Dainippon files for approval of blockbuster schizophrenia drug

Dainippon Sumitomo has filed for FDA approval of its prospective blockbuster schizophrenia drug lurasidone, beating its own timetable as the Japanese pharma giant stays on course toward an expected 2011 market launch.

Dainippon was willing to spend $2.6 billion for Sepracor last fall, at least in part because it plans to deploy its 1,200 sales people in a national campaign to sell the drug. "This NDA marks a significant milestone for our company as we accelerated the global clinical development of lurasidone and achieved an earlier than anticipated submission to the FDA," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma.

Analysts expect the drug's safety profile will allow it to break the billion-dollar barrier in the U.S. if it is approved. But it won't be easy. The antipsychotic market in the U.S. is intensely competitive. Lurasidone is designed to work much like Zyprexa, Risperdal or Seroquel, without the weight gain that many patients experience. And the Japanese company is also testing the therapy as a treatment for bipolar disorder.  

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