Late Breaking Data Presented at the American Diabetes Association 71st Annual Scientific Sessions Evaluate the Safety and Tolerability of TAK-875, Takeda's Investigational Compound for the Treatment of Type 2 Diabetes

DEERFIELD, Ill. and OSAKA, Japan, June 28, 2011 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) announced today that results from late breaking data presented by Takeda Global Research & Development Center, Inc. evaluated the safety, tolerability and hemoglobin A1c (HbA1c) lowering activity for TAK-875, an investigational compound for the treatment of type 2 diabetes, at the American Diabetes Association (ADA) 71st Annual Scientific Sessions in San Diego, California. TAK-875 is the first GPR40 agonist to reach clinical development, and completed studies have demonstrated glucose-lowering effects in patients with type 2 diabetes by stimulating glucose-dependent insulin secretion.

Agonists of GPR40, one of the G-protein-coupled receptors expressed in pancreatic islet cells, have a novel mechanism of action for type 2 diabetes. They work by selectively improving glucose-dependent insulin secretion with a low risk of inducing hypoglycemia, which is different from the mechanisms of sulfonylurea or incretin hormones.

"These data presented as a late breaker at ADA further evaluate the potential of TAK-875 as a novel therapeutic option for patients living with type 2 diabetes," said Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc. "Takeda remains committed to the clinical investigation of TAK-875 in order to further the development of a new therapy with the potential to innovate patient care."

The data were presented from a Phase 2 randomized, double-blind, placebo- and active (glimepiride) comparator-controlled, parallel-group, multicenter study, which was conducted to evaluate the efficacy, safety and tolerability of once-daily treatment with five different doses of TAK-875 (6.25 mg, 25 mg, 50 mg, 100 mg, and 200 mg) in type 2 diabetes patients (n=426) over 12 weeks. The primary efficacy endpoint was the change from baseline in HbA1c levels at week 12.

Study results found that all doses of TAK-875 showed significantly greater HbA1c reductions at week 12 vs. placebo, and the magnitude of decrease in HbA1c produced by TAK-875 greater than or equal to 50 mg was comparable to glimepiride at week 12. Compared to placebo, approximately twice as many subjects (33-48 percent) treated with TAK-875 greater than or equal to 25 mg achieved HbA1c less than seven percent at week 12, similar to glimepiride. The incidence of hypoglycemia was significantly lower for all doses of TAK-875 (2.3 percent) compared to glimepiride (16.1 percent) and similar to placebo (3.3 percent). Treatment-emergent adverse events ranged from 43.5 percent to 61.3 percent and were highest with glimepiride. There was minimal discontinuation due to adverse events (1.6-3.3 percent) among all active treatment groups.

"Diabetes is an increasingly complex disease. As each patient responds differently to medications, the availability of multiple treatment options allows for a more individualized management approach," said Strack. "Takeda will continue to invest in TAK-875 and further explore the GPR40 agonist class in an effort to provide health care professionals and patients with additional therapeutic options to manage type 2 diabetes."

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions in the United States. Almost 26 million Americans currently live with diabetes, and at least 7 million are unaware that they have it. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications in order to help manage glucose control. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About TAK-875

TAK-875 is one of Takeda's investigational therapies for type 2 diabetes. TAK-875 is a selective agonist of GPR40, one of the G-protein-coupled receptors that are expressed in pancreatic islet cells. This compound has a novel mechanism of action for type 2 diabetes by improving glucose-dependent insulin secretion, different from sulfonylurea or incretin hormones. Phase 2 studies are currently in progress in the United States, Europe and Japan.

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, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.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.

SOURCE Takeda Global Research & Development Center, Inc.