Takeda Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.

March 26, 2015

New Drug Application for a Single Pack Containing TAKECAB for Eradication of Helicobacter pylori in Japan

  • Takeda has submitted an application for a single pack for the first eradication of Helicobacter pylori. It contains three drugs, namely, TAKECAB® -- developed by Takeda for treating acid-related disease--amoxicillin, and clarithromycin, as well as a single pack for the second eradication of Helicobacter pylori containing three drugs: TAKECAB®, amoxicillin, and metronidazole.
  • 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 (Head office: Chuo-ku, Osaka; President and COO: Christophe Weber; "Takeda") and Otsuka Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo; President and Representative Director: Tatsuo Higuchi; "Otsuka") announced today 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 ("H. 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®).

TAKECAB was launched in Japan on February 26 this year. The eradication of H. pylori for "Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, gastric diseases after endoscopic resection of early stage gastric cancer, and Helicobacter pylori gastritis" are approved as well.

Each blister card has the daily dose of the single pack containing two antibacterial drugs and TAKECAB for the treatment of H. pylori eradication. The packaging helps improve the medication adherence of patients. By ensuring that patients follow the dosage and administration of each drug used for the treatment of H. pylori eradication, the effectiveness of the treatment is expected to improve further. In addition, we consider that this will also increase the convenience of healthcare professionals, helping us contribute further to the treatment of eradication in Japan.

The co-promotion agreement

Details of the agreement are as follows:

  • Takeda will receive from Otsuka an up-front payment of 20 billion yen and a milestone payment upon receiving regulatory approval.
  • Otsuka will receive from Takeda a co-promotion fee based on the sales amount (based on conditions specified in the contract).
  • Applicable drugs: TAKECAB and the single pack containing TAKECAB
  • Territory: Japan

Further details are not disclosed.