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

WASHINGTON, May 9, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the first quarter ended March 31, 2013.

Key Highlights:

  • On March 25, 2013, Vanda announced that it held a successful Pre-New Drug Application meeting with the U.S. Food and Drug Administration (FDA).  The FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in a tasimelteon New Drug Application (NDA) for Non-24-Hour Disorder (Non-24) is adequate to support filing. Vanda is targeting an NDA submission for tasimelteon for Non-24 in mid-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.
  • Full year 2013 decrease in cash, cash equivalents and marketable securities (Cash) is expected to be between $45.0 and $50.0 million, compared to $47.5 million for 2012.  2013 expenses are expected to reflect lower research and development spending as compared to 2012 and an increase in commercial spending that is commensurate to progress with the tasimelteon NDA filing.
  • During the first quarter of 2013, Vanda withdrew its Marketing Authorization Application (MAA) for Fanaptum™ (oral iloperidone tablets) in the European Union.
  • On April 18, 2013, Vanda announced that Paolo Baroldi, M.D., Ph.D. joined its management team as Senior Vice President, Chief Medical Officer.
  • FIRST QUARTER 2013 REPORTED RESULTSTotal revenues for the first quarter of 2013 and 2012 were each $8.1 mi
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