February 28, 2015 1:08 PM 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. 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.

Sunovion Pharmaceuticals Inc. Announces FDA Acceptance for Review of Supplemental New Drug Application for the Use of Aptiom® (eslicarbazepine acetate) as Monotherapy Treatment for Partial-Onset Seizures

Sunovion Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Aptiom® (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures. The sNDA was submitted to the FDA by Sunovion on October 29, 2014 and included data from two Phase 3 double-blind, historical-controlled, multi-center randomized trials involving patients with partial-onset seizures. The two trials (Studies 093-046 and 093-045) were designed identically to evaluate the safety and efficacy of APTIOM (1,600 mg/day or 1,200 mg/day) as monotherapy treatment for partial-onset seizures in patients 16 years of age or older whose seizures were not well-controlled by other antiepileptic drugs (AEDs). All patients in Study 093-045 were evaluated in North America. Study 093-046 included approximately 25% of patients from the United States and approximately 75% from four European countries. The primary endpoint for both studies was the proportion of patients with partial-onset seizures meeting pre-defined exit criteria (signifying worsening seizure control) 16 weeks post-titration of APTIOM, in comparison to historical controls.

Sunovion Pharmaceuticals Announces Positive Results from ADHD Study

Sunovion Pharmaceuticals Inc. has announced positive results from the first placebo-controlled clinical study of the company's investigational drug dasotraline for the treatment of adult patients with attention deficit hyperactivity disorder, or ADHD. Dasotraline, a new chemical entity discovered by Sunovion, inhibits the pre-synaptic reuptake of dopamine and norepinephrine. In the 4-week, double-blind, randomized, placebo-controlled clinical trial, adults with ADHD were randomized to dasotraline 4 mg/day, dasotraline 8 mg/day or placebo. Dasotraline 8 mg/day demonstrated statistically significant improvement in symptoms of ADHD compared to placebo as measured by the ADHD Rating Scale-Version IV (RS-IV) total score (LS mean -13.9 vs. -9.7; p=0.019), the primary efficacy endpoint of the study, and the inattentiveness (LS mean -8.0 vs. -5.6; p=0.016) and hyperactivity/impulsivity (LS mean -5.9 vs. -4.1; p=0.027) subscale scores. The dasotraline 4 mg/day dose was associated with improvement on the ADHD RS-IV total (LS mean -12.4 vs. -9.7; p=0.076) and subscale scores compared to placebo. Both dasotraline 4 mg/day (LS mean -1.1 vs. -0.7; p=0.021) and 8 mg/day (LS mean -1.1 vs. -0.7; p=0.013) demonstrated statistically significant improvement compared to placebo on the Clinical Global Impression-Severity of Illness (CGI-S) - modified for ADHD scale, a secondary efficacy endpoint of the study. The most common treatment-emergent adverse events (incidence greater than or equal to 5% and greater than or equal to 2-times placebo) leading to discontinuation for dasotraline 4 mg/day and 8 mg/day vs. placebo were insomnia (2.6% and 10.8% vs. 0.0%), anxiety (2.6% and 1.8% vs. 0.0%) and panic attacks (0.0% and 2.7% vs. 0.0%). Sunovion recently initiated a second study that will evaluate the use of dasotraline in the treatment of adults with ADHD. The results from the first study and the recently initiated second study are intended to support a future New Drug Application in this patient population. Sunovion also intends to initiate a clinical development program to assess the safety and efficacy of dasotraline in pediatric patients with ADHD.

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