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MERCK'S FOSAMAX GAINS FDA CLEARANCE TO PREVENT OSTEOPOROSIS AND ITS FRACTURES IN POSTMENOPAUSAL WOMEN
WEST POINT, Pa., April 28, 1997 -- Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared its drug Fosamax"š (alendronate sodium) to prevent osteoporosis in postmenopausal women. Fosamax is now one of the few drugs indicated to prevent a chronic disease. In addition, Fosamax was cleared to prevent fractures in postmenopausal women with osteoporosis.
The FDA's decision to clear Fosamax for prevention of the bone-thinning disease gives millions of postmenopausal women in the United States and their physicians a nonhormonal option for preventing rapid bone loss in the early postmenopausal period; bone loss may lead to osteoporosis and its fractures.
"In the first five years after menopause, women will lose about one-third of the bone they will lose in their lifetime -- up to 15 percent of their bone," said Michael McClung, M.D., director of the Oregon Osteoporosis Center in Portland. "As bone loss occurs, the bone structure deteriorates irreversibly, making bones weak and prone to fracture. Current treatments can strengthen bone that remains, but cannot completely replace bone once it has been lost. That's why preventing osteoporosis now is better for postmenopausal women than waiting to treat once the damage has begun."
The FDA's decision to clear Fosamax 5 mg (once daily) for prevention of osteoporosis was based primarily on the Early Postmenopausal Interventional Cohort (EPIC) study in 1,609 women ages 45 to 59. Two-year data from that ongoing six-year study showed that treatment with Fosamax stopped bone loss in most women. Women treated with Fosamax significantly increased bone mass at the spine (by 3.46 percent over baseline) and total hip (by 1.85 percent over baseline). In contrast, women in the placebo group lost significant bone mass at the spine (-1.78 percent compared to baseline) and total hip (-1.42 percent compared to baseline). - more -
Shown to Prevent Hip, Spine and Wrist Fractures in Women with Osteoporosis
For postmenopausal women who already have osteoporosis, the FDA also cleared Fosamax 10 mg (once daily) as the only nonhormonal medication to prevent fractures of the hip, spine and wrist. In fact, Fosamax is the only drug demonstrated to prevent hip fractures in a large, prospective, randomized trial of community-dwelling women. Fosamax 10 mg was introduced in October 1995 to treat osteoporosis in postmenopausal women based on studies that showed it built healthy bone and on pooled data that showed Fosamax reduced the risk of spinal fractures.
Now, the ability of Fosamax to prevent fractures at the hip, spine and wrist has been demonstrated in the Vertebral Fracture arm of the Fracture Intervention Trial (FIT), which included 2,027 women ages 55 to 81 who had osteoporosis and at least one previous spinal fracture. This study showed that Fosamax reduced the risk of hip fracture by 51 percent (1.1 percent in patients on Fosamax vs. 2.2 percent of patients on placebo) and the risk of spinal fracture by 47 percent (8.0 percent on Fosamax vs. 15.0 percent on placebo). Positive findings led an independent Data Safety and Monitoring Board to stop the study early because the board believed withholding Fosamax from the placebo group would be unethical. In this study, Fosamax also reduced the risk of wrist fractures by 48 percent (2.2 percent on Fosamax vs. 4.1 percent on placebo), the risk of painful spinal fractures by 55 percent (2.3 percent on Fosamax vs. 5.0 percent on placebo) and the risk of two or more additional spinal fr
Patients with certain disorders of the esophagus, inability to stand or sit upright for at least 30 minutes, low levels of calcium in their blood, severe kidney disease or who are pregnant or nursing should not take Fosamax. Some patients may develop severe digestive reactions, including irritation, inflammation or ulceration (occasionally with bleeding) of the esophagus (the tube that connects the mouth with the stomach). These reactions can cause chest pain, heartburn or difficulty or pain upon swallowing. This may occur especially if patients do not follow dosing instructions. Esophageal reactions may worsen if patients continue to take Fosamax after developing symptoms suggesting irritation of the esophagus. Like all prescription drugs, Fosamax may cause side effects. Side effects usually have been mild.
They generally have not caused patients to stop taking Fosamax. The most commonly reported side effect was abdominal pain.
To receive maximum benefit from Fosamax, patients must take the drug upon waking for the day at least 30 minutes before the first food, beverage or other medication of the day with a full glass of plain water (six to eight ounces) only. After swallowing Fosamax, patients must not lie down and should stay fully upright (sitting or standing) for at least 30 minutes and until after first food of the day.
