February 2002

From Ketchum

Concerta® approved for ADHD in first European market

Medication offers relief from 'home to homework'

25 FEBRUARY 2002 -- London, UK -- A new, once-daily treatment for attention deficit hyperactivity disorder (ADHD), Concerta® XL (methylphenidate HCl), has been approved in the United Kingdom, the first European Union country to license the product. Other regulatory reviews of the Janssen-Cilag medication are planned in the remainder of the European Union, and are in process in Latin America and the Asia-Pacific region.

It is estimated that ADHD affects 3-10 percent of school-age children. ADHD is characterised by a persistent inability to concentrate and pay attention, as well as by chronic hyperactivity and uncontrolled impulsiveness. The long-term results may include dysfunctional relationships with family and peers, poor academic achievement, and difficulty in obtaining and keeping gainful employment later in life. Medication is often part of a comprehensive management programme, including social, family and educational interventions.

"ADHD can cause serious disruptions in children's home and school lives, preventing their ability to perform well academically, be accepted by their peers and to integrate into their families," says Dr. Peter Hoare, an expert in ADHD at the Royal Hospital for Sick Children in Edinburgh, Scotland. "ADHD requires proper diagnosis and consistent, ongoing intervention. An effective, once-daily medication can increase initial acceptance of medical treatment and improve longer-term compliance."

Research has shown that Concerta can effectively control ADHD symptoms for 12 hours in adolescents and children as young as age six. This eliminates the need to take medication for the condition during school or extracurricular activities -- a routine that can be difficult to follow and have a negative impact on children's self-esteem. Concerta offers the most sustained relief of any form of methyphenidate -- the active ingredient in Concerta and the compound recommended for use by the UK's National Institute for Clinical Excellence as part of a comprehensive management programme for children with severe ADHD. Methylphenidate also is described as "usually the first choice when drug treatment is called for" in clinical guidelines for hyperkinetic disorder published in the journal European Child & Adolescent Psychiatry.

Concerta is an extended-release formulation of methylphenidate, using a proprietary, tri-layer drug-delivery system called OROS®. Medication is delivered into the bloodstream at a controlled rate, ensuring smooth therapeutic blood levels throughout the day, thus minimising the fluctuations associated with conventional, immediate-release methylphenidate products such as Ritalin®.*

Concerta was developed by the Alza Corp., now a wholly owned subsidiary of Johnson & Johnson [NYSE: JNJ] along with Janssen-Cilag. The product was approved by the U.S. Food and Drug Administration on 1 August 2000 for the treatment of ADHD in adolescents and children aged six and older. In the United States, Concerta is marketed by McNeil Consumer & Specialty Pharmaceuticals, also a member of the Johnson & Johnson family of companies. In the European Union, the UK is serving as the reference state for the mutual-recognition approval procedure. The product will be marketed in the EU and elsewhere by Janssen-Cilag, which has a long track record in developing and marketing treatments for central nervous system disorders.

* Ritalin is a registered trademark of Novartis.











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