Shares of Celgene Corp. (CELG) plunged 11 percent Thursday after the drug maker withdrew its application for additional indication marketing approval in Europe of blood-cancer drug Revlimid. The decision came after the European authorities requested the company to resubmit the application with more mature data.
Summit, New Jersey-based Celgene's application widened the marketing of Revlimid for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and Revlimid, or maintenance therapy following autologous stem cell transplantation.
Celgene said it will resubmit the application with more mature data, which would help the Committee for Medicinal Products for Human Use (CHMP) to conclude a clear benefit/risk ratio.
Meanwhile, Celgene is going forward with submissions for Revlimid for the additional indications in Switzerland, Australia and other core markets. In the US, the company indicated reevaluating the submission to FDA and expects to submit an application in 2013.
Nonetheless, the company reaffirmed its full-year 2012 and 2015 earnings and revenue outlook.
Celgene continues to expect full-year 2012 adjusted earnings in a range of $4.70 to $4.80 per share, and total revenues of $5.40 billion to $5.60 billion. Analysts polled by Thomson Reuters currently expect earnings of $4.79 per share and revenues of 5.47 billion. Analysts' estimates typically exclude one-time items.
Revlimid sales is expected to be in a range of $3.75 billion to $3.85 billion for 2012.
For 2015, Celgene expects adjusted earnings of $8.00 to $9.00 per share, and revenues of $8 billion to $9 billion.
CELG is currently trading on the Nasdaq at $59.59, down $7.57 or 11.27%, on a volume of 16.2 million shares, above the three-month average volume of 3.2 million.
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