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PREVIEW-Amgen meeting to focus on bone drug prospects

Wed Nov 5, 2008 3:28pm EST

Stocks

   

* Who: Amgen Inc

Stocks  |  Global Markets

* When: Friday

* What: Meets with analysts

* Analysts looking for details on denosumab launch

By Deena Beasley

LOS ANGELES, Nov 5 (Reuters) - All eyes will be on promising bone drug denosumab when Amgen Inc (AMGN.O) meets with analysts on Friday to discuss commercial plans for the experimental drug, as well as progress in its drug development pipeline.

Spokesman David Polk said he did not expect Amgen, the world's largest biotechnology company, to issue financial forecasts at the New York meeting.

Denosumab is viewed as the next key growth engine at Amgen, which has seen sales of its flagship anemia drugs slide after the emergence of data nearly two years ago showing that the drugs raised the risk of death for some cancer patients.

Thousand Oaks, California-based Amgen said in September that a large trial of denosumab in post-menopausal women suffering from osteoporosis showed that it reduced the risk of spine fractures by about 68 percent.

"Amgen is poised to enter another cycle of growth .... assuming a successful launch of denosumab in 2010 with $5 billion potential," Goldman Sachs analyst May-Kin Ho said in a research note on Wednesday.

Amgen hopes to have its data package for denosumab ready by the end of this year, with submission to U.S. regulators "shortly thereafter," said spokeswoman Kerry Beth Daly.

Amgen is well-known for its anemia drugs and other specialty pharmaceuticals, like arthritis drug Enbrel, but denosumab would be the company's first product aimed at primary-care physicians.

"What makes me nervous is that there are huge revenue expectations for the drug -- first year sales of more than $500 million," said Christopher Raymond, an analyst at Robert W. Baird.

Bullish expectations for denosumab have helped lift Amgen's stock nearly 28 percent so far this year, compared with a drop of 15 percent for the American Stock Exchange Biotech index .BTK over the same period.

Raymond said analysts and investors will be looking for guidance on Amgen's "blocking and tackling plan" for denosumab's launch as well as details on how much money the company expects to spend on it before the drug is approved.

Denosumab, given twice a year by injection, is the first in a new class of drugs that inhibit proteins that activate bone-destroying cells. Competitors would include drugs like Merck & Co Inc's (MRK.N) Fosamax, which is also available as a low-cost generic.

Amgen Chief Executive Kevin Sharer was quoted in September as saying the company was unlikely to sign a partnership agreement to market denosumab in United States.

"The question is how does Amgen get maximum coverage with a specialty sales force?" Raymond said.

The analyst said Wall Street is already projecting "fairly flat" earnings growth for Amgen, and any big increase in spending on sales would put downward pressure on earnings estimates.

Amgen is unlikely to reveal its pricing plans for denosumab, but that is another factor likely to play a large role in the drug's commercial prospects. (Reporting by Deena Beasley, editing by Gerald E. McCormick)



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