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

ROCKVILLE, Md., May 5, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced financial and operational results for the first quarter ended March 31, 2011.

"We are very excited about the significant progress we have made to date in 2011," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer. "Our first product, Fanapt®, which is marketed in the U.S. for the treatment of schizophrenia has now entered a Phase I study to evaluate the safety and pharmacokinetic profiles of two different long-acting formulations in patients with schizophrenia.  In addition, we have expanded the tasimelteon clinical program with a Phase IIb/III Study in Major Depression that will begin in the second half of 2011."

Key Highlights:

  • Vanda recorded first quarter 2011 revenue of $7.5 million including royalties of $0.9 million. Fanapt® prescriptions, as reported by IMS, reached 25,000 in the first quarter of 2011.
  • Fanapt® long-acting injectable (depot) formulation advanced into clinical studies.
  • European filing for oral Fanapt® is targeted for the second half of 2011.
  • Tasimelteon program expanded to include a Phase IIb/III study in patients with Major Depressive Disorder.   Study expected to begin in the second half of 2011.
  • The European Commission (EC) granted orphan drug designation for tasimelteon for Non-24-Hour Sleep/Wake Disorder (N24HSWD.)  
  • Top-line efficacy results for tasimelteon for N24HSWD are expected in mid 2012; NDA submission planned for the first half of 2013.

  • FIRST QUARTER 2011 REPORTED RESULTSTotal revenues for the first quarter of 2011 were $7.5 million, com
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    SOURCE Vanda Pharmaceuticals Inc.
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