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): October 30, 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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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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Item
8.01. Other Events.
On
October 30, 2006, Vanda Pharmaceuticals Inc. issued a press release announcing
the top-line results from its Proof-of-Concept Phase II clinical trial
evaluating VSF-173 in a clinical model of excessive sleepiness. 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 October 30,
2007.
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SIGNATURE
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:
October 30, 2007
Press
Release
Vanda
Pharmaceuticals' VSF-173 Excessive Sleepiness Phase II
Clinical
Trial Suggests Wake-Promoting Properties
ROCKVILLE,
Md.,
-
October 30, 2007 - /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, today announced top-line results from the Company's
Proof-of-Concept Phase II clinical trial evaluating VSF-173 in a clinical model
of excessive sleepiness.
This
Phase II study examined the effects of VSF-173 on a model of excessive
sleepiness among 55 healthy volunteers treated with 3 doses of VSF-173
administered at 50 mg, 100 mg and 200 mg and placebo administered at 25 mg,
50
mg and 100 mg at the usual bedtime and at four hours after the first dose.
In this model, the effect of the compound was evaluated with a series of six
Maintenance of Wakefulness Tests (MWT) given two hours apart starting one hour
after the first dose. The effect of the drug was also evaluated on the scheduled
daytime recovery sleep following the night time and morning
evaluations.
On
the
primary endpoint which evaluated the effect of the compound on the first four
series of MWT tests, VSF-173 demonstrated improvements over placebo. The mean
MWT sleep onset scores for the 50 mg, 100 mg and 200 mg, and placebo groups
were
10.3, 12.9, 10.6 and 9.2 minutes, respectively. While the pair-wise analysis
did
not reach statistical significance, this magnitude of effect, ranging from
1.1
to 3.7 minutes, is generally similar to that observed with modafinil in the
treatment of patients with narcolepsy.
In
a
subset of 37 subjects with no observed impairment in pre-dose daytime
wakefulness (MWT cutoff equal to 30 minutes), the mean of all six MWT scores
for
the 50 mg, 100 mg and 200 mg groups showed improvements of 2.1, 3.4 and 2.1
minutes, respectively, compared to placebo. For the dose group of 100 mg, this
observation of improvement was statistically significant (p <
0.05).
Further
evidence of the wake-promoting properties of VSF-173 was also observed during
the scheduled daytime recovery sleep following the night time and morning
evaluations. Statistically significant (p<.05; non-parametric) dose-dependent
correlations were observed with the following polysomnography (PSG) parameters:
increased number of awakenings, decreased sleep efficiency and total sleep
time
for the first third of the sleep period, and increased wake time after sleep
onset for the first 3 hours of the sleep period.
These
wake-promoting effects of VSF-173 on MWT and PSG measures suggest that VSF-173
possesses a novel mechanism to address disorders of excessive sleepiness. Vanda
plans to conduct additional studies to further understand timing of
administration, dose-response and appropriate populations to treat. VSF-173
was
also demonstrated to be safe and well-tolerated.
“We
are
encouraged by the results of this proof-of-concept study on VSF-173” stated
Mihael Polymeropoulos, M.D., President and CEO of Vanda. “We believe that the
compound has the potential to address the symptoms of excessive sleepiness
in
the context of a number of disorders including narcolepsy and shift worker
sleep
disorder, as well as neurodegenerative disorders.”
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 VSF-173, Vanda is developing Iloperidone,
a
drug for schizophrenia, which has recently been submitted for marketing approval
to the FDA, and VEC-162, a compound for the treatment of sleep and mood
disorders, which has recently initiated a Phase III study in primary insomnia.
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 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.
#
# #
Contact
information
Steven
A.
Shallcross, Chief Financial Officer, Vanda Pharmaceuticals Inc.:
(Tel)
240-599-4500; steven.shallcross@vandapharma.com
Chip
Clark, Chief Business Officer, Vanda Pharmaceuticals Inc.:
(Tel)
240-599-4500; chip.clark@vandapharma.com