Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

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May 20 2013Shire plc

Research explores data on treatments for psychiatric disorders; health economics and outcomes research also to be presented

Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association (APA) 166th Annual Meeting in San Francisco, May 18-22. The data being presented represent Shire's ongoing commitment to the clinical research of Vyvanse^® (lisdexamfetamine dimesylate) Capsules, (CII) and INTUNIV® (guanfacine) Extended-Release Tablets, its approved prescription medicines for Attention-Deficit/Hyperactivity Disorder (ADHD). Data being presented include post-hoc analyses from several of its phase 2 clinical studies investigating potential new psychiatric uses of Vyvanse for the adjunctive treatment for Major Depressive Disorder (MDD) and for the treatment of Binge Eating Disorder (BED). Shire also will present health economic data on INTUNIV and outcomes research in ADHD. Vyvanse and INTUNIV should only be used to treat ADHD.

"Shire is committed to research in the field of neuroscience and developing treatment options for conditions that have significant unmet patient need, such as MDD and BED," said Arnaud Partiot, MD, PhD, Shire senior vice president, Research and Development.

Vyvanse is a once-daily prescription medication for patients ages 6 and above with Attention-Deficit/Hyperactivity disorder (ADHD) and may be used as part of a total treatment program that may include counseling or other therapies.

Vyvanse is a Schedule II controlled substance. CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence.

INTUNIV is indicated for the treatment of ADHD as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 8 weeks has not been systematically evaluated. The physician electing to use INTUNIV for extended periods should periodically reevaluate its long-term usefulness for the individual patient.

Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine should not take INTUNIV. Hypotension, bradycardia, and syncope were observed in clinical trials. Somnolence and sedation were commonly reported adverse reactions in clinical studies.

The titles, dates, and times of the APA scientific presentations are noted below. Specific information about the data contained in these scientific presentations is embargoed until the respective presentation sessions have occurred at the meeting.

Lisdexamfetamine Dimesylate (Investigational New Uses)

Sunday, May 19, 2013; 8:00am - 9:30am

Poster #NR4-25: "Lisdexamfetamine Dimesylate Safety and Efficacy on Binge Eating Days/Episodes and Behavior in Adults With Moderate to Severe Binge Eating Disorder"

Presenter: Susan McElroy , MD

Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-20: "Effects of Lisdexamfetamine Dimesylate Augmentation on Sexual Function in Adults With Fully or Partially Remitted Major Depressive Disorder"

Presenter: Anita Clayton , MD

Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-41: "Response to Lisdexamfetamine Dimesylate Augmentation in Major Depression in People With or Without Baseline Executive Function Impairment"

Presenter: Andrew Cutler , MD

Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-30: "Lisdexamfetamine Dimesylate Augmentation Therapy in Anxious or Nonanxious Major Depressive Disorder"

Presenter: Bryan Dirks , MD

Monday, May 20, 2013; 2:00pm - 4:00pm

Poster #NR9-38: "Post Hoc Analysis of Lisdexamfetamine Dimesylate Augmentation Therapy Effects on Sleep-Related Endpoints in Adults With Major Depressive Disorder"

Presenter: Angelo Sambunaris , MD

Guanfacine Extended Release (Health Economics and Outcomes Research)