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Vanda Pharmaceuticals Reports First Quarter 2013 Results
Date:5/9/2013

57,250(1)  Unaudited(2)  Non-cash stock-based compensation is allocated to both Research & development and General & administrative expenses OPERATIONAL HIGHLIGHTSOn March 25, 2013, Vanda announced that it held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing an NDA for tasimelteon, a circadian regulator, for the treatment of Non-24.  At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing.  The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing. Based on this successful completion of the pre-NDA meeting, Vanda is targeting an NDA submission for tasimelteon in mid-2013.  Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals.  Currently there is no FDA approved treatment for Non-24. 

Vanda continues to expand its activities in support of Non-24 disease awareness and education with professional, advocacy and patient groups.  In June 2013, Vanda will present data from the SET and RESET studies at the 27th Annual Meeting of the Associated Professional Sleep Societies, SLEEP 2013, and the 95th Annual Endocrine Society Meeting, ENDO 2013.  In addition, Vanda continues to build its registry of individuals who have the potential to be Non-24 patients.
The U.S. based registry has over 1,500 individuals and was created to facilitate the recruitment of patients for the tasimelteon Non-24 clinical studies. 

On April 25, 2013, Vanda and Bristol-Myers Squibb (BMS) entered into an amendment to the tasimelteon licensing agreement.  Subsequent to this amendment, BMS waived its option to re-acquire rights to develop and commercialize tasimelteon in count
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SOURCE Vanda Pharmaceuticals Inc.
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