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Vanda Pharmaceuticals Reports Fourth Quarter 2011 and Full Year 2011 Results
Date:2/14/2012

y the end of 2012.

The tasimelteon MAGELLAN efficacy study for MDD is ongoing and Vanda expects to report top-line results in the first half of 2013. This Phase IIb/III study in MDD was initiated in September 2011 and is expected to enroll 500 patients across approximately 40 sites.

Full year 2011 Fanapt® prescriptions, as reported by IMS, exceeded 120,000 compared to approximately 55,000 for 2010.  Vanda has been informed that Novartis is continuing the Phase II development program for the long-acting injectable formulation of Fanapt®.

The review of Vanda's Marketing Authorization Application (MAA) for oral iloperidone tablets in the European Union is ongoing.  The European Medicines Agency (EMA) has provided its standard 120-day list of questions and has granted Vanda a 3-month extension, through mid-May 2012, for Vanda to prepare its response.  After further evaluation of the regulatory and commercial environment, Vanda has no current plans to pursue registration for Fanapt® in Singapore and Australia.  Regulatory filings for market approval of Fanapt® by Vanda's commercial partners are under review in Israel, Mexico and Argentina.  

CONFERENCE CALLVanda has scheduled a conference call for today, Tuesday, February 14, 2012, at 10:00 AM ET.  During the call, Vanda's management will discuss the fourth quarter and full year 2011 results and other corporate activities.  Investors can call 866-271-0675 (domestic) and 617-213-8892 (international) and use passcode 76685033.  A replay of the call will be available beginning Tuesday, February 14, 2012 at 12:00 PM ET and will be accessible until Tuesday, February 21, 2012, at 5:00 PM ET.  The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers.  The access number is 37381299.

The conference call will be broadcast simultaneously on Vanda's website,

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
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