Takeda's Edarbi® (azilsartan medoxomil) Receives European Marketing Authorisation for the Treatment of Essential Hypertension

London and Osaka, Japan (ots/PRNewswire) -

Takeda Pharmaceutical Company Limited (Takeda) today announced
that the European Commission has granted marketing authorisation for
Edarbi(R) (azilsartan medoxomil), a new once-daily angiotensin
receptor blocker (ARB) (also known as angiotensin II receptor
antagonist [AIIRA]) for the treatment of essential hypertension (high
blood pressure) in adults.[1]

Takeda will launch azilsartan medoxomil across Europe in 2012
starting with Germany in January.

"The marketing authorisation for azilsartan medoxomil marks an
important milestone for Takeda, building on our 30-year heritage in
cardiovascular disease and reinforcing our commitment to expand the
boundaries of hypertension treatment, address unmet needs and
ultimately optimise patient outcomes across Europe," said Trevor
Smith, Head of Europe and Canada. "We believe azilsartan medoxomil
provides clinicians with a highly effective new option for patients
with essential hypertension."

The marketing authorisation follows a positive opinion from the
Committee for Human Medicinal Products (CHMP) based on the results
from an extensive pre-clinical and clinical development programme,
including seven phase III clinical trials involving nearly 6,000
patients with essential hypertension.[2,3] Pivotal phase III studies
showed that the highest approved dose of azilsartan medoxomil
(80mg/day) resulted in significantly greater reductions in mean
24-hour and clinic systolic blood pressure than the highest approved
doses of the ARBs olmesartan medoxomil (40mg/day)[4,5], valsartan
(320mg/day)[4,6] and the ACE inhibitor ramipril (10mg/day)[7]. In
clinical studies, adverse reactions associated with treatment with
azilsartan medoxomil were mostly mild or moderate, with an overall
incidence similar to placebo.[8] The most commonly observed
treatment-related adverse reactions were dizziness, increased blood
creatine phosphokinase and diarrhoea.[3]

"We have been treating hypertension for decades with numerous
different treatment regimens, yet achieving sufficient 24 hour blood
pressure control, with the associated beneficial effects on
cardiovascular morbidity and mortality still remains a challenge,"
says Professor Neil Poulter, Professor of Preventive Cardiovascular
Medicine, National Heart and Lung Institute at Imperial College
London. "Any new treatment option that can improve effective BP
control will be well received, and will help to reduce the huge
health burden due to the adverse effects on cardiovascular events
which raised BP currently causes."

Notes to Editors

About Edarbi(R) (azilsartan medoxomil)

- Azilsartan medoxomil is an angiotensin receptor blocker (ARB) (also known
as angiotensin II receptor antagonist [AIIRA]) developed by Takeda for the treatment
of high blood pressure in adults[3]
- Azilsartan medoxomil either when used alone or when co-administered with other
classes of antihypertensive agents[3] lowers blood pressure by blocking the action of
the hormone angiotensin II, a hormone which is generated by the activation of the
renin-angiotensin-aldosterone system (RAAS), one of the major blood pressure
regulating systems.
- 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 hypertension[8]
- Azilsartan medoxomil has also been further tested in two long term open label
studies, bringing the total number of phase III studies to nine involving over 7,000
patients with essential hypertension

About high blood pressure (essential hypertension)

- High blood pressure, or hypertension, is a chronic medical condition in
which clinic blood pressure is elevated to levels of 140mmHg or greater systolic or
90mmHg or greater diastolic[9]
- Almost half (44%) of the adult population in Europe is affected by high blood
pressure[10]
- High blood pressure was responsible for 7.5 million preventable deaths
worldwide in 2004[11]
- High blood pressure typically has no symptoms.[10] 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) European Commission. Available at: http://ec.europa.eu/index_en.htm
[Last accessed December 2011]
2) EMA. Summary of opinion. 2011. Available at :
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002293/WC500112771.pdf
[Last accessed October 2011]
3) Azilsartan medoxomil Summary of Product Characteristics.
4) 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
5) 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
6) 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
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, 18-21 2010, Oslo, Norway
8) Taubman, M. Angiotensin II. A vasoactive hormone with ever-increasing
biological roles. Circulation Research. 2003; 92:9
9) NICE clinical guideline 127. Hypertension: Clinical management of primary
hypertension in adults. Available from:
http://www.nice.org.uk/nicemedia/live/13561/56008/56008.pdf [Last accessed
November 2011]
10) Wolf-Maier K, Cooper RS, Banegas JR, 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
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_full.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 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,
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.

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
+44-208-939-2458
Victoria.boswell-smith@virgohealth.com

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