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Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Shire Announces Filing of SPD465 for the Treatment of Adult ADHD

BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, July 21, 2006 -- Shire plc announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population. The application is subject to a 12-month FDA review period. SPD465 has the same active ingredient as Adderall XR (mixed salts of a single-entity amphetamine product), but is designed to provide ADHD symptom control for up to 16 hours. Upon approval, this novel product will be the first and only ADHD stimulant product that controls inattention, hyperactivity and impulsivity for up to 16 hours.

"The FDA filing for SPD465 is another milestone met and underscores Shire's commitment to be the market leader in ADHD treatments by offering patients new solutions to manage this chronic disorder," said Matthew Emmens, Shire Chief Executive Officer. "If approved, the 16-hour formulation of SPD465 would make it the longest-acting stimulant medication for adult patients with ADHD, while also providing the efficacy of Adderall XR, the most prescribed brand of ADHD treatment."

ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level. Scientists now agree that up to 65 percent of adolescents with ADHD will continue to have the ADHD diagnosis as adults. More than 9 million American adults currently exhibit symptoms of ADHD, based on independent research by the National Institute of Mental Health. Approximately 36 percent of ADHD prescriptions are currently written for adult patients.

About SPD465

SPD465, a mixed amphetamine salt formulation designed to provide sustained release of medication and symptom control for up to 16 hours, is being studied for the treatment of ADHD in adults. The most common adverse events reported in SPD465 phase 3 studies were insomnia, decreased appetite and stomachache.

About Adderall XR

Adderall XR was generally well tolerated in clinical studies. The most common side effects in studies included: children - decreased appetite, difficulty falling asleep, stomachache, and emotional lability; adolescents - loss of appetite, difficulty falling asleep, stomachache, and weight loss; adults - dry mouth, loss of appetite, difficulty falling asleep, headache, and weight loss.

Tell your doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Adderall XR should not be taken by patients who are currently taking or have recently taken a type of antidepressant called a MAO inhibitor, have a history of high blood pressure, problems with alcohol or drugs, agitated states, or glaucoma. Patients should also tell the doctor if they have seizures, visual disturbances, thyroid problems, abnormal thoughts/behaviors, bipolar disorder, depression, or other mental illness, or a known allergy to this type of medication.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use. Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. There is a potential for worsening of motion or verbal tics and Tourette's syndrome. Report any new psychological symptoms to the doctor and inform the doctor immediately of any symptoms that suggest heart problems, such as chest pain or fainting.

Source: Shire plc

Posted: July 2006

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