Amgen Q3 profit beats but FDA concern hits shares
Oct 22, 2009 Make Money Online
By Bill Berkrot
NEW YORK (Reuters) – Amgen Inc (AMGN.O) reported a better-than-expected profit as cost cuts and lower taxes helped offset a steep decline in sales of its Aranesp anemia drug, but regulatory concerns about its closely-watched osteoporosis drug sent shares lower.
The company said on Wednesday U.S. health regulators have requested additional clinical trial data on its experimental osteoporosis drug denosumab for prevention of bone loss in prostate and breast cancer patients.
That could mean a lengthy delay before any approval decision for those uses and may have negative implications for Amgen’s efforts to get the drug approved for the larger market of reducing fracture risk in cancer patients.
Roger Perlmutter, Amgen’s research and development chief, said the company still expects to file for regulatory approval in the bone cancer setting sometime after its expected first-quarter report of results from a third pivotal trial.
“It looks as though the operating business has stabilized,” said Sanford Bernstein analyst Geoffrey Porges. “The problem is the FDA requested additional (denosumab) data in breast and prostate cancer patients undergoing hormone ablation therapy.” Read the rest of this entry »
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