Approval Obtained for Manufacture of Risedronate Sodium Hydrate, a Treatment for Osteoporosis

Risedronate sodium hydrate (generic name), a treatment for osteoporosis developed jointly by Ajinomoto Co., Inc., Takeda Chemical Industries, Ltd. and Aventis Pharma Ltd., has been approved for manufacture by the Ministry of Health, Labour and Welfare of Japan. Both Ajinomoto and Takeda Chemical Industries have approval for manufacturing. Risedronate sodium hydrate is a bisphosphonate with an organic ring structure containing nitrogen synthesized by Norwich-Eaton Pharmaceuticals of the United States (currently Procter & Gamble Pharmaceuticals of the United States) and developed jointly in Japan by Ajinomoto Co., Inc., Takeda Chemical Industries, Ltd. and Aventis Pharma Ltd. Since 1999, it has received approval in the United States and major European countries. The following is a profile of risedronate sodium hydrate. Product Characteristics ·Significant increase in lumbar spine BMD (bone mineral density) ·Significant reduction in vertebral fractures (overseas data) ·Significant reduction in Bone Resorption Markers one month after administration ·6.6mm diameter, film-coated tablet Indication Osteoporosis Use/Dosage Generally, a single adult dosage is one 2.5mg tablet of risedronate sodium, taken with an adequate amount (approximately 180ml) of water. Patients should not lie down for 30 minutes after taking the drug, and should avoid taking it with any other drugs or with any food or beverage other than water. After National Health Insurance price listing, the drug will be sold by Aventis Pharma Ltd. (product supplied by Ajinomoto Co., Inc.) under the product name Actonel Tablet 2.5mg and by Takeda Chemical Industries, Ltd. under the product name BENET Tablets 2.5mg. For further information: Ajinomoto Co., Inc. Public Relations Department +81-3-5250-8180 Takeda Chemical Industries, Ltd. Public Relations (Osaka) +81-6-6204-2060 (Tokyo) +81-3-3278-2039 Aventis Pharma Ltd. Communications Department +81-3-5571-6314