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Biotechnology company Amgen Inc. will release
the results of the study on its osteoporosis drug candidate, denosumab, shortly after the market opens Tuesday, giving
investors a clearer image of the effectiveness of their osteoporosis drug. Preliminary
results of the study supported by Amgen showed that its experimental drug
denosumab reduced the risk of osteoporosis and fracture in men with prostate
cancer treated with drugs that cause bone loss. The drug targets a protein
involved with bone-destroying cells called osteoclasts. Data from two studies
of its denosumab were presented at the American Society of Bone and Mineral
Research meeting in Montreal.
The studies compared Amgen’s osteoporosis
drug candidate with Merck & Co.’s Fosamax. The first study, involving 504
postmenopausal women with osteoporosis, found that those who were given
denosumab as an injection every six months increased bone density by about 2
percent compared with a 1 percent increase in women taking Fosamax.
The drug was also tested on more than 1,400
men with non-metastatic prostate cancer undergoing androgen deprivation
therapy. After a three-year follow-up period, denosumab produced greater
increase in bone mineral density at the lumbar spine and non-vertebral sites
than a placebo. Side effects of the drug were minimal.
Denosumab is involved in one of the largest
programs in Amgen’s history. The company currently has trials involving more
than 19,000 patients globally.
The company should have all of data for its
first denosumab filing with US regulators by the end of 2008 or early 2009. The
drug could reach the market by 2010, Amgen said.
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