Company Overview of Ipsen Biopharmaceuticals, Inc.
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
Basking Ridge, NJ 07920
Founded in 2000
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
Compensation as of Fiscal Year 2015.
Ipsen Biopharmaceuticals, Inc. Key Developments
Ipsen Biopharmaceuticals Announces Results from Phase III Study (NCT01249417) Evaluating Investigational Use of AbobotulinumtoxinA (Dysport®) for Injection in Treatment of Spastic Equinus Foot
Oct 22 15
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
Oct 1 15
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.
Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (Abobotulinumtoxina) for Injection in the Treatment of Upper Limb Spasticity in Adults in the United States
Jul 16 15
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 the treatment of upper limb spasticity (ULS) in adult patients to decrease the severity of increased muscle tone in elbow flexors, wrist flexors and finger flexors. Clinical improvement may be expected one week after administration of Dysport. A majority of patients in clinical studies were retreated between 12 and 16 weeks; however, some patients had a duration of response as long as 20 weeks. The Dysport Phase III trial was the first registration study to evaluate ULS treatment in adult patients with both stroke and traumatic brain injury. The approval was based on a rigorous development program that included clinical trials conducted in over 600 patients. In the Phase III pivotal study, 238 adult patients with upper limb spasticity participated in the study for up to one year. The international, multi-center, double-blind, randomized, placebo-controlled study compared the efficacy of Dysport® (n=159) against placebo (n=79) in hemiparetic patients following stroke or brain trauma. The trial also included patients who were botulinum toxin naïve or previously treated with a botulinum toxin, encompassing a broad patient population. The co-primary endpoints of the study were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) against placebo and the clinical benefit for patients as assessed by the Physician Global Assessment (PGA) against placebo at Week 4. The trial was followed by an open-label study wherein patients received Dysport® for up to five treatment cycles to assess the long term safety. The Phase III pivotal data showed that those treated with Dysport demonstrated statistically significant improvement in muscle tone measured by the MAS and a significantly higher physician-rated clinical benefit measured by the PGA against placebo at Week 4 (p= 0.05). At Week 4, both doses of Dysport® (500 units and 1,000 units) significantly reduced muscle tone as measured by MAS in all primary target muscle groups, which included elbow, wrist, and finger muscles, with approximately 3 out of 4 patients responding to Dysport®. The most frequently reported adverse reactions (=2%) are urinary tract infection, nasopharyngitis, muscular weakness, musculoskeletal pain, dizziness, fall and depression. The safety profile observed in the study was consistent with the known safety profile of Dysport®,and there were no differences in the rate of serious adverse events between the treatment groups: placebo (3.7%), Dysport® 500 U (3.7%), Dysport® 1000 U (3.7%).
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