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Takeda Global Research & Development Center, Inc. Progressing Well in Asia With New Drug Applications (NDA)



10/4/2012 10:15:58 AM

Singapore, October 4, 2012—Takeda Global Research and Development (Asia) Pte Ltd (TGRD Asia), a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (Takeda) announced that it is progressing well with New Drug Applications (NDA) in the Asian region. Within the first eight months of this year, seven NDAs have been filed in various countries/territories. These prescription drugs include:

• azilsartan medoxomil (development code: TAK-491) for hypertension in Hong Kong SAR

• azilsartan medoxomil with chlorthalidone (development code: TAK-491+CLD) for hypertension in Taiwan, Thailand and Indonesia

• alogliptin (development code: SYR-322) for type 2 diabetes in Australia, Mainland China and South Korea

Typically, NDA approvals take about 12 to 18 months to be approved by health regulatory bodies depending on the respective countries/territories.

Dr James Garner, general manager for TGRD Asia said, “Patients are central to our focus and we strive towards better health for patients through leading innovation in medicine. We are very pleased with our progress in Asia as this region forms an important part of Takeda’s plans. Over the past three years, we have quadrupled the proportion of clinical trial subjects we recruit in Asia and we are actively conducting clinical trials in several countries/territories, including Australia, Mainland China, Hong Kong SAR, India, Malaysia, New Zealand, the Philippines, South Korea, Taiwan and Thailand. In the meantime, we are working closely with regulatory agencies and with our local affiliates in each country to ensure that new medicines are made available to patients and physicians in Asia as rapidly as possible.”

In China, TGRD Asia works closely with Takeda Shanghai Development Center (TSDC) to conduct Takeda’s clinical development activities within the Asian region. TSDC has a focus on China for non-oncology, and across Asia for oncology with Millennium: The Takeda Oncology Company.

TAK-491 (azilsartan medoxomil) is for the treatment of hypertension, or high blood pressure, in adults. Already approved in the United States and the European Union, it is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone that constricts blood vessels. When the angiotensin II receptor is blocked, blood vessels stay relaxed and open and blood pressure can be reduced. TAK-491 is a once-daily oral therapy for use alone and in combination with other antihypertensive medications.

TAK-491+CLD is also for the treatment of hypertension to lower blood pressure in adults. Already approved in the United States, TAK-491+CLD combines azilsartan medoxomil (TAK-491) with the diuretic chlorthalidone in a once-daily, single tablet. Chlorthalidone reduces the amount of salt and water in the body by increasing the flow of urine, which helps lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. Results of a 12-week, head-to-head, phase 3 study published online in the American Heart Association journal Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. It is the first and only hypertension medication to combine an angiotensin II receptor blocker (ARB) with chlorthalidone, a diuretic, in a once-daily, single tablet.

SYR-322 is used for the treatment of type 2 diabetes. It is a dipeptidyl peptidase-IV (DPP-4) inhibitor, used as an adjunct to diet and exercise. It exhibits extremely high selectivity for DPP-4 inhibition and a once daily dosing provides the benefit of convenience. It is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels. As for indications, it is the only DPP-4 inhibitor that currently permits combination with alpha-glucosidase inhibitors, which are in common use in Japan, China and the Philippines.

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated at levels of 140 mm Hg or greater systolic and/or 90 mm Hg or greater diastolic. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. The number of adults with hypertension is predicted to increase from about 972 million worldwide in 2000 to 1.56 billion in 2025[1].

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes. Type 2 diabetes is a progressive and chronic condition which results from the body’s ineffective use of insulin. In addition to diet and exercise, patients often need to take medication in order to help manage glucose control. The global health care expenditures to treat diabetes and prevent its complications were estimated at US$376 billion in 2010. By 2030, this number is projected to exceed US$490 billion[2].

About Takeda Global Research and Development Center Asia, Pte. Ltd.

Headquartered in Singapore, Takeda Global Research and Development Center Asia, Pte. Ltd. (TGRD Asia) is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Fully integrated into the global development organisation, TGRD Asia serves as a regional hub for non-oncology clinical development. TGRD Asia seeks to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular diseases, respiratory and immunology, central nervous system diseases, vaccines and other therapeutic areas. For more information on Takeda, visit www.takeda.com

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, www.takeda.com.


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