Sumitomo Dainippon Pharma said the results of Phase III clinical trials for its Latuda schizophrenia treatment in Japan disappointed and it would evaluate the next steps forward, but noted that a separate clinical trial on a bipolar disorder candidate would proceed.
"Sumitomo Dainippon Pharma does not believe the test results would warrant approval of production and distribution of lurasidone for the treatment of patients with schizophrenia in Japan, and is now reviewing its lurasidone development policy for Japan, which will be announced as soon as decided." the company said April 24 after markets closed in Tokyo.
"A Phase III clinical study conducted for application for approval of production and distribution of lurasidone for the treatment of patients with bipolar disorder in Japan will be continued as planned.
The results failed to demonstrate a statistically significant improvement over the placebo, Sumitomo Dainippon said. However, as noted in the statement, the planned Phase III trials for bipolar disorder will continue on schedule with a new drug application possible in 2018.
Analysts had earlier eyed the firm to bring a version of Latuda to market in 2016 in Japan.
- here's the Sumitomo Dainippon release