AP News

Celgene falls on Revlimid application delays

NEW YORK (AP) — Shares of Celgene Corp. slumped Thursday after the company slowed its plans to gain additional marketing approval for its cancer drug Revlimid.

Celgene said it withdrew an application to market Revlimid in the European Union for newly diagnosed cases of the bone-marrow cancer multiple myeloma, and plans to file a new application when it has more clinical data showing the benefits of the drug. Celgene is also slowing its plans to get additional marketing clearance in the U.S. The company said it now plans to file for approval of Revlimid in newly diagnosed patients in 2013 instead of in 2012.

Revlimid brings in most of Celgene's revenue. It is approved as a treatment for multiple myeloma in patients who have received at least one previous round of treatment. Celgene had asked European Union regulators to approve the drug as a maintenance treatment for patients who have received a stem-cell transplant or in patients whose cancer has not progressed after a treatment regimen including Revlimid.

Shares of Celgene lost $7.80, or 11.6 percent, to $59.36 in morning trading.

The Summit, N.J., company said it still plans to file for the additional marketing approvals in some markets, including Switzerland and Australia.

Revlimid is also used as a treatment for anemia in patients with myelodysplastic syndrome, a blood and bone marrow disease.

Celgene maintained its 2012 profit and revenue forecasts, saying it expects to earn $4.70 to $4.80 per share excluding one-time charges on $5.4 billion to $5.6 billion in revenue. The outlook includes $3.75 billion to $3.85 billion in Revlimid sales.

Analysts expect the company to report a profit of $4.79 per share excluding one-time costs and stock-based compensation. They are projecting revenue of $5.45 billion on average.

Celgene said it expects its adjusted profit to grow to $8 to $9 per share in 2015, with sales rising to a range of $8 billion to $9 billion.

The company also said the Food and Drug Administration is reviewing an application for pomalidomide, a drug that is intended to treat multiple myeloma that has returned after treatment or not responded to treatment. Celgene said the FDA will complete its review by Feb. 10. The company has also filed for approval to market the drug in Europe.

Steve Ballmer, Power Forward
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