Firms aim to evaluate Tomm40 assay alongside pioglitazone.

Takeda Pharmaceutical is paying Zinfandel Pharmaceutical $9 million up front for a worldwide license to the latter’s Tomm40 biomarker assay, which is in development for use in predicting the five-year risk of Alzheimer’s disease in high-risk older adults. The firms will work together to prospectively validate the Tomm40 biomarker as a test of individual risk, and in particular in patients receiving pioglitazone, the active ingredient in Takeda’s marketed type 2 diabetes drug Actos®. Over the last few years pioglitazone has been debated as a potential therapy for Alzheimer disease.

Under terms of the agreement with Zinfandel Takeda has an exclusive license to the Tomm40 assay along with sublicensing rights for applications including identifying high-risk older adults eligible for clinical trials with pioglitazone. Zinfandel could receive up to $78 million in development milestones on top of the initial signing fee, plus commercial milestones and sales royalties. The firm was established to develop the Tomm40 biomarker, which was discovered by a team led by Allen Roses, M.D., Zinfandel’s CEO.

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