,
it is critical to raise awareness of Dysport® as a potential option for appropriate patients.”
Dysport® 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 see below for additional Important Safety Information.
Under the terms of the agreement, Saol’s sales force will promote Dysport® to healthcare
professionals largely in the hospital setting beginning August 2017. Ipsen will maintain its current
number of sales representatives fully dedicated to Dysport® including all its therapeutic
indications. Additional details of the agreement are not disclosed.
Based in Roswell, GA, Saol Therapeutics is a privately held specialty pharmaceutical company
focused on providing therapies to patients with unmet medical needs. The company has a
strategic emphasis on spasticity and neurologic areas. Saol currently markets Lioresal®
Intrathecal (baclofen injection), the first FDA-approved intrathecal baclofen for the treatment of
severe spasticity. By detailing both products, Saol believes it can further support healthcare
professionals and the patients they serve with forms of spasticity that each product is FDA
approved to treat.
“At Saol, we are committed to the treatment of patients with spasticity. As a cornerstone to that,
we believe it is important that physicians are made aware of available treatment options,” said
Saol Therapeutics Chief Executive Officer, David Penake. “Our agreement with Ipsen helps us in that mission. It also allows us to align with a company that matches our passion for doing
everything we can to support and educate physicians. We look forward to working with Ipsen and
growing our organization, with the goal of helping patients in the United States.”
Please find included Important Safety Information – including BOX WARNINGS – for Dysport®
and Lioresal® Intrathecal (baclofen injection).
About Dysport® (abobotulinumtoxinA) for Injection
Dysport® is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified
from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder. Dysport®
has approved indications in the United States for the treatment of adults with Cervical Dystonia
(CD) and for the treatment of spasticity in adult patients. Dysport® is also the first and only FDAapproved botulinum toxin for the treatment of lower limb spasticity in pediatric patients
two years of age and older.
About IPSEN CARES®
IPSEN CARES® (Coverage, Access, Reimbursement, & Education Support) is dedicated to
ensuring patients, providers and caregivers have the resources needed to help access the
Ipsen medications that are critical to managing their conditions. IPSEN CARES® is staffed
Monday to Friday by experts who can assist with a broad range of medical, educational,
logistical and coverage information regarding Ipsen medicines. Involving the entire treatment
team that surrounds patients on a daily basis, IPSEN CARES® can provide benefits verification
(research of a patient’s medical or pharmacy benefit insurance coverage); prior authorization
information; a patient assistance program (free medications for uninsured patients); co-pay
assistance programs for eligible patients; billing and coding support; coordination with specialty
pharmacies. Additional information is also available by visiting (http://www.ipsencares.com).
INDICATIONS AND IMPORTANT SAFETY INFORMATION
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.
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.
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%).
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
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
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.
INDICATIONS AND IMPORTANT SAFETY INFORMATION
Lioresal® Intrathecal (baclofen injection)
Indications and Usage
– Lioresal® Intrathecal (baclofen injection) is a muscle relaxant and antispastic that is indicated
for use in the management of severe spasticity of cerebral or spinal origin.
-Lioresal® Intrathecal is intended for use by the intrathecal route in single bolus test doses
(via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps
approved by the FDA specifically for the administration of Lioresal® Intrathecal into the
– Lioresal® Intrathecal via an implantable pump should be reserved for patients unresponsive
to oral baclofen therapy or those who experience intolerable CNS side effects at effective
– Patients with spasticity due to traumatic brain injury should wait at least one year after the
injury before consideration of long term intrathecal baclofen therapy.
– Prior to implantation of a device for chronic intrathecal infusion of Lioresal® Intrathecal,
patients must show a response to Lioresal® Intrathecal in a screening trial. Please review
the dosing and administration section of the Lioresal® Intrathecal prescribing information for
|Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in
sequelae that include high fever, altered mental status, exaggerated rebound spasticity,
and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organsystem failure and death.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to
programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen
withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).
– Hypersensitivity to baclofen
-Lioresal® Intrathecal is not recommended for intravenous, intramuscular, subcutaneous
or epidural administration.
Select Warnings and Precautions
-It is mandatory that all patients, caregivers, and treating physicians receive adequate
information regarding the risks of the mode of treatment. Instruction should be given on
signs and symptoms of overdose, procedures to be followed in the event of an overdose,
and proper home care of the pump and insertion site.
-Due to the possibility of life-threatening CNS depression, cardiovascular collapse, and/or
respiratory failure, physicians must be adequately trained and educated in chronic
intrathecal infusion therapy.
– Patients should be infection-free prior to both a screening trial and a pump implantation.
