Takeda Pharmaceutical Company Limited

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

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


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