Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 7, 2016

VONOSAP® pack 400, VONOSAP® pack 800 and VONOPION®pack (triple-drug blister packs containing TAKECAB® tablet) Now Available for Helicobacter pylori* Eradication in Japan

  • VONOSAP® pack 400 and VONOSAP® pack 800, each a triple-drug blister pack containing the potassium-competitive acid blocker TAKECAB® tablet developed by Takeda for primary eradication of Helicobacter pylori (H. pylori), are now available in Japan.
  • VONOPION®pack, a triple-drug blister pack containing TAKECAB® tablet for secondary eradication of H. pylori, is also now available in Japan.
  • Takeda and Otsuka will implement promotional activities on VONOSAP® pack 400, VONOSAP® pack 800 and VONOPION®pack for eradication of H. pylori, in accordance with the agreement reached in March 2014 for co-promotion of TAKECAB® tablet, thereby addressing healthcare needs in acid-related disorders .

Takeda Pharmaceutical Company Limited (head office, Chuo-ku, Osaka; President and CEO, Christophe Weber; hereafter "Takeda") and Otsuka Pharmaceutical Co., Ltd. (Head office, Chiyoda-ku, Tokyo; President and Representative Director, Tatsuo Higuchi; hereafter "Otsuka") announced today that VONOSAP® pack 400 and VONOSAP® pack 800 (hereafter "VONOSAP") together with VONOPION®pack (hereafter "VONOPION") for H. pylori eradication are now available in Japan.
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. VONOPION is a triple-drug blister pack containing TAKECAB, Amolin and Fragile® tablet (generic name, metronidazole) for secondary eradication of H. pylori.

"Since 2002, Takeda has made available for patients of acid-related disease a triple-drug blister pack containing two antibiotics used for H. pylori eradication and the acid suppressant "TAKEPRON" with the aim of improving patient adherence," said Masato Iwasaki, Ph.D., director, president of Japan Pharma Business Unit of Takeda. "I am delighted that together with Otsuka, an excellent co-promotion partner, we are able to offer patients a new triple-drug blister pack containing TAKECAB, which is known to exert potent and sustained acid-inhibitory effects. Through VONOSAP and VONOPION, we will make further contributions to H. pylori eradication in Japan."

Susumu Tamai, vice president and executive director of Otsuka commented, "Otsuka has developed a diagnostic system for H. pylori infections, enabling a broad contribution from diagnosis to treatment. Through our promotional collaboration with Takeda of H. pylori pack formulations containing TAKECAB, we are enthusiastic about this opportunity to deliver a new eradication therapy to more patients."

  • Helicobacter pylori are one type of bacteria present in the human stomach and are primarily known to be implicated in the onset of peptic ulcers. H. pylori eradication therapy has been shown to be effective in preventing peptic ulcer recurrence with markedly low peptic ulcer recurrence rates reported following treatment, providing substantial benefits to patients with H. pylori infection.

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