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Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Date:9/3/2009

PHILADELPHIA, September 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, INTUNIV is thought to directly engage receptors found in the prefrontal cortex - an area of the brain that has been linked in preclinical research to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.

"Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option," said Mike Cola, President of Shire Specialty Pharmaceuticals. "This is a complex disorder in which patients may present with multiple symptoms and behaviors that can be disruptive. INTUNIV expands the Shire ADHD portfolio with a nonscheduled medication, allowing clinicians to optimize their overall approach toward managing ADHD and may help provide symptom control for children and teens with ADHD who often have difficulty responding appropriately to everyday situations and challenges."

Once-daily INTUNIV is expected to be available in US pharmacies in November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg). INTUNIV will be marketed in the United States by the existing Shire ADHD sales team
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