Vanda Pharmaceuticals, Inc. (VNDA)

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European Medicines Agency Accepts Vanda Pharmaceuticals Inc.'s Marketing Authorization Application For Oral Iloperidone Tablets

Press Release Source: Vanda Pharmaceuticals Inc. On Tuesday July 26, 2011, 7:00 am

ROCKVILLE, Md., July 26, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA - News) announced today that the European Medicines Agency (EMA) accepted for evaluation Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets. Iloperidone is an atypical antipsychotic for the treatment of schizophrenia in adults.

"The submission in the European Union is an important milestone towards advancing the iloperidone franchise," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "This continues our efforts to expand the availability of Fanapt® to markets outside the U.S. and Canada."

Iloperidone is currently marketed in the U.S. by Novartis Pharmaceuticals Corporation, an affiliate of Vanda's sublicensor Novartis Pharma AG, under the name Fanapt®. Under a 2009 agreement, Novartis has exclusive rights relating to the development and commercialization of iloperidone in the U.S. and Canada. Under the terms of such agreement, Vanda retained rights to commercialize iloperidone oral and long-acting injectable formulations outside the U.S. and Canada.