FDA Advisory Committee Recommends Approval of HETLIOZ™ for the Treatment of Non-24-Hour-Disorder (Non-24) in the Totally

 FDA Advisory Committee Recommends Approval of HETLIOZ™ for the Treatment of
              Non-24-Hour-Disorder (Non-24) in the Totally Blind

HETLIOZ™ is the First Potential Treatment to be Reviewed by the FDA for Non-24

PR Newswire

WASHINGTON, Nov. 14, 2013

WASHINGTON, Nov. 14, 2013 /PRNewswire/ --Vanda Pharmaceuticals Inc. (VANDA)
(NASDAQ: VNDA) announced today that the U.S. Food and Drug Administration's
(FDA) Peripheral and Central Nervous System Drugs Advisory Committee (Advisory
Committee) voted overwhelmingly to recommend the approval of Vanda's New Drug
Application (NDA) for tasimelteon, proposed tradename HETLIOZ™, for the
treatment of Non-24-Hour Disorder (Non-24) in the totally blind.

The advisory panel found that:

  oNon-24 is an appropriate indication for an FDA-approved therapy;
  othe clinical endpoints are appropriate to support the indication;
  othere is substantial evidence of tasimelteon efficacy in Non-24; and
  oand the safety of tasimelteon in Non-24 has been adequately addressed.

"We are extremely pleased that the FDA's advisory committee has recommended
that the FDA approve HETLIOZ™ for the treatment of Non-24 in the totally
blind," said Mihael H. Polymeropoulos M.D., Vanda's President and Chief
Executive Officer. "We are now one step closer toward our goal of providing a
treatment option that addresses the physiologic cause of this serious,
debilitating orphan condition that impacts a majority of totally blind

Vanda's tasimelteon NDA is currently under Priority Review by the FDA for the
treatment of Non-24 in the totally blind, with an action target date under the
Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014. 

The FDA grants Priority Review status for a "drug that treats a serious
condition and, if approved, would provide a significant improvement in safety
or effectiveness" over current therapies.Currently, there is no approved
treatment for Non-24 and HETLIOZ™ has the potential to address this unmet
medical need.

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 www.Non-24.com.

About Tasimelteon
Tasimelteon, proposed tradename HETLIOZ™, 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 authority.

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

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:
the FDA not following the Advisory Committee's recommendation, Vanda's failure
to obtain, or any delay in obtaining, 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 and quarterly report on Form 10-Q for the quarter
ended September 30, 2013, which are 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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