
Home > Newsroom > 2007 > Ajinomoto and Takeda submits Additional Indication for Paget's Disease of Bone for Risedronate
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July 31, 2007
July 31, 2007 --- Ajinomoto Co., Inc. ("Ajinomoto") and Takeda Pharmaceutical Company Limited ("Takeda") jointly announced today that both parties have submitted an Additional Indication to the Ministry of Health, Labor and Welfare (MHLW) in Japan to seek marketing approval of risedronate sodium hydrate (generic name) for the treatment of Paget's disease of bone as an orphan drug.
Paget's disease of bone is a metabolic disorder of unknown etiology, and it causes deformity and thickening of the bone due to its excessive bone formation, which may lead to pain, bone fracture and osteosarcoma. There surely are unmet needs for the effective treatment for this disease, while prevalence of this disease in Japan is 200 - 300 cases. Under this situation, phase III clinical trial of Paget's disease of bone had been conducted in Japan by Ajinomoto and Takeda, and the orphan drug designation allowed priority review of application for this additional indication.
Risedronate sodium hydrate is a bisphosphonate antiosteoporotic agent, which was originally synthesized by Norwich Eaton Pharmaceuticals, Inc, in the United State, which was a subsidiary of the Procter & Gamble Company at that time, and now is Procter & Gamble Pharmaceuticals Inc.. In Japan, a once-daily formulation of this agent was launched in May 2002 and a once-a-week formulation was launched in June 2007 for the treatment of a osteoporosis.
In Japan, risedronate sodium hydrate is being marketed under the brand names, "Actonel® 2.5mg, 17.5mg tablets" and "Benet ® 2.5mg, 17.5mg tablets", for the treatment of osteoporosis by Eisai (supplied by Ajinomoto) and Takeda respectively.
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| Contact: Ajinomoto Co., Inc. Pharmaceutical Personnel & Risk Management Department Pharmaceutical Company Tel: +81 3-6280-9500 (Tokyo) |
Takeda Pharmaceutical Company Limited Corporate Communications Department Public Relations/Investor Relations Tel: +81 3-3278-2037 (Tokyo) |