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 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 Cohen
Account Supervisor
Makovsky & Company, Inc.
(212)-508-9643
lcohen@makovsky.com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
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 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.