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Vanda Pharmaceuticals Reports Third Quarter 2012 Results
Date:11/7/2012

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Select Balance Sheet Data1 September 30June 30September 30(in thousands)201220122011Total cash and marketable securities

$ 134,404$ 144,701$ 180,459  

(1) Unaudited
(2) Non-cash stock-based compensation is allocated to both Research & development and General & administrative expenses OPERATIONAL HIGHLIGHTS
The tasimelteon Non-24 program continues towards the goal of a projected mid-2013 NDA filing with the FDA.  Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission, and while no agreement has been reached with the agency, the FDA has suggested that Vanda present its Non-24 study results to further the discussions.  The SET and RESET Phase III efficacy studies for Non-24 are both fully enrolled.  Vanda expects to report top-line results for the SET study by the end of 2012 and to report top-line results for the RESET study in the first quarter of 2013.In October 2012, Vanda announced that tasimelteon was shown for the first time to restore daily cortisol rhythms in totally blind patients suffering from Non-24.  Tasimelteon's effect has now been demonstrated on both melatonin and cortisol circadian rhythms, which further supports its potential to reset the master body clock.  This observation was made during an open-label screening segment of the RESET study.  Tasimelteon has the potential to be the first pharmaceutical product to address the circadian dyssynchrony which is definitional for Non-24.

The tasimelteon MAGELLAN Phase IIb/III efficacy study for MDD is fully enrolled and Vanda expects to report top-line results in the first quarter of 2013.  

The review of Vanda's Marketing Authorization Application for oral iloperidone tablets in the European Union is ongoing. Vanda is preparing for an expected oral hearing in November 2012 as it continues to evaluate its European strate
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SOURCE Vanda Pharmaceuticals Inc.
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