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Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder



Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder

Data presented as a late breaking abstract at SLEEP 2013, the 27th Annual
Meeting of Associated Professional Sleep Societies

PR Newswire

WASHINGTON, June 5, 2013

WASHINGTON, June 5, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) presented additional entrainment and patient-level clinical
data at SLEEP 2013, the 27th Annual Meeting of Associated Professional Sleep
Societies in Baltimore, from its SET (Safety and Efficacy of Tasimelteon) and
RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon
to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian
regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind
individuals.  Non-24 is a serious, rare and chronic circadian rhythm disorder
that affects a majority of totally blind individuals who lack light perception
and cannot entrain (synchronize) their master body clock to the 24-hour day. 
Currently there is no approved FDA treatment for Non-24.

In the SET study, tasimelteon achieved the primary endpoints of entrainment
(synchronizing) of the melatonin (aMT6s) rhythm as compared to placebo and
clinical response as measured by entrainment plus a score of greater than or
equal to 3 on the Non-24 Clinical Response Scale (N24CRS).  Tasimelteon also
demonstrated significant improvement versus placebo across a number of sleep
and wake parameters including measures of total sleep time, nap duration, and
timing of sleep, as well as in the Clinical Global Impression of Change
(CGI-C), an overall global functioning scale.  In treated patients, daytime
naps decreased by 46 minutes per day in the worst 25% of days in a cycle and
nighttime sleep increased by 57 minutes per day during the worst 25% of nights
in a cycle.

The RESET study demonstrated that continued treatment with 20mg of tasimelteon
was required to maintain entrainment of melatonin and cortisol circadian
rhythms in individuals with Non-24. Patients treated with tasimelteon
maintained their clinical benefits while patients who received placebo showed
significant deterioration in measures of nighttime sleep, daytime naps and
timing of sleep.  Furthermore, discontinuation of tasimelteon resulted in a
rapid relapse of circadian entrainment and a return to misaligned circadian
rhythms, reinforcing the importance of chronic therapy. 

Study investigator, Steven W. Lockley, Ph.D., Associate Professor of Medicine,
Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical
School, commented, "the results clearly demonstrate that tasimelteon can
entrain the circadian clock, and that continued treatment is necessary to
maintain entrainment."

About Non-24-Hour Disorder
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized
by the inability to entrain (synchronize) the master body clock with the
24-hour day-night cycle. Non-24 affects the majority of totally blind
individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs
almost entirely in individuals who lack the light sensitivity necessary to
entrain the master body clock in the brain with the 24-hour day-night cycle. 
Most people have a master body clock that naturally runs longer than 24-hours
and light is the primary environmental cue that resets it to 24-hours each
day.  Individuals with Non-24 have a master body clock that continually
delays, resulting in prolonged periods of misalignment  between their
circadian rhythms and the 24-hour day-night cycle, including the timing of
melatonin and cortisol secretion and the sleep-wake cycle.  As a result of
this misalignment, Non-24 is associated with significant impairments in social
and occupational functioning and marked subjective distress.  For more
information on Non-24, please visit www.Non-24.com.

About Tasimelteon
Tasimelteon is a circadian regulator in development for the treatment of
Non-24.  Tasimelteon is a dual melatonin receptor agonist (DMRA) with
selective agonist activity at the MT1 and MT2 receptors.^  Tasimelteon's
ability to reset the master body clock in the suprachiasmatic nucleus (SCN)
results in the entrainment of the body's melatonin and cortisol rhythms with
the 24-hour day-night cycle.  The patent claiming tasimelteon as a new
chemical entity extends through December 2022, assuming a 5-year extension to
be granted under the Hatch-Waxman Act.  Tasimelteon has been granted orphan
drug designation for the treatment of Non-24 from both the U.S. and the
European Union. 

About Vanda Pharmaceuticals Inc.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders.  For more on Vanda, please visit
www.vandapharma.com.  

Company Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.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," "project," "target," "goal,"
"likely," "will," "would," and "could," or the negative of these terms 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.  Important
factors that could cause actual results to differ materially from those
reflected in the company's forward-looking statements include, among others:
Vanda's failure to obtain regulatory approval for tasimelteon for the
treatment of Non-24-Hour Disorder or to comply with ongoing regulatory
requirements; and other factors that are described in the "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the fiscal year
ended December 31, 2012 which is on file with the SEC and available on the
SEC's website at www.sec.gov.  In addition to the risks described above and in
Vanda's annual report on Form 10-K and quarterly reports 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.

 

SOURCE Vanda Pharmaceuticals Inc.

Website: http://www.vandapharma.com
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