PARIS--(BUSINESS WIRE)--Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its US affiliate 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, Executive Vice-President and President, North American Commercial Operations, Ipsen. “As the only botulinum toxin approved by the FDA for the treatment of spasticity in adult 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 FDA-approved 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 for the United States
DYSPORT® 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.
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 intrathecal space.
- 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 doses.
- 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 further details.
Contraindications
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 organ-system 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 dosing.
- 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 stable.
- 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 coma.
- 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.
Adverse Reactions
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® Intrathecal.
- Fatalities have been reported with Lioresal® Intrathecal use.
Postmarketing Experience
-
The following adverse events have been reported during post-approval
use of Lioresal® Intrathecal.
- 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.
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 established.
- 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 dysreflexia.
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 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 www.ipsen.com.
Forward Looking Statement
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 fulfil 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.
The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2016 Registration Document available on its website (www.ipsen.com).
References
1. Martin A, et al. Epidemiological, humanistic, and economic burden of
illness of lower limb spasticity in adults: a systematic review. Neuropsychiatric
Disease and Treatment. 2014; 10 (111-122)
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. https://www.ninds.nih.gov/Disorders/All-Disorders/Spasticity-Information-Page
Accessed 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).
