UPDATE 1-Lilly osteoporosis drug passes new test

Wed Apr 8, 2009 9:46pm BST

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* Arzoxifene meets primary goals of second Phase III study

* Raises bone mineral density, compared with placebo (Adds details on trial, results, share price)

By Ransdell Pierson

NEW YORK, April 8 (Reuters) - Eli Lilly and Co (LLY.N) said on Wednesday its experimental osteoporosis drug arzoxifene has achieved its primary goals in a second late-stage clinical trial among postmenopausal women.

The Indianapolis drugmaker said the latest favorable results for the drug were seen in a Phase III study among 311 women aged 45 to 60, all of whom had normal or low bone mass. Low bone mineral density is considered a risk for developing the bone-thinning condition.

Subjects received either daily 20 milligram doses of arzoxifene or a placebo. All women also received daily 500-milligram supplements of calcium.

After two years, arzoxifene increased bone mineral density of the lumbar spine and of the total hip by 2.9 percent and 2.2 percent, respectively, compared with placebo. The results were deemed statistically significant.

There was no significant difference among the two groups in incidence of adverse events, except that vaginal yeast infections were seen among 4 percent of women taking the Lilly drug, but among none in the placebo group.

There were no significant differences among the arzoxifene and placebos groups in incidence of cancer or endometrial hyperplasia, a thickening in the lining of the uterus that can be a precursor to endometrial cancer.

Data from the trial, called Foundation, were described in the online edition of the Journal of Clinical Endocrinology & Metabolism.

The published results come several weeks after favorable data from another Phase III study of arzoxifene, called Next, among postmenopausal women with osteoporosis. In that trial, arzoxifene proved superior to Lilly's older osteoporosis drug Evista in increasing bone mineral density in the lumbar spine, total hip and femoral neck regions.

Both Lilly drugs are members of the family of osteoporosis-prevention drugs called selective estrogen receptor modulators, or SERMs.

Lilly shares rose 1.4 percent to close at $32.34 on the New York Stock Exchange. (Reporting by Ransdell Pierson; Editing by Andre Grenon)

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