August 8, 2019

Regulatory Approval for Marketing Cariprazine (MP-214)
for the Treatment of Schizophrenia
in Part of the ASEAN (Singapore and Thailand)
Mitsubishi Tanabe Pharma Corporation (MTPC, Chuo-ku, Osaka, Japan;
President & Representative Director, CEO: Masayuki Mitsuka) announced todaythat MTPC’s subsidiaries in ASEAN obtained the regulatory approval ofcariprazine (generic name; development code: MP-214; dopamine D3/D2
receptor partial agonist) for the treatment of schizophrenia in Singapore fromthe Singaporean Health Sciences Authority on July 11, and from Food and Drug
Administration Thailand in Thailand on July 22, following the completion of theapproval application procedure in both countries.
In Singapore, Mitsubishi Tanabe Pharma Singapore Pte. Ltd., the locally based
subsidiary of MTPC, will market as the Marketing Authorization Holder (MHA)
cariprazine under the name SYMVENU®. In Thailand, Mitsubishi Tanabe Pharma(Thailand) Co., Ltd., will market as the MAH the product under the name
REAGILA®.
While the mechanism of action of cariprazine is unknown, it has been confirmedthat cariprazine produces few extrapyramidal adverse reactions such asparkinsonian symptoms (tremors in the limbs, muscle stiffness, and/or lack ofcalmness), and has improving effects on negative symptoms such as lowered
motivation and blunted and/or flat affect.
Schizophrenia is a mental disorder, causes have not yet been accuratelyidentified. The symptoms of schizophrenia are broadly classified into three
types: positive symptoms (including delusions and hallucinations), negative
symptoms, and cognitive dysfunctions (abnormalities in the abilities toconcentrate on, memorize, or plan things, or solve problems). Patients differ interms of the type and level of their symptoms. It is estimated that there areapproximately 30,000 patients suffering from schizophrenia in Singapore, andapproximately 360,000 in Thailand.
MTPC has been developing cariprazine for the Asian market under the licensethat its right has been granted by Gedeon Richter Plc. (Budapest, Hungary). This
product has already been launched by Gedeon Richter Plc. and its partner inEurope and the U.S.

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The symptoms of schizophrenia pose many difficulties for many patients in theireveryday lives in Asian countries.
MTPC will strive to provide this product to patients who are forced to experience
difficulties in their lives due to schizophrenia, in order to improve their qualityof life (QOL).
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110

■ About Cariprazine (MP-214)
Cariprazine is an oral, once daily atypical antipsychotic approved by FDA and EMA
for the treatment of schizophrenia in adults (1.5 to 6 mg/day). While themechanism of action of cariprazine is unknown, the efficacy of cariprazine could
be mediated through a combination of partial agonist activity at central
dopamine D₂ and serotonin 5-HT1A receptors and antagonist activity at serotonin
5-HT2A receptors. Pharmacodynamic studies with cariprazine have shown thatit acts as a partial agonist with high binding affinity at dopamine D3, dopamine
D2, and serotonin 5-HT1A receptors.
■ About Mitsubishi Tanabe Pharma Singapore Pte. Ltd.
Mitsubishi Tanabe Pharma Singapore Pte. Ltd. was founded as a wholly-owned
subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Singapore in2016. As a company in charge of supervising the ASEAN region, where theeconomies and pharmaceutical markets have been rapidly growing, thecompany carries out its operations, including development, in order to promptly
provide patients in ASEAN countries with our innovative pharmaceuticalproducts that can satisfy local unmet medical needs. Future Symvenu® will bepromoted by itself.
■ About Mitsubishi Tanabe Pharma (Thailand) Co., Ltd.
Mitsubishi Tanabe Pharma (Thailand) Co., Ltd. was founded as a wholly-owned
subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Thailand in 2016.
In Thailand, which has one of the largest pharmaceutical market in ASEAN
region, the company sells drugs for cardiovascular diseases, such as
HERBESSER®. Future Reagila® will be promoted by itself.

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