UPDATE 1-Amgen braces for biosimilars, looks to denosumab

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Mon Jan 12, 2009 2:25pm EST

(Adds share price, no outlook update, conference venue)

By Bill Berkrot

NEW YORK Jan 12 (Reuters) - Biotechnology giant Amgen Inc (AMGN.O) is bracing for generic competition for one of its key products, but its chief executive is confident sales will not be decimated by the availability of cheaper versions of its medicines.

So-called biosimilar versions of Amgen's white blood cell booster Neupogen are expected to be available this year in Europe. The United States has yet to come up with a pathway for generic versions of biotech medicines, but one is expected as early as this year.

"We believe we can hold very significant market share at attractive revenues for a long time post patent expiry," Amgen CEO Kevin Sharer said at the JP Morgan Global Healthcare Conference in San Francisco on Monday.

Sharer does not believe biosimilars will have the same devastating impact generic competition has on traditional branded chemical drugs that can quickly lose 80 percent or more of their sales when faced with cheaper copies.

"This is nothing like the pill world," Sharer said.

Amgen is already facing biosimilar competition for its older anemia drug Epogen in Europe.

"We felt the effects of a biosimilar, but did substantially better than expected," Sharer said. "In a year or two we'll have a good sense of what a biosimilar transition will look like."

Neupogen and a newer version of the medicine called Neulasta had combined worldwide sales of $1.19 billion in the third quarter of 2008. Amgen does not release separate sales figures for the two drugs.

Sharer said restructuring and most of the impact of safety concerns that hurt sales of its flagship anemia drugs, Aranesp and Epogen, are now behind the company.

"To have to downsize the company 15 percent was a very, very painful thing," Sharer told investors, calling it "some really dark days."

But he did not update Amgen's 2008 forecast ahead of release of fourth-quarter results later this month. The company had said it expects 2008 earnings of $4.45 to $4.55 per share.

The company is now focused on denosumab, which is widely considered to be Amgen's most important future growth driver.

Amgen last month filed for its U.S. approval as a treatment for osteoporosis in post-menopausal women, which Sharer called "a very large and growing indication."

It is also being developed for cancer treatment induced bone loss with pivotal cancer data expected this year.

Amgen is already gearing up for an anticipated denosumab approval.

"We're going full speed ahead on commercialization," Sharer said.

Amgen shares fell $1.15, or 2 percent, to $56.63 on Nasdaq. (Reporting by Bill Berkrot; Editing by Andre Grenon, Richard Chang)

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