Takeda, Zinfandel enter global licensing agreement for TOMM40 biomarker assay for Alzheimer's disease

Takeda Pharmaceutical Company Limited and Zinfandel Pharmaceuticals, Inc. today announced that they have entered into an exclusive, worldwide licensing agreement regarding Zinfandel's TOMM40 assay as a biomarker for the risk of Alzheimer's disease in high-risk older adults with normal cognition. The companies will study pioglitazone in connection with the TOMM40 biomarker and Alzheimer's disease. Pioglitazone is the active ingredient currently marketed in Takeda's ACTOS® (pioglitazone HCl).

The TOMM40 biomarker, recently discovered by a team led by Allen Roses, M.D., Chief Executive Officer 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.

"There is intense interest within the medical community in identifying treatments to help delay progression or potentially prevent the onset of Alzheimer's disease, in an effort to reduce the burden of this disease," said Shigenori Ohkawa, Ph.D., Chief Scientific Officer, Takeda Pharmaceutical Company Limited. "We are energized by this partnership and the opportunity to develop an effective treatment for healthy at-risk older adults."

Under the terms of agreement, Zinfandel will receive an upfront payment of $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.

"At Zinfandel, we have been exploring pharmacogenetics in general, and the TOMM40 biomarker specifically, to identify at-risk individuals who may be candidates for treatment in a pharmacogenetics-assisted clinical trial," said Dr. Roses. "We look forward to working with a partner like Takeda, who shares our commitment to reducing the prevalence of Alzheimer's disease over the next 20-30 years."

Alzheimer's disease is a degenerative brain disease characterized by a progressive decline in memory, thinking, comprehension, calculation, language, learning capacity and judgment sufficient to impair personal activities of daily living. Approximately 18 million people worldwide are currently suffering from Alzheimer's disease, and the rate of occurrence doubles every five years for those between 65 and 85 years of age.