Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The

Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon
        For The Treatment Of Non-24-Hour Disorder In The Totally Blind

PR Newswire

WASHINGTON, March 25, 2013

WASHINGTON, March 25, 2013 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ:VNDA) today announced that the company held a pre-NDA meeting with the
Division of Neurology Products of the U.S. Food and Drug Administration (FDA)
to discuss the regulatory path for filing a New Drug Application (NDA) for
tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder
(Non-24). Non-24 is a serious, rare circadian rhythm disorder that affects a
majority of totally blind individuals. Currently there is no FDA approved
treatment for Non-24.

At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data
proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is
adequate to support filing. The NDA supporting package that includes data
from clinical pharmacology, pre-clinical pharmacology program, chemistry and
manufacturing was also deemed adequate to support filing.

"We are pleased with the positive interaction we had with the FDA as we are
moving closer to providing a treatment for blind individuals with Non-24,"
said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda.

Based on this successful completion of the pre-NDA meeting, Vanda is targeting
an NDA submission for tasimelteon in mid-2013.

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

Media Contact:
Laney Cohen
Account Supervisor
Makovsky & Company, Inc.


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 inability to reach agreement with the FDA regarding Vanda's regulatory
approval strategy or proposed path to approval for tasimelteon for the
treatment of Non-24-Hour Disorder; Vanda's failure to obtain 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 which is on
file with the SEC and available on the SEC's website at 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.

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