January 19, 2017 10:47 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 Pharmaceuticals Inc. Announces Pivotal Study Results for Novel Drug Candidate Dasotraline Demonstrating Significantly Improved Attention Deficit Hyperactivity Disorder Symptoms in Children Compared to Placebo

Sunovion Pharmaceuticals Inc. announced that results of a pivotal Phase 2/3 study (SEP360-202) evaluating novel drug candidate dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD) showed statistically significant improvement in the 4mg/day dose arm compared to placebo. The 2mg/day dose arm did not demonstrate a statistically significant difference from placebo. Sunovion announced top-line results from this study on September 20, 2016. The full study results will be presented at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting, being held January 13-15 in Washington, D.C. Pending successful completion of ongoing studies and discussions with the U.S. Food and Drug Administration (FDA), Sunovion intends to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults. Results from SEP360-202 pivotal study: Children taking dasotraline 4mg/day experienced a statistically significant improvement in ADHD symptoms compared to placebo, as measured by the ADHD Rating Scale IV: Home Version (ADHD RS-IV HV) total score (least squares [LS] mean change from Baseline at Week 6: -17.53 [95% CI:-20.12, -14.95] vs -11.36 [-13.89, -8.83], respectively; effect size (ES)=0.48, p<0.001). This statistically significant and clinically relevant improvement over placebo was maintained each week through Week 6. Improvements in Clinical Global Impression-Severity of Illness Scale (CGI-S) scores were also statistically significant in the 4 mg/day dose arm compared to placebo. The 2 mg/day dose arm did not demonstrate a statistically significant difference from placebo in the ADHD RS-IV total score and did not statistically separate from placebo in the CGI-S scores. Both dasotraline 4mg and 2mg arms were generally well tolerated with an adverse event (AE) profile consistent with completed adult dasotraline studies. 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.

Sunovion Pharmaceuticals Inc. Announces Phase 2/3 Study (SEP360-221)

Sunovion Pharmaceuticals Inc. announced that a Phase 2/3 study (SEP360-221), the first of two planned pivotal studies, evaluating its novel drug candidate dasotraline in adults ages 18 to 55 years with moderate to severe binge eating disorder (BED) met the primary efficacy endpoint as well as all key secondary efficacy endpoints.1 Sunovion also announced that the Phase 3 study (SEP360-301) evaluating dasotraline in adults ages 18 to 55 years with attention deficit hyperactivity disorder (ADHD) did not meet its primary endpoint. In study SEP360-221, flexibly-dosed dasotraline 4-8 mg/day demonstrated statistically significant improvement at the 12 week primary endpoint on the change from baseline in number of binge days per week compared to the placebo-treated group. In addition, dasotraline treatment was associated with statistically significant improvement on all key secondary assessments: Clinical Global Impression of Severity of Illness Scale (CGI-S), the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) and percent of subjects with four-week cessation from binge eating. In study SEP360-301, fixed doses of dasotraline 4 mg/day and 6 mg/day did not demonstrate statistically significant improvement at the 8 week primary endpoint on the ADHD Rating Scale (RS) IV (with adult prompts) total score compared to the placebo-treated group.1 A trend toward greater improvement for the 6 mg/day group at study endpoint compared to placebo was observed (p=0.074). Statistically significant improvement on the CGI-S was observed for the 6 mg/day group (but not the 4 mg/day group) at study endpoint (p=0.011). While the overall improvement associated with the dasotraline treatment groups was consistent with prior studies, a relatively large improvement was seen in the placebo group on the ADHD RS-IV, which may have contributed to the observed lack of statistical separation at primary endpoint. The studies reported add to previously reported efficacy and safety data for dasotraline including a pivotal Phase 2/3 study in children ages 6 to 12 years with ADHD that met its primary endpoint for the 4 mg/day dose and a positive, pivotal adult ADHD Phase 2 study that met its primary endpoint for the 8 mg/day dose. Adverse events for study SEP360-221 and study SEP360-301 were consistent with completed adult dasotraline studies1 and included insomnia, dry mouth, decreased appetite, anxiety, nausea and decreased weight. Full results of study SEP360-221 and study SEP360-301 are being analyzed and will be presented at upcoming scientific meetings.

Novartis Signs Licensing Agreement with Sunovion Pharmaceuticals Inc

Novartis announced signed a licensing agreement with Sunovion Pharmaceuticals Inc., for the US commercial rights to its three treatments for chronic obstructive pulmonary disease, Utibron(TM) Neohaler® (indacaterol/glycopyrrolate) inhalation powder, Seebri(TM) Neohaler® (glycopyrrolate) inhalation powder, and Arcapta® Neohaler® (indacaterol) inhalation powder. This license is specific to the US and has no implications outside this market. Novartis will continue to manufacture these medicines for Sunovion. Novartis will also continue to commercialise Ultibro® Breezhaler® (indacaterol/glycopyrronium), Seebri® Breezhaler® (glycopyrronium) and Onbrez® Breezhaler® (indacaterol) to COPD patients outside of the US.

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