Celgene reports more apremilast data

Celgene Corp. (NASDAQ:CELG) reported additional data for apremilast on Monday and also announced revenue guidance for the oral phosphodiesterase-4 (PDE-4) inhibitor. In the Phase III PALACE-4 trial to treat psoriatic arthritis in patients who had not previously received a DMARD, twice-daily oral apremilast met the primary endpoint of improving ACR20 response rate at week 16 vs. placebo.

In March, Celgene submitted an NDA to FDA for apremilast to treat active psoriatic arthritis based on data from the Phase III PALACE-1, PALACE-2 and PALACE-3 trials. Last year, Celgene reported that apremilast met the primary endpoint of ACR20 response rate vs. placebo in each of the three trials, which enrolled patients with active psoriatic arthritis who had an inadequate response to oral DMARDs. Celgene could not be reached for details, including whether they plan to submit the data to FDA (see BioCentury Extra, Sept. 6, 2012). ...