August 28, 2016 6:27 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 2016.

Sunovion Pharmaceuticals Inc. Key Developments

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.

Sunovion Pharmaceuticals Inc. Announces Positive Results from GOLDEN-5

Sunovion Pharmaceuticals Inc. announced positive results from GOLDEN-5, a long-term safety study evaluating SUN-101 (glycopyrrolate), a nebulized, long-acting muscarinic antagonist (LAMA) delivered via an innovative investigational nebulizer system (SUN-101/eFlow). The study results showed that SUN-101/eFlow was well-tolerated as a twice-daily maintenance treatment for bronchoconstriction in people with moderate-to-very severe chronic obstructive pulmonary disease (COPD), with a similar overall incidence of adverse events to standard of care treatment. Results also showed that the incidence of major adverse cardiovascular events (MACE) was similar to the approved active comparator. The innovative, proprietary eFlow nebulizer system, developed by PARI Pharma GmbH, is a unique closed system delivery device currently in development for the treatment of moderate-to-very severe COPD. It is a portable, hand-held, electronic nebulizer system that uses a vibrating, perforated membrane to generate an inhalable aerosol. The eFlow nebulizer closed system is designed to deliver the entire dose of medication in two to three minutes from a distinctive proprietary drug vial inserted into the device. A standard jet nebulizer typically takes up to 10 minutes. The investigational combined product, consisting of SUN-101 and the eFlow nebulizer closed system, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.

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