Celgene Corporation (CELG - Free Report) recently announced positive results from the PALACE 4 study on apremilast. The study is evaluating apremilast (20 mg and 30 mg), a novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), in patients suffering from psoriatic arthritis.
Results from the phase III study showed that apremilast achieved statistical significance for ACR 20 at week 16 in psoriatic arthritis patients across both dosage strengths. Results also revealed that the candidate showed benefit over placebo in other secondary objectives of the study. We note that the 52-week PALACE 4 study is currently underway.
Besides the PALACE 4 study, the PALACE program also consists of three more phase III studies (PALACE 1, PALACE 2 and PALACE 3) on apremilast in the psoriatic arthritis indication. We remind investors that Celgene presented encouraging data from the PALACE-2 and PALACE-3 studies in Sep 2012 and from the PALACE 1 study in Nov 2012. Top-line results from PALACE 3 study and 52-week results from PALACE 1 study are expected in June this year.
Earlier this year, Celgene submitted 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 the treatment of psoriasis, ankylosing spondylitis, and Behçet’s disease.
Celgene intends to seek US approval for the psoriasis indication in the latter half of the year. European approval of psoriatic arthritis and psoriasis indications is expected to be sought in the second half of the year on a combined basis.
Celgene, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Other biopharma stocks, such as Athersys Inc. (ATHX - Free Report) , XOMA Corporation (XOMA - Free Report) and Santarus, Inc. are comparatively well placed and carry a Zacks Rank #1 (Strong Buy).