August 25, 2016 12:57 AM ET

Biotechnology

Company Overview of Ipsen Biopharmaceuticals, Inc.

Company Overview

Ipsen Biopharmaceuticals, Inc. develops and commercializes growth hormone based therapeutics for the treatment of endocrine and neurological diseases. It offers Increlex injection for the long-term treatment of children with short stature due to severe primary Insulin-like Growth Factor-1 Deficiency; Somatuline Depot (lanreotide) injection for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and radiotherapy, or for whom surgery and radiotherapy is not an option; and Dysport for injection (abobotulinumtoxinA), a drug for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in toxin-naïv...

106 Allen Road

3rd Floor

Basking Ridge, NJ 07920

United States

Founded in 2000

141 Employees

Phone:

908-275-6300

Fax:

908-275-6301

Key Executives for Ipsen Biopharmaceuticals, Inc.

Chief Executive Officer and President
Investor Relations Director
Senior Vice-Président of Public Affairs and Communication
Vice President of Medical Affairs Oncology and Endocrinology
Vice President of North America Communications
Age: 60
Compensation as of Fiscal Year 2016.

Ipsen Biopharmaceuticals, Inc. Key Developments

Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport® (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older

Ipsen Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Dysport® is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. Those treated with Dysport® showed statistically significant improvement in co-primary efficacy assessments: mean change from baseline in Modified Ashworth scale (MAS) in ankle plantar flexor muscle tone and mean Physician's Global Assessment (PGA) response to treatment score at Week 4 and Week 12. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks; however, some had a longer duration of response. This approval is based on a randomized, multicenter, double-blind, placebo-controlled, international Phase III pivotal study in 235 pediatric patients (158 received Dysport® and 77 received placebo) aged 2 to 17 years with lower limb spasticity due to cerebral palsy causing dynamic equinus foot deformity. 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.

Ipsen Biopharmaceuticals Announces Results from Phase III Study (NCT01249417) Evaluating Investigational Use of AbobotulinumtoxinA (Dysport®) for Injection in Treatment of Spastic Equinus Foot

Ipsen Biopharmaceuticals, Inc. announced results from a Phase III study (NCT01249417) evaluating the investigational use of abobotulinumtoxinA (Dysport®) for injection in the treatment of spastic equinus foot, a condition associated with cerebral palsy (CP) in children aged 2-17. This global, multicenter, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of abobotulinumtoxinA (ABO) versus placebo on the mean change from baseline in ankle joint hypertonicity in 241 children with cerebral palsy. Eligible patients were randomized (1:1:1) to injections of ABO 10U/kg/leg, ABO 15U/kg/leg or placebo into the gastrocnemius and soleus muscles (one or both legs injected). The primary endpoint was change in Modified Ashworth Scale (MAS) from baseline to Week 4. Selected secondary endpoint data presented were the mean Goal Attainment Scale (GAS) score at Week 4. Data presented also included the secondary endpoint of Goal Attainment Scale (GAS). In this study, the most frequently chosen goals were improved walking pattern (70.2% of patients), improved balance (32.3%), and decreased falling (31.1%). As measured by the GAS, where a score of 50 represents goal achieved as expected, patients with ABO showed higher goal achievement than the expected score of 50 (GAS of 50.9 for 15U/kg and 51.5 for 10U/kg), whereas patients on placebo did not reach the expected level (GAS score of 46.2). Treatment effects for GAS were significant for both ABO groups versus placebo (p=0.0031 & p=0.0006, respectively). The effects of abobotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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 great in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

Ipsen Biopharmaceuticals, Inc. Announces Release of Additional Batch of Increlex (Mecasermin [rDNA Origin] Injection) in the U.S

Ipsen Biopharmaceuticals announced that in collaboration with the U.S. Food and Drug Administration an additional batch of Increlex will be available for commercial distribution starting in November 2015. 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 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.

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