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May 24, 2015 8:13 PM ET

Pharmaceuticals

Company Overview of Ipsen Biopharmaceuticals, Inc.

Company Overview

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

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
Senior Vice President of North American Medical and Regulatory Affairs
Treasurer and Director
Investor Relations Director
Senior Vice-Président of Public Affairs and Communication
Compensation as of Fiscal Year 2014.

Ipsen Biopharmaceuticals, Inc. Key Developments

IPSEN Biopharmaceuticals Appoints Lyndal Walker as Country Manager - Canada, Effective January 1, 2015

IPSEN Biopharmaceuticals announced the appointment of Lyndal Walker to the position of Country Manager - Canada, effective January 1, 2015. Ms. Walker will be reporting to Cynthia Schwalm, Ipsen President and CEO, North America. In her new role Ms. Walker will lead the Canadian team to develop and launch Ipsen Biopharmaceuticals in Canada including new product indications. Previously, Ms. Walker served in a number of leadership roles in the biopharma sector including; President of Pharmaexact; Country Manager - Canada and Global Marketing Vice President - Asia Pacific Region for Abraxis BioScience; and Associate Director (Team Leader) Oncology at Eli Lilly Canada Inc. Ms.Walker has also served as a board member of BIOTECanada.

Ipsen Biopharmaceuticals, Inc. Announces the FDA Approval of Somatuline® Depot® (Lanreotide) Injection for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

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

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.

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