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Swiss Approval for Takeda/ Dainippon's Latuda

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Takeda Pharmaceutical Co. (TKPYY) and its partner Dainippon Sumitomo Pharma Company Limited recently announced the approval of Dainippon’s atypical antipsychotic medication, Latuda, for the treatment of patients with schizophrenia in Switzerland. It is the first approval of Latuda in Europe. The Marketing Authorization Application was submitted in Mar 2012.

According to the World Health Organization, schizophrenia affects 24 million people globally. Roughly seven out of one thousand adults (15-35 years of age) are affected by schizophrenia.

We note that Dainippon and Takeda joined forces in Mar 2011, for the joint development and exclusive commercialization of Latuda by Takeda in the EU at that time excluding the UK, Switzerland, Norway, Turkey and Russia.

Latuda has been discovered and developed by Dainippon. It was approved in the U.S. for the treatment of schizophrenia in Oct 2010 and for major depressive episodes associated with bipolar I disorder in Jun 2013. It is marketed in the U.S. and Canada by Sunovion Pharmaceuticals Inc., a wholly owned subsidiary of Dainippon.

Latuda was accepted for review in the EU in Oct 2012 while in Japan, phase III study for the treatment of schizophrenia is in progress. It is also filed for approval with the Australian authorities for the treatment of schizophrenia. 

For the quarter ended Jul 31, 2013, Latuda generated sales of $68 million, up 74% year over year, in the North American region.

Takeda carries a Zacks Rank #3 (Hold). Currently, companies like Questcor Pharmaceuticals Inc. (QCOR), Biogen Idec Inc. (BIIB) and Actelion Ltd. (ALIOF) look well positioned in the pharma space with a Zacks Rank #1 (Strong Buy).

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