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 26, 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
26, 2008, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release announcing
the top-line results from its Phase III clinical trial evaluating tasimelteon
(VEC-162) in patients with chronic insomnia. The full text of this press release
is furnished as Exhibit 99.1 to this Form 8-K. Dr. Mihael H. Polymeropoulos,
M.D., Vanda’s Chief Executive Officer, will discuss these results on a
conference call at 10:00 AM Eastern Time on June 26, 2008.
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 Vanda Pharmaceuticals Inc. dated June 26,
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 26, 2008
News
Release
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Media
Contact:
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Bora
Lee
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Investor
Contact:
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Steven
Shallcross
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(212)
798-9522
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(240)
599-4500
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PHASE
III DATA SHOW VANDA PHARMACEUTICALS’ TASIMELTEON (VEC-162) SIGNIFICANTLY
IMPROVES SLEEP IN
PATIENTS
WITH CHRONIC INSOMNIA
Study
Meets Primary Endpoint, with Positive Effect
Sustained
Through Duration of 4-Week Study
ROCKVILLE,
MD, JUNE 26, 2008 - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (Vanda) today
announced positive top-line results from a Phase III trial showing that its
investigational drug candidate, tasimelteon (VEC-162), a novel melatonin
agonist, met the primary endpoint of the trial and significantly improved sleep
in adult patients with chronic insomnia.
“We
are
excited that the results of this Phase III chronic insomnia study demonstrate
the clinical utility of tasimelteon and the ability of the compound to treat
sleep disorders over a period of four weeks. The mechanism of action of
tasimelteon as a circadian regulator gives Vanda the opportunity to explore
its
use for the treatment of circadian rhythm sleep disorders as well as chronic
primary insomnia,” stated Paolo Baroldi, MD, PhD, Vanda’s Chief Medical
Officer.
This
Phase III, multi-center, placebo-controlled, 4-week trial evaluated 322 patients
with chronic primary insomnia. Patients were randomized to receive either 20
mg
or 50 mg of tasimelteon or placebo over the course of four weeks. The primary
endpoint consisted of the evaluation of the immediate and short-term (average
of
Nights 1 and 8) ability of tasimelteon to improve sleep onset as measured by
Latency to Persistent Sleep (LPS) through polysomnography (PSG). Secondary
endpoints evaluated tasimelteon’s ability to maintain improvements on sleep
onset after long-term (average of Nights 22 and 29) use of the compound as
well
as measures of sleep duration (Total Sleep Time, TST) and sleep maintenance
(Wake After Sleep Onset, WASO). Patients were eligible for the study if symptoms
of insomnia were chronic and LPS was greater than 30 minutes.
Significant
Improvement in Sleep Onset Sustained through Study
Duration
These
results demonstrate that tasimelteon was able to improve LPS significantly,
and
that this effect persisted for the 4 week duration of the study. The results
on
LPS at night 1 (N1)/night 8 (N8), and night 22 (N22)/night 29 (N29) are as
follows.
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Mean
LPS at baseline (before drug treatment) was 78.8 minutes in the 20mg
group, 76.4 minutes in the 50mg group, and 78.2 minutes in the placebo
group. On Nights 1 and 8 of treatment, mean LPS improved by 45.0
minutes
in the 20mg group (p<.001), by 46.4 minutes in the 50mg group
(p<.001), and by 28.3 minutes in the placebo group. On Nights 22 and
29
of treatment, mean LPS improved by 49.4 minutes in the 20mg group
(p<.001), by 45.1 minutes in the 50mg group (p=.016), and by 33.9
minutes in the placebo group. All statistical comparisons are between
tasimelteon dose versus placebo.
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Importantly,
this effect was also seen acutely on the first night of treatment. Patients
in
the 20mg and 50mg groups fell asleep 22.9 minutes (p<.001) and 25.9 minutes
(p<.001) faster, respectively, than those in the placebo group, as measured
objectively through PSG. Data from subjective patient self-reports on these
nights were consistent with this finding.
Additional
Phase III Results on Sleep Maintenance Parameters
The
trial
also evaluated parameters of sleep maintenance, including TST and WASO.
