Nostrum Pharmaceuticals Confident Regarding Outcome Of Shire Laboratories' Carbamazepine ER Litigation

EDISON, N.J., July 26 /PRNewswire/ -- Nostrum Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company engaged in the development and commercialization of generic drugs (ANDAs) and improved formulations of previously approved drugs based upon proprietary drug delivery technologies (505(b)(2) applications), announced today that it remains confident regarding a favorable outcome in the Federal District Court action that Shire Laboratories, Inc., Chesterbrook, Pennsylvania, brought in 2003 alleging that Nostrum's Abbreviated New Drug Application seeking approval from the Food and Drug Administration for an extended release form of Carbamazepine capsule infringes U.S. Patent No. 5,326,570, one of Shire's patents for its product Carbatrol(R). Nirmal Mulye, Ph.D., founder and President of Nostrum, said the following in response to Shire's lawsuit: "Nostrum had asked the Court to rule as a matter of law that the patent would not be infringed. After a day- long hearing on July 15, 2005 in which the Court reviewed the patent and the issues in the case, the Court denied Nostrum's motion 'without prejudice,' indicating the Court's desire to review expert testimony on the meaning of the patent's claims before ruling on the merits. Nevertheless, Nostrum is encouraged by the Court's statement that Nostrum may re-introduce its motion after the parties complete expert discovery in the next few months, and is extremely pleased with the Court's attention to the case and the issues raised in its motion. Nostrum remains confident that its formulation does not infringe the Shire patent."

Nostrum Pharmaceuticals, Inc.

CONTACT: Nirmal Mulye, Ph.D., President and Chairman of the Board, +1-732-635-0036, nirmal@nostrumpharma.com, or Lynne Robertson, Ph.D., VicePresident - Operations, +1-732-635-0042, both of Nostrum Pharmaceuticals,Inc.

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