NEW YORK (GenomeWeb News) - Takeda Pharmaceutical Company will use a biomarker assay developed by Zinfandel Pharmaceuticals as part of a clinical trial investigating the utility of Takeda's drug Actos in Alzheimer's disease, the companies said this week.
Under the terms of the agreement, Takeda has taken an exclusive, worldwide license for the use of Zinfandel's TOMM40 assay as a biomarker for the risk of Alzheimer's disease in high-risk older adults with normal cognition.
Zinfandel will receive an upfront payment of $9 million and is eligible for subsequent milestone payments of up to $78 million, as well as additional commercial milestones and royalties.
Takeda has also gained the right to sublicense, develop, make, use and commercialize the TOMM40 biomarker assay, and to use the assay to identify high-risk older adults as candidates for clinical trials investigating the utility of Actos (pioglitazone) for treating Alzheimer's disease.
Takeda currently markets Actos for use in treating type 2 diabetes.
As reported by GenomeWeb Daily News sister publication Pharmacogenomics Reporter, Zinfandel's TOMM40 test is based on research led by Allen Roses, director of Duke University's Dean Drug Discovery Institute and CEO at Zinfandel.
The assay is based on the finding that varying lengths of the TOMM40 rs10524523 poly-T polymorphism — located at intron 6 of the TOMM40 gene and linked to APOE3 and APOE4 polymorphisms — can be used to craft a three-allele risk prediction system for gauging those who are likely to see early onset or late onset of Alzheimer's disease.