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Vanda Pharmaceuticals Reports Third Quarter 2010 Results
Date:11/3/2010

rnal body clock and the 24-hour environmental light/dark cycle.

Vanda has also initiated a one-year safety study of tasimelteon for the treatment of N24HSWD.  This is an open-label safety study that will enroll approximately 140 patients with N24HSWD.  Vanda plans to conduct additional clinical trials over the next one to two years to support U.S. and European regulatory submissions.  Tasimelteon was granted orphan drug designation by the FDA on January 19, 2010. The application for orphan designation from the European Medicines Agency is pending.

On October 29, 2010, Vanda received certification for qualified research and development investments under the Internal Revenue Service's Therapeutic Discovery Project Credit Program and will receive a cash payment of approximately $0.5 million.

FINANCIAL DETAILS-Revenues decreased by $1.1 million from $8.3 million for the third quarter of 2010 due to an increase of $0.4 million in royalty revenue offset by a decrease of $1.5 million in product revenue.  During the second quarter of 2010, the company sold the remaining Fanapt® inventory to Novartis.  -Cost of sales for the third quarter of 2010 was $0.4 million resulting from the amortization of the capitalized intangible asset related to the milestone payment to Novartis, compared to cost of sales for the second quarter of 2010 of $1.9 million, consisting of $0.4 million resulting from the amortization of the capitalized intangible asset related to the milestone payment to Novartis and $1.5 million for inventory sold to Novartis.Research and development (R&D) expenses were $4.1 million for the third quarter of 2010, compared to $2.4 million for the second quarter of 2010 and $2.1 million for the third quarter of 2009.  The increase in R&D expenses in the third quarter of 2010 relative to the second quarter of 2010 is primarily due to costs incurred in connection with the preparation of the Phase III trial
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SOURCE Vanda Pharmaceuticals Inc.
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