Otsuka And Takeda Announce TAK-438 Co-Promotion Agreement In Japan

Otsuka Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Company Limited announced that the companies have signed into a co-promotion agreement for TAK-438 (Vonoprazan Fumarate). TAK-438 was discovered by Takeda for the treatment of acid-related diseases.

Taro Iwamoto, Otsuka President and Representative Director, said, “We are very enthusiastic about entering this collaboration in Japan with Takeda, which has a leadership position in the gastrointestinal therapy area. Together we have the opportunity to bring to market an innovative new medicine that is hypothesized to significantly change the way in which acid-related disorders can be treated and thereby improve the QOL of many patients.”

Under the terms of the new agreement, Otsuka will pay Takeda an up-front 20 billion yen with an additional milestone payment upon New Drug Application (NDA) approval of the drug. Otsuka will also receive a percentage of sales from Takeda based on agreed terms. Japan will be the area of promotion for the drug.

TAK-438 belongs to the new class of acid secretion inhibitors called potassium-competitive acid blockers (P-CAB). The drug has shown strong and sustained acid secretion inhibitory effects centered on the inhibition of binding of potassium ion to H+, K+-ATPase (proton pump) in the final step of gastric acid secretion in gastric parietal cells. Since the drug is stable in acid and its immediate-release formulation is readily available without the need for an optimized formulation design, the onset of efficacy does not significantly differ among treated patients.

Yasuchika Hasegawa, Takeda’s President and CEO, said, “TAK-438 offers a new therapy option for acid-related diseases that require strong acid secretion inhibitory effects. I am pleased that we have been able to sign a co-promotion agreement with the most suitable partner. Takeda will take every possible step in order to meet the diverse needs of patients and healthcare professionals. ”

The drug is currently undergoing regulatory review for its NDA in Japan.