Takeda and Zinfandel Pharmaceuticals to Present Data at Upcoming Alzheimer's Association International Conference® Highlightin

 Takeda and Zinfandel Pharmaceuticals to Present Data at Upcoming Alzheimer's
 Association International Conference® Highlighting Innovative Approaches to
                 Alzheimer's Disease Research and Development

PR Newswire

OSAKA, Japan and DURHAM, N.C., July 10, 2014

OSAKA, Japan and DURHAM, N.C., July 10, 2014 /PRNewswire/ --Takeda
Pharmaceutical Company Limited ("Takeda") and its partner, Zinfandel
Pharmaceuticals, Inc. ("Zinfandel"), will present data during multiple poster
and oral sessions at the upcoming Alzheimer's Association International
Conference^® 2014 (AAIC^®), taking place in Copenhagen, Denmark from July
12-17, 2014.

"Studies show that individuals with mild cognitive impairment—a slight,
although noticeable and measurable decline in cognitive abilities—are at an
increased risk of developing Alzheimer's disease or another dementia. An
option to be able to predict an individual's risk for developing this disease
would be welcomed by the medical community," said Stephen Brannan, M.D.,
Central Nervous System Development Therapeutic Area Head, Takeda. "Therefore,
a special focus for Takeda at this conference will be presenting updates on
the TOMMORROW Trial—a trial that challenges the status quo and aims to
accelerate the progress toward identifying effective therapeutic agents for
Alzheimer's disease."

Takeda presentations at AAIC^® 2014 are as follows:
Monday, July 14, 2014
Poster No:                  P2-392
                                        Cross-Cultural Validation and
                                        Normative Study of a
Poster Title:                   Neuropsychological Battery Used in the
                                        Determination of Clinical Endpoints to
                                        Delay Onset of MCI
                                        Kathleen A. Welsh-Bohmer, Heather R.
                                        Romero, Kathleen M. Hayden, Brenda L.
                                        Plassman, Alexandra Atkins, Adam
                                        Vaughan, Nicole Turcotte, Richard S.
                                        E. Keefe, Oksana Makeeva, Andreas U.
Authors:                 Monsch, Giovanni B. Frisoni, Zara
                                        Melikyan, Shyama Brewster, Carl
                                        Chiang, Janet O'Neil, Jennifer
                                        Schuster, Margarita Lymboura, Grant
                                        Runyan, Mark Atkinson, Kumar Budur for
                                        the TOMMORROW Study Investigators
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Tuesday, July 15, 2014
Poster No:                  P3-398
                                        Deriving an Informed Neurocognitive
Poster Title:                   Composite Measure for Delay of Onset
                                        Trials in Mild Cognitive Impairment
                                        due to Alzheimer's disease (MCI-AD)
                                        Mark Espeland, Leslie Vaughan, Heather
Authors:                 Romero, Kathleen M. Hayden, Brenda L.
                                        Plassman, Kathleen A. Welsh-Bohmer for
                                        the TOMMORROW Study Investigators
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Poster No:                  P3-021
                                        Identification and Characterization of
Poster Title:                   Polymorphic Structural Variants
                                        Associated with Alzheimer's Disease
                                        and Diseases of Aging
                                        Michael W. Lutz, Robert Saul, Daniel
Authors: K. Burns, Ann M. Saunders, Allen D.
                                        Roses
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Poster No:                   P3-255
                                        Cultural Adaptation of Translated
                                        Neurocognitive Assessments in Russia,
Poster Title:                   Switzerland and Italy: Pilot Testing
                                        for a Program to Delay the Onset of
                                        Mild Cognitive Impairment due to
                                        Alzheimer's Disease
                                        Alexandra S. Atkins, Richard S. E.
                                        Keefe, Adam W. Vaughan, Nicole M.
                                        Turcotte, Oksana A. Makeeva, Andreas
                                        U. Monsch, Giovanni B. Frisoni, Maura
Authors:                 Parapini, Zara A. Melikyan, Shyama
                                        Brewster, Janet O'Neil, Jennifer
                                        Schuster, Margarita Lymboura, Heather
                                        Romero, Kathleen M. Hayden, Brenda
                                        Plassman, Kathleen A. Welsh-Bohmer
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Wednesday, July 16, 2014
Session No:                    FTS-03
                                        The Collaboration for Alzheimer's
Session Title:                    Prevention (CAP): Advancing the
                                        Evaluation of Alzheimer's Prevention
                                        Therapies
                                        Kathleen A. Welsh-Bohmer, Daniel K.
Authors:                       Burns, Stephen K. Brannan, Kumar Budur
                                        for the TOMMORROW investigators
Location:                  Auditorium 15 (8:30 am - 10:00 am UTC)
Poster No:                  P4-073
                                        A Pharmacogenetics Supported Clinical
                                        Trial to Delay Onset of Mild Cognitive
Poster Title:                   Impairment Due to Alzheimer's Disease
                                        Using Low Dose Pioglitazone: An Update
                                        on the TOMMORROW Study
                                        Kumar Budur, Kathleen A. Welsh-Bohmer,
                                        Daniel K. Burns, Carl Chiang, Janet
                                        O'Neil, Grant Runyan, Marcia
Authors:                 Cyganowski, Donna G. Crenshaw, Michael
                                        W. Lutz, Craig A. Metz, Ann M.
                                        Saunders, Deborah Yarbrough, David
                                        Yarnall, MS, Eric Lai, Stephen K.
                                        Brannan, Allen D. Roses
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Poster No:                  P4-284
                                        Genetic Relationship of APOE and
Poster Title:                   TOMM40 Haplotypes in African American,
                                        West African, and Caucasian Cohorts
                                        Allen D. Roses, Michael W. Lutz,
                                        Robert Saul, Daniel K. Burns, Ann M.
                                        Saunders, Dmitry Goldgaber, Scott S.
                                        Sundseth, Patrick A. Akkari, Stephanie
Authors:                 M. Roses, William K. Gottschalk, Keith
                                        E. Whitfield, Alexander A. Vostrov,
                                        Michael A. Hauser, R. Rand Allingham,
                                        Ornit Chiba-Falek, Kathleen A.
                                        Welsh-Bohmer
                                        Bella Center A/S, Center Boulevard 5,
Location:                 DK-2300 Copenhagen S (11:45 am - 2:15
                                        pm UTC)
Session No:                    O4-07-01
                                        Effects of Pioglitazone on Mnemonic
Session Title:                     Hippocampal Function: A Pharmacologic
                                        BOLD fMRI Study in Healthy Elderly
                                        Subjects
                                        Stephen K. Brannan, Ahmad R. Hariri,
                                        Annchen Knodt, Adam X. Gorka, James
Authors:                 Burke, Kathleen Welsh-Bohmer, Brenda
                                        L. Plassman, Michael Kukulka, Daniel
                                        K. Burns, Allen D. Roses
Location:                 Hall C5A (4:00 pm - 5:30 pm UTC)

