Application for an Additional Indication of CombinationTherapy of Glufast® and Insulin Sensitizer in Japan

MATSUMOTO and OSAKA, Japan, April 23, 2007 --- Kissei Pharmaceutical  Co., Ltd (President, C.E.O. Mutsuo Kanzawa, "Kissei") and Takeda Pharmaceutical  Company Limited (President, Yasuchika Hasegawa, "Takeda") announced today that Kissei filed an application for an additional indication of "combination therapy with  insulin sensitizer" for Glufast® (generic name: mitiglinide) 5mg tablet and 10mg  tablet, which is being co-marketed by Kissei and Takeda, to the regulatory authorities in Japan.

   Glufast, originally created and developed by Kissei, co-marketed in tandem with Takeda in Japan since May 2004, is a diabetic medicine that promotes insulin secretion by stimulating the pancreatic ?-cells. It demonstrates effects promptly after dosing, thereby it brings insulin secretion closer to its natural patterns  and improves postprandial hyperglycemia. Because of its duration of action, Glufast is less liable to trigger hypoglycemia.

   Insulin-resistance is a condition where the body does not effectively use the  insulin it produces, and pioglitazone HCl, which is insulin sensitizer discovered  and marketed by Takeda, is available in Japan under the tradename Actos®. Actos suppresses the production of the glucose in the liver while improving the  sensitivity to insulin in the peripheral tissues.

   In the randomized, double-blind, controlled comparative study, in which clinical usefulness  of Actos monotherapy and that of Glufast/Actos combination therapy were evaluated, the latter showed a statistically significant difference in improving HbA1c that is an indicator of plasma glucose control, without increasing the risk of hypoglycemia.

Note: Kissei filed an application for an additional indication of combination therapy of Glufast and alpha-glucosidase inhibitor in October 2005 and now it is under evaluation by regulatory authorities.

Posted: April 2007


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