New Drug Application Approval for GLUBES® - Fixed dose combination tablet of a rapid-acting insulin secretagogue and improving agent for postprandial hyperglycemia

April 22, 2011, Matsumoto, Japan - Kissei Pharmaceutical Co., Ltd (President, C.E.O. Mutsuo Kanzawa, "Kissei") announced today that a New Drug Application for GLUBES^®, a fixed dose combination tablet of a rapid-acting insulin secretagogue (generic name: mitiglinide calcium hydrate, hereinafter "mitiglinide") and an improving agent for postprandial hyperglycemia (generic name: voglibose), was approved by the Ministry of Health, Labour and Welfare (Japan).

GLUBES^® approved today for treatment of type 2 diabetes is a fixed dose combination tablet with mitiglinide (Japanese brand name: Glufast^®) which was a rapid short acting form insulin secretagogue originally developed by Kissei, and with voglibose which was an improving agent for postprandial hyperglycemia. This combination tablet was filed for application in Japan to manufacture and market in April 2010 by Kissei.

This drug is a fixed dose combination tablet that strongly improves postprandial hyperglycemia by bringing the postprandial insulin secretion closer to its physiological pattern by mitiglinide and the action of delaying the postprandial digestion and absorption of carbohydrates by voglibose.
In the clinical study for combination therapy with mitiglinide and voglibose, the efficacy of mitiglinide combination therapy was studied in Type 2 diabetes patients whose blood glucose control was inadequate with the voglibose therapy alone. Patients in the combination therapy group were confirmed to show significant improvements in glucose levels for both one hour and 2 hours after meals, as well as in HbA1c value and fasting blood glucose, compared to the group that remained on the voglibose only regimen.
The approval of this drug is expected to improve dosing convenience for patients who are already on a combination regimen of mitiglinide plus voglibose. Also, aggressively treating postprandial glucose increase from the early stage of diabetes is thought to be important from the standpoint of inhibiting the subsequent progression of diabetes and the development of various complications, including cardiovascular complications. Therefore, Kissei will make a more significant contribution to diabetic care by providing the optimized treatment option through mitiglinide medication.

Kissei has positioned the metabolic/endocrine area that includes diabetes as one of our priority marketing areas. We are building up our presence in this area by conducting Japanese clinical studies to support additional indications for combination treatment with Glufast^®, a Biguanide drug, and a DPP-4 inhibitor.

＜GLUBESR reference＞

Brand Name :GLUBESR Combination Tablet

Ingredients and Quantity :It contains 10mg of mitiglinide calcium hydrate and 0.2mg of voglibose in one tablet.

Indications :Type 2 Diabetes
In patients appropriate to the treatment by combination therapy of
mitiglinide calcium hydrate and voglibose only.

Dosage and Usage :Usually, for adults, GLUBESR Tablet is orally administrated in a single
dose of 10mg as mitiglinide calcium hydrate and 0.2mg as voglibose,
three times a day, just before each meal.

Manufactured and Distributed by :KISSEI PHARMACEUTICAL COMPANY LIMITED