WASHINGTON, July 21, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today
that the European Medicines Agency's Committee for Medicinal
Product for Human Use (CHMP) has adopted a negative opinion
recommending against the marketing authorization 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. Vanda intends to
appeal this opinion and request a re-examination by the
CHMP.
About Vanda Pharmaceuticals Inc.
Vanda is a
global biopharmaceutical company focused on the development and
commercialization of innovative therapies to address high unmet
medical needs and improve the lives of patients. For more on
Vanda Pharmaceuticals Inc., please visit www.vandapharma.com.
About Fanapt®
For full U.S. Prescribing
Information for Fanapt®, including indication, Boxed
Warnings and Important Safety Information, visit our Web site
at www.fanapt.com.
CAUTIONARY NOTE REGARDING Forward-Looking
Statements
Various statements in this press release,
including statements regarding Vanda's intentions to appeal the
decision by the CHMP and request a re-examination, are
"forward-looking statements" under the securities laws. These
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 Vanda's
forward-looking statements include, but are not limited to, the
CHMP's willingness to grant a re-examination 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, 2016 and quarterly report on
Form 10-Q for the quarter ended March 31, 2017, which are
on file with the SEC and available on the SEC's website at
www.sec.gov. Additional factors may be described in those
sections of Vanda's quarterly report for the quarter ended
June 30, 2017, to be filed with the
SEC in the third quarter of 2017. 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.
Investor Contact:
Jim
Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.