• In collaboration with the FDA, Ipsen will release a second batch of Increlex® in September 2014
• Ipsen continues to work with the FDA to release future batches of Increlex®
In collaboration with the U.S. Food and Drug Administration (FDA), Ipsen is releasing a second batch of Increlex® in 2014. The first batch was made available for distribution in June of 2014.
“We are pleased that an additional supply of Increlex® has been released for distribution to treat pediatric patients with severe primary IGF-1 deficiency, a condition which can cause permanent short stature,” said Cynthia Schwalm, President and CEO of Ipsen N.A. “These children depend on this product for the treatment of this rare and debilitating condition.”
Ipsen is committed to working closely with regulators with the goal of ensuring that additional lots of Increlex® are made available on a timely basis.
Increlex® (increlex.com) 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 antiinflammatory 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.
Allergic reactions. 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.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit 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.
Ipsen (ipsen.com) is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 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 urology-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 €260 million, representing more than 21% of Group sales. 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 trades on the over-the-counter market in the United States under the symbol IPSEY.
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 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 generatelower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance.
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The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
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