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Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2009 Results
Date:2/16/2010

ds that bind selectively to melatonin receptors are candidates to treat sleep disorders, including Circadian Rhythm Sleep Disorders (CRSDs), and additionally are believed to offer potential benefits in mood disorders.  Tasimelteon is currently in Phase III stage of development for the treatment of sleep disorders and CRSDs and is ready for Phase II trials for the treatment of depression.  On January 19, 2010, the U.S. Food and Drug Administration (FDA) granted orphan drug designation status for tasimelteon in a specific CRSD, Non-24-Hour Sleep/Wake Disorder in blind persons.  The FDA grants orphan drug designation to drugs that may provide significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year.  Orphan drug designation provides potential financial and regulatory incentives, including study design assistance, tax credits, waiver of FDA user fees, and up to seven years of market exclusivity upon marketing approval.  As Vanda continues to explore the path to a New Drug Application (NDA) for tasimelteon, the orphan drug designation in Non-24 Hour Sleep/Wake Disorder has the potential to strengthen the tasimelteon program by offering clinical development and commercialization benefits.

FINANCIAL DETAILS

  • Operating Expenses.  R&D expenses of $2.3 million for the fourth quarter of 2009 consisted primarily of $0.9 million of salaries and benefits, $0.5 million of non-cash stock based compensation costs for R&D personnel, $0.3 million in consulting fees and $0.2 million for an on-going carcinogenicity study.  This compares to $2.1 million for the third quarter of 2009 and '/>"/>

SOURCE Vanda Pharmaceuticals Inc.
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