Takeda submits new drug application for alogliptin (syr-322) in the US

January 04, 2008

Deerfield, IL, January 3, 2008 --- Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes. Discovered by Takeda San Diego, Inc., alogliptin was designed to selectively inhibit DPP-4 taken orally once daily.

DPP-4 inhibitors are a new class of oral agents for the treatment of type 2 diabetes, which slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and may have the potential to improve pancreatic beta-cell function.

The NDA submission was supported by six Phase 3 clinical trials involving over 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.

"The NDA submission for alogliptin is a significant milestone for Takeda, as it has the potential to position us as one of the global leaders in diabetes treatment," said Yasuchika Hasegawa, president of Takeda. "Takeda's continued growth, now and in the future, will be based on our ability to focus and have success in this therapeutic area. Our hope is that alogliptin will become an important treatment option for patients with type 2 diabetes and the healthcare providers who treat them."

GLP-1 and GIP are produced by the digestive tract in response to food, and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness.
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About Type 2 Diabetes

Type 2 diabetes has reached epidemic proportions in the United States with almost 20 million people currently living with the disease. A progressive disease, type 2 diabetes requires continued monitoring by a physician and patients are often required to take multiple medications at any time--in addition to diet and exercise--in order to maintain glucose control. There are two primary defects associated with type 2 diabetes: the body does not efficiently use the insulin it produces--insulin resistance--and/or it does not produce enough insulin--insulin deficiency. DPP-4 inhibitors offer a new way to treat insulin deficiency and have the potential to improve pancreatic beta-cell function.

About Takeda's Commitment to Type 2 Diabetes

Takeda has a long-standing tradition of striving toward better health for people living with type 2 diabetes by developing innovative pharmaceutical solutions to help manage their condition. In 1999, Takeda launched ACTOS® (pioglitazone HCl) -- an insulin sensitizer which today is available globally -- followed in recent years by the introduction of the ACTOS family of products, with more than 75 million prescriptions written, covering more than 8.5 million patients and 4.5 million patient years.

Over the past decade, Takeda has furthered their commitment to people living with type 2 diabetes and pursued the development of alogliptin, an investigational DPP-4 inhibitor. ACTOS and alogliptin have distinct but complementary mechanisms of action, addressing insulin resistance and insulin deficiency, and potentially providing patients with multiple monotherapy and combination therapy options.

About ACTOS

ACTOS works by directly targeting insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS, a prescription medication, is taken once daily as an adjunct to diet and exercise, and is approved for use for type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas, or metformin.

Important Safety Information About ACTOS® (pioglitazone HCl)

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath.

Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, and anemia. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking ACTOS.

Please visit the ACTOS Web site at www.actos.com for Complete Prescribing Information.

Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., and London, U.K., Takeda Global Research & Development Center, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. Takeda Global Research & Development was established in 2004 and is responsible for Takeda's clinical research and development in the U.S. and Europe, supporting clinical and product development activity for Takeda commercial organizations in the U.S. and in Europe. With a robust pipeline of compounds in development for diabetes, cardiovascular disease and other conditions, Takeda rapidly brings innovative products to market to improve patient health and enhance the practice of medicine. To learn more about the company, visit www.tgrd.com.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda (TSE:4502) 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 by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

Takeda Pharmaceuticals North America

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