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): December 12, 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
December 12, 2007, Vanda Pharmaceuticals Inc. issued a press release disclosing
certain Phase III efficacy data from its New Drug Application for iloperidone.
The full text of this press release is furnished as Exhibit 99.1 to this Current
Report on Form 8-K. Posters describing such data in greater detail will be
posted on Vanda’s website at http://www.vandapharma.com
on
December 13, 2007.
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 December 12,
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:
December 12, 2007
`
PRESS
RELEASE
VANDA
PRESENTS PHASE III ILOPERIDONE EFFICACY DATA
Findings
also demonstrate favorable safety and tolerability
profile
ROCKVILLE,
Md. - December 12, 2007 - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced
today that data from four Phase III efficacy and safety trials demonstrate
that
iloperidone, an investigational atypical antipsychotic, is associated with
significantly greater improvements in the symptoms of schizophrenia versus
placebo and has a favorable safety and tolerability profile. These
results were included as part of the recently filed New Drug Application (NDA)
for iloperidone and were presented for the first time this week at a major
psychiatric congress.
Posters
containing the data presented will be posted on Vanda’s Web site, http://www.vandapharma.com,
on
Thursday, December 13, 2007. The
U.S.
Food and Drug Administration (FDA) accepted the NDA submitted by Vanda for
marketing
approval on November 26, 2007.
The
Phase
III study conducted by Vanda evaluated the efficacy of iloperidone versus
placebo in patients with schizophrenia. The study was a randomized,
double-blind, placebo-controlled, multi-center, four-week inpatient study that
enrolled 604 patients. Following fixed-dose titration, inpatients were
randomized to receive iloperidone at 24 mg/day, ziprasidone at 160 mg/day,
or
placebo. Patients
treated with iloperidone had significantly greater improvements in Positive
and
Negative Syndrome Scale-Total (PANSS-T) scores than those on placebo and had
PANSS-T improvement comparable to ziprasidone.
“There
is
a great need for new treatment options for schizophrenia, particularly as
patients often discontinue treatment due to efficacy and tolerability issues,
as
seen in the NIMH-funded CATIE trial on antipsychotics,” said Andrew J. Cutler,
M.D., principal investigator of the Phase III study and Assistant Professor
of
Psychiatry at the University of Florida. “Iloperidone’s
combination of comparable efficacy and favorable tolerability profile is good
news for physicians and patients as a potential new treatment
option.”
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharmaceuticals.com
Iloperidone
and ziprasidone showed similarly low effects on glucose, cholesterol,
triglyceride and prolactin levels compared to placebo. Iloperidone also had
a
similar akathisia profile to placebo, whereas ziprasidone
was
associated with a significant worsening of akathisia versus placebo on the
Barnes Akathisia Scale (BAS), with 26 percent of patients experiencing a
worsening of akathisia. Iloperidone was also associated with a favorable profile
on the Extrapyramidal Symptoms Rating Scale (ESRS) versus placebo.
“Akathisia
is a debilitating sensation of restlessness that can be unrelenting and around
the clock. The new research findings from the recent clinical trials of
iloperidone suggest that iloperidone may have a very low akathisia profile,
one
of the features of this new medication that should be very good news for
patients with schizophrenia and the physician community,” said Dr. Peter Weiden,
M.D., Director of the Psychosis Program of the Department of Psychiatry at
the
University of Illinois at Chicago and one of the leading experts on adverse
events of antipsychotic medications.
A
post-hoc, pooled analysis of three additional Phase III trials was also
presented this week. Each trial was a randomized, double-blind, placebo- and
active-controlled, parallel-group, six-week trial of patients with schizophrenia
or schizoaffective disorder. The analysis evaluated change from baseline using
the Brief Psychiatric Rating Scale (BPRS) for the 1,553 patients who remained
on
treatment for more than two weeks. Iloperidone demonstrated generally
significant improvements over placebo in doses ranging from 4-8 mg/day to 20-24
mg/day; similar reductions in BPRS scores were observed at six weeks for
iloperidone in doses of 20-24 mg/day, as
compared to the active comparators risperidone and haloperidol.
The
analysis further demonstrated that iloperidone had a favorable safety profile,
most notably with regard to extrapyramidal symptoms (EPS) and akathisia rates,
weight and metabolic parameters, and prolactin levels.
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 percent of
patients taking antipsychotics discontinued treatment within 18 months,
primarily because of insufficient efficacy and tolerability issues.
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharmaceuticals.com
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.
#
# #
Contact
information
Steven
Shallcross, Chief Financial Officer, Vanda Pharmaceuticals Inc.: (Tel)
240-599-4500;
steven.shallcross@vandapharma.com
Vanda
Pharmaceuticals Inc. • 9605 Medical Center Drive • Suite 300 • Rockville, MD
20850 USA • p 240.599.4500 • f 301.294.1900
www.vandapharmaceuticals.com