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Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide
Date:11/9/2009

Once-daily INTUNIV is now available in US pharmacies in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg) and is marketed in the United States by the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

"INTUNIV is the newest ADHD treatment to receive FDA approval and the latest addition to the Shire ADHD portfolio. The availability of INTUNIV now allows physicians to prescribe the first and only nonscheduled alpha-2A receptor agonist indicated for the treatment of ADHD to help their patients manage a range of ADHD symptoms," said Michael Yasick, Senior Vice President of the ADHD Business Unit at Shire. "Shire is proud to provide physicians and the ADHD community with a novel treatment choice, which expands the range of available treatment options, allowing physicians to optimize the management of ADHD."

The commitment of Shire to making INTUNIV available for ADHD patients is consistent with the company's strategy to expand and diversify its ADHD portfolio, which now consists of four ADHD treatment options of scheduled and nonscheduled medicines in the United States and three medicines approved for the treatment of ADHD outside the United States.

About INTUNIV

The efficacy of INTUNIV in the treatment of ADHD was established in two, similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV®) criteria for ADHD. Statistically significant improvements were reported by investigators, parents, and teachers.

The first pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 345 children aged 6 to 17 years to either
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SOURCE Shire plc
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