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| |  Miacalcin Cleared for Treatment of Postmenopausal Osteoporosis EAST HANOVER, N.J., Aug. 18, 1995 -- Sandoz Pharmaceuticals Corporation announced today that it has received clearance to market MIACALCIN(R) Nasal Spray (calcitonin-salmon) for the treatment of postmenopausal osteoporosis. Widening the therapeutic options for a crippling and sometimes life-threatening bone disease affecting more than 20 million American women, MIACALCIN Nasal Spray offers a new approach in the delivery of osteoporosis therapy. Clinical studies with MIACALCIN Nasal Spray have shown significant increases in spinal bone mineral density in women more than five years after menopause. "While estrogens are considered first line therapy for postmenopausal osteoporosis approximately 30-50 percent of women refuse, cannot tolerate or should not use estrogen. MIACALCIN Nasal Spray represents an exciting new option for many of these women," said Louis V. Avioli, M.D., Shoenberg Professor of Medicine and Director, Division of Bone and Mineral Diseases, Washington University School of Medicine. It is estimated that approximately one in four women are at risk of developing postmenopausal osteoporosis. Currently, in addition to MIACALCIN Nasal Spray, only estrogen and calcitonin-salmon in injectable form are available to treat postmenopausal osteoporosis. "Osteoporosis is a devastating disease, and treatment options are very limited, " said Sandra Raymond, Executive Director of the National Osteoporosis Foundation, the nation's leading resource for people seeking up-to-date, medically sound information on the causes, prevention, detection and treatment of osteoporosis. "The fact that postmenopausal osteoporosis patients and their health care providers will soon have MIACALCIN Nasal Spray available to them is very exciting positive news. This is a well-established compound -- calcitonin-salmon -- and now that it has been cleared for marketing in the United States as a convenient nasal spray, it should be a welcome option for postmenopausal osteoporosis patients. It is our mission to keep patients and physicians informed of promising therapies for osteoporosis." MIACALCIN Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women who are more than five years past their menopause and who have low bone mass compared with women before menopause. MIACALCIN Nasal Spray is recommended for women who refuse or cannot tolerate estrogens or in whom estrogens should not be used. MIACALCIN Nasal Spray should be taken with adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (400 IU 1/8international units3/8 per day). In clinical trials with MIACALCIN Nasal Spray, the overall incidence of side effects was comparable to placebo. Nasal irritation and other symptoms of the nose such as dryness, redness, itching, or bleeding were the most commonly reported side effects. Nasal irritation was reported in 12% of MIACALCIN patients versus 6.9% of placebo patients in clinical trials; other symptoms of the nose were reported in 10.6% of MIACALCIN patients versus 16% of placebo patients. Because calcitonin is a protein, the possibility of a systemic allergic reaction exists although in clinical trials and in foreign marketing experience with MIACALCIN Nasal Spray, no serious allergic-type reactions have been reported. MIACALCIN Nasal Spray is contraindicated in patients who are allergic to calcitonin. There have been more than 20 years of clinical experience with MIACALCIN in injectable form. The medication has been used by many thousands of women across the world. MIACALCIN in injectable form is available in 88 countries; MIACALCIN Nasal Spray is available in 72 countries outside the U.S.
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