Positive top-line results from Shire’s Vyvanse Phase 2 study on binge eating disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy of Vyvanse^® (lisdexamfetamine dimesylate) Capsules, (CII) in adults with binge eating disorder. Following discussions with the US Food and Drug Administration (FDA), Shire plans to conduct additional larger studies to confirm the validity of the findings.

The primary objective of the study was to evaluate the efficacy of 30, 50 or 70 mg of Vyvanse compared to placebo in the treatment of binge eating disorder at Week 11 as measured by the number of binge days per week as assessed by clinical interview based on patient diary. A binge day was defined as a day during which at least one binge episode occurred. The primary study end point was the change from baseline to Week 11 in log transformed (number of binge days per week + 1). Vyvanse 50 mg and 70 mg were statistically superior to placebo on the primary end point. Vyvanse 30 mg was not statistically superior to placebo on the primary end point, clarifying the dose range for future trials in this patient population.

Vyvanse is a prescription medicine currently approved in the US and Canada, as well as in Brazil under the name Venvanse, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat ADHD.

Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

The Diagnostic and Statistical Manual of Mental Disorders,Fourth Edition,Text Revision (DSM-IV-TR^®) research criteria for binge eating disorder, as set forth in Appendix B (Criteria Sets and Axes Provided for Further Study), characterizes the disorder by recurrent episodes of eating unusually large amounts of food in a short period of time (eg, within a 2-hour period), and a sense of lack of control over the act of eating during the episode. Binge eating disorder episodes also are associated with at least three of the following: eating more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; often eating alone because of embarrassment by how much food is being eaten; feeling disgusted with oneself, depressed or feeling guilty after overeating. Binge eating occurs, on average, at least two days a week for six months. In addition, marked distress regarding binge eating is present. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.

"Binge eating disorder is a serious condition for which there is no FDA-approved pharmacologic treatment," said Jeffrey Jonas, M.D., Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals and Regenerative Medicine Businesses. "We plan to use these results to work with regulatory agencies to determine our path forward for completing a clinical development program for Vyvanse as a treatment for patients suffering with binge eating disorder. After reviewing our data we will also explore opportunities for identifying biomarkers to aid in the diagnosis and treatment of patients with binge eating disorder."

Susan McElroy, MD, Chief Research Officer, Lindner Center of HOPE and Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine said, "Binge eating disorder is a common and serious condition. Given the lack of any approved pharmacologic treatment, physicians often find it difficult to design effective treatment plans for patients suffering from binge eating disorder. Shire's commitment to research with Vyvanse in this area is encouraging for those afflicted with binge eating disorder."