Vanda Pharma 1Q Loss on Sleep Disorder Drug Costs

Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA),. said Tuesday it took a loss in the first quarter as it spent more money developing its sleep disorder drug tasimelteon.

Vanda said over the first three months of the year it lost $8 million, or 28 cents per share. A year ago it reported a profit of $136,000, which was break-even on a per-share basis. Its revenue rose to $8.1 million from $7.5 million.

The company said its research and development costs nearly tripled to $12.2 million from $4.3 million as it studied tasimelteon as a treatment for sleep disorders in people who are blind. Vanda said it expects to finish two late-stage trials of tasimelteon by the end of 2012 and file for marketing approval of the drug in mid-2013.

Key Highlights:

  • The tasimelteon Non-24-Hour Disorder (Non-24) program continues to advance towards the goal of a projected mid-2013 New Drug Application (NDA) filing with the U.S. Food and Drug Administration(FDA).  Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012. 

  • Initial clinical data in the RESET study revealed potential of tasimelteon to reset the body clock in Non-24.  

  • The tasimelteon MAGELLAN Phase IIb/III efficacy study for Major Depressive Disorder (MDD) is ongoing and Vanda expects to report top-line results in the first half of 2013.

Source: Vanda Pharma

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