Program Provides Coverage, Access, Reimbursement, & Education Support Regarding Ipsen Medicines to Patients and their Healthcare Providers
BASKING RIDGE, N.J. November 24, 2014 – Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced the implementation of IPSEN CARESTM (Coverage, Access, Reimbursement, & Education Support). 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, including Increlex® (mecasermin), Somatuline® Depot® (lanreotide), and Dysport® (abobotulinumtoxinA).
"At Ipsen, improving the lives of patients is what drives us each and every day," said Cynthia Schwalm, President and CEO, Ipsen N.A. "We are committed to providing information and support to our patients to help them access, receive and properly use our medications.
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; billing and coding support; coordination with specialty pharmacies; injection training and adherence calls. IPSEN CARES is available 8:00 a.m. to 8:00 p.m. EST, Monday throughFriday, by calling (866) 435-5677. Additional information is also available by visiting http://www.ipsenus.com/4-0_
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding EUR1.2 billion in 2013. Ipsen's ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. 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. In 2013, R&D expenditure totaled close to EUR260 million, representing more than 21% of Group sales. Moreover, Ipsen also has a significant presence in primary care. The Group has close to 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 part of 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, visit www.ipsen.com.
Increlex® is used to treat children who are very short for their age because their bodies do not make
enough IGF-1. This condition is called severe primary IGF-1 deficiency. Increlex® should not be used for other causes of growth failure and should not be used instead of growth hormone.
Increlex® is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (IGFD), or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH. Severe primary IGFD is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH).
Increlex® is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex® treatment. Increlex® is not a substitute to GH for approved GH indications. Increlex® has not been studied in children < 2 years of age.
Important Safety Information about Increlex® for Patients and Caregivers
Who should not use Increlex®?
Your child should not take Increlex® if your child: has finished growing (the growth plates at the end of the bones are closed), has cancer, OR is allergic to mecasermin or any of the inactive ingredients in Increlex®. Increlex® has not been studied in children under 2 years of age and should never be used in newborns. Your child should never receive Increlex® through a vein.
Before your child takes Increlex®, you should tell your child's doctor about:
All of your child's health conditions, including: diabetes, kidney problems, liver problems, allergies, scoliosis (curved spine), pregnancy, or breast-feeding.
All the medicines (prescription and nonprescription), vitamins, and herbal supplements your child takes, especially insulin or other anti-diabetes medicines; some medicines may require dose adjustments.
What are possible side effects of Increlex® (some of which can be serious)?
Low blood sugar (hypoglycemia). Only give your child Increlex® right before or right after (20 minutes on either side of) a snack or meal to reduce the chances of hypoglycemia. Signs include dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, and fast or irregular heartbeat. Do not give your child Increlex® if your child is sick or cannot eat. Severe hypoglycemia may cause unconsciousness, seizures, or death. People taking Increlex® should avoid participating in high risk activities (such as driving) within 2 to 3 hours after an Increlex® injection.
Your child may have a mild or serious allergic reaction with Increlex®. Call your child's doctor right away if your child gets a rash or hives. If hives do occur, they generally appear minutes to hours after the injection as an itchy, raised skin reaction, pale in the middle with a red rim around them, and may sometimes occur at numerous places on the skin. Get medical help immediately if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin, and/or passing out.
Increased pressure in the brain (intracranial hypertension). Increlex®, like growth hormone, can sometimes cause a temporary increase in pressure within the brain. Symptoms include persistent headache, blurred vision, and nausea with vomiting.
Enlarged tonsils. Signs include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear.
A bone problem called slipped capital femoral epiphysis. This happens when the top of the upper leg (femur) slips apart from the rest of the bone. Seek immediate medical attention if your child develops a limp or has hip or knee pain.
Worsened scoliosis (caused by rapid growth).
Injection site reactions including: swelling, loss of fat, increase of fat, pain, redness, or bruising. This can be avoided by changing/rotating the injection site at each injection.
Your child's doctor is your primary source of information about treatment. For more information, please talk to your doctor.
Patient Information for Increlex® available at http://increlex.com/pdf/
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Important Safety Information about Increlex® for Healthcare Professionals
· Presence of active or suspected malignancy
· Hypersensitivity to mecasermin (rhIGF-1) or any of the inactive ingredients in Increlex®
· Intravenous administration
· Closed epiphyses
Warnings and Precautions:
· Hypoglycemic effects: Increlex® should be administered 20 minutes before or after a meal or snack, and should not be administered when the meal or snack is omitted.
· Hypersensitivity: Allergic reactions have been reported, including anaphylaxis requiring hospitalization.
· Intracranial hypertension: Funduscopic examination is recommended at the initiation of and periodically during the course of therapy.
· Tonsillar/adenoidal hypertrophy: Patients should have periodic examinations to rule out potential complications.
· Slipped capital femoral epiphysis: Evaluate any child with onset of limp or hip/knee pain.
· Progression of scoliosis: Monitor any child with scoliosis.
Common adverse reactions include: hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
Please see the full Prescribing Information for Increlex® available at at http://increlex.com/pdf/hcp-
Dysport® is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium BoNT-A bacteria. It is supplied as a lyophilized powder.
Dysport® was first registered for the treatment of blepharospasm and hemifacial spasm in the United Kingdom in 1990, and is licensed in more than 75 countries for various indications including: blepharospasm, adult upper and lower limb spasticity, hemifacial spasm, spasmodic torticollis (ST) (previously referred to as cervical dystonia), pediatric lower limb spasticity due to cerebral palsy (CP), axillary hyperhidrosis, and glabellar lines.
