Otsuka, Takeda partner to co-promote gastrointestinal drug TAK-438 in Japan

Discovered by Takeda, TAK-438 belongs to a new class of acid secretion inhibitors called potassium-competitive acid blockers (P-CAB).

In February 2014, a new drug application (NDA) for TAK-438 was submitted in Japan by Takeda and is currently undergoing regulatory review.

Currently, proton pump inhibitors (PPIs) are widely prescribed as first-line therapy for the treatment of acid-related diseases in Japan.

However, PPIs do not always offer sufficient therapeutic efficacy, and the acid secretion inhibitory effects of PPIs could differ among individuals, because of the protein CYP2C19 which has gene polymorphisms that are involved in metabolism.

Takeda said that 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.

Unlike PPIs, TAK-438 is not primarily metabolized by CYP2C19.

The onset of efficacy does not significantly differ among treated patients, as TAK-438 is stable in acid and its immediate-release formulation is available without requiring an optimized formulation design.

Two of Otsuka’s products, which have allowed them to establish a strong presence in the gastrointestinal therapeutic area, are MUCOSTA, a gastric mucosal protecting agent, and UBT a diagnostic drug for helicobacter pylori infections.

As part of the deal, Otsuka will pay Takeda an up-front payment of JPY20bn ($195m) and a milestone payment upon NDA approval, while Otsuka will receive a percentage of the sales from Takeda based on certain conditions specified in the deal.

Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o