UPDATE 4-Celgene soars on successful drug trial result

Thu Jul 23, 2009 1:29pm EDT

* Celgene reports positive drug trial results

* Ex-items EPS 46 cents, matching Street view

* Higher-than-expected Revlimid sales

* Shares rise 16 pct (Updates with analyst comment)

By Toni Clarke

BOSTON, July 23 (Reuters) - Shares of Celgene Corp (CELG.O) rose 16 percent on Thursday after it surprisingly announced that a clinical trial involving its multiple myeloma drug Revlimid showed clear benefit in newly diagnosed patients.

A trial known as MM-015 showed a highly statistically significant improvement in progression-free survival for patients taking Revlimid as a first-line treatment for multiple myeloma, suggesting it could be approved for use in this setting earlier than expected.

The company announced the news along with its second-quarter financial results.

Net earnings rose 19 percent to $143 million, or 31 cents a share, from $119.8 million, or 26 cents a share, a year earlier.

Excluding one-time items, the company earned 46 cents a share, matching analysts' expectations, according to Reuters Estimates.

Sales of Revlimid, the company's key growth driver, rose 22 percent to $397 million as it benefited from market share gains and increased duration of therapy.

Revlimid is currently approved for use in patients who have failed other therapies. In the United States it is also used off-label, meaning doctors prescribe it in the first-line setting, even though the company cannot market it for such use.

The company said it aims to show that treatment with Revlimid as early as possible for as long as possible is in patients' best interests.

Outside the U.S. it is not used off-label, and Celgene said the results of the MM-015 study represent a potential opportunity to significantly expand Revlimid use overseas.

Analysts welcomed the news.

"We forecast significant Revlimid sales growth driven by positive front-line and maintenance myeloma data," said Joel Sendek, an analyst at Lazard Capital Markets, in a research note.

Total revenue in the quarter rose more than expected to $629 million from $571.5 million. Analysts had expected $622.1 million.

The Summit, New Jersey-based biotech company said it expects sales of Revlimid in 2009 of $1.65 billion. In April it had forecast $1.7 billion.

"Overall, we would characterize the quarter as very positive, where key products performed well," said Geoffrey Meacham, an analyst at JP Morgan. "The company did however lower Revlimid guidance from $1.7 billion to $1.65 billion, but we don't see this as a big deal as the consensus was already at $1.65 billion."

Celgene said results of the trial were originally expected in the second half of this year and that the full data set is not yet available. Once it has been analyzed, the company plans to meet with multiple regulatory agencies around the world.

The trial tested Revlimid in combination with the drugs melphalan and prednisone. It is currently approved for use with dexamethasone.

Sales of its blood disorder drug Vidaza rose 54 percent to $92 million in the second quarter.

The company said it expects 2009 revenue will be at the lower end of a range of $2.6 billion to $2.7 billion, and earnings excluding items at the lower end of a range of $2.05 a share to $2.10 a share.

Previously it had forecast earnings of $2.05 to $2.15 a share.

Celgene's shares rose 16 percent to $54.91 on Nasdaq. (Reporting by Toni Clarke; Editing by Gerald E. McCormick and Brian Moss)

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