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February 14, 2016 3:52 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.

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
Head of Global Business Development and Executive Vice President
Compensation as of Fiscal Year 2015.

Sunovion Pharmaceuticals Inc. Key Developments

Sunovion Pharmaceuticals Inc. Announces Results from a Study Evaluating the Abuse Potential of Investigational Drug Dasotraline

Sunovion Pharmaceuticals Inc. announced results from a human abuse liability study of dasotraline, the company’s investigational medicine in late-stage development to evaluate its use in treating the symptoms of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder. Human abuse liability studies are conducted to evaluate the abuse potential associated with drugs that affect the central nervous system. This Phase I study found that dasotraline single doses of 8 mg, 16 mg and 36 mg were not significantly different compared to placebo on the primary endpoint and most secondary endpoints – all of which assessed the potential for abuse – and were associated with significantly lower “drug liking” compared to 40 mg and 80 mg single doses of methylphenidate. Results of the study were published online in Drug & Alcohol Dependence, an international journal sponsored by the College on Problems of Drug Dependence, and will also appear in a forthcoming print edition of the journal. In this randomized, double-blind, double-dummy, 6-way crossover study, the abuse potential of single doses of dasotraline (8 mg, 16 mg and 36 mg) was compared to placebo and methylphenidate (40 mg and 80 mg; positive controls) in a total of 48 randomized subjects who were healthy adult recreational stimulant users. Dasotraline 16 and 36 mg doses were included in the study for the purpose of assessing abuse potential. The 36 mg dose is considered supratherapeutic. The pharmacodynamic effect was assessed pre-dose and over 72 hours post-dose using the Drug Liking Visual Analog Scale (VAS). The primary endpoint was the drug liking VAS score at the time of peak effect (Emax). This is a standard measure of abuse liability in human abuse liability studies and is considered one of the most sensitive indices of abuse liability. Both doses of methylphenidate were associated with significantly higher VAS-drug liking scores at Emax compared with dasotraline 8 mg (P<0.001), 16 mg (P<0.001) and 36 mg (P<0.01). There were no significant differences between dasotraline (8 mg, 16 mg) and placebo across secondary endpoints. Results showed that 36 mg of dasotraline was associated with statistically significant disliking compared to placebo and methylphenidate, as measured by Overall Drug Liking (Emin) VAS scores. Additionally, significantly greater peak effects were observed for both doses of methylphenidate compared to placebo, thus confirming the validity of both the study population and the study measures as an assay for potential stimulant abuse liability. The 8 mg and 16 mg of dasotraline were generally well-tolerated in this study, with an incidence of adverse events that was similar to placebo, with the exception of a higher incidence of insomnia on the two dasotraline doses and headache on the 16 mg dose. A higher incidence of adverse events was observed on dasotraline 36 mg – a dose that is higher than the anticipated maximum therapeutic dose – and on the two doses of methylphenidate.

SanBio, Inc. and Sunovion Pharmaceuticals, Inc. Begin Patient Recruitment for Phase 2B Trial to Test Regenerative Treatment for Chronic Stroke in North America

SanBio, Inc. announced that it has initiated patient recruitment for a Phase 2b clinical trial to further test the safety and efficacy of its proprietary cell therapy. SanBio is working closely with Sunovion Pharmaceuticals, Inc. on the conduct of the clinical trial. Earlier clinical trial results suggested the therapy's potential to improve motor function following an ischemic stroke. SanBio and Sumitomo Dainippon Pharma have entered into a joint development and license agreement for exclusive marketing rights in North America for SB623 for chronic stroke. Ischemic strokes account for approximately 87% of all strokes in the United States and occur when there is an obstruction in a blood vessel supplying oxygen to the brain. With approximately 800,000 strokes occurring in the United States every year, stroke is the leading cause of acquired disability in the United States. Therapies for acute stroke generally do not result in meaningful improvement beyond the first six months following a stroke. The ACTIsSIMA Phase 2b clinical trial follows a Phase 1/2a clinical trial in which the SB623 cell treatment suggested improvements in motor function. The Phase 2b clinical trial will further evaluate the safety and efficacy of SB623 treatment. There are expected to be approximately 60 clinical trial sites throughout the United States, and total enrollment is expected to reach 156 patients. The ACTIsSIMA trial will examine the efficacy of SB623, modified adult bone-marrow-derived stem cells, when administered to patients with chronic motor deficit secondary to ischemic stroke. A secondary purpose is to evaluate the safety of SB623 in these patients.

Sunovion Announces Results of Health Outcomes Analyses Exploring the Effectiveness of Aptiom® (Eslicarbazepine Acetate) in People with Partial-Onset Seizures

Sunovion Pharmaceuticals Inc. announced results of Health Economics and Outcomes Research (HEOR) analyses from two Phase 3 Aptiom® (eslicarbazepine acetate) monotherapy clinical trials; and a claims analysis of a large database of patients with epilepsy. The results were presented during the 69thAmerican Epilepsy Society (AES) Annual Meeting in Philadelphia. In August 2015, Sunovion announced that the U.S. Food and Drug Administration (FDA) approved the use of APTIOM as monotherapy for the treatment of partial-onset seizures. APTIOM may be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs (AEDs) to APTIOM. A post-hoc pooled analysis of two historical-controlled Phase 3 APTIOM monotherapy clinical trials (Studies 093-045 and 093-046) showed that patients with partial-onset seizures who achieved a clinical response after converting from a multi-AED regimen to APTIOM monotherapy experienced quality of life improvements after 10 weeks. A separate analysis of these studies also showed that patients with partial-onset seizures experienced statistically and clinically significant improvements in depressive symptoms after 10 weeks, following successful conversion from their current AED regimen to APTIOM monotherapy. During AES, Sunovion also presented an analysis from the IMS PharMetrics Plus database. The results indicated that, after controlling for baseline confounders, patients initiating AED therapy with one pill/day had fewer annual hospitalizations and emergency room visits than initiating AED therapy with two or more pills/day. Pooled data from two historical-controlled Phase 3 studies (093-045 and 093-046) evaluated patients who had completed 10 weeks of APTIOM monotherapy (n=224) for change in health-related quality of life, using Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire. The QOLIE-31 is an instrument that assesses daily functioning and overall well-being in patients with epilepsy. The mean change in QOLIE-31 Total Score and seven subscale scores from baseline to Week 18 were compared to standard minimal clinically-important difference (MCID) change scores. The results showed that the mean change in QOLIE-31 Total Score and five of the seven subscales (Medication Effects, Seizure Worry, Social Functioning, Overall Quality of Life, Cognitive Functioning, and Energy/Fatigue) were greater than their respective MCIDs; these changes were statistically significant for Medication Effects (p=0.011), and Social Functioning (p=0.008). Change in Depressive Symptoms Among Patients With Refractory Partial-Onset Seizures Treated With Eslicarbazepine Acetate Monotherapy: A Pooled Analysis of Clinical Trials (Poster 2.249, Presented Sunday, December 6, 8:00 a.m. 4:00 p.m. ET). Pooled data from two historical-controlled Phase 3 studies (093-045 and 093-046) evaluated patients who had completed 10 weeks of APTIOM monotherapy (Completers, n=224), as well as a subset of these patients who achieved a clinical response after 10 weeks of treatment (Responders, n=117), for change in depressive symptoms, using the Montgomery-.sberg Depression Rating Scale (MADRS) questionnaire. The MADRS is a 10-item instrument used to identify moderate-to-severe depressive symptoms. MADRS scores were compared to Population-level MCID change scores (range: 1.3 to 1.6); and Treatment effect MCID change scores (1 point versus active treatment or 2 points versus placebo).

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