The presence of infection may interfere with an assessment of the patient’s response to
bolus Lioresal® Intrathecal, increase the risk of surgical complications and complicate
-Reservoir refilling must be performed by fully trained and qualified personnel following
the directions provided by the pump manufacturer. Extreme caution must be used when
filling an FDA approved implantable pump, following strict aseptic technique and
ensuring refill directly into the reservoir and not the catheter access port.
-An attempt should be made to discontinue concomitant oral antispasticity medication to
avoid possible overdose or adverse drug interactions, either prior to screening or
following implant and initiation of chronic Lioresal® Intrathecal infusion.
-Following pump implantation, and for each adjustment of the dosing rate of the pump
and/or concentration of Lioresal® Intrathecal, the patient should be monitored closely
until it is certain the patient’s response to the infusion is acceptable and reasonably
– Early symptoms of baclofen withdrawal may include return of baseline spasticity,
pruritus, hypotension and paresthesias.
-Priapism may develop or recur if treatment with intrathecal baclofen is interrupted.
– Signs of overdose may appear suddenly or insidiously, and a massive overdose may
present as coma. Less sudden and/or less severe forms of overdose may present with
signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression,
seizures, rostral progression of hypotonia and loss of consciousness progressing to
– Should overdose appear likely, the patient should be taken immediately to a hospital for
assessment and emptying of pump reservoir.
– Except in overdose related emergencies, the dose of Lioresal® Intrathecal should
ordinarily be reduced slowly if the drug is discontinued for any reason.
Common Adverse Reactions
– The most frequent drug adverse events vary by indication but include: hypotonia
(34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%),
urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Dosing and
programming errors may result in clinically significant overdose or withdrawal. Acute
massive overdose may result in coma and may be life threatening.
– Drowsiness has been reported in patients on Lioresal® Intrathecal. Patients should be
cautioned regarding the operation of automobiles or other dangerous machinery and
activities made hazardous by decreased alertness. Patients should also be cautioned
that the central nervous system depressant effects of Lioresal® Intrathecal may be
additive to those of alcohol and other CNS depressants.
Serious Adverse Reactions
-Seizures have been reported during overdose and with withdrawal from Lioresal®
Intrathecal as well as in patients maintained on therapeutic doses of Lioresal®
-Fatalities have been reported with Lioresal® Intrathecal use.
- The following adverse events have been reported during post-approval use of Lioresal®
- Musculoskeletal – The onset of scoliosis or worsening of a pre-existing scoliosis
has been reported.
- Urogenital – Sexual dysfunction in men and women including decreased libido
and orgasm dysfunction have been reported.
- Musculoskeletal – The onset of scoliosis or worsening of a pre-existing scoliosis
Use in Specific Populations
-There are no adequate and well controlled studies in pregnant women. Lioresal®
Intrathecal should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
-Nursing mothers should exercise caution, as oral baclofen has been shown to pass into
milk at therapeutic doses.
-Safety and effectiveness in pediatric patients below the age of 4 have not been
-Patients suffering from psychotic disorders, schizophrenia, or confusional states should
be treated cautiously with Lioresal® Intrathecal and kept under careful surveillance.
-Lioresal® Intrathecal should be given with caution in patients with impaired renal
function. Dose reduction may be necessary.
– Lioresal® Intrathecal should be used with caution in patients with a history of autonomic
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen
injection) prescribing information, located here.
About Ipsen in North America
Ipsen Biopharmaceuticals, Inc. is the US affiliate of Ipsen, a global specialty-driven
biopharmaceutical 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 the discovery of highly differentiated and competitive products
in oncology and rare diseases, 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
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
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macroeconomic conditions based on the information available today. Use of the words
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regulatory filings and determinations. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and potential future
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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
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For further information:
Vice President, North American
Internal & External Communications
# # #
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spasticity in adults: a systematic review. Neuropsychiatric Disease and Treatment. 2014; 10
2. Sköld A, et al. Spasticity after traumatic spinal cord injury: nature, severity, and location.
Archives of Physical Medicine and Rehabilitation. 1999; 80 (1548-57)
3. National Institute of Neurological Disorders and Stroke. Spasticity Information Page.
May 16, 2017.
4. Gray H. Anatomy of the Human Body. “The Muscles and Fasciæ of the Leg.”
http://www.bartleby.com/107/129.html. Accessed June 23, 2016.
5. Delgado M, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: A
randomized clinical trial. Pediatrics. 2016;137(2).
Dysport® (abobotulinumtoxinA) for injection, for intramuscular use 300- and 500-Unit vials.
DYSPORT is a registered trademark of Ipsen Biopharm Limited.
IPSEN CARES is a registered trademark of Ipsen S.A.
Lioresal® is a registered trademark of Saol International Limited Corporation.
© 2017 Ipsen Biopharmaceuticals, Inc.
June 2017 DYS-US-001875