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November 9, 2007

Takeda Pharmaceutical Company Limited

The Results of HIJ-CREATE Study, a Large-scaled Clinical Study of Candesartan with Coronary Artery Disease Patients with Hypertension in Japan

Osaka, Japan, November 9, 2007 --- During the American Heart Association’s Scientific Session 2007, held at Orland, Miami, the results of the HIJ-CREATE[*] study (“CREATE study”) were presented in late-breaking clinical trials session.

[*] HIJ-CREATE: The Heart Institute of Japan-Candesartan Randomized trial for Evaluation in Coronary Artery Disease.

This is a large-scaled outcome study with coronary artery disease patients with hypertension in Japan, comparing the reduction of incidence of major adverse cardiovascular events (“MACE”) between therapy with candesartan cilexetil (tradename in Japan: Blopress®), an angiotensin receptor blocker (“ARB”), and that with non-ARB standard therapy, and the total number of patients is 2,049. The CREATE study is an Investigators Initiated Trial (“IIT”) started in June 2001, by 14 medical institutions headed by Department of Cardiology, Graduate School of Medicine, Tokyo Women’s Medical University.

The following three main findings were obtained in the CREATE study.
• Reduction of incidence of MACE <Primary endpoint>

Blopress showed 11% reduction in incidence of MACE as compared to the non-ARB standard therapy, though there is no statistically significant difference. (p=0.194)

• The new onset rates of diabetes mellitus <Secondary endpoint>

The new onset rate with Blopress and non-ARB standard therapy are 1.1% and 2.9% respectively. (p=0.027)

• Reduction of incidence of MACE in patients with impaired renal function <sub-analysis>

Blopress showed 21% reduction in incidence of MACE as compared to the non-ARB standard therapy. (p=0.039)

“Blopress therapy may reduce the incidence of MACE in patients with impaired renal function in addition to reduction of new onset of diabetes mellitus,” said the chief investigator of The HIJ-CREATE, Hiroshi Kasanuki, MD (Chief Professor, Department of Cardiology, Graduate School of Medicine, Tokyo Women’s Medical University). “Although there is no statistically significant difference in primary endpoint between Blopress therapy and non-ARB standard therapy, drug-related adverse events were lesser in Blopress therapy, and the results are meaningful in view of the increasing attention to the importance of organ protection by suppression of renin-angiotensin system for coronary artery disease patients with hypertension.”

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Outline of HIC-CREATE study
Patients: A total of 2,049 Japanese coronary artery disease patients with hypertension
Follow-up period: 3 years or longer
Study design: Open-label randomized controlled trial
Primary endpoint: Major Adverse Cardiovascular Events (MACE)[*]
Secondary endpoint: New-onset of diabetes mellitus, Revascularization

[*] Death from cardiovascular cause / Non-fatal myocardial infarction / Unstable angina pectoris, heart failure, stroke and other cardiovascular events, which required hospitalization.

About Candesartan

Candesartan was discovered and originally synthesized by Takeda Pharmaceutical Company Limited, and was jointly developed with AstraZeneca. Candesartan is currently marketed in about 90 countries worldwide under the brand names of Blopress®, Amias® and Kenzen® by Takeda, and Atacand® by AstraZeneca.

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About Takeda

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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

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