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Title: Results Of Head-To-Head Efficacy Study Of Osteoporosis Drugs Unveiled - Fosamax® (Alendronate Sodium), The Only Once Weekly Osteoporosis Medication Approved In Canada, Shown To Be More Effective Than Risedronate

"Results Of Head-To-Head Efficacy Study Of Osteoporosis Drugs Unveiled - Fosamax® (Alendronate Sodium), The Only Once Weekly Osteoporosis Medication Approved In Canada, Shown To Be More Effective Than Risedronate"

Second Study Reveals Once-Weekly Dosing Preferred Over Daily Therapy LISBON, PORTUGAL -- May 13, 2002 -- In the first head-to-head efficacy study(1) comparing Fosamax® (alendronate sodium) 70 mg once weekly and Actonel® (risedronate) 5 mg once daily, alendronate was shown to be more effective in the treatment of postmenopausal osteoporosis. Alendronate produced a nearly 50 per cent greater increase in lumber spine bone mineral density (BMD) and a 2.5 times greater increase in total hip BMD over risedronate after only six months of treatment. Furthermore, alendronate demonstrated a 50 per cent greater reduction in bone resorption when compared to risedronate after three months. The six-month data from a 12-month international study was presented this weekend at the World Congress of Osteoporosis in Lisbon, Portugal. "This is the first major study comparing the efficacy of two different compounds in the bisphosphonate class, and clearly Fosamax® was fast and significantly more effective in helping patients build bone at the spine and hip," said Dr. David Hosking, from the Nottingham City Hospital, Nottingham, England, the study's principal investigator. "These findings will help physicians make informed decisions when they prescribe osteoporosis therapy for their patients." The 10-country, double blind, randomized, placebo-controlled study examined 550 postmenopausal women with osteoporosis. Each patient received alendronate 70 mg Once Weekly using standard morning dosing, risedronate 5 mg once daily at least 2 hours after the largest meal of the day and two hours prior to the next meal or beverage, or placebo. All patients maintained a calcium intake of at least 1000 mg daily through food and supplements. Key Study Findings Bone mineral density (BMD) was measured in all groups after six months of treatment and compared to baseline. - Patients treated with alendronate showed a 3.7 per cent increase in lumbar spine BMD compared to a 2.5 per cent increase for the risedronate group. - Patients treated with alendronate showed a 2.6 per cent increase in total hip BMD compared to a 1.0 per cent increase for the risedronate group. - Bone resorption was measured through the amount of N-telopeptides of type 1 collagen (NTx) present in the urine. Higher levels of NTx are usually found among postmenopausal women with osteoporosis and the treatment goal for osteoporosis includes the lowering of urinary NTx values to normal levels. - During the study, improvement in NTx levels were achieved at three months and patients treated with alendronate demonstrated a 50 per cent greater improvement in bone resorption over the risedronate group with a 55 per cent decrease in NTx compared to a 36 per cent decrease shown by patients receiving risedronate. - The tolerability of both therapies was examined and no apparent differences in any adverse events were reported in either group. "Adherence to therapy is critical in the management of long-term diseases such as osteoporosis," said Dr. David Kendler, Director of the Osteoporosis Program and the Osteoporosis Research Centre, St. Vincent's Hospital, Vancouver, B.C. "Physicians require both proven efficacy of a therapy and its convenience." Worldwide Study Shows Patients Prefer Taking Their Medication Once A Week There are a number of studies demonstrating that patients prefer once- daily dosing to multiple daily dosing and that adherence to therapy is improved with once-daily dosing. Whether patients would prefer once weekly dosing had not, until now, been studied in controlled trials. A new 19-country study(2), led by Canadian investigator David Kendler examined dosing preference, convenience and willingness to continue therapy long term. Findings showed that 84 per cent of postmenopausal women with osteoporosis preferred a 70 mg once-weekly dosing regimen of alendronate over a 10 mg once- daily regimen of alendronate. The study was conducted in 45 centres, eight of which were in Canada(3). "The results confirm that patients prefer the once-weekly dosing option and that they consider it more convenient," said Dr. Kendler. The nine-week, open-label study in over 400 postmenopausal women with osteoporosis assessed the patients' preference, convenience and willingness to continue long term between the two dosing regimens. Women entering the study had not previously been treated for osteoporosis with other therapies including bisphosphonates, calcitonin or selective estrogen receptor modulators. Patients were randomized to: Alendronate 70 mg once-weekly for four weeks, followed by one week off therapy, and then four weeks on alendronate 10 mg once daily, or: Alendronate 10 mg once daily for four weeks, followed by one week off therapy, and then four weeks on alendronate 70 mg once weekly. At the conclusion of the study, participants completed a questionnaire which