Takeda Submits European Marketing Authorisation Application for Azilsartan Medoxomil, an Investigational Compound for the Treatment of Essential Hypertension

LONDON and OSAKA, Japan, October 20, 2010 - Takeda Pharmaceutical Company Limited (Takeda) today announced that
Takeda Global Research & Development Centre (Europe), Ltd. submitted a
Marketing Authorisation Application (MAA) for azilsartan medoxomil
(development code: TAK-491), an angiotensin II receptor blocker (ARB), to the
European Medicines Agency (EMA) for the treatment of essential hypertension.
The EMA has confirmed that the submission has been validated for assessment.

High blood pressure, or hypertension, was responsible for 7.6 million
preventable deaths worldwide in 2001.(1) Almost half (44 percent) of the
adult population in Europe is affected by hypertension - much (approximately
60 percent) higher than in the United States and Canada.(2) Discovered by
Takeda, azilsartan medoxomil is a prodrug of the active moiety azilsartan,
which lowers blood pressure by blocking the action of a vasopressor hormone,
angiotensin II.(3) The discovery and development of azilsartan medoxomil
continues Takeda's commitment to the treatment of hypertension, and builds
upon the company's long-standing clinical experience with its previously
discovered antihypertensive agent candesartan.

The MAA submission for azilsartan medoxomil monotherapy was supported by
positive results from a clinical development program which included nine
phase 3 clinical trials in which approximately 7000 subjects with essential
hypertension were enrolled of whom 4814 unique subjects received at least 1
dose of azilsartan medoxomil.(4) The safety and efficacy of azilsartan
medoxomil was studied for initial therapy as a once-daily oral monotherapy or
for co-administration with other antihypertensive medications, including the
diuretics chlorthalidone and hydrochlorothiazide, and the calcium channel
blocker, amlodipine.(5) It was also studied in comparison with olmesartan
medoxomil,(6) valsartan(6) and ramipril.(7)

Results from the phase 3 clinical trials showed azilsartan medoxomil
successfully met the primary endpoints: change in 24-hour mean systolic blood
pressure (SBP) by ambulatory blood pressure monitoring (ABPM) and key
secondary endpoint, clinic SBP, producing a statistically significant and
clinically meaningful lowering of blood pressure in subjects with essential
hypertension.(4) The most commonly reported treatment-related adverse
reactions in phase 3 monotherapy placebo-controlled clinical trials were
dizziness, increased blood creatine phosphokinase, diarrhoea, fatigue and
peripheral oedema.(8)

In April 2010, Takeda submitted a New Drug Application for azilsartan
medoxomil to the U.S. Food and Drug Administration. The filing is currently
under regulatory review.

"This MAA represents a significant milestone for our company and carries
positive clinical implications for both physicians and patients for the
treatment of essential hypertension," said Suhail Nurbhai, M.D., vice
president & head of Clinical Science, Takeda Global Research & Development
Centre (Europe), Ltd. "Based on the encouraging results of phase 3 clinical
studies demonstrating the compound's efficacy, safety and tolerability, we
believe azilsartan medoxomil, once approved, will provide clinicians in
Europe with an important additional treatment for patients with essential
hypertension."

"Takeda is committed to developing treatments for patients with
cardiovascular disease and for use by healthcare providers for their
patients," said Steve Coles, Ph.D., managing director, Takeda Global Research
& Development Centre (Europe), Ltd. "We are proud to continue expanding our
cardiovascular expertise in Europe to potentially address this serious health
problem."

About Azilsartan Medoxomil

Discovered by Takeda, azilsartan medoxomil, also known as TAK-491, is a
prodrug of the active moiety azilsartan, which lowers blood pressure by
blocking the action of a vasopressor hormone, angiotensin II, either when
used alone or when co-administered with other classes of antihypertensive
agents.(4) Angiotensin II, a vasopressor, is a hormone that naturally exists
within the body and plays a key role in cardiovascular function.(3) The
hormone induces contraction, or tightening, of blood vessels and thus plays
an important role in mediating hypertension.(3) The most commonly reported
treatment-related adverse reactions occurring at a higher rate than placebo
in phase 3 clinical trials (based on pooled data [40 and 80 mg doses] from
monotherapy placebo-controlled studies) were dizziness (2.1%), increased
blood creatine phosphokinase (1.1%), diarrhoea (1.0%), fatigue (0.8%) and
peripheral oedema (0.6%).(8)

About Takeda Global Research & Development Centre (Europe), Ltd.

Based in London, England, Takeda Global Research & Development Centre
(Europe), Ltd., (TGRD Europe), is a subsidiary of Takeda Pharmaceutical
Company Limited, the largest pharmaceutical company in Japan. TGRD Europe
seeks to bring innovative products to patients through a pipeline that
includes compounds in development for diabetes, cardiovascular disease,
neurology, oncology and other conditions.

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 striving toward better health for
individuals and progress in medicine. Additional information about Takeda is
available through its corporate Web site, www.takeda.com.

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(1) Lawes, C. M.M., et. al., Global Burden of Blood-Pressure-Related
Disease, 2001. The Lancet. 2008; 371: 1513-18.

(2) Wolf-Maier, K. et al. Hypertension Prevalence and Blood Pressure
Levels in 6 European Countries, Canada, and the United States. Journal of the
American Medical Association. 2003;289(18):2363-2369

(3) Taubman, M. Angiotensin II. A Vasoactive Hormone With Ever-Increasing
Biological Roles. Circulation Research. 2003;92:9.

(4) Data on file.

(5) Weber, M. Antihypertensive Efficacy of the New Angiotensin Receptor
Blocker Azilsartan Medoxomil in Combination with Amlodipine. The Journal of
Clinical Hypertension. April 2010, Vol. 12. Suppl. 1. A115.

(6) White, W., et. al. The New Angiotensin Azilsartan Medoxomil Has
Superior 24-Hour Blood Pressure Lowering Efficacy to Both Olmesartan and
Valsartan. The Journal of Clinical Hypertension. April 2010, Vol. 12. Suppl.
1. A116.

(7) Bonner, G. Comparison of Antihypertensive Efficacy of the new
Angiotensin Receptor Blocker Azilsartan Medoxomil with Ramipril. Abstract.
Presented at European Society of Hypertension meeting, June 18-21 2010, in
Oslo, Norway.

(8) Draft Azilsartan Medoxomil Summary of Product Characteristics. Page
4. Table 1.

    Contacts:

    Julia Ellwanger
    Takeda Pharmaceuticals, Inc.
    +1-224-554-7681
    julia.ellwanger@tpna.com

    Corporate Communications Dept.
    Takeda Pharmaceutical Company Limited
    +81-3-3278-2037

    Helen Rae
    Packer Forbes
    +44-(0)20-7036-8550
    helen@packerforbes.com

    Rob Gallo
    Takeda Pharmaceuticals Europe Ltd
    +44-203-116-8874
    robert.gallo@tpeu.co.uk

Contacts: Julia Ellwanger, Takeda Pharmaceuticals, Inc., +1-224-554-7681, julia.ellwanger at tpna.com. Corporate Communications Dept., Takeda Pharmaceutical Company Limited, +81-3-3278-2037. Helen Rae, Packer Forbes, +44-(0)20-7036-8550, helen at packerforbes.com. Rob Gallo, Takeda Pharmaceuticals Europe Ltd, +44-203-116-8874, robert.gallo at tpeu.co.uk