UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported): September 27, 2007
VANDA
PHARMACEUTICALS INC.
(Exact
name of Registrant as specified in its charter)
Delaware
(State
or
other jurisdiction of incorporation)
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000-51863
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03-0491827
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(Commission
File No.)
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(IRS
Employer Identification No.)
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9605
Medical Center Drive
Suite 300
Rockville,
Maryland 20850
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: (240)
599-4500
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Not
Applicable
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(Former
Name or Former Address, if Changed Since Last
Report)
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Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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On
September 27, 2007, Vanda Pharmaceuticals Inc. issued a press release announcing
the filing of a New Drug Application for iloperidone with the United States
Food
and Drug Association. The full text of this press release is furnished as
Exhibit 99.1 to this Current Report on Form 8-K.
Item
9.01. Financial
Statements and Exhibits.
(d) Exhibits
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Exhibit No.
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Description
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99.1
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Press
release of Vanda Pharmaceuticals Inc. dated September 27,
2007.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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VANDA
PHARMACEUTICALS INC.
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By:
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/s/
STEVEN
A. SHALLCROSS
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Name:
Steven A. Shallcross
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Title:
Senior Vice President, Chief Financial Officer and
Treasurer
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Dated:
September 27, 2007
PRESS
RELEASE
VANDA
PHARMACEUTICALS SUBMITS ILOPERIDONE
NEW
DRUG APPLICATION
ROCKVILLE,
Md., Sept. 27 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq:
VNDA) announced today that it has submitted a New Drug Application (NDA) to
the
U.S. Food and Drug Administration (FDA) for iloperidone, an investigational
atypical antipsychotic for the treatment of schizophrenia. The application
includes data from 35
clinical
trials and more than 3,000 patients treated with iloperidone.
Iloperidone
has demonstrated efficacy in treating the symptoms of schizophrenia both in
the
acute and the chronic setting. Iloperidone's binding to a number of dopamine
and
serotonin receptors provides a favorable safety profile on adverse symptoms,
such as weight gain, extrapyramidal symptoms, akathisia and prolactin elevation.
The NDA submission also contains pharmacogenetic
data aimed to further improve the benefit/risk profile of iloperidone in the
treatment of patients with schizophrenia.
“The
submission of the iloperidone NDA marks a significant milestone for Vanda.
Iloperidone
may become an important instrument in the treatment of patients with
schizophrenia and may help to usher the field of psychiatry into an era of
personalized medicine,”
said
Mihael H. Polymeropoulos, M.D., President and CEO, Vanda Pharmaceuticals
Inc.
“For
a
serious brain disorder like schizophrenia, which affects about three million
Americans in the prime of life, it is vital that new pharmacotherapeutic agents
be developed in light of the fact that existing antipsychotic treatments work
partially in some patients and not others, leaving many patients continuously
disabled. The NIMH-funded CATIE effectiveness study revealed the efficacy or
safety limitations of current agents. Iloperidone is a new antipsychotic that
could offer an important new option for many patients suffering from
schizophrenia,”
said Dr.
Henry Nasrallah, Professor of Psychiatry, Neurology, and Neuroscience,
University of Cincinnati College of Medicine.
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharma.com
First
Step Towards Personalized Medicine
“The
application of
personalized medicine in schizophrenia is significant because response to drugs
varies considerably and discontinuation of treatment is high among
patients,”
said Dr.
Anil
Malholtra, Director,
Psychiatry Research, Zucker Hillside Hospital.
“Advancements
in personalized medicine could change the treatment paradigm for schizophrenia,
and possibly other mental illnesses,”
said
Michael
Fitzpatrick, Executive Director, NAMI (National Alliance on Mental
Illness).
Unmet
Needs in Schizophrenia
Schizophrenia
is a chronic, severe and disabling brain disorder that affects approximately
one
percent of Americans. 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 particular 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 for sleep disorders. Vanda's
third
product candidate in clinical development, VSF-173, is currently in a Phase
II
trial for the treatment of excessive sleepiness. For
more
on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
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 June 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.
#
# #
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharma.com
Contact
information
Steven
A.
Shallcross, Chief Financial Officer, +1-240-599-4500, steven.shallcross@vandapharma.com,
or Chip Clark, Chief Business Officer, +1-240-599-4500,
chip.clark@vandapharma.com, both of Vanda Pharmaceuticals Inc.
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharma.com