August 20, 2017 2:32 AM 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 2017.

Sunovion Pharmaceuticals Inc. Key Developments

Sunovion’s Latuda® (Lurasidone HCI) Receives Health Canada Approval to Treat Adolescents with Schizophrenia

Sunovion Pharmaceuticals Inc. announced that Health Canada approved the Supplemental New Drug Submission (SNDS) for Latuda® (lurasidone HCI) for the management of the manifestations of schizophrenia in adolescents aged 15 to 17 years. LATUDA is currently indicated in Canada for the management of the manifestations of schizophrenia and the acute management of depressive episodes associated with bipolar I disorder in adults. The approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of LATUDA 40 mg/day, LATUDA 80 mg/day or placebo. At study endpoint, patients treated with LATUDA 40 mg/day and 80 mg/day demonstrated statistically significant and clinically meaningful improvement in symptoms of schizophrenia compared to placebo. LATUDA was also generally well tolerated with limited effects on weight and metabolic parameters.

Sunovion Pharmaceuticals Inc. Announces FDA Acceptance for Review of New Drug Application Resubmission for SUN-101/eFlow (Glycopyrrolate) for the Treatment of Chronic Obstructive Pulmonary Disease

Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application for SUN-101/eFlow® (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This resubmission is in response to the Complete Response Letter Sunovion received from the FDA on May 26, 2017. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is December 15, 2017. The NDA for SUN-101/eFlow is supported by data from clinical trials in the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program, which demonstrated a statistically significant change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV1) versus placebo in addition to safety and tolerability in a long-term study. Sunovion was not required by the FDA to conduct any additional clinical studies prior to NDA resubmission.

Sunovion Announces Utibron™ Neohaler® Inhalation Powder Data Showing Lung Function and Health-Related Quality of Life Improvement in Patients with Moderate-To-Severe Chronic Obstructive Pulmonary Disease

Sunovion Pharmaceuticals Inc. announced that multiple data analyses from two Phase 3 studies demonstrating that Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder improved lung function, health-related quality of life (HRQL), dyspnea and night-time symptoms compared to placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), were presented at the 2017 American Thoracic Society International Conference (ATS 2017) held May 19-24, 2017, in Washington, D.C. Findings from the FLIGHT1 and FLIGHT2 pivotal efficacy and safety studies, as well as from the FLIGHT3 long-term safety study, were included in nine posters for UTIBRON NEOHALER presented at the meeting. UTIBRON NEOHALER is a twice-daily combination long-acting beta2 agonist (indacaterol) and long-acting muscarinic antagonist (glycopyrrolate) (LABA/LAMA) for the long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. UTIBRON NEOHALER is not indicated to treat asthma or for the relief of sudden symptoms of COPD. Key data presented at ATS 2017 include: A pooled analysis of efficacy results from FLIGHT1 and FLIGHT2 studies, which showed that UTIBRON NEOHALER demonstrated significant and sustained improvement in lung function compared to placebo, as measured by time-weighted mean forced expiratory volume in 1 second (FEV1). Treatment differences between UTIBRON NEOHALER and placebo ranged from 0.159 to 0.179 L on Day 1 and from 0.223 to 0.281 L at Week 12 (all p-values). Results from a pooled analysis of HRQL data from FLIGHT1 and FLIGHT2 studies showed that patients treated with UTIBRON NEOHALER for moderate-to-severe COPD had statistically and clinically significant improvements in disease specific health related quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) and dyspnea, as measured by the Transition Dyspnea Index (TDI), compared to placebo treated patients after 12 weeks of treatment. These improvements were seen in all patients, irrespective of age, gender, severity of disease, smoking status or baseline use of drugs like corticosteroids. Two pooled analyses of FLIGHT1 and FLIGHT2 trials evaluated the effect of UTIBRON NEOHALER on patient-reported daily total COPD symptoms, night-time use of rescue medication and sleep disturbance. One of these presentations showed that patients treated with UTIBRON NEOHALER reported significant reduction in their total night-time COPD symptoms score versus placebo over the 12-week treatment period. A separate pooled analysis showed that 12 weeks of treatment with UTIBRON NEOHALER significantly reduced the use of rescue medications at night and significantly increased the number of nights with no awakenings, compared to placebo. Specifically, a significant reduction in the number of night-time rescue medication puffs use (treatment difference: -0.50; standard error (SE): +/- 0.06; p < 0.001) and significant increases in the percentage of nights with no awakenings (treatment difference: 7.7; SE: +/- 1.58; p < 0.001) compared to placebo, were seen after 12 weeks of treatment.

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