Celgene Corporation Announces FDA Acceptance of d-Methylphenidate NDA

The U.S. Food and Drug Administration has accepted for filing the New Drug Application for d-methylphenidate, Celgene's chirally pure version of Ritalin. This marks a crucial milestone in the development and potential marketing of the drug, which is expected to be completed in the third quarter of 2001. Under a worldwide license agreement with Novartis Pharma AG, Celgene will receive a $5 million payment and potentially significant milestone payments and royalties upon approval.

Key Takeaways:

• The FDA has accepted for filing the New Drug Application (NDA) for d-methylphenidate, a chiral version of Ritalin.
• The review is expected to be completed in the third quarter of 2001.
• Celgene will receive a $5 million payment from Novartis Pharma AG upon this milestone.
• Celgene retains the marketing rights to the chirally pure form of Ritalin for potential use in the cancer market.
• Ritalin is a commonly used treatment for attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD) in school-age children, with approximately 1-2 million children in the U.S. treated for these conditions.
• The condition affects 3-6% of school-age children (elementary to high school) and is characterized by symptoms of inattention, hyperactivity, and impulsiveness.

Statistics:

• 3-6% of school-age children (elementary to high school) have ADD/ADHD.
• Between 1 and 2 million children in the U.S. are treated for ADD/ADHD.
• North American sales of drugs treating the symptoms of ADD and ADHD exceed $600 million per year.

Sources:

• PRNewswire, "Celgene Corporation Announces FDA Acceptance of d-methylphenidate NDA", Dec. 27

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• The Journal of the American Medical Association (no specific date or title provided)