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Vanda Pharmaceuticals Reports First Quarter 2012 Results
Date:5/8/2012

24.  The tasimelteon Non-24 program continues to advance towards the goal of a projected mid-2013 NDA filing with the FDA.  Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission.  Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by 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 is expected to enroll 500 patients across approximately 40 sites in the U.S.

On April 16, 2012, Vanda announced that it had obtained exclusive world-wide rights from Eli Lilly and Company to develop and commercialize VLY-686, a small molecule neurokinin 1 receptor (NK-1R) antagonist for all human indications.  In 2012, Vanda intends to initiate and complete the technology transfer activities and further examine the clinical and commercial profile of VLY-686.  This strategic evaluation will further inform potential indications for an early clinical development program.  VLY-686 is a Phase II ready program.

First quarter 2012 sales of Fanapt® were reported by Novartis to be $15.4 million.  Fanapt® prescriptions, as reported by IMS, reached 35,000 for the first quarter of 2012.  This represents a 39% increase over first quarter 2011 prescriptions.

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.  Vanda expects to respond to the EMA questions by such time.  Regulatory filings for market approval of Fanapt® by Vanda's commercial partners are under review in Israel, Mexico and Argentina. 

2012 FINANCIAL GUIDANCE

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