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Executive Summary

CIBA-GEIGY's CIBACALCIN IS FIRST SYNTHETIC HUMAN CALCITONIN APPROVED for treatment of symptomatic Paget's Disease of the bone, the company announced Nov. 20. Ciba-Geigy maintains that Cibacalcin offers an advantage over animal-derived calcitonins in that neither tolerance to Cibacalcin nor an antibody reaction has been observed. Calcitonin from animals causes antibodies with high binding capabilities to form which interfere with the effect of those calcitonins, said Henry Bone, MD, Director of Clinical Investigation at Ciba-Geigy. "This essentially never occurs with human calcitonin . . . the patients that have had a problem of this kind or an allergy developing . . . would be effectively treated with human calcitonin," Bone stated in an introductory teleconference on Nov. 20. Most people with Paget's Disease, 80-90% do not experience symptoms, noted John Haddad, Jr., MD, Department of Medicine, University of Pennsylvania. Haddad also said that treatment is usually initiated when the pain is extreme and cannot be relieved with analgesia, or when bone deformity is detected, or when nerve compression from sickened bones occurs. Dr. Bone said his experience with various forms of calcitonin has been that "two out of three patients" experience pain relief and that relief can occur "fairly soon, perhaps a couple to three weeks," or it can take "two to three months before we see a full effect on pain." Marianne Bange, Product Manager of Ciba-Geigy, noted that Cibacalcin has been marketed in Switzerland since 1977 and that the hormone is now marketed in several other European countries. Bange said that in most other countries Cibacalin is used for additional indications other than for Paget's Disease, such as osteoporosis and high calcium levels. "Osteoporosis is probably the indication for which calcitonin is most widely prescribed worldwide and this is certainly a subject not only of academic interest but interest to the pharmaceutical industry and Ciba-Geigy in particular. I think we'll see an increasing amount of information about the use of calcitonins and in particular the use of human calcitonins for osteoporosis and other indications as well," Bone remarked. Cibacalcin is "made by a direct chemical synthesis, essentially a process of putting together the correct amino acids in a building blocks fashion. It is structurally identical to the normal human calcitonin," Bone stated. Cibacalcin comes in a double chambered prefilled syringe. The vial contains Cibacalcin and the syringe contains a mannitol/water solution. The injection can be self-administered subcutaneously into the thigh or buttocks. The treatment consists of a daily injection of .05 mg and over time the dosage amount and frequency of administration may be reduced to three times a week. Cibacalcin therapy costs $208.50 per month. USV Pharmaceutical's Calcimar, a salmon calcitonin, which is approved for Paget's Disease, osteoporosis, and hypercalcemia, costs $196 per month. The 6% difference is "justified by the availablity of the syringe for Cibacalcin," Bange maintained.

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