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Vanda Pharmaceuticals Reports First Quarter 2011 Results
Date:5/5/2011

totally blind individuals. Top line efficacy results are expected in mid 2012 and an NDA submission is planned for the first half of 2013.

On March 8, 2011, tasimelteon was granted orphan drug designation by the European Commission (EC) for the treatment of N24HSWD in totally blind individuals.  Orphan designation for a medicinal product by the EC provides benefits that can take a variety of forms including tax incentives, protocol assistance, eligibility for grants and initiatives supporting research and development related to this orphan indication, reduction of marketing application fees and annual fees for qualifying companies, and potential marketing exclusivity for up to 10 years in the European Union.

REVISED FULL YEAR 2011 FINANCIAL GUIDANCE

  • General and administrative expenses are expected to be between $10.0 and $12.0 million.  
  • Research and development expenses are expected to be between $30.0 and $34.0 million.  
  • Total U.S. GAAP operating expenses are expected to be between $41.0 and $47.0 million.  This includes $1.5 million related to amortization of an intangible asset and $5.0 to $6.0 million of stock-based compensation.

  • CONFERENCE CALLVanda has scheduled a conference call for today, Thursday, May 5, 2011, at 10:00 AM ET.  During the call, Mihael H. Polymeropoulos, M.D., President and CEO, and James P. Kelly, Senior Vice President and Chief Financial Officer, will discuss the first quarter 2011 results and other corporate activities.  Investors can call 1-866-383-7998 (domestic) and 1-617-597-5329 (international) prior to the 10:00 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos (participant passcode 44118664).  A replay of the call will be available beginning Thursday, May 5, 2011 at 1:00 PM ET and will be accessible until Thursday, May 12, 2011, at 5:00 PM ET.  The replay call-in number is 1-888-286-
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    SOURCE Vanda Pharmaceuticals Inc.
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