Otsuka and Takeda to co-promote TAK-438 in the GI therapy area in Japan

Japanese drugmakers Otsuka Pharmaceutical (TYO: 4768) and Takeda Pharmaceutical (TYO: 4502) have entered into a co-promotion agreement in Japan for TAK-438 (vonoprazan fumarate), a drug discovered by Takeda for the treatment of acid-related diseases.

Under the terms of the agreement, Otsuka will pay Takeda, Japan’s largest pharma company, an up-front payment of 20 billion yen ($195 million) and a milestone payment on the approval of a New Drug Application, and Otsuka will receive a percentage of the sales (based on certain conditions specified in the contract) from Takeda. A New Drug Application for TAK-438 was submitted in Japan by Takeda and is currently undergoing regulatory review.

Proton pump inhibitors (PPIs) are currently widely prescribed as first-line therapy for the treatment of acid-related diseases in Japan. However, PPIs do not always provide sufficient therapeutic efficacy, and the acid secretion inhibitory effects of PPIs may differ among individuals, because of the protein CYP2C19 which has gene polymorphisms that are involved in metabolism. TAK-438 inhibits proton pumps without the need for activation by acid, and the compound is distributed at high concentrations into the stomach, the target organ, thereby exerting a nearly maximum inhibitory effect from the first dose and remaining effective for 24 hours.