Hetlioz

Treatment for Non-24-Hour Disorder

Update: Hetlioz (tasimelteon) Now FDA Approved - January 31, 2014

Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind

WASHINGTON, May 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products.

Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and who therefore cannot entrain (synchronize) their master body clock to the 24-hour day.

"The NDA submission of tasimelteon for Non-24 represents a significant accomplishment for Vanda in our efforts to address unmet medical needs," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief Executive Officer. "We are excited to have submitted an application for the first circadian regulator, representing a new class of therapeutics. The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".

Vanda previously announced that the FDA confirmed, at a recent pre-NDA meeting, that the efficacy, safety and supporting data package proposed to be included in the NDA would be adequate to support filing of the NDA for review by the Agency. The tasimelteon Non-24 NDA includes data from the largest clinical program conducted to date for any investigational therapy for the treatment of Non-24.

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

SOURCE Vanda Pharmaceuticals Inc.

Web Site: http://www.vandapharma.com

Posted: May 2013

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