HETLIOZ™ (tasimelteon) Data in Patients with Non-24-Hour Sleep-Wake Disorder to be presented at SLEEP 2014 meeting

 HETLIOZ™ (tasimelteon) Data in Patients with Non-24-Hour Sleep-Wake Disorder
                    to be presented at SLEEP 2014 meeting

PR Newswire

WASHINGTON, June 2, 2014

WASHINGTON, June 2, 2014 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) will present additional data from its HETLIOZ™ (tasimelteon)
clinical development program at SLEEP 2014, the 28th Annual Meeting of
Associated Professional Sleep Societies in Minneapolis, Minnesota.

HETLIOZ^TM data at SLEEP 2014 will be presented in one oral and six poster
sessions. The data presentation schedule is as follows:

Oral Presentation

  oJune 4^th at 2:15 – 2:30pm, Assessment of clinical measures in Non-24
    Disorder in Patients Entrained by Tasimelteon with Dr. Steven Lockley

Poster Presentations

  oJune 2^nd at 4 – 6pm

       oPoster 74 Evaluation of the effect of concomitant consumption of
         tasimelteon and ethanol on cognitive function, balance, and
         subjective measures in healthy subjects

  oJune 4^th at 10am – 12:20pm – Posters

       o122 Causes of total blindness associated with Non-24-Hour Disorder
       o124 Assessment of Potential for Withdrawal or Abuse with the use of
         the circadian regulator tasimelteon
       o123 Tasimelteon a novel treatment for Non-24 Hour Disorder: Pooled
         safety analysis of two Phase II and two Phase III placebo controlled
         studies
       o125 LQ-nTST, UQ-dTSD, and MoST: Circadian Specific Sleep/Wake
         Measures for Non-24 Patients
       o126 Phase Analysis of nighttime total sleep time and daytime total
         sleep duration in patients with Non-24-Hour Disorder

About Non-24-Hour Sleep-Wake Disorder
Non-24 was first described more than 60 years ago, and is a chronic, circadian
rhythm disorder resulting from the misalignment of the endogenous master body
clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep
disturbance causes significant distress or impairment in social, occupational
and other important areas of functioning. Non-24 affects the majority of
totally blind individuals and it is estimated that approximately 80,000
Americans have the disorder.

About HETLIOZ™
HETLIOZ™ is a melatonin receptor agonist. HETLIOZ™ has been approved by the
U.S. Food and Drug Administration for the treatment of Non-24-Hour Sleep-Wake
Disorder (Non-24).

Full HETLIOZ™ Prescribing Information can be found at:www.hetlioz.com.

For more information about HETLIOZ™ call 1-844-HETLIOZ (1-844-438-5469).

Indication and Important Safety Information About HETLIOZ™

Indication
HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder
(Non-24).

Important Safety Information
HETLIOZ™ may cause somnolence:After taking HETLIOZ™, patients should limit
their activity to preparing for going to bed, because HETLIOZ™ can impair the
performance of activities requiring complete mental alertness.

The most common adverse reactions (incidence >5% and at least twice as high on
HETLIOZ™ than on placebo) were headache, increased alanine aminotransferase,
nightmares or unusual dreams, upper respiratory or urinary tract infection.
The risk of adverse reactions may be greater in elderly (>65 years) patients
than younger patients because exposure to HETLIOZ™ is increased by
approximately 2-fold compared with younger patients.

Use of HETLIOZ™ should be avoided in combination with fluvoxamine or other
strong CYP1A2 inhibitors, because of a potentially large increase in exposure
of HETLIOZ™, and a greater risk of adverse reactions. HETLIOZ™ should be
avoided in combination with rifampin or other CYP3A4 inducers, because of a
potentially large decrease in exposure of HETLIOZ™, with reduced efficacy.

There are no adequate and well-controlled studies of HETLIOZ™ in pregnant
women. Based on animal data, HETLIOZ™ may cause fetal harm. HETLIOZ™ should
be used during pregnancy only if the potential benefit justifies the potential
risks. Caution should be exercised when HETLIOZ™ is administered to a nursing
woman.

HETLIOZ™ has not been studied in patients with severe hepatic impairment and
is not recommended in these patients.

Safety and effectiveness of HETLIOZ™ in pediatric patients have not been
established.

Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com.

AboutVanda 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.

U.S. full prescribing information for HETLIOZ™ is available at
www.HETLIOZ.com.

HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals Inc.

Corporate 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

SOURCE Vanda Pharmaceuticals Inc.

Website: http://www.vandapharma.com
 
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