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FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults
Date:4/23/2008

Basingstoke, U.K. and Philadelphia, PA April 23, 2008 Shire plc (LSE: SHP, NASDAQ: SHPGY,), the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE (lisdexamfetamine dimesylate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. VYVANSE, introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years, is now the first and only once-daily prodrug stimulant approved to treat adults with ADHD. In its first eight months of availability, more than one million VYVANSE prescriptions have been filled.

We are very pleased with this FDA approval of the adult indication for VYVANSE, said Matthew Emmens, Chief Executive Officer of Shire. This approval provides physicians a new treatment option that can help their adult patients by significantly improving their ADHD symptoms. VYVANSE has been well accepted by the medical community. With Shires experience as a leader in the development and commercialization of ADHD medications, we are confident that this approval for adult patients will help continue to increase prescription share and volume of VYVANSE.

Many people may think of ADHD as only a childhood disorder but the fact is that the majority of children diagnosed with ADHD still have symptoms as an adult. These symptoms can significantly impact them at work, home and in relationships, where they have important responsibilities, said David W. Goodman, assistant professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine and director of the Adult Attention Deficit Disorder Center of Maryland. The good news is that in a clinical study with adults, one daily dose of VYVANSE significantly improved ADHD symptoms of inattention, such as the ability to focus and organize, as well as hyperactivity and impulsivity.

Since VYVANSE became available for children with ADHD in
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Contact: Matthew Cabrey, Shire
484-595-8248
Porter Novelli
Source:Eurekalert

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