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April 19, 2015 8:18 AM ET

Pharmaceuticals

Company Overview of Sunovion Pharmaceuticals Inc.

Company Overview

Sunovion Pharmaceuticals Inc. is a research-based pharmaceutical company that is engaged in discovering, developing, and commercializing therapeutic products to help patients suffering from central nervous system (CNS) and respiratory disorders, as well as other illnesses. It focuses on treating various CNS conditions, such as anxiety, insomnia, bipolar depression, epilepsy, and schizophrenia. The company offers Latuda (lurasidone HCl) tablets for the treatment of adult patients with depressive episodes associated with bipolar I disorder, as well as with schizophrenia; Aptiom (eslicarbazepine acetate) tablet, an antiepileptic drug for use as adjunctive treatment of partial-onset seizures; an...

84 Waterford Drive

Marlborough, MA 01752

United States

Founded in 1984

2,400 Employees

Phone:

508-481-6700

Fax:

508-481-7683

Key Executives for Sunovion Pharmaceuticals Inc.

Vice Chair, President and Head of Global Clinical Development - Sumitomo Dainippon Pharma Group
Chief Financial Officer and Senior Vice President
Chief Administrative Officer and Executive Vice President
Chief Compliance & Ethics Officer and Senior Vice President
Chief Medical Officer and Executive Vice President
Compensation as of Fiscal Year 2014.

Sunovion Pharmaceuticals Inc. Key Developments

Sunovion Pharmaceuticals Inc. to Present Data on Aptiom® (eslicarbazepine acetate) at 67th American Academy of Neurology Annual Meeting

Sunovion Pharmaceuticals Inc. will present five research posters at the 67th American Academy of Neurology (AAN) Annual Meeting (April 18-25, Washington, D.C.), including findings from two pooled Phase 3 studies (Studies 093-045 and 093-046) evaluating the safety and efficacy of Aptiom® (eslicarbazepine acetate) as a potential monotherapy treatment of partial-onset seizures. Sunovion's supplemental New Drug Application (sNDA) for the use of APTIOM as monotherapy for partial-onset seizures is currently under review by the U.S. Food and Drug Administration (FDA). An analysis of two pooled Phase 3 clinical trials evaluating eslicarbazepine acetate as monotherapy showed that exit rates for eslicarbazepine acetate as monotherapy (1,600 mg/day and 1,200 mg/day) were superior to a historical control. The two identically designed Phase 3 trials investigated conversion from adjunctive therapy (1-3 concomitant antiepileptic drugs [AEDs]) to monotherapy with eslicarbazepine acetate. The primary endpoint for both studies was the proportion of patients meeting pre-defined exit criteria (signifying worsening seizure control) compared to a historical control. Treatment was considered effective if the upper limit of the 95% confidence interval (CI) for the exit rate was lower than a pre-specified threshold based on historical controls. The pooled estimated exit rates for eslicarbazepine acetate were 20.6% (95% CI: 15.6-26.8%) for the 1,600 mg/day dose and 30.8% (95% CI: 23.0-40.5%) for the 1,200 mg/day dose, lower than historical thresholds of 65.3% (for a single study) and 72.2% (for two independent studies). Eslicarbazepine acetate was also well-tolerated as monotherapy, with only headache occurring in 5% of both dose groups. Data from these trials, including Study 093-045, the first AED trial of its kind conducted in an exclusively North American population, was included in Sunovion’s sNDA submission for APTIOM as monotherapy treatment. Findings from an analysis of three pooled Phase 3 studies (Studies 301, 302 and 304) showed that the incidence of falls, fractures and injuries was low (<10%). The overall incidence of falls, fractures and injuries was similar for the eslicarbazepine acetate 400 mg, 800 mg and 1,200 mg/day groups (5.1%, 9.4% and 5.1%) and for the placebo group (6.1%) and the incidence did not increase with eslicarbazepine acetate dose. Falls, contusions and head injuries were reported most frequently (<2%) in this category of treatment-emergent AEs.

Sunovion Pharmaceuticals Inc. Presents at 10th Annual Neurotech Investing & Partnering Conference, Apr-08-2015 09:00 AM

Sunovion Pharmaceuticals Inc. Presents at 10th Annual Neurotech Investing & Partnering Conference, Apr-08-2015 09:00 AM. Venue: Hotel Nikko, 222 Mason Street, San Francisco, California, United States. Speakers: Thomas Large, Senior VP Discovery and Preclinical Research.

Sunovion Pharmaceuticals Inc. Announces Initiation of Phase 3 Clinical Trial Program for SUN-101

Sunovion Pharmaceuticals Inc. announced the start of enrollment for the Phase 3 clinical trial program for SUN-101 (glycopyrrolate) inhalation solution delivered through the innovative investigational eFlow nebulizer system (SUN-101/eFlow) from PARI Pharma GmbH. SUN-101/eFlow is being investigated for the twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SUN-101/eFlow is the first nebulized long-acting muscarinic antagonist (LAMA) in Phase 3 development. Phase 2 efficacy and safety data were presented at the 2014 American College of Chest Physicians Annual Meeting (CHEST 2014) in Austin, Texas. While LAMAs are effective in controlling COPD, LAMAs delivered via nebulizer are not currently approved by the U.S. Food and Drug Administration (FDA). The SUN-101/eFlow Phase 3 clinical trial program includes three separate studies currently enrolling approximately 2,340 adults with moderate-to-very severe COPD. GOLDEN-3 and GOLDEN-4 are randomized, double-blind, placebo-controlled, safety and efficacy studies comparing twice-daily SUN-101/eFlow 25 mcg and 50 mcg with placebo. GOLDEN-3 and GOLDEN-4 began enrollment in February 2015. GOLDEN-5, an open-label long-term safety study (48 weeks) that began enrollment in October 2014, compares 50 mcg of SUN-101/eFlow delivered twice-daily and Spiriva® (tiotropium bromide) 18 mcg delivered once-daily by the HandiHaler device.

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