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

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.


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 MT1 and MT2 receptors, with greater specificity for MT2.  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,  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  

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

Media Contact:
Cristina Murphy
Senior Communications Manager
Vanda Pharmaceuticals Inc.
(202) 734-3414

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, 2011 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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Vanda Pharmaceuticals Reports First Quarter 2012 Results
2. Vanda Pharmaceuticals Inc. Presents Scientific Posters at Society for Research on Biological Rhythms (SRBR) Annual Meeting
3. Vanda Pharmaceuticals to Present at the Jefferies 2012 Global Healthcare Conference
4. Vanda Pharmaceuticals Announces Date of Annual Meeting of Stockholders
5. Michael Cola Joins the Board of Directors of Vanda Pharmaceuticals
6. Vanda Pharmaceuticals to Present at the JMP Securities Healthcare Conference
7. Vanda Pharmaceuticals to Announce Second Quarter 2012 Financial Results on August 2, 2012
8. Vanda Pharmaceuticals to Participate in Two September Healthcare Investor Conferences
9. Vanda Pharmaceuticals Reports Third Quarter 2012 Results
10. Vanda Pharmaceuticals to Announce Fourth Quarter 2012 Financial Results on February 12, 2013
11. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
Post Your Comments:
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
Breaking Medicine Technology:
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
Breaking Medicine News(10 mins):