Celgene Corporation (CELG - Free Report) recently announced results from a phase III study (PALACE 3: n=495) on its pipeline candidate apremilast. The study evaluated apremilast in patients suffering from psoriatic arthritis at 20 mg and 30 mg dosages (twice daily). Results were presented at the annual meeting of the European Congress of Rheumatology held in Spain.
Results from the multi-center, double-blind, placebo-controlled, parallel-group phase III study showed that treatment with apremilast caused significant improvements in the symptoms of the disease compared to placebo in psoriatic arthritis patients across both dosage strengths.
We note that the primary endpoint of the study was the proportion of patients who reached the criteria laid down by the American College of Rheumatology of 20% improvement (ACR20) in disease symptoms compared to baseline at week 16. Moreover, patients undergoing apremilast therapy demonstrated improvement across key secondary objectives of the phase III study.
Besides the PALACE 3 study, the PALACE program also consists of three more phase III studies (PALACE 1, PALACE 2 and PALACE 4) on apremilast in the psoriatic arthritis indication. At the EULAR, Celgene also presented results after an analysis of pooled safety data from the PALACE 1, 2 and 3 studies.
Earlier this year, Celgene made regulatory submissions for the approval of apremilast (psoriatic arthritis) in the US and Canada, based on the positive results from PALACE 1, 2 and 3 studies.
We note that apart from psoriatic arthritis, apremilast is also being developed for other indications including psoriasis. Celgene intends to seek US approval for the psoriasis indication in the latter half of the year. European approval for apremilast in the psoriasis and psoriatic arthritis indications (combined) is expected to be sought in the second half of 2013. Apremilast, on approval, would compete with drugs such as Amgen Inc./ Pfizer Inc.’s (AMGN - Free Report) /(PFE - Free Report) Enbrel in the market for inflammatory diseases.
Celgene carries a Zacks Rank # 3(Hold). Companies such as Biogen Idec Inc. (BIIB - Free Report) , appear to be favorably placed with a Zacks Rank #1 (Strong Buy).