Celgene gains on apremilast data
Celgene Corp. (NASDAQ:CELG) gained $3.53 to $74.49 on Thursday after apremilast met the primary endpoint in each of two identical Phase III trials to treat psoriatic arthritis. Top-line data from the PALACE-2 and 3 trials showed that the oral phosphodiesterase-4 (PDE-4) inhibitor significantly improved ACR20 response rates at week 16 vs. placebo. The trials, which are the final two in the PALACE program in psoriatic arthritis, each enrolled about 500 patients who had failed oral DMARDs, and/or an anti- tumor necrosis factor (TNF) agent. In July, Celgene said apremilast met the primary endpoint of ACR20 response rate in the PALACE-1 trial (see BioCentury Extra, July 12).
Apremilast is also in the Phase III ESTEEM 1 and 2 trials to treat moderate to severe psoriasis, with data expected by year end. Celgene plans to submit an NDA to FDA for apremilast to treat psoriatic arthritis in 1Q13. The company plans to submit a combined MAA to EMA for both indications in 2H13. ...