Aventis: Actonel Approved In Japan
Frankfurt, Germany, - Aventis Pharma announced that the Ministry of Health, Labor and Welfare (MHLW) has approved Actonel (risedronate sodium tablets) for the treatment of osteoporosis in Japan. Actonel, which is currently available in 49 other countries worldwide, is expected to be available to patients in Japan during the second quarter of 2002.
The approval of Actonel in Japan gives Aventis access to a US$1 billion osteoporosis market, the world's second largest after the United States.
"We expect that Actonel, with its proven rapid and sustained fracture protection, will be competitively positioned in Japan," said Frank Douglas, executive vice president and head of drug innovation and approval at Aventis Pharma. "Osteoporotic patients in Japan are very often under-treated, taking only vitamin supplements or calcitonins. This leaves them at great risk for fractures. The availability of Actonel in Japan offers physicians and patients with osteoporosis a major opportunity to improve the treatment outcome."
Studies have shown that Actonel is the only osteoporosis treatment proven to reduce fracture risk within six months and sustain fracture protection over five years.
"We welcome new treatment options that help physicians and patients more effectively manage osteoporosis and its potentially debilitating consequences, especially since it is estimated that the osteoporosis patient population in Japan will increase to approximately 10 million in the next 10 years," said Professor Toshitaka Nakamura from the Department of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health in Kitakyushu, Japan.
The International Osteoporosis Foundation lists Asian women among those at higher risk for osteoporosis. Approximately six million women in Japan are believed to have osteoporosis, but only 20 percent of those women receive pharmacological treatment for the disease.
About Actonel® (risedronate sodium tablets) Studies demonstrated that risedronate (Actonel®/Optinate®, risedronate sodium) provides a rapid and sustained fracture benefit. Significant vertebral fracture reduction has been demonstrated as early as six months. More recently, significant and consistent vertebral fracture reduction has been shown up to five years. In clinical studies, risedronate was well tolerated and adverse events were comparable to placebo even in patients taking non-steroid anti-inflammatory drugs (NSAIDS) or with gastrointestinal disease history.
Procter & Gamble has licensed risedronate to Ajinomoto in Japan, where it will be co-marketed as Benet by Takeda Pharmaceuticals and as Actonel by Aventis Pharma.
Aventis (NYSE: AVE) is dedicated to improving life through the discovery and development of innovative pharmaceutical products. In 2000, Aventis generated group sales of ? 22.3 billion and employed around 92,500 people in its Pharma and Agriculture businesses. Corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com
Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Aventis Pharma focuses on important therapeutic areas such as cardiology, oncology, infectious diseases, arthritis, allergies and respiratory disorders, diabetes and the central nervous system disorders. Aventis Pharma has its corporate headquarters in Frankfurt, Germany. Aventis Pharma encompasses Aventis Pasteur, a world leader in vaccines based in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins headquartered in King of Prussia, Pennsylvania, USA.
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