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

June 7, 2016

- 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.

 

 

Osaka and Tokyo, Japan, June 7, 2016—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 Helicobacter pylori infections, enabling a broad contribution from diagnosis to treatment. Through our promotional collaboration with Takeda of Helicobacter 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

Product names

VONOSAP® pack 400/ VONOSAP® pack 800

Generic names

Vonoprazan fumarate tablet; amoxicillin capsule (JP); and clarithromycin tablet (JP)

Indications

<Bacteria>
Helicobacter pylori susceptible to amoxicillin or clarithromycin.

<Infections>
Helicobacter pylori infection in patients with gastric ulcer ∙ duodenal ulcer ∙ gastric MALT lymphoma ∙ idiopathic thrombocytopenic purpura ∙ after endoscopic resection of the stomach in early-stage gastric cancer∙ Helicobacter pylori gastritis

Dosages and administration

The usual adult dosage for oral administration is 20 mg of vonoprazan, 750 mg (potency) of amoxicillin hydrate, and 200 mg (potency) of clarithromycin twice daily taken together for seven days.

The dose of clarithromycin may be increased as required, but not to exceed 400 mg (potency) twice daily.

NHI drug price

VONOSAP® pack 400 : 733.80 yen per sheet
VONOSAP® pack 800 : 884.00 yen per sheet

 JP: Japanese Pharmacopoeia

 

Overview of VONOPION

Product name

VONOPION® pack

Generic names

Vonoprazan fumarate tablet; amoxicillin capsule (JP); and metronidazole tablet (JP)

Indications

<Bacteria>
Helicobacter pylori susceptible to amoxicillin or metronidazole.

<Infections>
Helicobacter pylori infection in patients with gastric ulcer ∙ duodenal ulcer ∙ gastric MALT lymphoma ∙ idiopathic thrombocyto-penic purpura ∙ after endoscopic resection of the stomach in early-stage gastric cancer∙ Helicobacter pylori gastritis

Dosages and administration

For use when triple therapy with a proton pump inhibitor, amoxicillin hydrate, and clarithromycin fails to eradicate Helicobacter pylori.

The usual adult dosage for oral administration is 20 mg of vonoprazan, 750 mg (potency) of amoxicillin hydrate, and 250 mg of metronidazole twice daily taken together for seven days.

NHI drug price

VONOPION® pack : 654.60 yen per sheet

JP: Japanese Pharmacopoeia

Details of co-promotion agreement

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

 

 

Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology, central nervous system and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news. 

Otsuka Pharmaceutical Co., Ltd.
Otsuka is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative and original products, focusing on pharmaceutical products for treating diseases and nutraceutical products to maintain everyday health. Otsuka invites you to visit its global website at https://www.otsuka.co.jp/en/.


Takeda Media Contacts:
Tsuyoshi Tada
+81-3-3278-2417
tsuyoshi.tada@takeda.com

 

Otsuka Pharmaceutical Co., Ltd. Media Contact:
Public Relations Department
+81-3-6361-7379