About the TOMMORROW Trial
The TOMMORROW trial is a global, multicenter, randomized, double-blind,
placebo-controlled, parallel-group study. The trial will use a genetic–based
biomarker risk assignment algorithm comprised of apolipoprotein E (APOE) and
Translocase of Outer Mitochondrial Membrane (TOMM40) genotypes and age, which
is being studied to determine the risk of individuals developing mild
cognitive impairment (MCI) due to Alzheimer's disease (AD) within a five year
period. Cognitively normal individuals assessed as low risk will be assigned
to receive placebo. Cognitively normal individuals assessed as high-risk will
be assigned to low dose pioglitazone (AD-4833 0.8 SR mg QD) or placebo. The
study duration is approximately five years or the time needed to achieve 410
conversions to MCI due to AD in the high-risk group. Approximately 5,800
cognitively normal individuals aged 65-83 at 60 centers worldwide will be
randomized into the study. The study will recruit internationally from large,
diverse, community-based populations.

The study has two objectives:

For the genetic-based biomarker risk assignment algorithm, the primary
objective is to qualify the genetic-based biomarker risk algorithm to
determine the risk of developing MCI due to AD within a five year period. The
primary endpoint for the genetic-based biomarker risk algorithm is time to
diagnosis of MCI due to AD for placebo-treated, high-risk subjects versus
placebo-treated, low-risk subjects; and to evaluate the efficacy of the
investigational agent, low dose pioglitazone (AD-4833 0.8 SR mg QD) in
delaying the onset of MCI due to AD in cognitively normal individuals (aged
65-83) as determined by the genetic-based biomarker risk algorithm. The
primary endpoint is time to diagnosis of MCI due to AD for pioglitazone
(AD-4833 0.8 SR mg QD) treated subjects versus placebo-treated subjects in the
high-risk stratum.

Key secondary objectives are to evaluate the effect of low dose pioglitazone
(AD-4833 0.8 SR mg QD) versus placebo on the progression of cognitive decline
and to compare the effects of low dose pioglitazone (AD-4833 0.8 SR mg QD)
versus placebo on functional decline and instrumental activities of daily
living.

For more information on the TOMMORROW trial, please visit:
www.clinicaltrials.gov.

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 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 people 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, N.C., 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

Website: http://www.takeda.com
Contact: Takeda Pharmaceutical Company Limited, Corporate Communications
Dept., +81-3-3278-2037; or Josephine Zammuto, Takeda Pharmaceuticals
International, Inc., 224-554-2795, josephine.zammuto@takeda.com; or Carrie
Rose, Ketchum, 646-935-3938, carrie.rose@ketchum.com
 
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