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

The FINANCIAL — 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 on March 26 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 H. pylori gastritis” are approved as well, according to Takeda.

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.