Vanda Receives Negative Opinion from CHMP on Fanaptum™ for the Treatment of Schizophrenia

 Vanda Receives Negative Opinion from CHMP on Fanaptum™ for the Treatment of

PR Newswire

WASHINGTON, Dec. 13, 2012

WASHINGTON, Dec. 13, 2012 /PRNewswire/ --Vanda Pharmaceuticals Inc. (NASDAQ:
VNDA), announced today that the European Medicines Agency's (EMA) Committee
for Medicinal Product for Human Use (CHMP) has issued a negative opinion
recommending against approval of Fanaptum™ (oral iloperidone tablets) for the
treatment of schizophrenia in adult patients in the European Union. The CHMP
was of the opinion that the benefits of Fanaptum™ did not outweigh its risks
and recommended against marketing authorization at this point in time. Vanda
intends to appeal this opinion and request a re-examination of the decision by
the CHMP.

About Vanda Pharmaceuticals Inc.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders. For more on Vanda, please visit 

Company Contact:
Cristina Murphy
Senior Communications Manager
Vanda Pharmaceuticals Inc.
(202) 734-3414

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," "project," "target," "goal,"
"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 inability to reach agreement with the FDA regarding Vanda's regulatory
approval strategy or proposed path to approval for tasimelteon; the failure of
Vanda's clinical trials to demonstrate the safety and/or efficacy of
tasimelteon in the treatment of Non-24-Hour Disorder or Major Depressive
Disorder; Vanda's failure to obtain regulatory approval for its products,
product candidates or partnered products or to comply with ongoing regulatory
requirements; 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 and its partners' clinical trials; a failure of
Vanda's products, product candidates or partnered products to be demonstrably
safe and effective; 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
revenues, costs, expenses and liabilities; 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, 2011 which is on file with the SEC and
available on the SEC's website at 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.

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