Vanda Pharmaceuticals Announces FDA Advisory Committee Meeting On November 14, 2013

Vanda Pharmaceuticals Announces FDA Advisory Committee Meeting On November 14,

PR Newswire

WASHINGTON, Oct. 16, 2013

WASHINGTON, Oct. 16, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VANDA)
(NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration
(FDA) has notified the company of the scheduling of a Peripheral and Central
Nervous System Drugs Advisory Committee meeting on November 14, 2013, for the
review of Vanda's New Drug Application (NDA) for tasimelteon, proposed trade
name HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the
totally blind. Vanda's tasimelteon NDA is currently under Priority Review by
the FDA with an action target date under the Prescription Drug User Fee Act
(PDUFA-V) of January 31, 2014. 

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 a 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 is not reset, and
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. As a result of this misalignment, Non-24
is associated with significant disruption of the sleep-wake cycle and
impairments in social and occupational functioning, and marked subjective
distress. Currently there is no approved treatment for Non-24. For more
information on Non-24, please visit

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 aims to
reset the master body clock in the suprachiasmatic nucleus (SCN), resulting in
the entrainment of the body's melatonin and cortisol rhythms to align to 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. Tasimelteon has not been approved by the FDA or any other regulatory

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

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

Investor Contact:
Chad Rubin
Vice President
The Trout Group
(646) 378-2947

Media Contact:
Laney Landsman
Assistant Vice President
(212) 508-9643

SOURCE Vanda Pharmaceuticals Inc.

Press spacebar to pause and continue. Press esc to stop.