Takeda in up to $87 million deal with Zinfandel for Alzheimer's biomarker in combination with Actos

Japan’s largest drugmaker Takeda Pharmaceutical (TSE: 4502 ) has entered into an exclusive, worldwide licensing accord with privately-held USA-based Zinfandel Pharmaceuticals regarding Zinfandel’s TOMM40 assay as a biomarker for the risk of Alzheimer’s disease, including potential use of the assay in combination with pioglitazone, the active ingredient in Takeda’s blockbuster AD drug Actos, in high-risk older adults with normal cognition.

Under the terms of the deal, Zinfandel will receive an upfront $9 million and subsequent payments of up to $78 million for development milestones from Takeda. Additional commercial milestones and royalties were also outlined in the agreement. Takeda will obtain an exclusive license, with the right to sublicense, develop, make, use and commercialize the TOMM40 biomarker assay, and to use the assay to identify high-risk older adults who would be candidates for clinical trials with pioglitazone to evaluate its utility.

The TOMM40 biomarker, recently discovered by a team led by Allen Roses, chief executive of Zinfandel, is being developed to identify individuals at high risk of developing Alzheimer’s disease within the subsequent five years. Under this license agreement, Takeda and Zinfandel will attempt to prospectively validate the TOMM40 biomarker as a test of individual risk.