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Vanda Pharmaceuticals Reports Second Quarter 2009 Results
Date:8/10/2009

first quarter of 2009 and $0.51 for the second quarter of 2008.

OPERATIONAL HIGHLIGHTS

On May 6, 2009, the FDA granted U.S. marketing approval of Fanapt(TM) for the acute treatment of schizophrenia in adults. Vanda expects to make Fanapt(TM) available in U.S. pharmacies later this year. Holders of a New Drug Application (NDA) have 60 days after approval to file for patent term restoration under the Hatch-Waxman Act. Vanda submitted its application for patent term restoration with respect to Fanapt(TM) on June 9, 2009.

Vanda also continues to pursue its clinical development plan for tasimelteon for the treatment of circadian rhythm sleep disorders. On June 26, 2009, Vanda met with the FDA to discuss the clinical development plan in an End of Phase II Meeting. Vanda will continue to work with the FDA to characterize the path to an NDA for tasimelteon.

FINANCIAL DETAILS

  • Operating Expenses. Second quarter 2009 R&D expenses of $7.2 million consisted primarily of $5.4 million of consulting fees, as well as $0.6 million of salaries and benefits, $0.6 million of non-cash stock based compensation costs for R&D personnel, and $0.3 million of pre-clinical work. This compares to $2.3 million for the first quarter of 2009 and $5.5 million for the second quarter of 2008. The increase in R&D expenses in the second quarter of 2009 relative to the first quarter of 2009 and second quarter of 2008 is primarily due to the $5.0 million in regulatory consulting fees paid and/or accrued as a result of the approval of Fanapt(TM) by the FDA.

  • General and administrative (G&A) expenses of $5.0 million for the second quarter of 2009 consisted primarily of $0.5 million of salaries and benefits and $2.2 million of non-cash stock based compensation costs for G&A personnel, as well as $0.6 mill
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SOURCE Vanda Pharmaceuticals Inc.
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