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Pivotal Phase 3 Data Demonstrated Investigational Compound Azilsartan Medoxomil Lowered Blood Pressure in Head-to-Head Comparator Trials

Monday, May 3, 2010 Research News J E 4
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DEERFIELD, Ill., May 3 Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) today announced results from pivotal phase 3 studies of azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB), demonstrating greater 24-hour systolic blood pressure (SBP) reduction compared to commonly prescribed ARBs olmesartan medoxomil and valsartan. Results were statistically significant and showed that azilsartan medoxomil (80 mg/day) lowered 24-hour SBP by Ambulatory Blood Pressure Monitoring (ABPM), the primary endpoint, in head-to-head trials with the highest approved doses of olmesartan medoxomil and valsartan in hypertensive patients. The studies were presented today at the American Society of Hypertension, Inc. (ASH) 25th Annual Scientific Meeting and Exposition in New York.

"We were encouraged at the results demonstrating azilsartan medoxomil achieved greater reductions in 24-hour mean systolic blood pressure when compared to two other commonly used ARBs at their respective maximum doses," said Stuart Kupfer, M.D., executive medical director, Takeda clinical science. "Having new treatment options is important to potentially address the estimated 42 million hypertensive patients in the United States who may not be adequately controlled and are at risk for other serious health problems."

The azilsartan medoxomil NDA was submitted in April 2010 and was supported by seven phase 3 clinical trials involving more than 5,900 patients. The most commonly reported treatment-related adverse reactions (>/= to 1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).

Azilsartan Medoxomil vs. Olmesartan Medoxomil and Valsartan (Poster #242)

This phase 3 study evaluated 24-hour mean SBP by ABPM of azilsartan medoxomil as compared to olmesartan medoxomil and valsartan and placebo. This 6-week, multicenter, double-blind, study randomized a total of 1,291 patients to receive azilsartan medoxomil 40 mg/day (n=237) or 80 mg/day (n=229), olmesartan medoxomil 40 mg/day (n=254), valsartan 320 mg/day (n=234) or placebo (n=134). Patients were titrated from intermediate to maximal doses of the drugs at two weeks. A total of 1,088 patients who had both baseline and 6 week ABPM data were evaluated (patients' mean age was 56 years, and 54 percent were men).

Results showed azilsartan medoxomil at doses of 80 mg/day and 40 mg/day lowered 24-hour mean SBP by 14.5 mm Hg and 13.4 mm Hg, respectively. The reductions were greater than those of the active comparators valsartan 320 mg/day (-10.2 mm Hg) and olmesartan medoxomil 40 mg/day (-12.0 mm Hg). The differences were statistically significant between azilsartan 80 mg/day and both active comparators, and between azilsartan 40 mg/day and valsartan.

Azilsartan Medoxomil vs. Olmesartan Medoxomil (Poster #221)

This phase 3 study evaluated 24-hour mean SBP by ABPM of azilsartan medoxomil as compared to olmesartan medoxomil and placebo. Secondary efficacy endpoints included clinic trough blood pressure measurements. This 6-week, multicenter, double-blind study randomized a total of 1,272 patients to receive azilsartan medoxomil 20 mg/day (n=283), 40 mg/day (n=281) or 80 mg/day (n=284); olmesartan medoxomil 40 mg/day (n=282) or placebo (n=142). Final ABPM data were available for 86 percent of patients (patients' mean age was 58 years, and there was a similar proportion of male and female subjects).

Results showed azilsartan medoxomil at doses of 80 mg/day, 40 mg/day and 20 mg/day significantly lowered 24-hour mean SBP by 13.2 mm Hg, 12.1 mm Hg and 10.8 mm Hg, respectively. The reduction in patients treated with azilsartan medoxomil 80 mg/day were statistically significantly greater than with olmesartan medoxomil 40 mg/day (-11.2 mm Hg). Results also showed azilsartan medoxomil 80 mg/day had a statistically significant greater reduction on clinic blood pressure (-8.6 mm Hg) than olmesartan medoxomil 40 mg/day (-7.1 mm Hg).

About Hypertension

High blood pressure, or hypertension, impacts approximately 75 million Americans and is the second-leading preventable risk factor for death in the U.S. Hypertension is defined as elevated blood pressure 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. Approximately 56 percent of all hypertension patients, or approximately 42 million Americans, still have uncontrolled hypertension despite current treatment options, or due to a lack of being diagnosed or treated. Hypertension can lead to serious or fatal health problems. Earlier this year, the Institute of Medicine issued a report calling hypertension a "neglected disease" because it is treatable and yet widely prevalent. High blood pressure often has no warning signs or symptoms, and many people don't realize they have it. People of all ages and backgrounds can develop hypertension, and the National Heart Lung and Blood Institute recommends blood pressure be checked every two years and that people with hypertension should check their blood pressure levels several times a year.

About Azilsartan Medoxomil

Discovered by Takeda, azilsartan medoxomil, also known as TAK-491, is an angiotensin II receptor blocker currently in development for the treatment of hypertension, or high blood pressure, either used alone or in combination with other classes of antihypertensive agents. Angiotensin II, a vasopressor, is a hormone that naturally exists within the body and plays a key role in cardiovascular function. The hormone induces contraction, or tightening, of blood vessels and thus plays an important role in mediating hypertension. The most commonly reported treatment-related adverse reactions (>/= to 1%) in phase 3 clinical trials were dizziness (2.1%), increased blood creatine phosphokinase (1.1%) and diarrhea (1.0%).

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Jaimee Lumm Elissa J. Johnsen GolinHarris Takeda Pharmaceuticals North America 312-729-4276 224-554-3185 jlumm@golinharris.com ejohnsen@tpna.com Julia Ellwanger Takeda Global Research & Development 224-554-7681 julia.ellwanger@tpna.com

SOURCE Takeda Global Research & Development Center, Inc., U.S.
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