Celgene Corporation (CELG) presented data from a phase II trial (BCT-001) evaluating apremilast in patients suffering from Behçet’s disease at the 2013 American College of Rheumatology (:ACR)/Association of Rheumatology Health Professionals (:ARHP) annual meeting.
Celgene had earlier presented results from the BCT-001 trial at the European League Against Rheumatism annual meeting in June 2013. Celgene announced that apremilast was successful in achieving the primary endpoint (the mean number of oral ulcers at week 12) as well as secondary endpoints of the multi-center, randomized, placebo-controlled, double-blind, parallel-group study. At week 12, approximately 71% patients receiving apremilast achieved a complete response as compared 29% in the placebo arm.
The company is currently evaluating opportunities to get apremilast approved in the Behçet’s disease indication in multiple countries.
Celgene is also developing apremilast for other indications including psoriatic arthritis and psoriasis. Celgene is seeking U.S. approval for apremilast in the psoriatic arthritis indication and submitted a marketing application for the same in the first quarter of 2013. Approval has also been sought for the same indication in Canada (second quarter of 2013). Celgene also has plans to seek U.S. Food and Drug Administration (:FDA) approval for the psoriasis indication by Dec 31, 2013. Moreover, Celgene intends to seek EU approval for apremilast in the combined psoriasis and psoriatic arthritis indication by year end.
At the ACR/ARHP 2013 meeting, the company also presented encouraging data from three long-term (52-week) phase III studies (PALACE 1, 2 and 3) evaluating apremilast for psoriatic arthritis. Apremilast was found to be safe in all three phase III studies. The pooled data from these studies suggested that the reduction in the number of swollen and tender joints observed at the end of 16 weeks was maintained at 52 weeks. The median percent reduction in swollen joint and tender joint counts reached up to 87.5% and 70.0%, respectively.
Apremilast is also undergoing phase III studies in the ankylosing spondylitis indication. Celgene is focused on advancing the development of early-stage candidates in its pipeline. We believe that the successful development and commercialization of the pipeline would boost Celgene’s top line further.
Celgene currently carries a Zacks Rank #3 (Hold). Companies such as Roche (RHHBY), Isis Pharmaceuticals, Inc. (ISIS) and Actelion Ltd. (ALIOF) appear to be more attractive, each with a Zacks Rank #1 (Strong Buy).