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Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Results
Date:2/11/2009

ter of 2008 and $0.78 for the fourth quarter of 2007.

OPERATIONAL HIGHLIGHTS

On November 6, 2008, Vanda submitted a Complete Response to the not approvable action letter that the Company received from the U.S. Food and Drug Administration (FDA) on July 25, 2008 regarding iloperidone. The FDA has indicated that it has accepted the Complete Response for review and has set a new target action date of May 6, 2009.

Pending a response from the FDA, Vanda is concentrating its efforts on the design and evaluation of clinical development options for tasimelteon, its compound for sleep and mood disorders. Results of prior phase II and III clinical trials for tasimelteon were published in the December 2008 issue of The Lancet.

On December 16, 2008, Vanda announced a workforce reduction of 17 employees, including two officers.

FINANCIAL DETAILS

  • Operating Expenses. Fourth quarter 2008 R&D expenses, primarily consisting of salaries and related costs of R&D personnel, including $0.6 million of severance expense and the costs of regulatory consultants, totaled $3.6 million, compared to $3.8 million for the third quarter of 2008 and $12.6 million for the fourth quarter of 2007. The decrease in R&D expenses in the fourth quarter of 2008 relative to the third quarter of 2008 is primarily due to the decrease in stock-based compensation expense for R&D personnel due to the cancellation of unvested options in connection with the workforce reduction. The decrease in R&D expenses in the fourth quarter of 2008 relative to the fourth quarter of 2007 is primarily attributable to lower clinical trial costs in the fourth quarter of 2008 compared to the costs from trials conducted in the fourth quarter of 2007. For the full year of 2008, total R&D expenses were $23.9 million, compared to $47.2 million for the full
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SOURCE Vanda Pharmaceuticals Inc.
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