IntelliPharmaCeuitics Ltd. Announces Generic Drug Commercialization Activities

    TORONTO, Oct. 22 /CNW/ - IntelliPharmaCeutics Ltd. (the "Company") today
announced the following with regard to its generic drug commercialization
    In late August of this year, we announced that the Company's operating
affiliate IntelliPharmaCeutics Corp. ("IntelliPharmaCeutics") had received
acceptance from the U.S. Food and Drug Administration for the filing of
IntelliPharmaCeutics' generic drug application (known as an ANDA) for a drug
product it has developed for commercialization with a drug development
partner, using IntelliPharmaCeutics' proprietary controlled release drug
delivery technology. The application seeks the FDA's approval to commercialize
generic versions of each of 4 strengths of a branded drug called FOCALIN
    IntelliPharmaCeutics also filed the FDA's customary form of Paragraph IV
certification which IntelliPharmaCeutics had delivered to the owners of
certain patents listed with the FDA as pertaining to FOCALIN XR(R). This
certification contains IntelliPharmaCeutics' indication that it believes that
its generic versions of FOCALIN XR(R) do not infringe those patents and/or
that the patents are invalid or unenforceable.
    These generic drug products have been developed by IntelliPharmaCeutics
under a collaboration arrangement with Par Pharmaceutical, Inc. ("Par" or "Par
Pharmaceutical") which includes agreement that Par will be responsible for
litigation and its costs. Par is the agent for IntelliPharmaCeutics in respect
of its filing with the FDA for approval to commercialize the generic versions
    Early in October, 2007, certain parties who have claimed to hold patents
relating to FOCALIN XR(R) filed complaints alleging patent infringement. The
complaints make such allegations against one or more of the Company,
IntelliPharmaCeutics and Par. They comprise a complaint by Elan Corporation,
PLC which alleges ownership of two pertinent U.S. patents and a complaint by
Celgene Corporation, Norvartis Pharmaceutical and Novartis Pharma AG, which
alleges ownership by Celgene of five pertinent U.S. patents. The latter
complaint alleges that Novartis AG is the exclusive licensee and that Novartis
Pharmaceutical is the manufacturer and distributor for FOCALIN XR(R) in the
United States.
    Lawsuits such as these are an ordinary and expected part of the process
of obtaining approval to commercialize a generic drug product in the United
States. The Company remains confident that IntelliPharmaCeutics' generic
versions of FOCALIN XR(R) do not infringe those patents. Together with its
development partner, Par Pharmaceutical, IntelliPharmaCeutics intends to
vigorously defend against the complaints described above.

For further information:

For further information: John Allport, VP Legal Affairs,
IntelliPharmaCeutics Corp., 30 Worcester Road, Toronto, Ontario, M9W 5X2, Tel:
(416) 798-3001 Ext. 104, Fax: (416) 798-4276

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