Takeda Obtains NDA Approval for Eradication triple-drug Blister Packs Containing TAKECAB tablet, "VONOSAP pack 400", "VONOSAP pack 800" and "VONOPION pack" in JapanHelicobacter pylori*®®®

Takeda has obtained New Drug Application approval in Japan for "VONOSAP pack 400" and "VONOSAP pack 800", each being a triple-drug blister pack containing the potassium-competitive acid blocker "TAKECAB tablet", developed by Takeda, for primary eradication of .®®®Helicobacter pylori (H. pylori) Approval was also received for "VONOPION pack", a triple-drug blister pack containing "TAKECAB tablet" for secondary eradication of .®®H. pylori As per the agreement reached at the end of March 2014 for co-promotion of "TAKECAB tablet" in Japan, Takeda and Otsuka will implement informational activities on "VONOSAP pack 400", "VONOSAP pack 800" and "VONOPION pack" for eradication of , thereby addressing the healthcare needs in acid-related disorders.®®®®H. pylori Otsuka will be compensated for all sales generated by its sales force for "TAKECAB tablet" as well for the TAKECAB-containing drug packs, "VONOSAP pack" and "VONOPION pack".®®®® Takeda Pharmaceutical Company Limited (Head office, Chuo-ku, Osaka; President and COO, Christophe Weber; hereafter "Takeda") and Otsuka Pharmaceutical Co., Ltd. (Head office, Chiyoda-ku, Tokyo; President and Representative Director, Tatsuo Higuchi; hereafter "Otsuka") announced that Takeda has obtained New Drug Application approval from the Ministry of Health, Labour and Welfare for "VONOSAP pack 400", "VONOSAP pack 800" (hereafter "VONOSAP") and "VONOPION pack" (hereafter "VONOPION") for eradication. "VONOSAP" is a triple-drug blister pack combining the acid suppressant (also called a potassium-competitive acid blocker (P-CAB) based on its mechanisms of action) "TAKECAB tablet" (generic name, vonoprazan fumarate; hereafter "TAKECAB") developed by Takeda, "Amolin capsule" (generic name, amoxicillin; hereafter "Amolin") and "Clarith tablet" (generic name, clarithromycin) for primary eradication of and "VONOPION" is a triple-drug blister pack containing "TAKECAB", "Amolin" and "Fragile tablet" (generic name, metronidazole) for secondary eradication of .®®®H. pylori ®®®H. pylori®H. pylori Combining a daily dose of each of the two antibiotics used for eradication with TAKECAB, which is known to exert potent and sustained acid-inhibitory effects, these blister packs have been developed to improve patient adherence by ensuring that each component drug is taken without fail. With the added benefit of convenience of use, these blister packs are also expected to provide an alternative treatment option for healthcare professionals to effectively treat their patients. Otsuka and Takeda also hope to further contribute to improving eradication therapy in Japan.H. pyloriH. pylori are one type of bacteria present in the human stomach and are primarily known to be implicated in the onset of peptic ulcer. eradication therapy has been shown to be effective in preventing peptic ulcer recurrence with markedly low peptic ulcer recurrence rates reported following treatment, thus providing substantial benefits to patients with infection.Helicobacter pyloriH. pyloriH. pylori Overview of VONOSAP JP, Japanese Pharmacopoeia Overview of VONOPION JP, Japanese Pharmacopoeia Details of co-promotion agreement Takeda is to receive from Otsuka an up-front payment of 20 billion yen and a milestone payment upon receiving regulatory approval. Otsuka is to receive from Takeda a co-promotion fee based on the sales volume (based on conditions specified in the contract). Applicable drugs: TAKECAB and the single packs containing TAKECAB Territory: Japan Further details are not disclosed.

The release as fetched from its publisher. otsuka.co.jp ↗