Very good news for CELG. Patent looks solid and clears up the confusion that has always surrounded this area. I would expect a US partnership on this now.
Peter
Topic: (NASDAQ:CELG) Celgene Corp,
Headline: Celgene Corporation Awarded Key Patent for Attention Deficit Drug;
Patient Enrollment in Pivotal Clinical Trials Completed, Company Reports
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WARREN, N.J., June 3 /PRNewswire/ -- Celgene Corporation (NASDAQ:CELG)
announced today that the company had been awarded U.S. Patent No. 5,908,850,
which covers methods of treatment for attention deficit disorder with the
company's version of a chirally pure version of RITALIN(R) (d-methylphenidate,
or d-MPH). The patent covers claims for use of the drug for the treatment of
attention deficit disorder (ADD) and attention deficit hyperactivity disorder
(ADHD). Multicenter studies are underway to evaluate different dosages,
therapeutic benefits and the potential for reduced side effects of the Celgene
pharmaceutical.
Celgene also reported that the pivotal clinical trials designed to
demonstrate efficacy of the d-MPH product are fully enrolled. The trials are
being conducted by leading investigators at 18 centers throughout the US
Celgene anticipates completion of the trials this year.
"This patent is a major milestone in our chiral program, and greatly
enhances our proprietary position in the marketplace," said Sol Barer, Ph.D.,
President and COO of Celgene.
Celgene is also developing a "pulse release" formulation of d-MPH.
Initial clinical trials of the "pulse release" formulation are scheduled to
commence later this year. Celgene was assigned a broad U.S. patent on the
"pulse release" formulation of both d-MPH and the racemate late last year.
Approximately one million American children are currently treated for
ADHD, a figure that represents only a portion of those thought to suffer from
the disease. Total North American sales of dl-MPH are estimated to exceed
$400MM/year.
Celgene Corporation, headquartered in Warren, NJ, is engaged in the
development of pharmaceuticals and agrochemicals.
This release contains certain forward-looking statements which 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
-0- 06/03/99
/CONTACT: Sol Barer, Ph.D., of Celgene Corporation, 732-271-1001/
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