News Release
Takeda Pharmaceutical Company Limited
AstraZeneca K.K.
Mitsubishi Tanabe Pharma Corporation
Eisai Co., Ltd.
Approval of Additional Indications for Helicobacter pylori Eradication by Concomitant
Therapy with Proton Pump Inhibitors
Osaka and Tokyo, Japan, June 18, 2010 --- Takeda Pharmaceutical Company
Limited (Osaka, President and CEO: Yasuchika Hasegawa), AstraZeneca K.K. (Osaka,President and CEO: Masahiro Kato), Mitsubishi Tanabe Pharma Corporation (Osaka;President and CEO: Michihiro Tsuchiya), and Eisai Co., Ltd. (Tokyo; President and CEO:Haruo Naito) jointly announced today that they have received approval from the Japanese
Ministry of Health, Labor and Welfare for additional indications for Helicobacter pylori (“H.
pylori”) eradication by concomitant therapy with three proton pump inhibitors, lansoprazole,omeprazole, and rabeprazole sodium, marketed in Japan under four brand names. Thisconcomitant therapy consists of a proton pump inhibitor, amoxicillin hydrate, and either
clarithromycin or metronidazole, and is indicated for the eradication of H. pylori in gastric
MALT lymphoma(*1), idiopathic thrombocytopenic purpura(*2) (“ITP”) and the stomach afterendoscopic resection of early stage gastric cancer.
The approved indications for eradication of H. pylori were limited to gastric and duodenal
ulcers, while recent findings have revealed that the H. pylori plays a central role in thecause and pathology of a variety of diseases including gastric cancer. The JapaneseSociety for Helicobacter Research submitted a letter to the Minister of Health, Labor andWelfare in December 2008, requesting the earliest possible approval of the additional
indications based on the abundant clinical evidence already published to date. In responseto this, the relevant companies(*3) submitted joint applications on September 30, 2009
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 the Evaluation and Licensing Division, dated February 1, 1999.
The four companies providing the proton pump inhibitors expect that these additional
indications will significantly contribute to improving the quality of life (QOL) and prognosisof a wider range of patients.
###1(*1)

Gastric MALT lymphoma is a B-cell lymphoma derived from Mucosa-AssociatedLymphoid Tissue (“MALT”) in the stomach.

(*2)

Idiopathic thrombocytopenic purpura is characterized by decrease in platelets, leading
to a variety of bleeding symptoms for which causes, such as underlying disease or
medicinal treatment, are unknown.

(*3)

Takeda Pharmaceutical Company Limited, AstraZeneca K.K., Mitsubishi Tanabe
Pharma Corporation, Eisai Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Astellas PharmaInc., Taisho Pharmaceutical Co., Ltd., ABBOTT JAPAN Co., LTD., and Shionogi & Co.,
Ltd.

###Notes for Editors
Products included in the application are as follows: (Generic name) and <name ofmanufacturer>
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.>
2. Amoxicillin hydrates- Pasetocin® Capsules 125 and 250; Pasetocin® Tablets 250 < Kyowa Hakko Kirin Co., Ltd.>- Sawacillin ® Capsules; Sawacillin ® Tablets 250 < Astellas Pharma Inc.>- Amolin® Capsules 125 and 250; Amolin® Granules 10% <Takeda Pharmaceutical CompanyLimited>
3. Clarithromycin products- Clarith® Tablets < Taisho Pharmaceutical Co., Ltd.>- Klaricid® Tablets < ABBOTT JAPAN Co., LTD.>
4. Metronidazole products- Flagyl® Oral Tablets < Shionogi & Co., Ltd.>
5. Combination package- Lansap® 400 and 800 <Takeda Pharmaceutical Company Limited>2

###Contacts:
Takeda Pharmaceutical Company Limited
Corporate Communications Department TEL: +81-3-3278-2037AstraZeneca K.K.
Corporate Communications, Corporate Management 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###3