News Release
Takeda Pharmaceutical Company Limited
AstraZeneca K.K.
Mitsubishi Tanabe Pharma Corporation
Eisai Co., Ltd.
Companies Submit Joint Application Seeking Approval for Additional Indication for
Helicobacter pylori Eradication by Concomitant Therapy with Proton Pump Inhibitors, Amoxicillin
Hydrate and either Clarithromycin or Metronidazole
Osaka and Tokyo, Japan, August 31, 2012 --- Takeda Pharmaceutical Company Limited(Headquarters: Osaka, President: Yasuchika Hasegawa), AstraZeneca K.K. (Headquarters: Osaka,President: Paul Hudson), Mitsubishi Tanabe Pharma Corporation (Headquarters: Osaka; President:Michihiro Tsuchiya), and Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito)
announced today that they have submitted a joint application* to Japan’s Ministry of Health, Labourand Welfare seeking approval of Helicobacter pylori (“H. pylori”) gastritis as an additional indicationfor H. pylori eradication by concomitant therapy with four proton pump inhibitors―lansoprazole,omeprazole, rabeprazole sodium and esomeprazole magnesium hydrate－manufactured and marketedby the four companies in Japan under five brand names. This concomitant therapy consists of aproton pump inhibitor, amoxicillin hydrate (generic name; marketed under two brand names), andeither clarithromycin (generic named: marketed under two brand names) or metronidazole (genericname; marketed under one brand name).
H. pylori gastritis is also known as chronic active gastritis due to the fact that it causes histologicalgastric mucosal injury as a result of the persistent infiltration of inflammatory cells in the gastricmucosa due to H. pylori infection, and is believed to be associated with the development of various H.
pylori-related diseases such as gastric and duodenal ulcers. However, under the Japanese National
Health Insurance (NHI) system, the approved indications for eradication of H. pylori are currently
limited to gastric and duodenal ulcers, gastric MALT lymphoma, idiopathic thrombocytopenic
purpura, and the stomach after endoscopic resection of early stage gastric cancer. Against thisbackdrop, the Japanese Society of Gastroenterology, the Japan Gastroenterological Endoscopy
Society and the Japanese Society for Helicobacter Research submitted a letter to the Minister ofHealth, Labour and Welfare in December 2011 requesting the earliest possible approval andsubsequent coverage under NHI of H. pylori gastritis as an additional indication for the eradication ofH. pylori by concomitant therapy based on the abundance of clinical evidence already published todate. In response to this, the companies submitted the latest joint application based on the said
published evidence in accordance with the "Handling of Ethical Drugs for Off-label Use",
Notification No. 4 of the Research and Development Division / Notification No. 104 of theEvaluation and Licensing Division, dated February 1, 1999.
The four companies expect that, once approved, this additional indication will significantly contributeto the prevention and treatment of diseases related to H. pylori.
*The joint applicants of the additional indication also include five other companies marketing amoxicillin
hydrate, clarithromycin and metronidazole: Kyowa Hakko Kirin Co., Ltd., Astellas Pharma Inc., ABBOTTJAPAN Co., LTD., Shionogi & Co., Ltd. and Taisho Pharmaceutical Co., Ltd.

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Notes for Editors
Products included in the application are as follows: (generic name) and <name of manufacturer>
1. Proton Pump Inhibitors- Takepron® Capsules 15 and 30; Takepron® OD Tablets 15 and 30 (lansoprazole) <Takeda Pharmaceutical
Company Limited>- Omepral® Tablets 10 and 20 (omeprazole) <AstraZeneca K.K.>- Omeprazon® Tablets 10 mg and 20 mg (omeprazole) <Mitsubishi Tanabe Pharma Corporation>- Pariet® Tablets 10 mg (rabeprazole sodium) <Eisai Co., Ltd.>- Nexium® Capsules 10 mg and 20 mg (esomeprazole magnesium hydrate) <AstraZeneca K.K (sales anddistribution by Daiichi Sankyo Co., Ltd)>
2. Amoxicillin hydrates- Pasetocin® Capsules 125 and 250; Pasetocin® Tablets 250 <Kyowa Hakko Kirin Co., Ltd.>- Sawacillin® Capsules 125 and 250; Sawacillin® Tablets 250 <Astellas Pharma Inc.>- Amolin® Capsules 125 and 250; Amolin® Granules 10% <Takeda Pharmaceutical Company Limited>
3. Clarithromycin products- Clarith® Tablets 200 <Taisho Pharmaceutical Co., Ltd. (Marketed by: Taisho Toyama Pharmaceutical Co.
Ltd.)>- Klaricid® Tablets 200mg <ABBOTT JAPAN Co., LTD.>
4. Metronidazole products- Flagyl® Oral Tablets 250 mg <Shionogi & Co., Ltd.>
5. Combination package- Lansap® 400; Lansap® 800 <Takeda Pharmaceutical Company Limited>- Lampion® Pack <Takeda Pharmaceutical Company Limited>Media Contacts:
Takeda Pharmaceutical Company Limited
Corporate Communications Department TEL: +81-3-3278-2037
AstraZeneca K.K.
Corporate Communications, Corporate Affairs TEL: +81-6-6453-8011
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department TEL: +81-6-6205-5211
Eisai Co., Ltd.
Public Relations Department TEL: +81-3-3817-5120###2