Paris, August 17, 2006 – The US Food and Drug Administration (FDA) this week approved Actonel® 35mg (risedronate sodium tablets) for 'treatment to increase bone mass in men with osteoporosis'. This follows the positive outcome in July 2006 of the European application for the additional indication of 'treatment of osteoporosis in men at high risk of fracture'. National approvals will now follow in all twenty-five EU member states. This new indication now opens the door for more men with osteoporosis to benefit from Actonel treatment.
"Male osteoporosis is neglected and under-treated," said Pierre Delmas, Professor of Medicine and Rheumatology at the Université Claude Bernard, in Lyon, France. "We have to ask ourselves why other conditions such as prostate cancer receive more attention than osteoporosis, when in reality men over 50 are at far greater risk of osteoporosis than they are of prostate cancer. We cannot accept the low levels of awareness that exist among patients and physicians because osteoporosis is such a devastating and debilitating disease for men."
Approximately half of male osteoporosis cases are associated with aging. Men with age-related osteoporosis usually develop the disease later in life than do women. With an aging population and increasing life expectancy, age-related cases of male osteoporosis are expected to increase. The other half of all male osteoporosis cases are due to secondary causes such as oral steroid use, low testosterone (hypogonadism), and heavy alcohol use. (1)
The approval of Actonel for men with osteoporosis is based on a two-year, placebo-controlled, double-blind multi-centre clinical trial of 284 male patients with osteoporosis. (2) In the trial, patients treated with once-a-week Actonel 35mg experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured, 6, 12 and 24 months. Likewise, statistically significant reductions in bone turnover markers were achieved at all time points measured, 3, 6, 12 and 24 months. Actonel was well-tolerated and adverse events were generally similar between patients receiving Actonel and patients receiving placebo. The most commonly reported adverse events were constipation, back pain, arthralgia, influenza and nasopharyngitis.
"This approval builds upon the efficacy of Actonel seen in women," said David Cahall, International Medical Director, sanofi-aventis. "With this new indication we hope many men, a group of patients that are often overlooked, will now be able to benefit from treatment with Actonel".
About Actonel® (risedronate sodium tablets)
In Europe, Actonel 5 mg daily and 35 mg once-a-week are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures and the treatment of established postmenopausal osteoporosis to reduce the risk of hip fractures. Actonel 5mg daily is indicated for the prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis and to maintain or increase bone mass in post menopausal women undergoing long-term (more than 3 months) systemic corticosteroid treatment at doses ≥ 7.5mg/day prednisone or equivalent. Actonel 35mg is indicated for the treatment of osteoporosis in men at high risk of fractures. The 5 mg dose is not approved for males receiving systemic corticosteroid treatment and is not approved for male osteoporosis. The 35 mg dose is not approved in men or women receiving long-term systemic corticosteroids and is not approved for the prevention of osteoporosis in postmenopausal women. Please see the Summary of Product Characteristics for Actonel® 5mg and 35mg (risedronate sodium tablets) for more information.
In the USA, Actonel 5 mg daily and 35 mg once-a-week are indicated for the prevention and treatment of postmenopausal osteoporosis in women. Actonel 35 mg once-a-week is indicated to increase bone mass in men with osteoporosis. Actonel 5mg daily is indicated for the prevention and treatment of 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. Please see full prescribing information for Actonel® (risedronate sodium tablets) for more information. For a copy of the full prescribing information for Actonel visit the Actonel website at www.actonel.com.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. It is a collaboration between Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
About Procter & Gamble (NYSE:PG)
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®. Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of almost 140,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)
For P&G: All statements, other than statements of historical fact included in this release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the ability to achieve business plans, including with respect to lower income consumers and growing existing sales and volume profitably despite high levels of competitive activity, especially with respect to the product categories and geographical markets (including developing markets) in which the company has chosen to focus; (2) successfully executing, managing and integrating key acquisitions (including the Domination and Profit Transfer Agreement with Wella); (3) the ability to manage and maintain key customer relationships; (4) the ability to maintain key manufacturing and supply sources (including sole supplier and plant manufacturing sources); (5) the ability to successfully manage regulatory, tax and legal matters (including product liability matters), and to resolve pending matters within current estimates; 6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas, including the success of the company's outsourcing projects; (7) the ability to successfully manage currency (including currency issues in volatile countries), interest rate and certain commodity cost exposures; (8) the ability to manage the continued global political and/or economic uncertainty and disruptions, especially in the company's significant geographical markets, as well as any political and/or economic uncertainty and disruptions due to terrorist activities; (9) the ability to successfully manage increases in the prices of raw materials used to make the company's products; (10) the ability to stay close to consumers in an era of increased media fragmentation; and (11) the ability to stay on the leading edge of innovation. For additional information concerning factors that could cause actual results to materially differ from those projected herein, please refer to our most recent 10-K, 10-Q and 8-K reports.
1. Kamel HK. Male Osteoporosis: New trends in diagnosis and therapy. Drugs Aging 2005; 22 (9): 741-748
2. Boonen S et al. Oral Risedronate Treatment in Men with Osteoporosis: Study Design and Baseline Characteristics. Poster presented at ASBMR 2005 (number SU404)
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