October 01, 2016 7:26 PM ET

Pharmaceuticals

Company Overview of Sunovion Pharmaceuticals Inc.

Company Overview

Sunovion Pharmaceuticals Inc. develops and markets pharmaceutical products. The company offers products for central nervous system disorders, such as insomnia, schizophrenia, bipolar depression, and epilepsy disorders; attention deficit hyperactivity and binge-eating disorders; and respiratory conditions, including asthma, allergy, and chronic obstructive pulmonary disease areas. Sunovion Pharmaceuticals Inc. was formerly known as Sepracor Inc. and changed its name to Sunovion Pharmaceuticals Inc. in October 2010. The company was founded in 1984 and is headquartered in Marlborough, Massachusetts. As of October 20, 2009, Sunovion Pharmaceuticals Inc. operates as a subsidiary of Dainippon Sumi...

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.

Chairman and Chief Executive Officer
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, Executive Vice President and Head of Global Clinical Development
Compensation as of Fiscal Year 2016.

Sunovion Pharmaceuticals Inc. Key Developments

Sunovion Announces Results from Pivotal Study Evaluating Novel Drug Candidate Dasotraline in Children with Attention Deficit Hyperactivity Disorder

Sunovion Pharmaceuticals Inc. (Sunovion) announced that its pivotal study (SEP360-202) evaluating dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD) met its primary efficacy endpoint in the 4mg/d dose arm. The SEP360-202 trial was a Phase 2/3, six-week, randomized, double-blind, multi-center, placebo-controlled, parallel-group, fixed dose safety and efficacy trial that evaluated once-daily dasotraline (2mg/d and 4mg/d dose arms) in 342 children ages 6 to 12 years with ADHD. The primary efficacy endpoint was the change from baseline to Week 6 in the ADHD Rating Scale-IV: Home Version (ADHD RS IV HV) total score. Results show that the 4mg/d dose arm demonstrated a statistically significant and clinically relevant difference compared to placebo. The 2mg/d dose arm was not statistically significantly different compared to placebo. Dasotraline was generally well tolerated. The most common treatment-emergent adverse events (TEAE) (reported in 5% or more of patients and greater than placebo) included: insomnia, decreased appetite and weight decreased. The overall discontinuation rate due to TEAEs in dasotraline treated individuals was 9.3%. The full results of the study are being analyzed, and Sunovion will present data from this study at upcoming scientific meetings. Dasotraline is a novel drug candidate that also is being evaluated in binge eating disorder (BED) in adults in the United States. SEP360-202 was a Phase 2/3, six-week, randomized, double-blind, multi-center, placebo-controlled, parallel-group efficacy and safety trial comparing dasotraline with placebo in children ages 6 to12 years with ADHD in the United States. Dasotraline 2mg, dasotraline 4mg or placebo was administered once-daily. Patients in the 4mg/d arm started at the 2mg/d dose for the first week of the trial and were increased to 4mg/d at week 2. The primary endpoint was the change from baseline at Week 6 in ADHD symptoms as measured by ADHD RS IV HV total score. Dasotraline is a new chemical entity that is considered to be a dopamine and norepinephrine reuptake inhibitor (DNRI). It has an extended half-life (47-77 hours) that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval at steady state. Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development to evaluate its use in treating ADHD in adults and children, and BED in adults in the United States. It has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD, BED, or any other disorder. Attention deficit hyperactivity disorder (ADHD) is a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning and development, as characterized by inattention (e.g., distractibility, forgetfulness) and/or hyperactivity and impulsivity (e.g., fidgeting, restlessness). Approximately 11% of children 4-17 years of age have been diagnosed with ADHD in the United States. Up to 60% of children with ADHD continue to experience symptoms into adulthood. It is estimated that 4.4% of adults between ages 18 and 44 years experience some symptoms and disabilities from ADHD in the United States. In children, ADHD is associated with social rejection and reduced school performance. Children with a history of ADHD are ten times as likely to have difficulties with friendships and can have more frequent and severe injuries than peers without ADHD.6 In adults, symptoms reduce the quality of social or occupational functioning. Studies have shown that ADHD is associated with higher levels of unemployment, and those who are employed experience workplace impairment, reduced productivity and behavioral issues. Adults with ADHD are also at increased risk of trauma, workplace injuries and traffic accidents, are more likely to be diagnosed with comorbid mental health conditions and have a higher incidence of separation and divorce. Binge eating disorder (BED) is characterized by recurrent episodes of binge eating that occur at least once per week for three months. An episode of binge eating is defined as eating an abnormally large amount of food in a discrete period of time. This is typically accompanied by a sense of lack of control. Binge eating must be characterized by marked distress and at least three of the following: eating more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of embarrassment and feeling disgusted, guilty or depressed afterwards. The lifetime prevalence of BED among adult women and men in the United States is 3.6% and 2.1%, respectively. BED typically begins in adolescence or young adulthood but can also start later. BED can lead to a number of psychological and physical problems, such as social isolation, feeling bad about oneself, problems functioning at work, obesity and related medical conditions (e.g., gastroesophageal reflux disease, joint problems, heart disease, type 2 diabetes and some sleep-related breathing disorders). It is also associated with increased healthcare utilization, medical morbidity and mortality.

