Takeda Receives Positive CHMP Opinion in Europe for Edarbi(TM) (azilsartan medoxomil) for the Treatment of Essential Hypertension

London and Osaka, Japan (ots/PRNewswire) -

Takeda Pharmaceutical Company Limited (Takeda) today announced
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion for
EdarbiTM (azilsartan medoxomil, development code: TAK-491), a new
once-daily angiotensin II receptor antagonist (AIIRA) (also known as
angiotensin receptor blocker [ARB]), for the treatment of essential
hypertension (high blood pressure).1

"With almost half of the adult population in Europe affected by
high blood pressure, this positive opinion for azilsartan medoxomil
means there is a new option for patients," said Trevor Smith, CEO,
Takeda Pharmaceuticals Europe. "Building on our long heritage in
cardiovascular disease the forthcoming launch of azilsartan medoxomil
reinforces our commitment to expanding the boundaries of hypertension
treatment across Europe."

The CHMP opinion was based on data from nine phase 3 clinical
trials, involving nearly 7000 patients with hypertension.2 Pivotal
phase 3 studies showed that the highest approved dose of azilsartan
medoxomil (80mg/day) resulted in significantly greater reductions in
systolic blood pressure than the highest approved doses of olmesartan
medoxomil (40mg/day)3,4 and valsartan (320mg/day)3,5 and the ACE
inhibitor ramipril (10mg/day)6 in lowering both clinic and 24-hour
mean blood pressure measurements. In clinical studies, adverse
reactions associated with treatment with azilsartan medoxomil were
mostly mild or moderate, with an overall incidence similar to
placebo.7 The most commonly observed treatment-related adverse
reactions are dizziness and increased blood creatine phosphokinase
and diarrhoea.7

"Although there are many treatment options available to help
manage hypertension, we know that many patients struggle to achieve
clinically relevant blood pressure reduction that is maintained over
a long term," commented Prof. Dr. Roland E. Schmieder, Professor of
Internal Medicine, University Hospital Erlangen, Germany. "Any new
medication which can help patients achieve even just an additional
2mmHg reduction of blood pressure, which we already know can make a
clinical difference, will always be welcome."

Notes to Editors

About EdarbiTM (azilsartan medoxomil)

- Azilsartan medoxomil, is an angiotensin II antagonist
developed by Takeda for the treatment of high blood pressure in adults7
- Azilsartan medoxomil lowers blood pressure by blocking the
action of the hormone, angiotensin II, either when used alone or when
co-administered with other classes of antihypertensive agents7
- Angiotensin II, a hormone that naturally exists within the body,
induces contraction, or tightening, of blood vessels and thus plays an
important role in mediating hypertension8

About high blood pressure (essential hypertension)

- High blood pressure or hypertension - is a chronic medical
condition in which blood pressure is elevated to levels of 140mmHg or
greater systolic or 85mmHg or greater diastolic9
- Almost half (44%) of the adult population in Europe is affected
by high blood pressure10
- High blood pressure was responsible for 7.5 million preventable
deaths worldwide in 200411
- High blood pressure typically has no symptoms.9 Although it can
affect adults of any age the risk of developing the condition increases
with age, with more than half of people over 60 affected 10

References

1. EMA. Available at : http://www.ema.europa.eu/docs/en_GB/docume
nt_library/Summary_of_opinion_-_Initial_authorisation/human/002293/WC
500112771.pdf [Last accessed September 2011]

2. Data on file

3. White WB, Weber MA, Sica D, et al. Effects of the angiotensin
receptor blocker azilsartan medoxomil versus olmesartan and valsartan
on ambulatory and clinic blood pressure in patients with stages 1 and
2 hypertension. Hypertension. 2011; 57(3):413-20

4. Bakris GL, Sica D, Weber M, et al. The comparative effects of
azilsartan medoxomil and olmesartan on ambulatory and clinic blood
pressure. The Journal of Clinical Hypertension. 2011; 13(2):81-88

5. Sica D, White WB, Weber MA. Comparison of the Novel
Angiotensin II receptor blocker azilsartan medoxomil vs valsartan by
ambulatory blood pressure monitoring. The Journal of Clinical
Hypertension. 2011; 13:467-472

6. Bonner, G. Comparison of antihypertensive efficacy of the new
angiotensin receptor blocker azilsartan medoxomil with ramipril.
Abstract. Presented at European Society of Hypertension meeting,
18-21 2010, Oslo, Norway

7. Azilsartan medoxomil Summary of Product Characteristics.

8. Taubman, M. Angiotensin II. A vasoactive hormone with
ever-increasing biological roles. Circulation Research. 2003; 92:9

9. British Heart Foundation. Blood pressure. Available at: http:/
/www.bhf.org.uk/heart-health/conditions/high-blood-pressure.aspx
[Last accessed August 2011]

10. Wolf-Maier, Ket 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

11. WHO. Global health risks: Mortality and burden of disease
attributable to selected major risks. 2009. Available at: http://www.
who.int/healthinfo/global_burden_disease/GlobalHealthRisks_report_ful
l.pdf [Last accessed September 2011]

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
theindustry, 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,
http://www.takeda.com.

About Takeda Pharmaceuticals Europe

Based in London, Takeda Pharmaceuticals Europe leads the overall
business activities of Takeda's European subsidiaries ("TES"),
providing strategic direction and management support across the
region.

Date of preparation: September 2011

EU/AZI-010007

ots Originaltext: Takeda Pharmaceuticals Europe Ltd
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Takeda Pharmaceutical Company Limited, Corporate
Communications Dept., +81-3-3278-2037; Takeda Pharmaceuticals Europe
Ltd,
Rob Gallo, +44 203 116 8874, robert.gallo@tpeu.co.uk; Victoria
Boswell-Smith, Virgo HEALTH, +44 (0)20 8939 2458,
Victoria.boswell-smith@virgohealth.com