Vanda Pharmaceuticals Provides Update on Iloperidone
11 9월 2008 - 10:11PM
PR Newswire (US)
ROCKVILLE, Md., Sept. 11 /PRNewswire-FirstCall/ -- Vanda
Pharmaceuticals Inc. (NASDAQ:VNDA), a biopharmaceutical company
focused on the development and commercialization of clinical-stage
product candidates for central nervous system disorders, reported
today that it met with the FDA on September 10, 2008 and discuss
the iloperidone non-approvable action letter that the company
received on July 25, 2008. Vanda presented arguments to support its
belief that iloperidone's benefit risk profile, as it was
characterized in over 3,000 patients, suggests that iloperidone may
be a useful agent for patients with schizophrenia. Vanda has now
agreed to provide a complete response to the FDA, in order to
address the concerns raised by the FDA in their July 25, 2008
action letter. The timing or outcome of any FDA review is uncertain
at this time. ABOUT VANDA PHARMACEUTICALS INC.: Vanda
Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of clinical-stage product
candidates for central nervous system disorders. For more on Vanda
Pharmaceuticals Inc., 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. Vanda is
at an early stage of development and may not ever have any products
that generate significant revenue. Important factors that could
cause actual results to differ materially from those reflected in
the company's forward-looking statements include, among others:
delays in the completion of Vanda's clinical trials; a failure of
Vanda's product candidates to be demonstrably safe and effective;
Vanda's failure to obtain regulatory approval for its products or
to comply with ongoing regulatory requirements; a lack of
acceptance of Vanda's product candidates in the marketplace, or a
failure to become or remain profitable; Vanda's inability to obtain
the capital necessary to fund its research and development
activities; Vanda's failure to identify or obtain rights to new
product candidates; 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" section
(Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the
quarter ended June 30, 2008 (File No. 000-51863). In addition to
the risks described above and in Part II, Item 1A of Vanda's
quarterly report 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. DATASOURCE: Vanda
Pharmaceuticals Inc. CONTACT: Steven A. Shallcross, Senior Vice
President, Chief Financial Officer of Vanda Pharmaceuticals Inc.,
+1-240-599-4500 Web site: http://www.vandapharma.com/
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