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| Initial Clinical Data Reveal Potential of Tasimelteon to Reset the Body Clock in Non-24-Hour Sleep-Wake Disorder |
This observation was made in four patients during the initial run-in segment of the RESET study. RESET is a Phase III study of the maintenance effect of tasimelteon in the treatment of Non-24-Hour Disorder. Vanda intends to enroll a total of 20 tasimelteon responders in this study. "We are extremely excited by this finding as it provides us with evidence that tasimelteon is able to reset the body clock in patients with Non-24-Hour Disorder," said Circadian regulation is necessary for the treatment of Non-24-Hour Disorder and it is predictive of a beneficial effect on both nighttime sleep and daytime naps. While light resets the body clock in sighted individuals, keeping it synchronized with the 24-hour day, this effect is lost in totally blind individuals with no light perception. Vanda is currently studying the efficacy of tasimelteon in Non-24-Hour Disorder in two Phase III studies, SET and RESET, which are ongoing and expected to be completed by the end of 2012. About the RESET Study RESET is a randomized withdrawal study designed to demonstrate the maintenance effect of 20 mg tasimelteon in the treatment of Non-24-Hour Disorder. Twenty totally blind individuals with no light perception and diagnosed as having a body clock period of greater than 24 hours, will be treated with tasimelteon for three months during a run-in phase. Patients who respond to tasimelteon treatment during the run-in phase, as measured by the resetting and alignment of their body clock to the 24-hour day, will then be randomized either to receive placebo or to continue receiving tasimelteon for 2 months. During the post-randomization phase, patients will be re-evaluated. For more information, please visit http://clinicaltrials.gov/. About Non-24-Hour Disorder Non-24-Hour Disorder is a chronic circadian rhythm sleep disorder that affects more than 50 percent of the totally blind individuals in the U.S., or 65,000 to 95,000 people. Non-24-Hour Disorder occurs almost entirely in individuals who are totally blind and lack the light sensitivity necessary to reset the circadian clock. Without light perception, the brain's circadian rhythms, which guide many of the body's functions, including sleep, are not reset to a regular 24-hour cycle. Individuals with Non-24-Hour Disorder are unable to synchronize their internal clock to the 24-hour day-night cycle, which disrupts their sleep-wake cycle. For more information, please visit http://24sleepwake.com/. About Tasimelteon Tasimelteon is the first compound in development for the treatment of Non-24-Hour Disorder. Tasimelteon is a specific and potent agonist of the human MT1 and MT2 receptors. Compounds that selectively bind to melatonin receptors are thought to be able to regulate the body clock, which may be useful to treat circadian rhythm disorders. Tasimelteon is being studied in both Non-24 and Major Depressive Disorder (MDD). About 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," 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 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 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. Investor Contact: Media Contact:
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