Sumitomo Dainippon Pharma and Takeda Pharmaceutical have canceled a four-year-old license and development agreement aimed at commercialization of lurasidone hydrochloride (Latuda) products. The decision follows disappointing Phase III trials to treat schizophrenia announced last month.
The two companies said in a news release, however, that the clinical results did not drive the decision.
"The termination of the agreement is based on market and business considerations of Takeda and is not the result of new safety or efficacy information on Latuda," the joint release said.
"Sumitomo Dainippon Pharma and Takeda continue to believe that Latuda is an appropriate treatment option for adult patients with schizophrenia with minimal impact on important measures of metabolic health. Latuda has been available in the United States since 2011, in Canada since 2012, and subsequently in six countries in Europe. During this time it is estimated that more than one million patients have been treated with Latuda."
In April, Sumitomo Dainippon Pharma said the results of Phase III clinical trials 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.
Analysts had earlier eyed the company to bring a version of Latuda to market in 2016 in Japan.
- here's the release