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Mean
TST at baseline (before drug treatment) was 325.7 minutes in the
20mg
group, 327.0 minutes in the 50mg group, and 328.9 minutes in the
placebo
group. On Nights 1 and 8 of treatment, mean TST improved by 51.4
minutes
in the 20mg group (p=.089), by 52.0 minutes in the 50mg group (p=.074),
and by 40.0 minutes in the placebo group. On Nights 22 and 29 of
treatment, mean TST improved by 60.3 minutes in the 20mg group (p=.057),
by 48.6 minutes in the 50mg group (not statistically significant,
nss),
and by 47.4 minutes in the placebo group. All statistical comparisons
are
between tasimelteon dose versus
placebo.
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Mean
WASO at baseline (before drug treatment) was 92.6 minutes in the
20mg
group, 93.8 minutes in the 50mg group, and 93.8 minutes in the placebo
group. On Nights 1 and 8 of treatment, mean WASO improved by 12.2
minutes
in the 20mg group (nss), by 14.1 minutes in the 50mg group (nss),
and by
11.7 minutes in the placebo group. On Nights 22 and 29 of treatment,
mean
WASO improved by 17.7 minutes in the 20mg group (nss), by 10.2 minutes
in
the 50mg group (nss), and by 20.3 minutes in the placebo group. There
were
no significant differences in this secondary endpoint comparing
tasimelteon versus placebo
groups.
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Analysis
of the baseline PSG data revealed that the sleep disruption in this patient
population occurred primarily during the first third of the 8-hour night. This
is not unexpected given that the entry criteria in the study focused upon
recruiting subjects with difficulty falling asleep and that there was no WASO
entry criterion. At baseline, sleep efficiency (i.e. the percent of time spent
asleep during the time available for sleep) during the first, second and last
thirds of the night were 50.7%, 79.4% and 74.5%, respectively. Therefore, Vanda
evaluated the effect of tasimelteon on sleep maintenance parameters in the
first
third of the night, when the sleep disruption was greatest in this population
of
chronic primary insomnia patients.
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Mean
TST during the first third of the night at baseline (before drug
treatment) was 79.0 minutes in the 20mg group, 82.3 minutes in the
50mg
group, and 82.2 minutes in the placebo group. On Nights 1 and 8 of
treatment, mean TST during the first third of the night improved
by 40.9
minutes in the 20mg group (p<.001), by 39.4 minutes in the 50mg group
(p<.001), and by 26.6 minutes in the placebo group. On Nights 22 and
29
of treatment, mean TST during the first third of the night improved
by
45.2 minutes in the 20mg group (p<.001), by 40.1 minutes in the 50mg
group (p<.01), and by 30.6 minutes in the placebo group. All
statistical comparisons are between tasimelteon dose versus
placebo.
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Mean
WASO during the first third of the night at baseline (before drug
treatment) was 20.8 minutes in the 20mg group, 21.3 minutes in the
50mg
group, and 21.3 minutes in the placebo group. On Nights 1 and 8 of
treatment, mean WASO during the first third of the night improved
by 2.3
minutes in the 20mg group (p<.01), and by 1.8 minutes in the 50mg group
(p<.05), but worsened by 3.1 minutes in the placebo group. On Nights
22
and 29 of treatment, mean WASO during the first third of the night
improved by 3.1 minutes in the 20mg group (nss), by 1.8 minutes in
the
50mg group (nss) and by 0.6 minutes in the placebo group. All statistical
comparisons are between tasimelteon dose versus
placebo.
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These
results reveal that tasimelteon was able to achieve a number of statistically
significant improvements on sleep maintenance parameters during the portion
of
the night in which the patient population studied suffered the greatest
impairment. These data are consistent with data from the prior Phase III study
(VP-VEC-162-3101), in which 20mg and 50mg of tasimelteon significantly improved
LPS (by 21.5 to 26.3 minutes compared to placebo), WASO (by 24.7 to 33.7 minutes
compared to placebo), and TST (by 33.7 to 47.9 minutes compared to placebo)
in a
model of transient insomnia. Taken together, the results of both of these
studies demonstrate the versatility of tasimelteon to treat the symptoms of
insomnia acutely and chronically both in a model of transient insomnia and
in
patients with chronic primary insomnia.
“These
results suggest that circadian misalignment may play an important role in the
pathophysiology of chronic primary insomnia in many patients, especially those
who have difficulty falling asleep,” said Charles A. Czeisler, PhD, MD, FRCP,
Chairman of Vanda’s Scientific Advisory Board.
