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Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
Date:6/17/2013

WASHINGTON, June 17, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) presented additional data today at ENDO 2013, the Endocrine Society's 95th Annual Meeting, demonstrating that tasimelteon can entrain (synchronize) both melatonin and cortisol rhythms. This effect further confirms tasimelteon's potential to reset the master body clock and address the circadian desynchrony which is inherent in Non-24-Hour Disorder (Non-24).  The 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 were designed to assess the safety, efficacy and maintenance effect of tasimelteon for Non-24. Currently there is no approved FDA treatment for Non-24.

The simultaneous entrainment of both melatonin and cortisol reinforces tasimelteon as a circadian regulator, resetting the master body clock in the suprachiasmatic (SCN) nucleus.  Cortisol is a key regulatory hormone which exhibits a strong circadian rhythm, usually rising in the early morning and falling in the evening. The circadian regulation of cortisol is necessary for the human body to be prepared for a wide range of daily activities and physiologic functions, including blood pressure variation, utilization of fatty acids, circulating lymphocytes and immunity.

"In addition to entrainment of melatonin, entrainment of cortisol establishes tasimelteon as a circadian regulator, addressing an unmet need for people living with Non-24, a debilitating circadian rhythm disorder," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer. 

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 to misaligned circadian rhythms, reinforcing the importance of chronic therapy. 

"These results clearly demonstrate that tasimelteon can entrain the circadian clock and is able to align melatonin and cortisol rhythms to the 24-hour social day," said Steven W. Lockley, Ph.D., Associate Professor of Medicine, Division of Sleep Medicine, Brigham and Women's Hospital, Harvard Medical School.

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.  A new drug application (NDA) was filed for tasimelteon in the U.S.

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 


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SOURCE Vanda Pharmaceuticals Inc.
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