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Long-term treatment with VYVANSE, first prodrug stimulant, demonstrates significant efficacy in ADHD

SAN DIEGO May 23, 2007 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced that VYVANSE (lisdexamfetamine dimesylate) effectively controlled Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children aged 6 to 12 years. In addition, 95 percent of children taking VYVANSE daily for 12 months showed overall improvement, according to phase III open-label extension trial results. Further analysis of phase II clinical data demonstrated that VYVANSE provided consistent time to maximum concentration of d-amphetamine from patient to patient. Both studies were presented today at the annual meeting of the American Psychiatric Association (APA).

The U.S. Food and Drug Administration (FDA) approved VYVANSE for the treatment of ADHD on Feb. 23, 2007. VYVANSE remains on track for commercial launch in June 2007.

"Our research concluded that patients taking a daily morning dose of VYVANSE for up to 12 months demonstrated consistent control in ADHD symptoms from month to month," said Robert Findling, M.D., lead investigator of the long-term open-label study and Professor of Psychiatry at Case Western Reserve University and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center. "As the first prodrug stimulant, VYVANSE will provide a novel approach to the delivery of stimulant medication for the treatment of ADHD."

Long-term Treatment with VYVANSE Yields Significant ADHD Symptom Improvement

In the long-term open-label extension trial, patients taking VYVANSE showed a greater than 60 percent improvement in the symptoms of ADHD, based on the participants' average change in ADHD Rating Scale (ADHD-RS-IV) scores* from baseline, the primary endpoint, after one year of treatment. Specifically, mean scores decreased 63 percent from baseline (P <.0001). Additionally, 95 percent of patients who received 12 months of daily treatment were rated as "very much improved" or "mu
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Contact: Marion E. Glick
212-601-8273
Porter Novelli
23-May-2007


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