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New Medication Announced For ADD/ADHD

Monday October 25, 7:32 am Eastern Time
Company Press Release
SOURCE: Celgene Corporation

Pivotal Data on Celgene's ATTENADE(TM) Presented at Annual Meeting of American Academy of Child and Adolescent Psychiatry ATTENADE Demonstrates Longer Duration of Action NDA Submission Anticipated by mid-2000; Trials for additional Indications and Claims, Including Adult ADD/ADHD, Planned

WARREN, N.J., Oct. 25 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) today announced that complete analysis of the two pivotal efficacy trials for ATTENADE(TM) (d-methylphenidate), found that the drug met all efficacy parameters for controlling the symptoms of attention deficit disorder (ADD) and attention deficit hyperactivity (ADHD) in school age children. ATTENADE is the chirally pure version of dl-methylphenidate (Ritalin®). The results were presented by James Swanson, Ph.D., professor of pediatrics, psychiatry, and social sciences at the University of California-Irvine at the annual meeting of the American Academy of Child and Adolescent Psychiatry in Chicago.

PLEASE NOTE: AttenadeT is a former trademark (as is RitadexT) and that the drug it is now named FocalinT

More than 200 children participated in the multi-center trials. Both trials compared ATTENADE to placebo; the second trial directly compared the efficacy of both ATTENADE and dl-methylphenidate to placebo. The trial compring and di-methylphenidate demonstrated a statistically significant longer duration of action for ATTENADE. ATTENADE controlled the symptoms of ADD/ADHD at all times measured in the study while dl-methylphenidate did not control the symptoms at the last measurements (5.5 to 6.5 hours after study dosing).

In both trials, behavioral and objective measures were examined. ATTENADE had favorable scores over dl-methylphenidate in all parameters measured. The results of the primary efficacy analysis indicated that ATTENADE was significantly more effective than placebo (p=0.0003) as evaluated by a behavioral scale (Teacher SNAP-ADD/ADHD), signifying an improvement in the clinical status of the children. The results of the second trial confirmed the drug's efficacy, and it demonstrated a significant longer duration of action for ATTENADE versus dl-methylphenidate (p=0.015) as measured by a behavioral scale.

"The results strongly confirmed the earlier Phase I/II trial protocol, which evaluated patients in a 'model classroom' setting and suggested the control afforded by ATTENADE for ADD/ADHD symptoms," said Dr. Swanson. Dr. Swanson is also the director of the UC-Irvine Child Development Center.

The Journal of the American Medical Association has reported that three to six percent of school-age children (elementary to high school) have ADD/ADHD. The condition is characterized by symptoms of inappropriate inattention, hyperactivity and impulsiveness. It estimated that between one and two million children in the U.S. are now being treated for this condition. North American sales of drugs treating these symptoms are estimated to exceed $500 million per year.

"Celgene will incorporate this important data in our New Drug Application (NDA) submission for ATTENADE, which we expect to be completed in the first half of next year," said Sol Barer, Ph.D., President and COO of Celgene. "The company also plans to initiate new clinical trials to assess several critical medical and commercial opportunities for ATTENADE, including the potential for a single-dose regimen to control ADD/ADHD symptoms for a typical school day. We will also assess whether at the end of the day when many children get highly agitated as the drug wears off -- i.e., the rebound effect -- occurs as often and with as much intensity as the currently commercialized racemic form of methylphenidate."

Celgene will also evaluate the potential of ATTENADE to treat the underserved, and commercially substantial, adult ADD/ADHD market, using a less-frequent dosing schedule than is currently employed with other psycho-stimulants including dl-methylphenidate," said Jerome Zeldis, MD, Ph.D., Vice President of Medical Affairs at Celgene. Development of the proprietary pulse-release formulation will also proceed, he noted.

"We are very encouraged by the completed analysis of these pivotal trials, and are optimistic ATTENADE can be an important addition to the ADD/ADHD treatment armamentarium," said Dr. Barer.

The incidence of side effects in the trials was very low. Compared to placebo, both ATTENADE and dl-methylphenidate were associated with decreased appetite and mild abdominal pain. Full evaluation of the safety profile awaits completion of on-going trials early next year.

Celgene holds five patents covering the use and manufacture of d-methylphenidate as both immediate and pulse release formulations.

Celgene Corporation is an independent biopharmaceutical company engaged in the discovery, development and commercialization of small molecule drugs headquartered in Warren, NJ. This release contains certain forward-looking statements that involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q, and 8K reports.

SOURCE: Celgene Corporation

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