addressed preference, convenience and willingness to take the regimen long term. Of the 92 per cent of patients who expressed a preference for dosing regimen, 84 per cent preferred the once-weekly regimen. In addition, 87 per cent found that the once-weekly regimen was more convenient and 84 per cent chose the once-weekly regimen as the one that they would be more willing to take long term. Results were statistically significant (P (less than) 0.001 for each item) and consistent across subgroups (including country, age, number of concomitant medications and medical conditions). "These results mirror those of a companion study(4) conducted in the United States which also confirmed the overwhelming preference of patients (90 per cent) for the once-weekly dosing option over multiple daily dosing, its convenience (92 per cent) and their willingness to comply (91 per cent)," noted Dr. Kendler. Fosamax® Once Weekly Efficacy And Tolerability The efficacy of alendronate 10 mg once daily was established with the Fracture Intervention Trial (FIT), which provided over 24,000 patient years of double-blind, placebo-controlled experience and is among the largest and most important studies ever conducted in osteoporosis.(5) The approval of alendronate 70 mg once weekly was based on clinical evidence demonstrating it has the equivalent therapeutic effect of alendronate 10 mg taken once daily in increasing bone mineral density (BMD) in postmenopausal women.6 The tolerability profile of alendronate 70 mg once weekly and the 10 mg once daily dosages are similar. To enhance compliance the once-weekly formulation of alendronate 70 mg is available in Canada in a "patient-friendly" package containing a four-week supply. About Osteoporosis - A Silent Disease Osteoporosis strikes one in four women and one in eight men over the age of 50. An estimated 1.4 million Canadians suffer from osteoporosis, a disease of the skeleton caused by progressive age-related loss of bone strength that leads to increased risk of fracture in men and women. It is a debilitating disease known as the 'silent thief' because bone loss occurs without any symptoms. The cost of treating osteoporosis and the fractures it causes is estimated to be $1.3 billion each year in Canada alone. Long term, hospital and chronic care account for the majority of these costs. There are approximately 25,000 hip fractures in Canada each year and 70 per cent of these are osteoporosis-related. Hip fractures result in death in up to 20 per cent of cases and disability in 50 per cent of those who survive and require hospitalization. More women die each year as a result of osteoporotic fractures than from breast and ovarian cancer combined.(7) Discovering Today For A Better Tomorrow Merck Frosst Canada & Co. is one of the country's leading research-based pharmaceutical companies. The Merck Frosst Centre for Therapeutic Research, one of the largest biomedical research facilities in Canada, has a mandate to discover new therapies for the treatment of respiratory, inflammatory and other diseases. In 2001, the company invested close to $120 million in research and development in Canada. For its part, Merck Frosst Canada Ltd. markets an extensive line of cardiovascular products for high blood pressure, elevated cholesterol and heart failure as well as a broad range of vaccines. Merck Frosst is a recognized leader in the treatment of arthritis, asthma, osteoporosis, HIV/AIDS, glaucoma, prostate disease, migraines and infectious diseases. Based in Kirkland, Quebec, Merck Frosst employs approximately 1,900 people including 300 of the world's leading scientific personnel. It is also firmly committed to science education and sponsors a number of programs designed to spark young people's interest in science. Merck Frosst Canada & Co. and Merck Frosst Canada Ltd. are affiliated companies of Merck & Co., Inc. of Whitehouse Station, New Jersey. Merck & Co., Inc. is a publicly traded company on the New York Stock Exchange under the symbol MRK. ® Registered trademark of Merck & Co., Inc. Used under license. REFERENCES: 1. D Hosking, S Adami, D Felsenberg, J Cannata, M Valimaki, A Kaur, A Santora, S Suryawanshi- Once Weekly Alendronate Produces a Greater Decrease in Bone Resorption Than Daily Risedronate 2. Kendler DL, Diez-Perez A, Gaines KA, Verbruggen N, and Melton ME- Patient Preference of Once Weekly or Daily Administration of Alendronate (Fosamax) for Osteoporosis: A Randomized Cross-Over Study 3. Dr. Mary Bell, Dr. Jacques Brown, Dr. David Hanley, Dr. Anthony Hodsman, Dr. David Kendler, Dr. Aliya Khan, Dr. Louis-Georges Sainte- Marie, Dr. Chui Kin Yuen 4. Lewiecki EM, Rosen C, Bockman RS, et al. ASBMR (Poster), October 2001 5. Black D, Bauer D, Thompson D, Hochberg M, for the FIT Research Group. The early antifracture efficacy of alendronate in women with osteoporosis: results from FIT. Osteoporos Int. 2000; 11(suppl 2): S173. 6. Schnitzer H et al. Aging Clin. Exp. Res. 2000; 12: 1-12 7. Osteoporosisonline(www.osteoporosis.ca) For further information: Marlene Gauthier, Manager, Public Affairs, Merck Frosst Canada Ltd., Cell.: (514) 240-6884; Elise Giasson, Tel: (514) 428-8567, Cell: (514) 882-8567; Roch Landriault, NATIONAL PharmaCom, (514) 843-2345, Cell.: (514) 249-4537 SOURCE: Merck Frosst

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