>NEWSROOM >January - March 2008 >Takeda Submits New Drug Application for Alogliptin (SYR-322)...

January - March 2008

Takeda Submits New Drug Application for
Alogliptin (SYR-322) in the U.S.

Osaka, Japan, January 4, 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-IV (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 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 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 strengthen Takeda's position 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 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 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 by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contacts:

Seizo Masuda
Takeda Pharmaceutical Company Limited
81-3-3278-2037

Jocelyn M. Gerst
Takeda Global Research & Development
224-554-5542

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