Vanda Pharmaceuticals Enters into an Exclusive License Agreement with Probiomed S.A. de C.V. for Commercialization of Fanapt™ in Mexico

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Jul 11, 2011, 07:00 ET

ROCKVILLE, Md., July 11, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced its exclusive license agreement with Probiomed S.A. de C.V., a wholly owned pharmaceutical operating unit of Proquifin S.A. de C.V., for the commercialization of Fanapt™ in Mexico.

"We are very excited to achieve this step on the path towards making Fanapt™ available in Mexico and are very pleased to have Probiomed as our commercial partner," said Mihael H. Polymeropoulos, M.D., Vanda's Chief Executive Officer. "This marks an important milestone for the Fanapt™ brand," added Dr. Polymeropoulos. Probiomed's founder and CEO, Jaime Uribe de la Mora, stated, "Fanapt™ represents a strategic franchise opportunity for our company's neurosciences business unit. We are very pleased to be Vanda's partner for Fanapt™ in Mexico. We expect to submit the regulatory dossier for market authorization review by the end of 2011."

Under the terms of the agreement, Probiomed will seek regulatory approval for Fanapt™ in Mexico. Vanda will supply Probiomed with Fanapt™ drug product for sale and Probiomed's specialty sales force will promote Fanapt™ to psychiatrists and commercialize the drug in Mexico.

With a market of $9.3 billion in annual sales, Mexico is the second largest pharmaceutical market in Latin America and the 14th largest pharmaceutical market in the world.(1)

(1) Source, IMS

About Probiomed

Probiomed is a privately owned Mexican company with more than 40 years of experience in research, development, manufacturing and commercialization of pharmaceutical, biotechnology and vaccines for human health. Probiomed's neuroscience expertise includes development, manufacturing, sales and marketing of antipsychotics and medicines to treat depression, anxiety and bi-polar diseases, in addition to other central nervous system disorders.

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 Pharmaceuticals Inc., 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.

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SOURCE Vanda Pharmaceuticals Inc.