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Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone
New Drug Application
ROCKVILLE, Md.
Nov. 27
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced
today that the U.S. Food and Drug Administration (FDA) has officially
accepted
the New Drug Application (NDA) for iloperidone, an investigational
atypical antipsychotic for the treatment of schizophrenia. Acceptance
of the NDA confirms that the application is sufficiently complete
for FDA review.
About Schizophrenia
Schizophrenia is a chronic,
severe and disabling brain disorder that affects approximately
one percent of Americans. Patients suffering
from schizophrenia exhibit a range of symptoms, which include positive
symptoms such as hallucinations, delusions, negative symptoms such
as emotional withdrawal and cognitive symptoms associated with
significant impairment in social and occupational functioning.
Unmet
Needs in Schizophrenia
Although there are many drugs approved to
treat schizophrenia, including the commonly prescribed "atypical antipsychotics," a
high degree of dissatisfaction remains among physicians and patients.
The recent CATIE (Clinical Antipsychotic Trials of Intervention
Effectiveness) study, conducted by the National Institute of Mental
Health (NIMH) and reported in The New England Journal of Medicine,
evaluated several antipsychotic medications and revealed that 74%
of patients taking antipsychotics discontinued treatment within
18 months, primarily because of insufficient efficacy and tolerability
issues.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals
Inc. is a biopharmaceutical company with a focus on the development
and commercialization of clinical-stage
product candidates for central nervous system disorders. The company
has three product candidates in clinical development. In addition
to iloperidone, Vanda is developing VEC- 162, a compound for the
treatment of sleep and mood disorders which is currently in Phase
III development for sleep disorders. Vanda's third product candidate
in clinical development, VSF-173, is currently in Phase II development
for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals
Inc., please visit http://www.vandapharma.com.
Note Regarding Forward-Looking
Statements
This release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended,
including statements regarding Vanda's plans for its product candidates.
Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and
similar expressions or words identify forward-looking statements.
Such 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 Vanda's forward-looking statements include, among
others, a failure of Vanda's product candidates to be demonstrably
safe and effective, a failure to obtain regulatory approval for
the company's products or to comply with ongoing regulatory requirements,
a lack of acceptance of Vanda's product candidates in the marketplace,
a failure of the company to become or remain profitable, Vanda's
inability to obtain the capital necessary to fund its research
and development activities, a loss of any of the company's key
scientists or management personnel, and other factors that are
described in the "Risk Factors" section (Part II, Item
1A) of Vanda's report on Form 10-Q for the quarter ended September
30, 2007 (File No. 000-51863). No forward-looking statements can
be guaranteed and actual results may differ materially from such
statements. The information in this release is provided only as
of the date of this release, and Vanda undertakes no obligation
to update any forward-looking statements contained in this release
on account of new information, future events, or otherwise, except
as required by law.
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