Vanda Withdraws Its Marketing Authorization Application For Fanaptum™ In The
WASHINGTON, March 14, 2013
WASHINGTON, March 14, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) announced today that it has withdrawn its Marketing
Authorization Application (MAA) submitted to the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™ (oral
iloperidone tablets) for the treatment of adult patients with schizophrenia.
This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for
Vanda to submit the results from an ongoing relapse prevention, randomized
iloperidone-placebo withdrawal study in patients with schizophrenia. The
results of this study will not be available in the timeframe allowed in the
Vanda intends to reassess its European regulatory strategy for Fanaptum™ once
the results from the Relapse Prevention Study in Patients with Schizophrenia
(REPRIEVE) become available.
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
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
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 for the
treatment of Non-24-Hour Disorder; Vanda's failure to obtain regulatory
approval for tasimelteon for the treatment of Non-24-Hour Disorder or to
comply with ongoing regulatory requirements; Vanda's failure to obtain
regulatory approval for Fanaptum™ for the treatment of schizophrenia in the
European Union; 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, 2012 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.
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