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May 05, 2015 6:07 AM ET

Pharmaceuticals

Company Overview of Otsuka Pharmaceutical Co., Ltd.

Company Overview

Otsuka Pharmaceutical Co., Ltd. engages in the development, production, distribution, export, and import of drugs for tuberculosis, rehydration, and central nervous system. It offers nutraceuticals, cosmedics, clinical testing equipment, medical device and equipment, medical food products, nutritional drinks, cosmetics, OTC drugs, and other related products. The company was founded in 1964 and is based in Tokyo, Japan with branch and district offices in Japan. It has operations in Asia, Europe, North America, and internationally. Otsuka Pharmaceutical Co., Ltd. operates as a subsidiary of Otsuka Holdings Co., Ltd.

2-9 Kanda Tsukasa-machi

Chiyoda-ku

Tokyo,  101-8535

Japan

Founded in 1964

Phone:

81 3 6717 1400

Fax:

81 3 6717 1499

Key Executives for Otsuka Pharmaceutical Co., Ltd.

President and Executive Director
Managing Director of Accounting, Finance & Business Promotion
Chairman of Otsuka Pharmaceutical Development & Commercialization Inc and Chief Executive Officer of Otsuka Pharmaceutical Development & Commercialization Inc
Senior Managing Director, General Manager of Production Headquarters and Director
Executive Director
Compensation as of Fiscal Year 2014.

Otsuka Pharmaceutical Co., Ltd. Key Developments

Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Co., Ltd. Enter into Agreement for Co-Promotion of TAKECAB

Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Co., Ltd. announced that Takeda submitted a new drug application to the Ministry of Health, Labour and Welfare for a single pack containing drugs which is the eradication of the Helicobacter Pylori. These drugs are available in the form of a single pack. One pack contains three drugs for the first eradication of H. pylori, namely, TAKECAB® (generic name: Vonoprazan fumarate, hereinafter “TAKECAB”) — developed by Takeda for treating acid-related diseases through a novel mechanism of action using potassium-competitive acid blockers (P-CABs) — amoxicillin (Japanese brand name: AMOLIN®), and clarithromycin (Japanese brand name: Clarith®). Another contains three drugs for the second eradication of H. pylori, namely, TAKECAB, amoxicillin, and metronidazole (Japanese brand name: Flagyl®). Takeda and Otsuka executed an agreement at the end of March 2014 to co-promote TAKECAB® (for treating acid-related diseases) in Japan. Under the agreement, the two companies will conduct informational activities about a single pack for the eradication of Helicobacter pylori for healthcare professionals after approval of it and address unmet clinical needs in the treatment of acid-related diseases. Otsuka will receive co-promotion fees from Takeda based on sales of TAKECAB® and the single pack containing TAKECAB® (in accordance with conditions specified in the agreement).

Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Company, Limited Unveil Takecab in Japan

Takeda Pharmaceutical Company Limited and Otsuka Pharmaceutical Company, Limited have announced the availability of Takecab 10mg and Takecab 20mg, or Vonoprazan fumarate, in Japan. TAKECAB, discovered by Takeda, is a new medicine for treating acid-related diseases with a novel mechanism of action called potassium-competitive acid blockers (P-CABs) which competitively inhibits the binding of potassium ions to H+,K+-ATPase (also known as the proton pump) in the final step of gastric acid secretion in gastric parietal cells. Vonoprazan fumarate has fast-acting, strong and sustained acid secretion inhibitory effects. Takeda and Otsuka executed an agreement at the end of March 2014 to co-promote TAKECAB in Japan.

The Committee for Medicinal Products for Human Use of the European Medicines Agency Recommends Otsuka Pharmaceutical Co., Ltd.'s JINARC (tolvaptan) for Approval

Otsuka Pharmaceutical Co., Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended JINARC (tolvaptan) for approval. This treatment has been recommended to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. Tolvaptan was developed over a period of 26 years through the persevering efforts of researchers in Otsuka's Japanese pharmaceutical research centre. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge, Otsuka launched an effort in 2004 to develop a drug for the disease in conjunction with the ADPKD medical specialists. The CHMP recommendation is based on data from a large clinical study conducted in ADPKD to date the pivotal Phase III randomised, double-blind and placebo-controlled TEMPO 3:4 trial. In the three-year trial, tolvaptan achieved its primary endpoint, demonstrating a statistically significant reduction of almost half (49%) in the annual increase in total kidney volume versus placebo (pAbout TEMPO 3:4 The TEMPO 3:4 trial (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) enrolled patients across 129 sites worldwide. In this trial a total of 1,445 adult patients (age 18-50 years) with evidence of rapidly-progressing early ADPKD were enrolled between January 2007 and January 2009 and administered tolvaptan or a placebo for up to three years. In the TEMPO 3:4 trial the risk of liver injury was identified in patients with ADPKD taking tolvaptan. Whilst this risk is small (4% in the trial), patients taking tolvaptan will have to undergo monthly blood tests for the first 18 months of treatment with tolvaptan and 3-monthly thereafter to mitigate this risk.

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