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): April 25, 2007
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
000-51863 03-0491827
(Commission File No.) (IRS Employer Identification No.)
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
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
|_| Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On April 25, 2007, Vanda Pharmaceuticals Inc. issued a press release
announcing the initiation of its Phase II trial of its product candidate VSF-173
for 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
Exhibit No. Description
- ----------- -----------------------------------------------------------------
99.1 Press release of Vanda Pharmaceuticals Inc. dated April 25, 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.
VANDA PHARMACEUTICALS INC.
By: /s/ STEVEN A. SHALLCROSS
------------------------------------
Name: Steven A. Shallcross
Title: Senior Vice President,
Chief Financial Officer
and Treasurer
Dated: April 25, 2007
Vanda Pharmaceuticals Initiates Phase II Clinical Trial
for VSF-173 in Excessive Sleepiness
ROCKVILLE, Md., April 25 /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 the initiation of a Phase II clinical trial of
its product candidate VSF-173 in excessive sleepiness (ES).
The trial is a randomized, double-blind, placebo-controlled study to
investigate the efficacy and safety of three oral doses of VSF-173 for the
treatment of induced excessive sleepiness in approximately 60 healthy male and
female subjects. The primary endpoint of the study is the difference from
placebo on the Maintenance of Wakefulness Test (MWT), a standard measure of
sleepiness.
About Excessive Sleepiness
Excessive sleepiness (ES) is a common symptom that can significantly
impair a person's ability to function. The effects of ES range from mild
sleepiness to unrecognized episodes of "microsleeps" and uncontrollable sleep
attacks. Excessive sleepiness is a symptom of many disorders including,
obstructive sleep apnea, narcolepsy, shift worker sleep disorder, Parkinson's,
and Alzheimer's disease.
ES may have significant consequences ranging from impairment in social and
occupational functioning to severe accidents. According to the National Sleep
Foundation 2005 Sleep in America Poll, 43% of adults reported that they are so
sleepy during the day that it interferes with their daily activities a few days
per month or more and 22% experience this level of daytime sleepiness at least a
few days per week. According to the same poll, 60% of adult drivers say they
have driven a vehicle while feeling drowsy in the past year, and more than
one-third of adult drivers have actually fallen asleep at the wheel. ES make
lapses of attention more likely to occur, and may play a role in behavior that
can lead to automobile accidents.
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 (Item 1A) of Vanda's annual report on
Form 10-K for the year ended December 31, 2006 (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.
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. The company has three product candidates in
clinical development. Vanda's lead product candidate, iloperidone, is a compound
for the treatment of schizophrenia and bipolar disorder and has recently
completed its Phase III program in schizophrenia. Vanda's second product
candidate, VEC-162, is a compound for the treatment of sleep and mood disorders
which is currently in Phase III for sleep disorders. Vanda's third product
candidate, VSF-173, is a compound for the treatment of excessive sleepiness that
is currently in a Phase II trial. For more on Vanda Pharmaceuticals Inc., please
visit http://www.vandapharma.com.
SOURCE Vanda Pharmaceuticals Inc.
-0- 04/25/2007
/CONTACT: Steven A. Shallcross, Senior Vice President, Chief Financial
Officer, of Vanda Pharmaceuticals Inc., +1-240-599-4500, or
steven.shallcross@vandapharma.com/
/Web site: http://www.vandapharma.com/