Celgene Gains Patent for Once-Daily Dosage of D-methylphenidate

The U.S. Patent and Trademark Office has awarded Celgene Corp. (Warren, NJ) U.S. Patent No. 5,922,736 for the once-daily administration of d-methylphenidate, the chirally pure version of Ritalin (dl-methylphenidate) for the treatment of attention deficit-hyperactivity disorder (ADHD). The patent covers both methods and formulations for the pharmaceutical, which is being evaluated in clinical trials in the United States and Canada.

Celgene believes that the single-dose administration of d-methylphenidate may help many ADHD patients better comply with their treatment. According to Jerome Zeldis, vice president for Medical Affairs and co-author of the patent, simplifying the dosage regimen for ADHD patients could afford substantial benefits for ADHD patients and their healthcare providers, particularly at school. "If demonstrated clinically, administration of d-methylphenidate for ADHD outside of the school setting would eliminate the need for children to report to their school nurse's offices for treatment, easing the visibility and stigma of their condition and easing the burden on the school," Zeldis noted.

Celgene's clinical trial for d-methylphenidate is fully enrolled at 18 centers throughout the United States, and will be completed this year. Clinical studies are underway to evaluate different dosages, as well as the therapeutic benefits and the potential for reduced side effects of d-methylphenidate.

Celgene Corp. is engaged in the development of pharmaceuticals and agrochemicals.

For more information: Jerome Zeldis, VP for Medical Affairs, Celgene Corp., 7 Powder Horn Dr., Warren, NJ 07059. Tel: 732-271-1001. Fax: 732-271-4184.