Company Overview of Ipsen Biopharmaceuticals, Inc.
Ipsen Biopharmaceuticals, Inc. develops and commercializes 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-naïve and previously trea...
106 Allen Road
Basking Ridge, NJ 07920
Founded in 2000
Key Executives for Ipsen Biopharmaceuticals, Inc.
Chief Executive Officer and President
Senior Vice President of North American Medical and Regulatory Affairs
Investor Relations Director
Senior Vice-Président of Public Affairs and Communication
Compensation as of Fiscal Year 2014.
Ipsen Biopharmaceuticals, Inc. Key Developments
Ipsen Biopharmaceuticals, Inc. Announces the FDA Approval of Somatuline® Depot® (Lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors
Dec 16 14
Ipsen Biopharmaceuticals, Inc. announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline®) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival (PFS). The approval of Somatuline® was based on a 96-week landmark registrational Phase III, double-blind, placebo-controlled study (CLARINET®)of 204 patients enrolled in 48 centers across 14 countries. The trial showed that Somatuline® reduced the risk of disease progression or death by 53% versus placebo in patients with advanced gastrointestinal and pancreatic neuroendocrine tumors (p<0.001). Safety data generated from the Phase III study were consistent with the known safety profile of Somatuline®. The rates of discontinuation due to treatment-emergent adverse reactions were 5% (5/101 patients) in the Somatuline® arm and 3% (3/103 patients) in the placebo arm. Somatuline® will be delivered via a newly approved, ready-to-use, prefilled syringe which incorporates Safe’n’Sound® technology, including a retractable needle guard to help avoid needle sticks, and it is manufactured without latex or natural dry rubber. The new delivery device does not require reconstitution and is a low volume (0.5 mL) deep subcutaneous injection offering a streamlined process that supports full dose delivery.
Ipsen Biopharmaceuticals, Inc. Announces FDA Acceptance of Filing for Dysport(R) (Abobotulinumtoxina) in Treatment of Upper Limb Spasticity in Adult Patients
Dec 1 14
Ipsen Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for Dysport(R) (abobotulinumtoxinA) for the treatment of upper limb spasticity in adult patients.
The regulatory filing was based on a Phase III study involving nearly 250 adult patients with upper limb spasticity. The international, multi-center, double-blind, randomized, placebo-controlled trial compared the efficacy of Dysport(R) versus placebo in hemiparetic patients following stroke or brain trauma. The data showed that those treated with Dysport(R) demonstrated a statistically significant improvement in muscle tone (p<0.0001), and a higher clinical benefit versus placebo. The safety profile observed in the study was consistent with the known safety profile of Dysport(R). Dysport(R) is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (U.S.). Dysport(R)'s only approved therapeutic indication in the U.S. is for the treatment of adults with cervical dystonia (referred to as spasmodic torticollis in other markets). As such, data from the Phase III study in adults with upper limb spasticity are with respect to an investigational use of Dysport(R) in the U.S. This phase III research study included 243 patients and was multicenter, prospective, double blind, randomized, and placebo-controlled. It was conducted in the USA, France, Italy, Belgium, Czech Republic, Poland, Slovakia, Russia and Hungary. The purpose of this study was to assess the efficacy of Dysport(R) compared to placebo in improving upper limb spasticity in hemiparetic patients following a stroke or brain trauma. The study co-primary endpoints were the improvement of muscle tone in the treated upper limb measured by the Modified Ashworth Scale (MAS) and the clinical benefit for the patients assessed by the Physician Global Assessment (PGA). In addition, Dysport(R)'s efficacy was assessed on passive function as measured by the Disability Assessment Scale (DAS). Patients were offered the option to continue in an open label long-term study where they would receive additional treatment with Dysport(R) for a total of 15 months.
Ipsen Biopharmaceuticals, Inc. Presents Dysport (AbobotulinumtoxinA) Data at American Academy of Physical Medicine and Rehabilitation Annual Assembly
Nov 14 14
Ipsen Biopharmaceuticals, Inc. announced multiple presentations of Dysport(R) data, which will be presented at the Annual Assembly of the Academy of Physical Medicine and Rehabilitation (AAPM&R) November 13-16 in San Diego, California. There will be five poster presentations based on trials that explored the use of Dysport(R) in both cervical dystonia and upper limb spasticity. Two presentations will provide findings from the large placebo-controlled, double-blind study conducted which evaluated the efficacy and safety of Dysport treatment in patients with cervical dystonia. This international, multicenter study involved 61 sites in 11 countries and randomized a total of 369 patients diagnosed with cervical dystonia to one of three treatment arms: current formulation of Dysport(R) (abobotulinumtoxinA) 500U (n=159), an investigational new formulation of abobotulinumtoxinA 500U (n=156) and placebo (n=54). Dysport(R), abobotulinumtoxinA, is effective with a favorable safety profile in the treatment of cervical dystonia: a Phase III, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Dysport(R), versus placebo at four (primary endpoint), eight and 12 weeks post injection. Efficacy was measured using the Toronto Western Spasmodic Torticollis Rate Scale (TWSTRS) total score and subscales (disability, severity and pain) as well as several investigator-led assessments. The data showed that significant improvement in TWSTRS total score versus placebo (-14.0 vs baseline for Dysport and -3.9 versus baseline for placebo, p<0.05)) at the week 4 primary endpoint. The significant improvement associated with Dysport(R) treatment on TWSTRS total score was sustained at week 8 and week 12 assessments. Adverse events were experienced by 37.8% of patients receiving Dysport(R) and 25.5% of patients receiving placebo during the single treatment cycle in the trial. Dysport(R), abobotulinumtoxinA, improves disease-specific quality of life in patients with cervical dystonia, as measured by Patient-Reported Outcomes, in a Phase III, randomized, double-blind placebo-controlled study, which showed that one single injection of Dysport(R) significantly improved patients' disease-specific quality of life. At week 4, total Cervical Dystonia Impact Profile (CDIP)-58 score was improved as were all eight CIPD-58 subscales (head and neck symptoms, pain and discomfort, sleep, upper limb activities, walking, annoyance, mood and psychosocial functioning) and visual analog scales (VAS) for pain and symptoms. Additionally, data from a Phase III study of Dysport(R) in upper limb spasticity will also be shared. Randomized, double-blind placebo-controlled Phase III study of Dysport, abobotulinumtoxinA, in the treatment of adults with upper limb spasticity showed that 500 and 1000IU of Dysport(R) in overactive limb muscles improved muscle tone, spasticity and active range of motion in the spastic upper limb at week 4. The international, multi-center trial involved 243 hemiparetic patients following a stroke or brain trauma and showed gains in active finger, elbow and wrist range of motion and passive function. No unexpected safety events were observed. Two additional posters explored the population characteristics and top five injected muscles as part of an interim analysis of the "INTEREST IN CD2" study of Dysport(R), which is planning to recruit 1,050 patients in 38 countries. Dysport(R) is approved for the treatment of upper limb spasticity in many international markets, but not in the United States (U.S.). The only approved therapeutic indication for Dysport in the U.S. is for the treatment of adults with cervical dystonia (referred to spasmodic torticollis in other markets). As such, data from the Phase III study in adults with upper limb spasticity are with respect to an investigational use of Dysport(R) in the U.S. The U.S. Food and Drug Administration (FDA) has accepted Ipsen's supplemental Biologics License Application (sBLA) for Dysport(R) in adult upper limb spasticity.
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