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FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
Date:7/28/2009

PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.

The FDA did not identify safety concerns regarding INTUNIV in the Complete Response letter or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4 to 8 weeks.

"Shire is confident that we will quickly come to agreement on the final product label and anticipates a launch in the fourth quarter as planned," said Mike Cola, President of Shire Specialty Pharmaceuticals. "When approved, INTUNIV will be the first selective alpha-2A receptor agonist for the treatment of ADHD, and will provide patients with an important new treatment option."

About INTUNIV

INTUNIV is being studied for the treatment of ADHD in children and adolescents aged 6 to 17 years. INTUNIV is a once-daily, extended release formulation of guanfacine, designed to provide steady delivery of drug throughout the day. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

Guanfacine, the active ingredient in INTUNIV, is thought to work directly by binding selectively to alpha-2A adrenergic receptors located in the prefrontal cortex - an area of the brain that has been linked to ADHD.(4-6) 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
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SOURCE Shire Plc
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