As I understand, this was not fully anticipated...
Company Press Release
SOURCE: Elite Laboratories, Inc.
Elite Develops Patented Drug
Delivery System for Methylphenidate Drugs
NORTHVALE, N.J., Nov. 19 /PRNewswire/ -- U.S. Patent No. 5,837,284 was awarded
yesterday to Dr. Atul M. Mehta of Elite Laboratories, Inc., a wholly owned subsidiary of Elite
Pharmaceuticals, Inc. (ELIP). The patent describes dosage forms of methylphenidate drugs which
permits the one-a-day administration of these valuable pharmaceuticals. A well-known form of
methylphenidate covered by the patent, racemic (dI) methylphenidate, is widely marketed as
RITALIN®. Prior dosage regimes required multiple dosages for treatment of attention deficit
disorder. Such prior regimes were inconvenient for the usual patients, school children, since it
required that drugs be administered during the school day. The pulsed release d-methylphenidate
formulation has as its objective to deliver similar effective blood levels equivalent to the standard
twice-daily dosage.
Pursuant to a Research and Development Agreement, Elite is in the process of assigning the patent
to Celgene Corporation (Nasdaq: CELG - news). However, Elite will retain the rights for this
technology with regard to all non-methylphenidate drugs. According to Dr. Sol J. Barer, President
and COO of Celgene, the pulsed release formulation covered under the new patent has
substantially expanded the intellectual property of Celgene in the methylphenidate area. Elite has
received progress payments from Celgene and has certain manufacturing rights under its agreement.
Elite specializes in the development of oral drug delivery systems. Elite has recently moved its
operations to an expanded facility in Northvale, New Jersey, which will accommodate Elite's
intention to manufacture pharmaceutical products in sufficient quantities to seek FDA approval of
drug products.
All statements other than statements of historical fact contained in this Press Release are
forward-looking statements. Forward-looking statements in this Press Release generally are
accompanied by words such as ''intend,'' ''anticipate,'' ''believe,'' ''estimate,'' ''project,'' or
''expect'' or similar statements. Although the Company believes that the expectations reflected in
such forward-looking statements are reasonable, no assurance can be given that such expectations
will prove correct. Factors that could cause the Company's results to differ materially from the
results discussed in such forward-looking statements include the risks described in the prospectus
of ELIP. All forward-looking statements in this Press Release are expressly qualified in their
entirety by the cautionary statements in this paragraph.
SOURCE: Elite Laboratories, Inc.
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Celgene Corp (Nasdaq:CELG - news)
Related News Categories: biotech, medical/pharmaceutical
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