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FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Date:4/23/2008

Within the First Eight Months Since its Introduction in the United States,

VYVANSE has Achieved Over One Million Prescriptions In a Clinical Study With Adults, VYVANSE was Shown to Significantly Improve

the Symptoms of ADHD (Inattention, Hyperactivity and Impulsivity)(1)

BASINGSTOKE, England and PHILADELPHIA, April 23 /PRNewswire-FirstCall/ -- 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(TM) (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.(2)

"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 Shire's 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
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SOURCE Shire PLC
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