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): July 28, 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 8.01. |
On
July
28, 2008, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release announcing
that it had received a not approvable letter from the U.S. Food and Drug
Administration for Vanda’s New Drug Application for iloperidone for the
treatment of schizophrenia. The full text of this press release is furnished
as
Exhibit 99.1 to this Form 8-K.
The
information in Item 8.01 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.
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Exhibits
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| Exhibit No. | Description |
| 99.1 |
Press
Release of Vanda Pharmaceuticals Inc. dated July 28,
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:
July 28, 2008
News
Release
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Investor
Contact:
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Steven
Shallcross
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(240)
599-4500
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VANDA
PHARMACEUTICALS ANNOUNCES RECEIPT OF NOT APPROVABLE LETTER FROM FDA FOR
ILOPERIDONE
ROCKVILLE,
MD, JULY 28, 2008 - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced today
the receipt of a not approvable letter from the U.S. Food and Drug
Administration (FDA) in response to its New Drug Application for iloperidone,
an
investigational atypical antipsychotic that was reviewed for the treatment
of
schizophrenia.
The
FDA
stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day
in the 3101 study for which the company reported results in December, 2006,
and
that the efficacy was similar to the active comparator, ziprasidone (Geodon®,
Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior
to
placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day
in a prior study. However, the FDA expressed concern about the efficacy of
iloperidone in patients with schizophrenia relative to the active comparator,
risperidone (Risperdal®, Johnson & Johnson), used in prior studies. The FDA
indicated that it would require an additional trial comparing iloperidone to
placebo and including an active comparator such as olanzapine (Zyprexa®, Eli
Lilly & Company) or risperidone in patients with schizophrenia to
demonstrate the compound’s efficacy further. The FDA also stated that it would
require Vanda to obtain additional safety data for patients at a dose range
of
20 to 24 mg/day.
“We
are
disappointed by this response, but will meet with the FDA to discuss this
decision further,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and
CEO.
Vanda
has
put on hold all iloperidone-related activities pending further review.
As
of
June 30, 2008, Vanda’s cash, cash equivalents, and marketable securities totaled
approximately $65.6 million. Additional financial details will be provided
on
the August 5, 2008 earning conference call.
Conference
Call
The
company has scheduled a conference call for today, Monday, July 28, 2008, at
10:30 AM ET to
discuss
the FDA’s response. Investors can call 1-866-202-3109 (domestic) and
1-617-213-8844 (international) prior to the 10:30 AM start time and ask for
the
Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay
of
the call will be available Monday, July 28, 2008, at 12:30 PM ET and will be
accessible until Monday, August 4, 2008, at 5:00 PM ET. The replay call-in
number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for
international callers. The access number is 48122809.
The
conference call will be broadcast simultaneously on the company's Web site,
http://www.vandapharma.com. Investors should click on the Investor Relations
tab
and are advised to go to the Web site at least 15 minutes early to register,
download, and install any necessary software. The call will also be archived
on
the Vanda Web site for a period of 30 days, through August 27,
2008.
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. In addition to iloperidone, Vanda is
developing tasimelteon (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.
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.
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