Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG), provided a regulatory update for REVLIMID (lenalidomide) and pomalidomide as treatments for multiple myeloma.
The company decided to withdraw the new indication submission to the Committee for Medicinal Products for Human Use, or CHMP, for REVLIMID (lenalidomide), which was intended for the maintenance treatment of newly diagnosed multiple myeloma patients who have not progressed following initial treatment with melphalan, prednisone and REVLIMID (lenalidomide), or maintenance therapy following autologous stem cell transplantation.
In response to the CHMP's request, Celgene plans to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio.
Celgene noted that it is proceeding with submissions for REVLIMID (lenalidomide) in newly diagnosed multiple myeloma in Switzerland, Australia and other core markets. In the U.S., the company is currently re-evaluating our REVLIMID (lenalidomide) newly diagnosed submission to FDA and anticipates submitting an application in 2013.
Further, the company said that the new drug application for pomalidomide plus low-dose dexamethasone for patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a Prescription Drug User Fee Act date of Feb. 10, 2013.
In addition, Celgene reaffirmed its 2012, 2015 targets. Adjusted EPS for 2012 is still expected to be in a range of $4.70 to $4.80. The company still expects non-GAAP Total Revenue to be in a range of $5.400 billion to $5.600 billion. Analysts polled by Thomson Reuters expect the company to report earnings of $4.79 per share, on revenues of $5.47 billion for 2012. Analysts' estimates typically exclude special items.
For 2015, non-GAAP Total Revenue is still expected to be between $8.000 billion to $9.000 billion. Non-GAAP EPS is still expected to be between $8.00 to $9.00.
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