Takeda Pharmaceutical Company Limited

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

London and Osaka, Japan (ots/PRNewswire) - 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, http://www.takeda.com. --------------------------------- (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 ots Originaltext: Takeda Chemical Industries Im Internet recherchierbar: http://www.presseportal.ch Contact: CONTACT: 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, PackerForbes, +44-(0)20-7036-8550, helen@packerforbes.com. Rob Gallo, TakedaPharmaceuticals Europe Ltd, +44-203-116-8874, robert.gallo@tpeu.co.uk

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