Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint

Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did
                        Not Meet The Primary Endpoint

PR Newswire

WASHINGTON, Jan. 31, 2013

WASHINGTON, Jan. 31, 2013 /PRNewswire/ --Vanda Pharmaceuticals Inc. (NASDAQ:
VNDA) today announced top-line results of the Phase IIb/III clinical study
(MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and
safety of tasimelteon as a monotherapy in the treatment of patients with MDD.
The clinical study did not meet the primary endpoint of change from baseline
in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as
compared to placebo. Both tasimelteon and placebo treated patients had an
approximately 40% reduction of their MDD symptoms from baseline. Tasimelteon
was shown to be safe and well-tolerated, consistent with observations in prior
studies. Given these current proof of concept clinical study results, Vanda
has decided to discontinue all activities in this indication.

"These results are disappointing, as there is still a significant unmet
medical need for patients with Major Depression," said Mihael H.
Polymeropoulos, M.D., President and CEO of Vanda. "Tasimelteon's application
in the treatment of blind individuals with Non-24 remains our top priority as
we pursue our planned NDA submission this year." 

Vanda has recently reported positive results in two phase III clinical studies
of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug
Application to the U.S. Food and Drug Administration in mid-2013.

About MAGELLAN

MAGELLAN was a proof of concept, two arm (tasimelteon 20mg and placebo),
8-week, double-masked, randomized, phase IIb/III clinical study in patients
with MDD. The study enrolled 507 patients in 43 sites in the U.S. The
primary endpoint of the study was the change from baseline in the Hamilton
Depression Scale (HAMD-17) at week 8.

About Tasimelteon

Tasimelteon is a circadian regulator in development for the treatment of
Non-24. Tasimelteon is a melatonin agonist of the human MT[1] and MT[2]
receptors, with greater specificity for MT[2].^ Tasimelteon's ability to
reset the master body clock in the suprachiasmatic nucleus (SCN), located in
the hypothalamus, results in the entrainment of the body's melatonin and
cortisol rhythms to align to the 24-hour day-night cycle. Tasimelteon is
currently in Phase III development for Non-24. A New Drug Application, is
expected to be submitted to the U.S. Food and Drug Administration in mid-2013
for Non-24.

Conference Call
Vanda has scheduled a conference call for today, Thursday, January 31, 2013 at
9 AM ET to discuss the MDD clinical trial results. Investors can call
1-888-895-5479 (domestic) and 1-847 619-6250 (international) and use passcode
34186999. A replay of the call will be available beginning Thursday, January
31, 2013, at 11:30 AM ET and will be accessible until Thursday, February 7,
2013, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for
domestic callers and 1-630 652-3042 for international callers. The access
number is 34186999.

The conference call will be broadcast simultaneously on Vanda's website,
http://www.vandapharma.com. Investors should click on the Investor Relations
tab and are advised to go to the website at least 15 minutes early to
register, download and install any necessary software. The call will also be
archived on Vanda's website for a period of 30 days, through March 2, 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
http://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:
Cristina Murphy
Senior Communications Manager
Vanda Pharmaceuticals Inc.
(202) 734-3414
cristina.murphy@vandapharma.com

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, 2011 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.

Website: http://www.vandapharma.com
 
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