This
study also demonstrated that tasimelteon was well-tolerated and exhibited a
safety profile generally similar to placebo.
About
Tasimelteon
Tasimelteon,
(VEC-162), is Vanda’s novel melatonin agonist in development for the treatment
of insomnia and circadian rhythm sleep disorders (CRSD). Researchers believe
that the interplay between the MT-1 and MT-2 pathways and environmental signals
such as external light-dark cues results in the drive for wakefulness during
daytime hours and sleepiness during night-time hours.1
In
patients with insomnia or CRSD, the regulation of the sleep/wake cycle is
disrupted.2
By
binding to both the MT-1 and MT-2 receptors in a balanced fashion, tasimelteon
helps modulate the patient’s circadian rhythm, re-setting the sleep/wake cycle
and providing simultaneous, immediate sleep-promoting benefits.1
About
Insomnia and Circadian Rhythm Sleep Disorders
Insomnia,
the most common sleep disorder, affects approximately 50-70 million American
adults.3,4
It is
characterized by difficulty falling asleep, waking frequently during the night,
waking too early and not being able to return to sleep, or waking up and not
feeling refreshed.5
CRSD,
another type of sleep disorder defined as the inability to sleep at usual or
customary times, affects millions of Americans in a number of forms, including
Shift Work Disorder, which affects 10% of Americans who are shift workers;
Delayed Sleep Phase Disorder, which affects 5-10% of chronic insomnia patients;
and Jet Lag Disorder, which typically affects air travelers crossing five or
more time zones.6-8
Conference
Call
The
company has scheduled a conference call for today, Thursday, June 26, 2008
at
10:00 AM ET. During the call, Mihael H. Polymeropoulos, M.D., Vanda’s President
and CEO, will discuss the trial results. Investors can call 1-866-831-6162
(domestic) and 1-617-213-8852 (international) prior to the 10:00 AM start time
and ask for the Vanda Pharmaceuticals conference call hosted by Dr.
Polymeropoulos. A replay of the call will be available Thursday, June 26, 2008,
at 12:30 PM ET and will be accessible until Thursday, July 3, 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 27175887.
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 July 26, 2008.
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. Vanda's lead product
candidate, iloperidone, is a compound for the treatment of schizophrenia for
which Vanda submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) in September 2007. The FDA accepted Vanda's iloperidone
NDA
for filing in November 2007 and Vanda expects a decision from the FDA on or
about July 27, 2008. Vanda's second product candidate, tasimelteon (VEC-162),
is
a compound for the treatment of sleep and mood disorders, which is currently
in
Phase III for chronic primary insomnia. Vanda's third product candidate,
VSF-173, is a compound for the treatment of excessive sleepiness in Phase II.
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.
###
References:
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1.
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Doghramji
K. Melatonin and its receptors: a new class of sleep-promoting
agents.
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Clin Sleep Med. 2007;3:S17-S23.
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2.
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Rajput
V, Bromley SM. Chronic insomnia: a practical review. AAFP.
1999;60:1431-1438.
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3.
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National
Sleep Foundation. Most Common Sleep Problems in Women. Available
at:
http://www.sleepfoundation.org/site/c.huIXKjM0IxF/b.2421125/k.6662/Most_Common_Sleep_Problems_in_Women.htm.
Accessed on June 18, 2008.
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Centers
for Disease Control and Prevention. Perceived Insufficient Rest
or Sleep -
Four States, 2006. MMWR.
2008;57:200-203.
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National
Institutes of Health. NIH State-of-the-Science Conference Statement
on
Manifestations and Management of Chronic Insomnia in Adults. Available
at:
http://consensus.nih.gov/2005/2005InsomniaSOS026html.htm. Accessed
on June
18, 2008.
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D’Alonzo
GE, Krachman SL. Circadian rhythm sleep disorders. JAOA.
2000;100(8):S15-21.
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7.
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Drake
CL, Roehrs
T,
Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence
and
consequences beyond that of symptomatic day workers. Sleep. 2004;27:1453-62.
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8.
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Carney
PR, Berry RB, Geyer JD, eds. Clinical
Sleep Disorders. Lippincott
Williams &
Wilkins, 2004.
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