Study shows Risedronta provides a significant and sustained 5-year fracture-reduction benefit in postmenopausal women with osteoporosis

June 22, 2001

Cincinnati, Ohio; Bridgewater, N.J. (June 22, 2001) - Results of the first and only five-year, continuous, placebo-controlled study with a bisphosphonate show that Actonel® 5 mg (risedronate sodium tablets) significantly reduced the incidence of vertebral fractures by 50 percent over 5 years. These results demonstrate a sustained five-year fracture-reduction benefit for postmenopausal women with osteoporosis who are taking Actonel. Previous bisphosphonate studies have only documented fracture benefits versus control for continuous periods of up to four years. The new data were presented today at the 83rd Annual Meeting of The Endocrine Society.

In this same study, Actonel had already been shown to rapidly protect patients with postmenopausal osteoporosis by reducing the risk of vertebral fractures within just one year. The results presented today indicate that the treatment effect is sustained for up to 5 years. Women taking Actonel in this study had 50 percent fewer new vertebral fractures compared to those in the control group over 5 years (a reduction in absolute risk of 16.6%). A significant reduction in nonvertebral fractures (measured as a composite endpoint of six nonvertebral sites) was also observed in patients taking Actonel over five years.

"Results of this study show that continued treatment with Actonel for 5 years is effective for preventing fractures in women who have osteoporosis," said Nelson Watts, M.D., Professor of Medicine, Director of the Osteoporosis Center, University of Cincinnati, Cincinnati, Ohio. "Actonel therapy is an important option for the 24 million American women who have or are at risk for this debilitating disease."

During the initial three-year study, postmenopausal women with osteoporosis in both groups were randomly assigned to take either Actonel or placebo daily. Each woman also took 1,000 mg of calcium each day, and 500 IU of vitamin D daily, if needed. Researchers at several institutions around the globe studied 265 patients in the double-blind, placebo-controlled two-year extension portion of the trial.

Consistent with previously published clinical trials, Actonel was well tolerated, and adverse events were comparable to placebo, even in patients taking NSAIDs.

Osteoporosis is common among older adults, particularly women past menopause, and is reaching epidemic proportions. According to the National Osteoporosis Foundation (NOF), more than 50 million Americans may be affected by osteoporosis over this century. The disease causes about 700,000 vertebral fractures in the United States each year, and it is estimated that 40 percent of American women age 50 and older will suffer an osteoporosis-related fracture in their lifetime. In the United States, expenditures for osteoporotic and associated fractures totaled an estimated $13.8 billion in 1995 alone. Actonel 5 mg is indicated for the treatment and prevention of postmenopausal osteoporosis in women and glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (>7.5 mg/d prednisone or equivalent) for chronic diseases.

Actonel should not be used in patients with low blood calcium, known allergy to Actonel, or an inability to stand or sit upright for at least 30 minutes. Low blood calcium and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe kidney disease.

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus), and esophageal or gastric ulcers. Patients should take Actonel with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug.

In clinical trials, Actonel was generally well tolerated. Most side effects were mild to moderate and did not require patients to stop taking Actonel. Overall, side effects regardless of causality, were comparable to placebo and included infection (primarily upper respiratory, placebo patients, 29.7% vs. Actonel patients 29.9%), back pain (23.6% vs. 26.1%), and joint pain (21.1% vs. 23.7%).
About the Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis Pharma in May 1997 to develop and market Actonel® (risedronate sodium tablets) collaboratively in Europe and the United States. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe.

About Procter & Gamble Pharmaceuticals
Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company (NYSE:PG) - a $40 billion global leader in the development, manufacturing and marketing of a broad range of consumer goods. In prescription drugs, P&G is focusing on musculoskeletal and cardiovascular health, as well as anti-infective therapies. Some of P&G's leading prescription products include Actonel® (risedronate sodium), Didronel® (etidronate disodium), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals).

About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.

Aventis Pharma AG is the pharmaceutical company of Aventis S.A. (NYSE:AVE). Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. Aventis Pharma is comprised of Aventis Pharmaceuticals; Aventis Pasteur, a world leader in vaccines, headquartered in Lyon, France; and Aventis Behring, a world leader in therapeutic proteins, headquartered in King of Prussia, Pa.

Aventis S.A., a world leader in pharmaceuticals and agriculture, is headquartered in Strasbourg, France. The company employs approximately 92,500 people in more than 20 countries. Aventis was launched in December 1999 through the merger of Hoechst AG and Rhône-Poulenc S.A. Copies of this release or any recent release are also available at the U.S. Web site, or by calling 800-207-8049.

Please see full prescribing information for Actonel for additional safety information. For a copy of the full prescribing information for Actonel please call 800-836-0658 or visit the Actonel Web site at

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.

Hill and Knowlton

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