Shire withdraws European application for Daytrana (Methylphenidate Transdermal System)

Mar 16 2009

Shire plc has announced that it has decided to withdraw the European Marketing Authorization Application (MAA) for Daytrana (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

A request from European regulators to conduct an additional clinical study on Daytrana in a European patient population combined with the recently announced planned acquisition of the worldwide rights (excluding the US, Canada and Barbados) to Equasym IR and XL (methylphenidate hydrochloride) for the treatment of ADHD are the basis for this decision.

The decision to withdraw the MAA does not impact Shire's commitment to Daytrana in the U.S. where the product has been used as a pediatric treatment for ADHD since 2006.

Equasym IR and XL will provide Shire with an entry to the European ADHD market upon completion of the transaction, which subject to customary completion conditions, is anticipated in Q2 2009. Equasym XL is approved and currently marketed for the treatment of ADHD in children over 6 years of age, and is available in 10 countries outside of the US, Canada and Barbados including Denmark, Finland, Germany, Ireland, Netherlands, Norway, Sweden, UK, Mexico and South Korea. Shire will be working to progress a number of additional planned launches for Equasym XL in European and ROW markets.

Equasym will allow Shire to build on its status as the leader in the United States ADHD market with patients and customers in Europe, and establishes a solid bridge for Shire's other ADHD treatments, including Vyvanse (lisdexamfetamine dimesylate), its flagship ADHD product, in territories outside of the United States. Vyvanse is approved in the US for the treatment of ADHD in children aged 6-12 and adults. Shire continues to enroll patients in two European ADHD trials for Vyvanse.

Shire remains committed to providing a variety of medicines for the treatment of ADHD to benefit ADHD patients and their families around the world.

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18-44 (approx 9.8 million) based on results from the National Comorbidity Survey Replication.

ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific aetiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10).

Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological, or behavioural modification, and medication.

Vyvanse

Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.

Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.

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.

Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.