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): June 5, 2008
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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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
7.01. Regulation
FD disclosure
On
June
5, 2008, Vanda Pharmaceuticals Inc. (“Vanda”) issued a joint press release with
Laboratory Corporation of America® Holdings announcing that they had entered
into an exclusive alliance to develop and commercialize a series of diagnostic
tests for genetic markers identified by Vanda in the course of its clinical
development of FanaptaTM
(iloperidone). The full text of this press release is furnished as Exhibit
99.1
to this Form 8-K.
The
information in Item 7.01 of this Form 8-K and the press release furnished
as
Exhibit 99.1 to this Form 8-K shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or
otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933,
as
amended, or the Exchange Act, except as expressly set forth by specific
reference in such a filing.
(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 Laboratory Corporation of America® Holdings and Vanda
Pharmaceuticals Inc. dated June 5,
2008.
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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:
June 5, 2008
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LabCorp®
and Vanda Pharmaceuticals Collaborate to Offer Genetic
Tests
Burlington,
NC and Rockville, MD, June 05, 2008
-
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH), one of the
world’s leading clinical trials and genetic testing laboratories, and 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 an exclusive alliance to
develop and commercialize a series of diagnostic tests for genetic markers
identified by Vanda in the course of its clinical development of Fanapta™
(iloperidone), a novel atypical antipsychotic drug candidate under FDA review
for the treatment of schizophrenia. Financial terms of the agreement were not
disclosed.
Vanda
has
identified a series of pharmacogenetic markers during its development of
Fanapta™, and the company continues its pioneering work in this area. Under the
terms of the collaboration, LabCorp will be Vanda’s exclusive commercialization
partner for tests for genetic markers of the Fanapta™ program.
“Working
with innovative companies like Vanda to commercialize predictive medicine tests
is a critical strategic focus for LabCorp,” said Andrew J. Conrad, Ph.D., Chief
Scientist and Global Head of Clinical Trials for LabCorp. “This collaboration is
an example of our commitment to the advancement of personalized medicine and
represents a successful translation of a research based assay into a valuable
diagnostic test. This relationship is consistent with our focus on companion
diagnostics.”
“We
are
pleased to be collaborating with LabCorp in this important effort,” said Mihael
H. Polymeropoulos, M.D., CEO of Vanda Pharmaceuticals Inc. “LabCorp’s diagnostic
development expertise, world-class testing capabilities, and national
distribution network make them an ideal choice.”
Schizophrenia
is a chronic, severe, and disabling mental disorder that affects more than
two
million Americans and approximately one percent of the world’s adult population.
Patients suffering from schizophrenia exhibit a range of symptoms, including:
positive symptoms, such as hallucinations and delusions; negative symptoms,
such
as emotional withdrawal; and cognitive symptoms associated with significant
impairment in social and occupational functioning.
About
LabCorp®
Laboratory
Corporation of America®
Holdings, a S&P 500 company, is a pioneer in commercializing new diagnostic
technologies and the first in its industry to embrace genomic testing. With
annual revenues of $4.1 billion in 2007, over 26,000 employees nationwide,
and
more than 220,000 clients, LabCorp offers clinical assays ranging from routine
blood analyses to HIV and genomic testing. LabCorp combines its expertise in
innovative clinical testing technology with its Centers of Excellence: The
Center for Molecular Biology and Pathology, National Genetics Institute, Inc.,
ViroMed Laboratories, Inc., The Center for Esoteric Testing, DIANON Systems,
Inc.,
US LABS, and Esoterix and its Colorado Coagulation, Endocrine Sciences, and
Cytometry Associates laboratories. LabCorp conducts clinical trial testing
through its Esoterix Clinical Trials Services division. LabCorp clients include
physicians, government agencies, managed care organizations, hospitals, clinical
labs, and pharmaceutical companies. To learn more about our organization, visit
our Web site at: www.labcorp.com.
Each
of
the above forward-looking statements is subject to change based on various
important factors, including without limitation, competitive actions in the
marketplace and adverse actions of governmental and other third-party payors.
Actual results could differ materially from those suggested by these
forward-looking statements. Further information on potential factors that could
affect LabCorp’s financial results is included in the Company’s Form 10-K for
the year ended December 31, 2007, and subsequent SEC filings.
About
Vanda Pharmaceuticals Inc.
Vanda
Pharmaceuticals Inc. (Nasdaq: VNDA) is a biopharmaceutical company focused
on
the development and commercialization of clinical-stage product candidates
for
central nervous system disorders. To learn more about Vanda, please visit
www.vandapharma.com.
Cautionary
Note Regarding Forward-Looking Statements
Various
statements in this release are “forward-looking statements” under the securities
laws. Words such as, but not limited to, “believe,” “expect,”
“anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,”
“would,” and “could,” and similar expressions or words, identify forward-looking
statements. 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
the
company’s forward-looking statements include, among others: delays in the
completion of Vanda’s clinical trials; a failure of Vanda’s product candidates
to be demonstrably safe and effective; Vanda’s failure to obtain regulatory
approval for its products or to comply with ongoing regulatory requirements;
a
lack of acceptance of Vanda’s product candidates in the marketplace, or a
failure to become or remain profitable; Vanda’s inability to obtain the capital
necessary to fund its research and development activities; Vanda’s failure to
identify or obtain rights to new product candidates; Vanda’s failure to develop
or obtain sales, marketing and distribution resources and expertise or to
otherwise manage its growth; a loss of any of Vanda’s key scientists or
management personnel; losses incurred from product liability claims made against
Vanda; a loss of rights to develop and commercialize Vanda’s products under its
license and sublicense agreements and other factors that are described in the
“Risk Factors” section (Part II, Item 1A) of Vanda’s quarterly report on
Form 10-Q for the quarter ended March 31, 2008 (File No. 000-51863). In
addition to the risks described above and in Part II, Item 1A of Vanda’s
quarterly report on Form 10-Q, other unknown or unpredictable factors also
could
affect Vanda’s results. There can be no assurance that the actual results
or developments anticipated by Vanda will be realized or, even if substantially
realized, that they will have the expected consequences to, or effects on,
Vanda. Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All
written and verbal forward-looking statements attributable to Vanda or any
person acting on its behalf are expressly qualified in their entirety by the
cautionary statements contained or referred to herein. Vanda cautions
investors not to rely too heavily on the forward-looking statements Vanda makes
or that are made on its behalf. The information in this release is
provided only as of the date of this release, and Vanda undertakes no
obligation, and specifically declines any obligation, to update or revise
publicly any forward-looking statements, whether as a result of new information,
future events or otherwise.
For
more information please contact:
At
LabCorp:
Eric
Lindblom
336-436-6739
media@labcorp.com
www.labcorp.com
At
Vanda:
Steven
A.
Shallcross
Senior
Vice President, Chief Financial Officer
240-599-4500
www.vandapharma.com
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