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Once-yearly Reclast Significantly Reduced Bone Fractures in Women,with Postmenopausal Osteoporosis

nual doses of Reclast.

Analysis of key safety parameters, including kidney and bone safety (including osteonecrosis of the jaw), found Reclast to be comparable to placebo. There was an increased number of cases of serious atrial fibrillation observed in the women on Reclast compared to those on placebo (1.3 percent vs. 0.5 percent). These findings have not been observed in other clinical studies or in post-marketing experience from over 1.5 million patients treated with zoledronic acid for oncology indications. Data from a large trial in men and women following hip fracture will provide additional efficacy and safety data for Reclast. These results will be available in the second half of 2007.

About Reclast

HORIZON, the ongoing clinical program of Reclast, is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases. Approximately 13,000 patients have participated in the program in more than 400 centers worldwide. It is the first program to study a once-yearly dosing regimen for the prevention and treatment of postmenopausal osteoporosis. Other studies involved in the program include prevention of fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis and male osteoporosis.

Reclast is currently approved by the FDA for the treatment of Paget's disease of bone, the second most common metabolic bone disorder. Reclast is the first and only single-dose infusion regimen approved to treat Paget's disease. Zoledronic acid, under the brand names Reclast or Aclasta(R), is now approved in more than 50 countries, including the US, Canada and the countries of the EU.

The active ingredient in Reclast is zoledronic acid, which is also available under the brand name Zometa(R) (zoledronic acid) Injection for use in certain oncology indications.

Reclast is also under review by the FDA for the treatment of postmenopausal osteoporosis. If approved
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