News Release

DSP and Takeda Announce Approval of the Marketing Authorization Application for Atypical Antipsychotic Agent Lurasidone in Switzerland Osaka, Japan, August 13, 2013 - Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Headquarters: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Headquarters: Osaka, Japan) today jointly announced that on August 12, Swiss local time, Takeda Pharma AG, a wholly owned subsidiary of Takeda, obtained the approval of the Marketing Authorization Application by Swissmedic for atypical antipsychotic medication lurasidone hydrochloride ("lurasidone") for the treatment of patients with schizophrenia.

Lurasidone, orally administrated once daily, is an atypical antipsychotic medication discovered and developed by DSP. In the U.S., it was approved for the treatment of schizophrenia and also for major depressive episodes associated with bipolar I disorder in October 2010 and June 2013, respectively. It is being marketed as LATUDA® in the U.S. and Canada by Sunovion Pharmaceuticals Inc., a wholly owned subsidiary of DSP. In March 2011, DSP and Takeda signed a license agreement for lurasidone for the joint development and exclusive commercialization by Takeda in the 26 member states of the European Union at that time excluding the United Kingdom, Switzerland, Norway, Turkey and Russia.
The Marketing Authorization Application was submitted in Switzerland in March 2012 based on the dossier used for submissions and subsequent approvals by the U.S. Food and Drug Administration and Health Canada. In the European Union, the Marketing Authorization Application was accepted for review by the European Medicines Agency in October 2012 and is currently under review.
DSP will work to grow lurasidone as its global strategic product, to maximize product value by expanding business regions in its third Mid-term Business Plan covering the period up to fiscal 2017.
Takeda believes that lurasidone will be an important driver for accelerating the exploration of its specialty care business in Europe as part of its Mid-Range Growth Strategy announced in May 2013.
According to the World Health Organization, schizophrenia is a severe form of mental illness affecting about seven of every one thousand adults, mostly in the age group 15-35 years, and it affects about 24 million people worldwide.