Osaka and Tokyo, Japan, February 21, 2013 --- Takeda Pharmaceutical Company Limited (Headquarters: Osaka, President & CEO: 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) jointly announced today that Helicobacter pylori ("H. pylori") gastritis has been approved by Japan's Ministry of Health, Labour and Welfare as an additional indication for H. pylori eradication by triple therapy with proton pump inhibitors. This therapy consists of a proton pump inhibitor*1, amoxicillin hydrate*1, and either clarithromycin*1 or metronidazole*1.
H. pylori gastritis is a histological gastric mucosal injury caused by the persistent infiltration of inflammatory cells in the gastric mucosa due to H. pylori infection, and is believed to be associated with the development of diseases such as gastric and duodenal ulcers. Existing indications approved for reimbursement under Japan's National Health Insurance (NHI) for H. pylori eradication were limited to gastric and duodenal ulcers, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, and the stomach after endoscopic resection of early-stage gastric cancer. Against this backdrop, the respective presidents of the Japanese Society of Gastroenterology, the Japan Gastroenterological Endoscopy Society, and the Japanese Society for Helicobacter Research submitted a joint letter to the Minister of Health, Labour and Welfare in December 2011 requesting the subsequent coverage under NHI of H. pylori gastritis as an additional indication for H. pylori eradication by triple therapy. In response to this, the four companies submitted a joint application in August 2012 based on the clinical evidence already published to date, together with five other companies*2 also seeking additional indication approval for each drug.
The four companies expect the approval of this additional indication to significantly contribute to the prevention and treatment of diseases related to H. pylori.
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|*1||For a full list of products, please refer to "Notes for Editors" below.
|*2||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., Abbott Japan Co., Ltd., Shionogi & Co., Ltd. and Taisho Pharmaceutical Co., Ltd.
Mylan Inc., Ohara Pharmaceutical Co., Ltd. and Takata Seiyaku Co., Ltd. submitted their respective applications for the additional indication of their drugs in December 2012.
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< Notes for Editors >
The approved products included in the application are as follows: (generic name) and < name of manufacturer >
1. Proton Pump Inhibitors
2. Amoxicillin Hydrates
3. Clarithromycin Products
4. Metronidazole Products
5. Combination Packages
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