Concerta approved for ADHD in first Europ...( compound recommended for use by the UK'...),Health

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.

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Contact: Carrie Monaghan
carrie.monaghan@ketchum.com
44-20-7611-3613
Ketchum
25-Feb-2002

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