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Takeda and Zinfandel Pharmaceuticals Inc. Announce Results of a Study of the Performance Characteristics of a Genetics-Based Biomarker Risk Assignment Algorithm to Identify Risk of Mild Cognitive Impairment Due to Alzheimer's Disease


7/17/2013 10:15:19 AM

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OSAKA, Japan, DEERFIELD, Ill. and DURHAM, N.C., July 17, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Development Center Americas, Inc. and its partner, Zinfandel Pharmaceuticals, Inc. ("Zinfandel"), today announced data from a late-breaker poster presented at the Alzheimer's Association International Conference (AAIC), taking place now in Boston, MA.

In a session titled "Performance of a Genetics-Based Biomarker Risk Algorithm to Support a Clinical Trial to Delay Onset of Mild Cognitive Impairment (MCI) Due to Alzheimer's disease (AD)," study principal investigator Dr. Michael W. Lutz, Ph.D., Senior Research Scientist, Department of Neurology, Duke University School of Medicine, presented findings showing positive predictive and negative predictive values in the range of 70-80%, comparing favorably with imaging and cerebrospinal fluid-based biomarkers.

The biomarker risk assignment algorithm will be evaluated as a predictor of the risk of cognitively normal individuals (ages 65-83) developing MCI due to AD in the next five years in a Phase 3 trial. While age and APOE status have previously been shown to indicate elevated risk of MCI due to AD, the addition of TOMM40 is hypothesized to further refine AD risk determination.

"Compared to only using APOE status and age as factors, the addition of TOMM40 makes this a promising biomarker risk assignment algorithm," commented Dr. Lutz. "There is a tremendous need for tests to identify and predict the risk of mild cognitive impairment due to Alzheimer's disease."

AD diagnoses are increasing as the world's population ages and the rate of occurrence doubles every five years for those between 65 and 85 years of age. Additionally, according to the Alzheimer's Association, a treatment breakthrough that slows the progression of AD would reduce the costs of AD care from $241 billion to $201 billion in 2020.

"When it comes to Alzheimer's disease treatment, the unmet need here is huge. We are very excited about these results," added Stephen Brannan, M.D., CNS Development Therapeutic Area Head, Takeda. "Predicting individual risk for mild cognitive impairment due to Alzheimer's disease and possibly delaying the onset of mild cognitive impairment due to Alzheimer's disease with its devastating neurological complications would provide an important tool to fight this disease."

About Alzheimer's Disease (AD)
AD 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 Americans are currently suffering from AD, and the rate of occurrence doubles every five years for those between 65 and 85 years of age. In the 2010 World Alzheimer Report, Alzheimer's disease International estimated that there are 35.6 million people living with dementia worldwide in 2010, increasing to 65.7 million by 2030 and 115.4 million by 2050.

About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center Americas, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Development Center Americas, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to people through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.takeda.us.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Zinfandel Pharmaceuticals
Zinfandel Pharmaceuticals, based in Durham, NC, is a privately held company dedicated to using pharmacogenetics to improve prediction of risk for Alzheimer's disease and thus facilitate the development of effective therapies.

SOURCE Takeda Pharmaceutical Company Limited



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