Vanda Pharmaceuticals Initiates Phase III Clinical Study Aimed at Resetting the Body Clock

ROCKVILLE, Md., Aug. 26 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), today announced it has initiated a Phase III clinical trial to evaluate tasimelteon in patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness.  Tasimelteon binds to high affinity melatonin receptors located in the brain that are believed to regulate circadian rhythms, or sleep/wake cycles.

"Blind individuals with no light perception do not receive external light and darkness signals that synchronize our internal body clocks," commented Mihael H. Polymeropoulos, M.D. President and Chief Executive Officer of Vanda.  "As a result, these individuals can live lives in a constant state of circadian misalignment.  Tasimelteon has the potential to be the first in the class of circadian regulators, drugs that may offer clinical benefits to patients with aberrant timing of the sleep/wake cycle."

About Study VP-VEC-162-3201

Vanda Study 3201 is designed to investigate the efficacy and safety of 20 mg tasimelteon versus placebo in totally blind individuals with N24HSWD, with a target enrollment of 160 individuals. The study includes a 6-month treatment period and an optional open-label extension. The primary endpoint of the study is improvement in Total Sleep Time (TST) during the night.  The study will also measure parameters of daytime sleep and laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle. Vanda expects to report top-line results for this trial in the fourth quarter of 2011.

For more information about the clinical study please visit:

http://www.vandapharma.com/tasi3201.html

Non-24-Hour Sleep Wake Disorder (N24HSWD)

N24HSWD is an orphan indication affecting approximately 65,000 to 95,000 in the U.S. and 140,000 in Europe.  N24HSWD occurs when individuals, primarily blind with no light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light/dark cycle.  Without light as a synchronizer, and because the period of the internal clock is typically a little longer than 24 hours, individuals with N24HSWD experience their sleep/wake cycles drifting later and later each day.  Individuals with N24HSWD have abnormal night sleep patterns, accompanied by difficulty staying awake during the day.  N24HSWD leads to significant impairment, with chronic effects impacting the social and occupational functioning of these individuals.

The ultimate treatment goal for individuals with N24HSWD is to lock or synchronize their circadian rhythms into an appropriate phase relationship with the 24-hour day so that they will have increased sleepiness during the night and increased wakefulness during the daytime.

Tasimelteon

Tasimelteon is a circadian regulator which 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 our sleep/wake cycle.  Tasimelteon has been shown to improve sleep parameters in prior clinical studies, which simulated a desynchronization of the circadian clock.  Tasimelteon has so far been studied in more than 900 individuals and has shown a good tolerability profile.  

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 inability to utilize a substantial portion of its prior net operating losses and research and development credits; 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; 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, 2009 and quarterly reports on Form 10-Q for the fiscal quarters ended March 31, 2010 and June 30, 2010, which are 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.