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

News provided by

Jul 26, 2011, 07:00 ET

ROCKVILLE, Md., July 26, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) 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.

About Schizophrenia

Schizophrenia is a chronic, severe and disabling mental disorder, characterized by profound disruptions in thinking, affecting language, perception, and the sense of self. It often includes psychotic experiences, such as hearing voices or delusions. Schizophrenia typically begins in late adolescence or early adulthood and affects approximately 5 million Europeans or 1.0% of the E.U. population.

About Fanapt®

Fanapt® belongs to a class of medications for schizophrenia known as atypical antipsychotics. Fanapt® has been approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. For full U.S. prescribing information, please visit www.fanapt.com.

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders. For more on Vanda, please visit http://www.vandapharma.com/.

Cautionary Note Regarding Forward-Looking Statements

Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the company's forward-looking statements include, among others: the extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives; Vanda's ability to successfully commercialize Fanapt® outside of the U.S. and Canada; delays in the completion of Vanda's clinical trials; a failure of Vanda's products, product candidates or partnered products to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products, product candidates or partnered products or to comply with ongoing regulatory requirements; a lack of acceptance of Vanda's products, product candidates or partnered products in the marketplace, or a failure to become or remain profitable; Vanda's expectations regarding trends with respect to its costs and expenses; Vanda's inability to obtain the capital necessary to fund additional research and development activities; Vanda's failure to identify or obtain rights to new products or product candidates; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; limitations on Vanda's ability to utilize some or all of its prior net operating losses and research and development credits; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products or product candidates under its license and sublicense agreements and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2010 which is on file with the SEC and available on the SEC's website at www.sec.gov. In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Media Contact:
Cristina Murphy
+1-240-599-4500
[email protected]

SOURCE Vanda Pharmaceuticals Inc.