May 13, 2004

DATA SHOW FOCALIN LA CAPSULES ARE SAFE, EFFICACIOUS IN TREATMENT OF ADHD IN ADULTS

Novartis Pharmaceuticals Corp. and Celgene Corp.'s Focalin LA (dexmethylphenidate, extended-release) capsules are safe and efficacious in the treatment of attention-deficit/hyperactivity disorder in adults, investigators reported.

Focalin LA is a long-acting formulation of Focalin, a pharma brand therapy introduced in 2001 that contains the active isomer of methylphenidate. Novartis has completed Phase III trials of Focalin LA in adults and children.

The current randomized, double-blind study enrolled 184 adults with ADHD, all of whom reported experiencing symptoms consistent with ADHD beginning in childhood.

Participants were assigned to receive one of three doses of Focalin LA (20, 30 or 40 mg) or placebo once daily for five weeks. Efficacy was measured using the Diagnostic and Statistical Manual-IV ADHD Rating Scale.

At study endpoint, mean changes from baseline on the Rating Scale total score were 13.7 with the 20 mg dose, 13.4 with the 30 mg dose and 16.9 with the 40 mg dose. All of these changes were significantly greater than the 7.9-point change observed with placebo.

Focalin LA was well tolerated; adverse events included headache, decreased appetite, dry mouth and insomnia. Withdrawal due to adverse events was similar across all treatment groups.

This study was presented in New York City at the annual meeting of the American Psychiatric Association.

Celgene has licensed worldwide Focalin rights, excluding Canada, to Novartis Pharma AG. The specific Focalin LA formulation was developed using drug-delivery technology from Elan Corp. Plc.

Novartis anticipates submitting a New Drug Application for Focalin LA later this year.

July 3, 2003

IN BRIEF: CELGENE CORP.

Celgene Corp. initiated a study of its pharmaceutical brand Focalin (dexmethylphenidate) LA extended-release capsules, intended to treat adults with attention deficit disorder or attention deficit/hyperactivity disorder. Novartis Pharmaceuticals Corp., which markets the treatment in the United States, will conduct the study of Focalin LA administered once daily in adult patients with ADD/ADHD.