Vanda Pharmaceuticals Receives Orphan Drug Designation in Europe for tasimelteon

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Mar 08, 2011, 07:00 ET

ROCKVILLE, Md., March 8, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), announced today that the European Commission (EC) has granted orphan drug designation for tasimelteon, an oral dual melatonin receptor agonist in Phase III clinical trails for Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception. This follows the positive opinion on the designation that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency adopted previously in the November 2010 COMP Committee Meeting.

Orphan designation for a medicinal product by the EC provides benefits that can take a variety of forms including tax incentives, protocol assistance, eligibility for grants and initiatives supporting research and development related to this orphan indication, reduction of marketing application fees and annual fees for qualifying companies, and potential marketing exclusivity for up to 10 years in the European Union.

"We are very pleased to receive orphan designation from the European Commission," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda. "This status represents an acknowledgement of the significant unmet medical need to develop and commercialize a treatment that may alleviate sleep/wake problems in people who are totally blind with no light perception."

About Non-24-Hour Sleep/Wake Disorder (N24HSWD)

N24HSWD is a chronic circadian rhythm sleep disorder that occurs when individuals are unable to synchronize their internal clock to the 24-hour light/dark cycle. As a result, the sleep/wake cycle of these individuals moves gradually later and later each day if their circadian period is more than 24 hours or earlier and earlier each day if their circadian period is less than 24 hours. This condition occurs almost entirely in individuals who are totally blind and lack the light sensitivity necessary to reset the circadian clock.

About Vanda Pharmaceuticals Inc:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage 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," 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 to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements for its products; a lack of acceptance of Vanda's 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; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; 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 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, 2009 and quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2010, which are on file with the SEC and available on the SEC's website at http://www.sec.gov/. Additional information will also be set forth in those sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2010, which will be filed with the SEC in the first quarter of 2011. 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.

SOURCE Vanda Pharmaceuticals Inc.