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Lisdexamfetamine Dimesylate Now Available

Philadelphia, PA– July 27, 2007 – Shire (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that Vyvanse (lisdexamfetamine dimesylate), a new once-daily medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), is now available in U.S. pharmacies nationwide. In a clinical study, Vyvanse provided consistent ADHD symptom control throughout the day based upon parent reports in the morning (approximately 10am), afternoon (approximately 2pm), and early evening (approximately 6pm). This may be of interest to mothers of children with ADHD based on a recent survey of 121 mothers of ADHD children aged 6 to 12 years, in which 60 percent of mothers reported that their child’s ADHD medication stopped working before 6pm and 40 percent reported that their child’s ADHD medication stopped working before 4pm.

“Vyvanse was shown in clinical studies to provide physicians with a treatment option for ADHD that offers consistent and effective control of ADHD symptoms throughout the day for up to 12 hours, from morning through homework and family time,” said Frank A. López, M.D., of the Children’s Developmental Center in Winter Park, Fla. “Consistent symptom control throughout the day is important because kids have homework and after-school activities that require the same concentration and focus needed during the school day.”

This new ADHD medication, Vyvanse , works with the patient’s natural metabolism to deliver active medication and significantly improves core ADHD symptoms of inattention (e.g. focus, listening to, and following instructions) and behavior (hyperactivity and impulsivity).

“I know that my son, Kevin, has unique talents and abilities. When his ADHD symptoms were consistently controlled throughout the day, others could see the wonderful, talented boy that I see,” said Rachel May, mother of Kevin Dixon, Jr. ”After my son started taking Vyvanse in a clinical trial, I saw a difference in Kevin within the first week; others saw it, too.”

The U.S. Food and Drug Administration (FDA) approved Vyvanse on February 23, 2007. Vyvanse is now available in retail pharmacies in 30 mg, 50 mg and 70 mg dosage strengths.

About Vyvanse
In the phase III, randomized, double-blind placebo-controlled study, all three doses of Vyvanse demonstrated significant improvements in ADHD Rating Scale (ADHD-RS-IV) scores compared with placebo (P <.0001 after="" four="" weeks="" of="" once-daily="" treatment.="" adhd-rs-iv="" is="" a="" standardized="" validated="" test="" for="" assessing="" symptoms="" adhd="" in="" children="" and="" their="" response="" to="" the="" effects="" were="" maintained="" throughout="" day="" based="" on="" parent="" ratings="" reported="" at="" approximately="" am="" pm="" using="" connors="" rating="" scale="" cprs="" rates="" child="" behavior="" home="" other="" environments="" where="" has="" opportunity="" observe="" child.="" most="" common="" side="" this="" study="" decreased="" appetite="" difficulty="" falling="" asleep="" stomachache="" irritability.=""> Additional information about Vyvanse , Full Prescribing Information, and Medication Guide are available at

About ADHD
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the onset of which appears before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning and the symptoms cannot be better explained by another psychiatric disorder.

Although there is no “cure” for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.

Source: Shire

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