Incidence of Osteoporosis to Nearly Double by 2015
A 1997 report issued by the National Osteoporosis Foundation projects that the number of women with the disease will grow to more than 35 million by the year 2015. Costs associated with osteoporosis -- currently about $13.8 billion annually -- will rise accordingly.
It's estimated that four in ten women aged 50 or older will suffer a fracture from osteoporosis in their remaining lifetimes. Osteoporosis leads to more than 1.3 million fractures in the United States each year, including 250,000 hip fractures, the most costly and debilitating of all osteoporotic fractures. The Centers for Disease Control and Prevention recently reported that broken bones cost the Medicare program $4.2 billion in 1992, about three percent of the program's total cost. Hip fractures alone cost Medicare $2.9 billion that year. These numbers are expected to increase as the population ages.
"Women who realize the seriousness of osteoporosis often turn to calcium and exercise to protect their bone health," said Dr. McClung. "However, while regular, weight-bearing exercise and calcium are important to maintaining bone health, after menopause they usually are not enough to stop bone loss, prevent osteoporosis or rebuild bone."
Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least one standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of Fosamax for prevention of osteoporosis.
"With new therapies for preventing bone loss and fractures we have new ways to help women remain active, strong and independent throughout their lives," said Sandra C. Raymond, executive director of the National Osteoporosis Foundation. "This can only happen if women past menopause talk with their physicians to evaluate their bone health, and, if appropriate, take action to help prevent osteoporosis and its fractures."
Education, Access to Technology Increasing Diagnosis
Of the 20 million American women with osteoporosis, 80 percent (16 million) don't know they have it and are undiagnosed. Efforts to increase the rate of diagnosis of the disease are accelerating. In 1995, there were only 1,000 diagnostic sites in the United States with machines for measuring bone density. This year, the number of sites is expected to increase to more than 4,000, expanding access to millions of undiagnosed women. Since 1995, two additional technologies for assessing bone mineral density have been cleared by the FDA.
Concern about osteoporosis has prompted more than 100 major women's and health advocacy organizations to begin a grassroots movement to educate health policy makers and the public. As a result, legislation is pending in the U.S. Congress to standardize Medicare reimbursement for bone mass measurement. Legislation also is pending in at least 12 states to develop state education programs on osteoporosis.
Additional Information on Fosamax
Fosamax was first cleared for marketing on Sept. 29, 1995, for the treatment of osteoporosis in postmenopausal women (10 mg once daily) and for the treatment of Paget's disease of bone, a chronic bone disorder (40 mg once daily). Fosamax was the first nonhormonal drug to meet the current (1992) FDA guidelines for assessing drugs for the treatment and prevention of postmenopausal osteoporosis. Estrogen, another product for the treatment and prevention of postmenopausal osteoporosis, was cleared prior to 1992. Fosamax is not a hormone and does not have the benefits and risks of estrogen (hormone replacement therapy) elsewhere in the body.
According to the treatment guidelines, each drug must build bone of normal quality, increase bone mass in three-year clinical studies and reduce risk of spinal fracture. The FDA guidelines for prevention of postmenopausal osteoporosis state that a drug must be cleared for treatment before being considered for prevention, that bone mass must be demonstrated to be an appropriate efficacy endpoint for that particular drug in clinical trials and that use of the drug results in reduction of fractures; Fosamax met or exceeded these guidelines.
Fosamax was licensed to Merck & Co., Inc. by Istituto Gentili SPA of Pisa, Italy, in 1988 and is available in 49 countries.
Merck has a promotional agreement with Wyeth-Ayerst Laboratories, a division of American Home Products Corp., under which Wyeth-Ayerst is promoting Fosamax to gynecologists in the United States. Merck will concentrate its promotional and educational efforts on other key groups such as endocrinologists, rheumatologists, orthopedic surgeons and primary care physicians.
Merck's catalog price to pharmacies for a 5 mg tablet of Fosamax (the recommended daily dose for prevention of osteoporosis in postmenopausal women) and for Fosamax 10 mg (the recommended daily dose for the treatment of osteoporosis and prevention of fractures in postmenopausal women) will be $1.49. Merck estimates that the retail price will be between $1.79 and $1.86 a day ($53.70 to $55.80 monthly, $653.35 to $678.90 annually), which includes markups of 20 to 25 percent that are based on historical audit data. Prices at the retail level are established by pharmacies, not by Merck, and can vary.
Merck & Co., Inc. is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health.
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Full prescribing information for Fosamax is attached.
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