Takeda Announces the Acceptance of the European Medicines Agency Submission of Alogliptin for the Treatment of Type 2 Diabetes

LONDON and OSAKA, Japan, May 23, 2012 /PRNewswire/ --

Takeda Pharmaceutical Company Ltd. (Takeda) today announced that Takeda Global Research & Development Centre (Europe) Ltd. ("TGRD Europe") received confirmation of the acceptance of the submission of a Marketing Authorisation Application (MAA) from the European Medicines Agency (EMA) for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4i) for the treatment of type 2 diabetes.

"The acceptance of the alogliptin MAA submission is a critical milestone for Takeda as we continue investigating and expanding our therapeutic offerings for people with type 2 diabetes," said Stuart Dollow, M.D., managing director, Takeda Global Research & Development Centre (Europe) Ltd. "As type 2 diabetes is an increasing global issue, our commitment includes expanding across the globe to reach a wider patient population who could benefit from new treatments."

The alogliptin submission is supported by robust clinical trials of alogliptin involving more than 11,000 patients treated for up to four years, and several ongoing studies, including the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) trial. Takeda is currently conducting the EXAMINE trial to evaluate cardiovascular endpoints following treatment with alogliptin, to comply with the U.S. Food and Drug Administration's (FDA) criteria outlined in the December 2008 "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." As a company, Takeda believes the interim results from this trial meet the FDA's cardiovascular safety guideline. Final study results are expected in 2015.

The efficacy of alogliptin was studied as an adjunct to diet and exercise as a once-daily monotherapy, and as an add-on therapy to several other classes of anti-diabetic medications, including metformin, thiazolidinediones (TZDs), insulin and sulfonylureas. In these studies, alogliptin 12.5 and 25 mg, taken once-daily, demonstrated clinically and statistically significant reductions in hemoglobin A1c, with a good tolerability profile. The common adverse events (≥5% and greater than placebo) reported in the phase 3 program include headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection.

About Alogliptin

Alogliptin is a DPP-4i being investigated, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. An NDA for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA^® in this market.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. Approximately 366 million adults are currently living with type 2 diabetes worldwide, and that number continues to grow. By 2030, it is estimated that one in nine adults, or 552 million adults, will be living with the disease. The global health care expenditures to treat diabetes and prevent its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion.

About Takeda Global Research & Development Centre (Europe) Ltd.

Based in London, England, Takeda Global Research & Development Centre (Europe) Ltd., (TGRD Europe), is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TGRD Europe seeks to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, neurology, oncology and other conditions.

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, http://www.takeda.com.

Contacts:

Takeda Global Research & Development Centre (Europe) Ltd.
Rebekah Childers
European Development
+44(0)780-949-5101

Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
+81-3-3278-2037