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

February 26, 2016

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

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

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 H. pylori 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 H. pylori and "VONOPION" is a triple-drug blister pack containing "TAKECAB", "Amolin" and "Fragile® tablet" (generic name, metronidazole) for secondary eradication of H. pylori.

Combining a daily dose of each of the two antibiotics used for H. pylori 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 H. pylori eradication therapy in Japan.

Overview of VONOSAP

Overview of VONOSAP
JP, Japanese Pharmacopoeia

Overview of VONOPION

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.


Information in this news release was current as of the original release date.

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