PANEL OF EXPERTS AGREE THAT BONE MINERAL DENSITY IS NO LONGER ENOUGH Understanding the Factors Which Contribute to Bone Strength
PANEL OF EXPERTS AGREE THAT Bone Mineral Density IS NO LONGER ENOUGH Understanding the Factors Which Contribute to Bone Strength Geneva, Switzerland, 28 June, 2005— The Alliance for Better Bone Health announced today that according to evidence presented by an international panel of osteoporosis experts, Bone Mineral Density (BMD) testing does not accurately reflect all factors important to bone strength. The panel’s findings, presented at the Second Joint Meeting of the European Calcified Tissue Society (ECTS) and the International Bone and Mineral Society (IBMS) in Geneva, Switzerland, are of utmost importance since BMD measurement has long been used to diagnose osteoporosis in the untreated patient by obtaining dual-energy X-ray absorptiometry (DXA) scans at the spine, wrist or, proximal femur.1,2 In a symposium, sponsored by the Alliance for Better Bone Health entitled, “Understanding the Factors Which Contribute to Fracture Risk Reduction,” leading osteoporosis expert, Nelson Watts, MD, Professor of Medicine at the University of Cincinnati College of Medicine and Director of the University of Cincinnati Bone Health and Osteoporosis Centre, chaired a series of lectures to discuss the many factors, other than BMD, that contribute to bone strength. "BMD measurement performs very well in untreated patients to find those at increased risk of fracture and to diagnose osteoporosis," stated Nelson Watts, MD. “However, in patients receiving treatment for osteoporosis, the change in BMD explains only a small part of the reduction in fracture risk. There are clearly other factors that contribute to bone strength.” Before the symposium, the Alliance for Better Bone Health hosted a unique demonstration that included an educational morning of paradoxes showcasing the importance of bone quality in osteoporosis treatment and the importance of the “quality” of every day life. The event included a recreation of the different “sensorial” experiences using the five senses: taste, sight, smell, touch and sound. The purpose of the event was to build awareness among international media highlighting that what may seem healthy and of similarly good quality upon first appearance may be very different at closer inspection, underlining the significance of maintaining bone quality in the treatment of osteoporosis. Osteoporosis is characterized by diminished bone strength leading to an increased risk of fracture.3 For untreated patients the BMD score strongly correlates with the risk for an osteoporosis-related fracture. But while BMD plays an important role in the diagnosis of osteoporosis in an untreated patient, it is also important to recognize that low BMD is just one of many factors that contribute to bone strength.4 In fact, over the years, multiple studies have demonstrated that a BMD increase with therapy, actually contributes a small percentage to improve bone strength and fracture reduction, accounting for less than one-third of the reduction in fracture risk of antiresorptive agents.5-6 Bone Quality: Factors contributing to bone strength The search for explaining bone quality resulted in the recent introduction of the Bone Quality Framework, a scientific paper written as a means of summarizing and explaining the determinants of bone strength, published in the January 2005 issue of Clinical Therapeutics. In this framework, bone quality can be understood as a set of characteristics that influence bone strength and explains the interrelationships of these characteristics. Leading professors and experts in the field of osteoporosis helped to summarize and explain the components of bone strength, and stated that not all determinants of bone strength are well represented by a BMD measurement.4 “Clinicians have been looking for some time for a more complete overview of the factors that contribute to bone strength and I believe we are making progress in this area,” also remarked Nelson Watts, MD. “This progress will ultimately help improve the assessment of fracture risk and the treatment for women with postmenopausal osteoporosis.” About The Alliance for Better Bone Health The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis, part of the sanofi-aventis Group, in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe. Risedronate sodium (Actonel/Optinate), a bisphosphonate, is currently approved in 82 countries worldwide and is marketed by the Alliance for Better Bone Health. About Procter & Gamble Two 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®, Bounty®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Actonel®, Olay® and Clairol Nice ‘n Easy®, Head & Shoulders®, and Wella. The P&G community consists of almost 110,000 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. About sanofi-aventis The sanofi-aventis Group is the world’s 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Copies of this release are available on the Procter & Gamble Pharmaceuticals website at www.pgpharma.com, and on the website of Aventis Pharmaceuticals U.S., part of the sanofi-aventis Group, at www.sanofi-aventis.us, or by calling (800) 207-8049. Contacts: Cristiana Gaburri P&G Pharmaceuticals +39 065 09 73 071 gaburri.c@pg.com Jean Marc Podvin Michel Joly Sanofi-aventis Sanofi-aventis +33 (0)1 53 77 42 23 +33 (0)1 53 77 47 86 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. For sanofi-aventis and Aventis: This press release may contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although management of sanofi-aventis and Aventis believe that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis and Aventis, including those listed under “Forward-Looking Statements” and “Risk Factors” in their respective annual reports on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, neither sanofi-aventis nor Aventis undertakes any obligation to update or revise any forward-looking information or statements. REFERENCES: 1. Kanis JA, Gluer CC, for the Committee of Scientific Advisors, International Osteoporosis Foundation. An update on the diagnosis and assessment of osteoporosis with densitometry. Osteoporos Int, 2000; 11:192-202. 2. Hodgson SF, Watts NB, Bilezikian JP, et al, for the AACE Osteoporosis Task Force. American Association of Clinical Endocrinologists medial guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003 [published correction appears in Endocr Pract. 2004;10:90]. Endocr Pract, 2003; 9:544-564. 3. NIH consensus development plan on osteoporosis prevention, diagnosis, and therapy. Osteoporosis prevention, diagnosis, and therapy. JAMA, 2001; 285:785-795. 4. Felsenberg D, Boonen, S. The Bone Quality Framework: Determinants of Bone Strength and Their Interrelationships, and Implications for Osteoporosis Management. Clinical Therapeutics, January 2005; 27(1):1-11. 5. Cummings SR, Karpf DB, Harris F, et al. Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs. Am J Med, 2002; 112:281-289. 6. Sarkar S, Mitlak BH, Wong M, et al. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res, 2002; 17:1–10. ------------------------------------------------------------ Informasjonen er sendt gjennom Waymaker http://www.waymaker.no Nedenstående filer kan lastes ned: http://wpy.waymaker.net/client/waymaker1/WOLReleaseFile.aspx?id=111668&fn=wkr0010.pdf Press release pdf