Shire's INTUNIV for treating ADHD now available in the U.S.

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17. INTUNIV, a once-daily formulation of guanfacine, is the first and only nonscheduled alpha-2A receptor agonist approved for the treatment of ADHD. In clinical trials, INTUNIV provided significant efficacy across the spectrum of ADHD symptoms that can be disruptive, such as being easily distracted, interrupting others, running around excessively, arguing with adults, and losing temper.

"INTUNIV has been shown to improve a range of ADHD symptoms and provides prescribers and patients with another treatment option for this complex disorder," said Rakesh Jain, MD, MPH, Director of Psychopharmacology Research at R/D Clinical Research, Inc, in Lake Jackson, Texas. "In clinical studies, INTUNIV was shown to provide significant ADHD symptom improvement across a full day, as reported by parents at approximately 6 pm, 8 pm, and 6 am the next morning. These findings suggest that INTUNIV may be an important treatment option for children and adolescents with ADHD who are faced with the complexities of the disorder, both at school and at home. Because of this, many clinicians such as myself, have been highly anticipating its availability."

The US Food and Drug Administration (FDA) approved INTUNIV on September 2, 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.