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

Fourth Quarter and Full Year 2012 Conference Call and Webcast Information

Celgene will host a conference call to discuss the results and achievements of its fourth quarter and full year 2012 operating and financial performance on January 24, 2013, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon ET January 24, 2013, until midnight ET January 31, 2013. To access the replay, in the U.S. dial 800-585-8367; outside the U.S. dial 404-537-3406; and enter reservation number 86013069. The Company’s first quarter 2013 financial and operational results are expected to be reported on April 25.

About REVLIMID

In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy. REVLIMID is also indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

If you liked this article you might like

How I've Prepared for Hurricane Irma -- and a Market Pullback

How I'm Prepared for Irma -- and a Pullback

Juno, bluebird In Focus as Targets Following Gilead-Kite Aquisition

Apple Is the Tom Brady of Stocks: Cramer's 'Mad Money' Recap (Thursday 8/31/17)

Cramer: Fantasy Shmantasy -- Let's Get Real With These Stock Picks