Sunovion Announces Publication of Data Evaluating Dose Escalation of Latuda® (lurasidone HCl) in the Treatment of Schizophrenia

Sunovion Pharmaceuticals Inc. announced the publication of results in the Journal of Clinical Psychiatry from a randomized, double-blind, placebo-controlled study that investigated the efficacy of low-dose LATUDA (20 mg/day) in adults with schizophrenia (primary endpoint). The study also investigated the effect of dose escalation in adults with schizophrenia who demonstrated inadequate initial response to standard dose Latuda® (lurasidone HCI). The study found that LATUDA 20 mg/day was not associated with significant improvement in psychotic symptoms in adult patients with schizophrenia, indicating that the lowest effective dose of LATUDA for the treatment of schizophrenia is 40 mg/day, consistent with current prescribing information. In addition, the study found that in adults with schizophrenia who did not respond to two weeks of treatment with LATUDA 80 mg/day, increasing the dose to 160 mg/day resulted in significant symptom improvement over the next four weeks when compared to those who continued taking LATUDA 80 mg/day. In this study, hospitalized patients with acute schizophrenia were assigned to treatment with LATUDA 20 mg/day, LATUDA 80 mg/day or placebo. Non-responders to LATUDA 80 mg/day, specifically those who had a Positive and Negative Syndrome Scale (PANSS) score decrease of <20% at two weeks, were re-randomized to LATUDA 80 mg/day or LATUDA 160 mg/day for the remaining four weeks of the study. The primary outcome measure was change from baseline to Week 6 in PANSS total score. Results were as follows: Low dose (LATUDA 20 mg/day): LS mean change from baseline to Week 6 in PANSS total score was not significantly different compared with patients receiving placebo (–17.6 vs. –14.5; p=0.26, effect size=0.19). Early non-responders (LATUDA 80 mg/day vs. LATUDA 160 mg/day): least square (LS) mean change from Week 2 to Week 6 in PANSS total score was significantly greater for patients whose dose was increased to LATUDA 160 mg/day compared with that for patients who continued receiving LATUDA 80 mg/day (–16.6 vs. –8.9; p<0.05, effect size=0.52). LATUDA was generally well-tolerated. Serious treatment-emergent adverse events (TEAEs) were reported in three patients in the LATUDA 20 mg/day group, four patients in the early non-responder LATUDA 80 mg/day group, one patient in the early non-responder LATUDA 160 mg/day group and eight patients in the placebo group. In early non-responders, patients whose dose was increased to LATUDA 160 mg/day reported a greater incidence of anxiety, abdominal discomfort, akathisia, insomnia, and somnolence compared with patients who continued on LATUDA 80 mg/day. LATUDA demonstrated low rates of change in weight and metabolic parameters.

Sunovion Submits New Drug Application for SUN-101/eFlow® to the FDA for the Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD)

Sunovion Pharmaceuticals Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SUN-101/eFlow®, an investigational treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The submission is based on the positive results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trials program, which evaluated the efficacy and safety of SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA) delivered via an innovative investigational eFlow® nebulizer system (SUN-101/eFlow®). The GOLDEN program included three Phase 3 clinical trials. GOLDEN-3 and GOLDEN-4 were Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety trials comparing SUN-101/eFlow® with placebo in patients with moderate-to-very severe COPD. GOLDEN-5 was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long term safety and tolerability of SUN-101/eFlow® in patients with moderate-to-very severe COPD.

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