Dysport® is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (US). Dysport®'s only approved therapeutic indication in the United States (US) is for the treatment of adults with cervical dystonia (referred to spasmodic torticollis in other markets). As such, data from this study in adults with upper limb spasticity are with respect to an investigational use of Dysport® in the USA.
Important Safety Information about Dysport®
Dysport® (abobotulinumToxinA) is contraindicated in individuals with known hypersensitivity to any of its components.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Adverse effects resulting from the distribution of the effects of the toxin to sites remote from the site of administration have been reported. Patients treated with therapeutic doses may present with excessive muscle weakness. The risk of occurrence of such undesirable effects may be reduced by using the lowest effective dose possible and by not exceeding the maximum recommended dose.
Very rare cases of death, occasionally in the context of dysphagia, pneumopathy and/or in patients with significant asthenia have been reported following treatment with botulinum toxin A or B.
Patients with disorders resulting in defective neuromuscular transmission, difficulty in swallowing or breathing are more at risk of experiencing these effects. In these patients, treatment must be administered under the control of a specialist and only if the benefit of treatment outweighs the risk.
Dysport® should be administered with caution to patients with pre-existing swallowing or breathing problems as these can worsen following the distribution of the effect of toxin into the relevant muscles. Aspiration has occurred in rare cases and is a risk when treating patients who have a chronic respiratory disorder.
Dysport® should only be used with caution and under close medical supervision in patients with clinical or sub-clinical evidence of marked defective neuro-muscular transmission (e.g. myasthenia gravis). Such patients may have an increased sensitivity to agents such as Dysport®, which may result in excessive muscle weakness.
The recommended posology and frequency of administration for Dysport® must not be exceeded.
Patients and their care-givers must be warned of the necessity to seek immediate medical treatment in case of problems with swallowing, speech or respiratory problems.
For the treatment of spasticity associated with cerebral palsy in children, Dysport® should only be used in children 2 years of age or over.
As with any intramuscular injection, Dysport® should only be used where strictly necessary in patients with prolonged bleeding times, or infection/inflammation at the proposed site(s) of injection.
It is essential to study the patient's facial anatomy prior to administering Dysport® for the correction of glabellar lines. Facial asymmetry, ptosis, excessive dermatochalasis, scarring, and any alterations to this anatomy as a result of previous surgical interventions should be taken into consideration.
Dysport® should only be used to treat a single patient, during a single session. Any unused product remaining should be disposed of in accordance with Special Precautions for Disposal and Handling.
Specific precautions must be taken during the preparation and administration of the product and the inactivation and disposal of any unused reconstituted solution.
This product contains a small amount of human albumin. The risk of transmission of viral infection cannot be excluded with absolute certainty following the use of human blood or blood products.
Antibody formation to botulinum toxin has been noted rarely in patients receiving Dysport®. Clinically, neutralizing antibodies might be suspected by a substantial deterioration in response to therapy and / or the need for consistent use of increased doses.
About Somatuline® Depot® in the United States
In the United States, Somatuline® Depot® is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
Somatuline® Depot® is not indicated for the treatment of GEP-NETs.
The active substance in Somatuline® Depot® is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions.
Select Important Safety Information about Somatuline® Depot for Patients
Somatuline Depot may cause serious side effects including:
· Changes in your blood sugar (high blood sugar or low blood sugar)
· Slow heart rate
· High blood pressure
The most common side effects of Somatuline Depot include diarrhea, gallstones, stomach area (abdominal) pain, nausea, and pain, itching, or a lump at the injection site.
These are not all the possible side effects of Somatuline Depot. Tell your doctor if you have any side effect that bothers you or that does not go away.
Before you receive Somatuline Depot, talk to your doctor about:
All of your medical conditions, including:
· Gallbladder, thyroid, heart, kidney, or liver problems
· Allergy to latex or natural dry rubber
· Pregnancy or plans to become pregnant
o It is not known if Somatuline Depot could harm your unborn baby
· Breast-feeding or plans to breast-feed
o It is not known if Somatuline Depot passes into breast milk
Any medicines (prescription and nonprescription) you are taking, including:
· Insulin or other diabetes medicines
· A cyclosporine (such as Gengraf™, Neoral®, or Sandimmune®)
· A medicine called bromocriptine (such as Parlodel®)
· Medicines that lower your heart rate (such as beta blockers)
While on Somatuline Depot:
· Tell your doctor if you have sudden pain in your upper right stomach (abdominal) area or in your right shoulder or between your shoulder blades, or if you have yellowing of your skin and whites of your eyes, fever with chills, or nausea as these could be symptoms related to gallstones
· If you have diabetes, test your blood sugar as your doctor tells you to. Your doctor may change your dose of diabetes medicine especially when you first start receiving Somatuline Depot or if your dose of Somatuline Depot changes.
· Before each treatment, read the Patient Information that comes with each Somatuline Depot package as there may be new information. Talk with your doctor about your medical condition or your treatment. Your doctor is your primary source of information about treatment.
Please see the Patient Information for Somatuline Depot at http://somatulinedepot.com/
Select Important Safety Information about Somatuline® Depot for Healthcare Professionals
Somatuline is contraindicated in patients with hypersensitivity to lanreotide or related peptides.
Warnings and Precautions
· Somatuline may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed
· Patients may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly
· Somatuline may decrease heart rate. In cardiac studies, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension. Dose adjustment of coadministered drugs that decrease heart rate may be necessary
· Somatuline may decrease bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted
The most common adverse reactions (incidence >5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).
Use in Special Populations
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment: Initial dose is 60 mg every 4 weeks.
Please see the full Prescribing Information for Somatuline Depot at
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 Generics 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. 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:
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Stéphane Durant des Aulnois
Investor Relations Director
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