BRIDGEWATER, N.J. and CINCINNATI, Sept. 28 /PRNewswire/ -- The Alliance for Better Bone Health announced its response to the results of Merck's bone mineral density (BMD) study released today.
"Bone mineral density (BMD) is important for determining if a patient needs therapy, but when determining which therapy, fracture reduction is the clinically relevant endpoint," says Dr. Nora Zorich, M.D., Ph.D., Head of Drug Development, P&G Pharmaceuticals. "If Merck had intended to fully compare efficacy, they would have run a head-to-head fracture trial."
Merck's own vice president of clinical research was quoted to this effect in response to another comparative BMD trial, "People can't interpret this kind of data without looking at longer-term fracture trials." The Alliance for Better Bone Health believes that this BMD trial should not be used as a head-to-head comparison of efficacy of osteoporosis treatments. In fact, Merck's own data for different doses of Fosamax(R) have shown markedly different effects on BMD, but similar effects on fracture.
The National Institutes of Health (NIH) states, "Fracture prevention is the primary goal in the treatment of osteoporosis." Many studies have shown that increases in BMD correlate poorly to fracture risk reduction. Using differences in BMD increases to compare the efficacy of different therapies is potentially misleading. Actonel(R) is still the only osteoporosis therapy proven to reduce vertebral fractures in just one year, and Actonel significantly reduces the risk of both vertebral and non-vertebral fractures over three and five years. These non-vertebral fracture sites are those most commonly associated with osteoporosis and include hip, pelvis, wrist, humerus, clavicle and leg. The Alliance remains committed to leading science by partnering with the medical community to better understand all the elements that contribute to fracture-resistant bone.
About Actonel(R) (risedronate sodium tablets)
Actonel is developed by Procter & Gamble Pharmaceuticals and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.
In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia 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 renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).
In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent). Please visit http://www.actonel.com/ for full prescribing information for Actonel.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.
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 largest and strongest portfolios of trusted, quality brands, including Pampers(R), Tide (R), Ariel(R), Always(R), Whisper(R), Pantene(R), Bounty(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Actonel(R), Olay(R) and Clairol Nice 'n Easy(R). The P&G community consists of nearly 98,000 employees working in almost 80 countries worldwide. Please visit http://www.pg.com/ for the latest news and in-depth information about P&G and its brands.
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of EUR 16.79 billion (US $18.99), invested EUR 2.86 billion (US $3.75) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit: http://www.aventis-us.com/.
Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com/, on the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com/, or by calling (800) 207-8049.
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 Aventis: Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant 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 and in the current Annual Report -"Document de Reference" - on file with the "Autorite des marches financiers" in France.
The Alliance for Better Bone Health