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Thursday September 9, 7:00 am Eastern Time
Company Press Release
SOURCE: Celgene Corporation
Celgene D-MPH (ATTENADE(TM)) Shows Longer Duration of
Action in Pivotal Trials Than Most Common ADHD Drug
NDA Submission Planned For First Half of 2000
WARREN, N.J., Sept. 9 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) today announced initial results of two pivotal efficacy trials
for ATTENADE(TM) (d-methylphenidate), its chirally pure version of dl-methylphenidate (Ritalin®), for the treatment of attention deficit disorder
(ADD) and attention deficit hyperactivity disorder (ADHD). These trials demonstrated that ATTENADE is superior to placebo in controlling the
symptoms of the disorders. In the trial that included ATTENADE, dl-methylphenidate and placebo, ATTENADE exhibited a statistically significant
longer duration of action than dl-methylphenidate. Scientific review of these results will be presented at the October meeting of the American Academy
of Child and Adolescent Psychiatry.
''These initial results are great news for the research into new treatments for this prevalent disorder. The data again confirms the value of Celgene's new
drug at half the dose of the most commonly prescribed treatment for ADHD. Pending regulatory reviews, this new formulation may be a significant step
in the pharmacological treatment of children with ADHD,'' said Declan Quinn, MD, a child and adolescent psychiatrist with the Royal University
Hospital of Saskatoon. The Hospital is affiliated with the University of Saskatchewan, Canada.
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 trials demonstrated a statistically significant longer duration of action for
ATTENADE than dl-methylphenidate.
In both trials, behavioral and objective measures were examined. ATTENADE had improved scores over dl-methylphenidate in all parameters
measured. The results of the primary efficacy analysis for the first trial indicated that ATTENADE was significantly more effective than placebo
(p=0.0003) as evaluated by a behavioral scale (Teacher SNAP-ADHD), signifying an improvement in the clinical status of the children. The results of
the second trial confirmed the drug's efficacy and duration of action. The trial also demonstrated a statistically significant longer duration of action for
ATTENADE versus dl-methylphenidate (p=0.015) as measured by a behavioral scale.
The incidence of side effects in the trials was very low. Compared to placebo, both ATTENADE(TM) and dl-methylphenidate were associated with
decreased appetite and mild abdominal pain. Full evaluation of the safety profile awaits completion of on-going safety trials early next year.
''Surprisingly in both multi-center studies, our initial hypothesis on the duration of action of ATTENADE based upon the Phase I/II study was
confirmed,'' said James Swanson, Ph.D., professor of pediatrics, psychiatry, and social sciences at UC-Irvine. Dr. Swanson served as primary
investigator of the studies.
The Journal of the American Medical Association has reported that three to six percent of school-age children (elementary to high school) have ADHD.
This 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.
''These results justify our optimism that ATTENADE may offer an important new capability in the treatment of ADHD. Data from these two trials, when
fully reviewed, will be incorporated into our New Drug Application (NDA) submission for ATTENADE to the Food and Drug Administration,'' said Dr.
Sol Barer, President of Celgene. ''We anticipate achieving this milestone in the first half of 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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