Vanda Receives Negative Opinion from CHMP on Fanaptum™ for the
Treatment of Schizophrenia
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 http://www.vandapharma.com.
Company Contact:
Cristina
Murphy
Senior Communications Manager
Vanda Pharmaceuticals Inc.
(202) 734-3414
cristina.murphy@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," "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 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.
SOURCE Vanda Pharmaceuticals Inc.