DSP and Takeda Announce the Acceptance of the European Medicines Agency Submission of an Atypical Antipsychotic Agent Lurasidone

Osaka, Japan (ots/PRNewswire) -

Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Headquarters: Osaka,
Japan) and Takeda Pharmaceutical Company Limited ("Takeda")
(Headquarters: Osaka, Japan) today announced that the European
Medicines Agency (EMA) has confirmed the acceptance for review of the
Marketing Authorization Application (MAA) for an atypical
antipsychotic medication lurasidone hydrochloride for the treatment
of schizophrenia. The MAA was filed by Takeda Global Research &
Development Centre (Europe).

Lurasidone, orally administrated once daily, is an atypical
antipsychotic medication discovered and developed by DSP with a
unique chemical structure as compared to other existing antipsychotic
medicines. Takeda entered into a license agreement with DSP
stipulating the joint development and grant of an exclusive
commercialization right of the product to Takeda in 26 member states
of the European Union (excluding the United Kingdom), and
Switzerland, Norway, Turkey and Russia in March 2011.

The MAA submission is based on the data from more than 50
clinical trials involving more than 3,800 lurasidone-treated
subjects. In phase 3 clinical trials, in which the efficacy and
safety of lurasidone in the treatment of patients with schizophrenia
were evaluated, lurasidone demonstrated significantly greater
improvement versus placebo in the primary efficacy endpoint [Positive
and Negative Syndrome Scale (PANSS)* total score]. The most commonly
observed adverse reactions in patients treated with lurasidone were
somnolence, akathisia, nausea and parkinsonism. Clinical trials also
demonstrated that lurasidone was well-tolerated with minimal impact
on weight or metabolic parameters.

"Lurasidone is the DSP Group's core product for overseas
expansion, and I am very pleased that we have achieved the important
milestone of submitting an MAA in Europe." said Masayo Tada,
President and Chief Executive Officer of DSP. "Through the
cooperation between our two companies, we are aiming for the swiftest
approval in order to provide this drug to more patients as soon as
possible."

"We are very pleased with the submission of lurasidone in the
E.U.," said Yasuchika Hasegawa, president & CEO of Takeda. "We
believe the submission will lead to the enhancement of our central
nervous system franchise, one of our core therapeutic areas. Once
approved, we believe we can contribute to the treatment of patients
with schizophrenia."

* A medical scale used for mainly measuring symptom severity of
patients with schizophrenia. It consists of 30 items---7 items of
positive scale, 7 items of negative scale and 16 items of general
psychopathology scale. Each item is rated from 1 (absent) to 7
(extreme).

About lurasidone

Lurasidone is an atypical antipsychotic, developed originally by
DSP with an affinity for dopamine D2, serotonin 5-HT2A and serotonin
5-HT7 receptors where it has antagonist effects. In addition,
lurasidone is a partial agonist at the serotonin 5-HT1A receptor and
has no appreciable affinity for histamine or muscarinic receptors.

Lurasidone (brand name LATUDA(R)) was approved for the treatment
of schizophrenia by the United States Food and Drug Administration on
28 October 2010 and by Health Canada on 13 June 2012. LATUDA was
launched in the United States for the treatment of schizophrenia in
adults on February 4, 2011 (US time) and in Canada on September 17,
2011 (Canada Time) through DSP's subsidiary Sunovion Pharmaceuticals
Inc.

In the U.S. and Canada, the recommended starting dose for LATUDA
is 40mg/day taken with food (at least 350 calories) with no initial
dose titration required. The maximum recommended dose is 160 mg/day.
The efficacy of lurasidone for the treatment of schizophrenia was
established in five, short-term (6-week), placebo-controlled clinical
studies in adult patients who met DSM-IV criteria for schizophrenia.
In these studies, lurasidone demonstrated significantly greater
improvement versus placebo on the primary efficacy measures [the
Positive and Negative Syndrome Scale (PANSS) total score and the
Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study
endpoint. Clinical trials contributed to the understanding of the
tolerability and safety profile of lurasidone. The most commonly
observed adverse reactions (greater than or equal to5% and at least
twice that for placebo) in patients treated with lurasidone in
short-term clinical studies were somnolence, akathisia, nausea and
parkinsonism. Efficacy and safety of lurasidone were also
demonstrated in long-term studies.

About Dainippon Sumitomo Pharma Co., Ltd.

Dainippon Sumitomo Pharma Co., Ltd., defines its corporate
mission as "to broadly contribute to society through value creation
based on innovative research and development activities for the
betterment of healthcare and fuller lives for people worldwide". By
pouring all our efforts into the research and development of new
drugs, we aim to provide innovative and effective pharmaceutical
solutions to people not only in Japan but also around the world in
order to realize our corporate mission. Additional information about
DSP is available through its corporate website,
http://www.ds-pharma.com.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global
company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to strive towards better health for
patients worldwide through leading innovation in medicine. Additional
information about Takeda is available through its corporate website,
http://www.takeda.com.

ots Originaltext: Takeda Pharmaceutical Company Limited and Dainippon Sumitomo Pharma Co., Ltd.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media Contacts: Dainippon Sumitomo Pharma Co., Ltd., Corporate
Communications Dept., Phone: +81-6-6203-1407; Takeda Pharmaceutical
Company
Limited, Corporate Communications Dept. (PR/IR), Phone:
+81-3-3278-2037