BioCentury
ARTICLE | Clinical News

Celgene reports psoriasis data, provides 2013 outlook

January 8, 2013 2:10 AM UTC

Celgene Corp. (NASDAQ:CELG) said twice-daily apremilast met the primary endpoint of improving PASI 75 response rate at week 16 vs. placebo in the Phase III ESTEEM 1 and ESTEEM 2 trials to treat moderate to severe plaque psoriasis. Celgene plans to submit an NDA to FDA in 1Q13 for apremilast to treat psoriatic arthritis and an sNDA in 2H13 for psoriasis. The company plans to submit a combined MAA to EMA for both indications in 2H13. Last year, Celgene reported the oral phosphodiesterase-4 (PDE-4) inhibitor apremilast met the primary endpoint of improving ACR20 response rates vs. placebo in three Phase III trials in patients with psoriatic arthritis.

Separately, Celgene introduced 2013 EPS and revenue guidances and updated its 2012 guidances. Celgene said it expects 2013 net product sales of about $6 billion and a 2013 adjusted diluted EPS of $5.50-$5.60. The Street is expecting 2013 revenues of $6.05 billion and a full year EPS of $5.56. Celgene said it now expects 2012 revenues of about $5.55 billion, at the upper end of its previous estimate of $5.4-$5.6 billion. The company expects an adjusted diluted EPS for the year of about $4.90, also at the upper end of its previous estimate of $4.84-$4.90. The Street is expecting $5.5 billion in 2012 revenues and an EPS of $4.88. ...