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Celgene Gets Good News on Blood Disorder Drug; FDA Panel Will Recommend Approval for Revlimid

Posted on: Thursday, 15 September 2005, 15:00 CDT

A Food and Drug Administration committee recommended Wednesday that Celgene Corp.'s experimental drug Revlimid be approved for treating life-threatening blood disorders.

Although the FDA is not bound by the decisions of its advisory committees, it usually follows their recommendations. It is scheduled to act on Revlimid on Oct. 7.

Celgene's stock, which has been on a steady upward slope for years, rose $1.86 on Wednesday to close at $54.77.

"We are excited," Celgene CEO John W. Jackson said in a statement after the 10-5 vote.

Merrill Lynch analyst Thomas McGahren predicted in a report Wednesday that if Revlimid is approved, it will have sales of about $206 million in 2006, adding about 10 cents to the company's earnings per share, now estimated at $1 a share.

Revlimid is a form of thalidomide, which caused serious birth defects when taken by pregnant women several decades ago. Summit- based Celgene already sells another form of thalidomide, Thalomid, which is used to treat leprosy and multiple myeloma under careful supervision so that pregnant patients are not given the drug.

In recent trials, Revlimid was found to be much more powerful than expected in treating myelodysplastic syndromes.

With this disorder, the bone marrow fails to make enough healthy blood cells, causing anemia and fatigue. About 300,000 people worldwide have the disease. Most need regular blood transfusions to survive, and life expectancy for patients ranges from about six months to 6 years after diagnosis.

But in a clinical trial sponsored by Celgene, about two-thirds of patients who took Revlimid for six months no longer needed transfusions, researchers found. And signs of the genetic mutation that causes the disease disappeared in many patients, the study found.

The FDA advisory committee debated whether approval should be held up until the completion of studies on proper dosing of Revlimid, McGahren wrote.

"But in the end, the sentiment seemed to be that physicians want the drug available and that hematologists are very capable of modulating dosing," McGahren wrote.

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E-mail: lynn@northjersey.com

Source: Record, The; Bergen County, N.J.

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