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

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Vanda plans to initiate a proof of concept study for VLY-686 in Treatment Resistant Pruritus in Atopic Dermatitis in the second half of 2013.  VLY-686 is a small molecule neurokinin-1 receptor (NK-1R) antagonist currently at the clinical stage of development.  An inappropriate NK-1R activation either in nervous tissue or peripherally could result in pathological conditions such as substance dependence, anxiety, nausea/vomiting, and pruritus.  An NK-1R antagonist may possess the ability to reduce this over-stimulation of the NK-1R, and as a result address the underlying pathophysiology of the symptoms in these conditions.

During the first quarter of 2013, Vanda withdrew its MAA submitted to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™  for the treatment of adult patients with schizophrenia.  This withdrawal was based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia.  The results of this study will not be available in the timeframe allowed by the EMA's Centralised Procedure.  Vanda intends to reassess its European regulatory strategy for Fanaptum™ once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) being conducted by Novartis, become available. 

Vanda recorded first quarter 2013 revenue of $8.1 million including Fanapt® royalties of $1.5 million.  Fanapt® prescriptions, as reported by IMS, were approximately 38,900 for the first quarter of 2013.  This represents a 9% increase over first quarter 2012 prescriptions and a 2% increase versus fourth quarter 2012 prescriptions.On April 18, 2013, Vanda announced that Paolo Baroldi, M.D., Ph.D. joined its mana
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SOURCE Vanda Pharmaceuticals Inc.
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