Vanda Pharmaceuticals to Evaluate Tasimelteon in Major Depression

Phase IIb/III Study Expected to Begin in the Second Half of 2011

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Mar 31, 2011, 07:00 ET

ROCKVILLE, Md., March 31, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced its plans to initiate a Phase IIb/III clinical trial of tasimelteon in patients with Major Depressive Disorder (MDD). The trial is expected to begin during the second half of 2011. Tasimelteon is currently being evaluated in Phase III clinical trials for the treatment of Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals without light perception.

"Research suggests that misalignment of the circadian rhythm, or body clock, may have significant health consequences, including those related to mood disorders such as major depression," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "Treating depression with a circadian regulator is a novel concept, which has more recently become an area of focus for the pharmaceutical industry. Expansion of our investigations into MDD is consistent with our vision for Vanda as a leading specialty pharmaceutical company focused on the development and commercialization of differentiated products for central nervous system disorders."

There is considerable evidence that suggests circadian rhythm disturbances are important in the pathophysiology of mood disorders. Depressed patients often show altered circadian rhythms, sleep disturbances, and diurnal mood variation. Chronotherapies, including bright light exposure, have been successfully used to treat seasonal and non-seasonal mood disorders. These observations suggest that aberrations of the circadian clock may significantly contribute to the production of the symptoms of MDD and therefore treatments that aim at restoring the regulation of the circadian clock could prove beneficial (1).

Despite the availability of a number of treatments for MDD, there remains a significant unmet medical need. In the large Star*D study sponsored by the National Institute of Mental Health, it was shown that two thirds of patients continued to exhibit symptoms even after a course with currently available treatments (2). In addition to this partial response to treatment, patients often experience a number of significant side effects including sexual dysfunction, insomnia and weight gain.

If successful, tasimelteon could add significant value to the treatment armamentarium for depression. Its novel mechanism of action as a circadian regulator could address both the mood as well as the sleep disruption in patients with MDD, and at the same time offer a mild side effect profile.

The Vanda Phase IIb/III trial will investigate the efficacy and safety of tasimelteon versus placebo in the treatment of MDD. The study is expected to include an 8-week treatment period and an optional open-label extension. Vanda plans to assess the antidepressant and circadian effects of tasimelteon, as well as further characterize the safety profile of the compound.

Tasimelteon and the Body Clock

Tasimelteon is a circadian regulator that binds to two high-affinity melatonin receptors, Mel1a (MT1R) and Mel1b (MT2R). These receptors are found in high density in the suprachiasmatic nucleus of the brain (SCN), which is responsible for synchronizing an individual's sleep/wake cycle. Tasimelteon is currently being evaluated for the treatment of N24HSWD, which is a chronic circadian rhythm sleep disorder (CRSD) that occurs when an individual is unable to synchronize their internal clock to the 24-hour light/dark cycle. Tasimelteon may also have applications in other CRSDs, including Delayed Sleep Phase Disorder, Jet Lag and Shift Worker Sleep Disorder.

References

1. Hum Psychopharmacol. 2008 October; 23(7): 571–585

2. National Institutes of Mental Health: http://www.nimh.nih.gov/trials/practical/stard

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders. For more on Vanda, please visit http://www.vandapharma.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," "targets," "likely," "will," "would," and "could," 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 extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives; Vanda's ability to successfully commercialize Fanapt® outside of the U.S. and Canada; delays in the completion of Vanda's clinical trials; a failure of Vanda's products to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements for its products; a lack of acceptance of Vanda's products in the marketplace, or a failure to become or remain profitable; Vanda's expectations regarding trends with respect to its costs and expenses; Vanda's inability to obtain the capital necessary to fund additional research and development activities; Vanda's failure to identify or obtain rights to new products; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; limitations on Vanda's ability to utilize some or all of its prior net operating losses and research and development credits; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products under its license and sublicense agreements 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, 2010, which is on file with the SEC and available on the SEC's website at http://www.sec.gov. In addition to the risks described above and in Vanda's annual report on Form 10-K, 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.