TORONTO, Oct. 22 /PRNewswire/ - IntelliPharmaCeutics Ltd. (the "Company") today announced the following with regard to its generic drug commercialization activities.
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 XR(R).
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 of FOCALIN XR(R).
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.
|SOURCE IntelliPharmaCeutics Corp.|
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