Celgene Reports Strong Fourth Quarter And Full Year 2012 Operating And Financial Results
Celgene plans to submit an NDA to the FDA for apremilast in psoriatic arthritis in the first quarter 2013 with a submission for psoriasis to follow in the second half of 2013. A submission with the EMA for both psoriasis and psoriatic arthritis is expected in the second half 2013.
New and Updated Data on Over Ten Pivotal Phase III Trials Expected in 2013
Data on over ten pivotal phase III trials on Celgene products are expected in 2013. This includes:
- Final progression free survival (PFS) data from the MM-020 trial of REVLIMID in newly diagnosed multiple myeloma (NDMM)
- Updated data on trials of REVLIMID in NDMM including MM-015
- Data on VIDAZA in acute myeloid leukemia (AML)
- Data on RBC-transfusion independence in myelofibrosis for POMALYST
- Mature overall survival (OS) data for ABRAXANE in metastatic melanoma
- Data from PALACE-2, -3 and -4 of apremilast in psoriatic arthritis
- Data from ESTEEM-1 and -2 of apremilast in psoriasis
Data on many of these trials are expected to be presented at major medical congresses throughout the year.
2013 Guidance Affirmed- Total net product sales expected to increase approximately 11 percent year-over-year to approximately $6,000 million
- REVLIMID net product sales anticipated to increase approximately 10 percent year-over-year to a range of $4,100 to $4,200 million
- Adjusted diluted EPS expected to increase approximately 13 percent year-over-year to a range of $5.50 to $5.60. Guidance assumes a constant fully diluted share count of 430 million from December 2012 through 2013
- GAAP diluted EPS expected to be in the range of $4.67 to $4.79
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