Celgene Corporation (CELG) announced recently that its pipeline candidate apremilast (30 mg, twice daily) has fared well in a phase II study (BCT-001). The study evaluated apremilast in patients suffering from Behçet’s disease, a chronic inflammatory disorder. The disease, whose cause is not known, often leads to ulcers in the mouth and genitals. Celgene presented encouraging results at the annual meeting of the European Congress of Rheumatology held in Spain.
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. Successful development and subsequent commercialization of apremilast for this rare (orphan) disease would be highly appreciated by the patients since the disease currently has no approved therapies in the US or Europe. Celgene is currently evaluating opportunities to seek approval of apremilast in the Behçet’s disease indication in multiple countries.
Celgene is also developing apremilast for other indications including psoriatic arthritis, and psoriasis. The company recently presented encouraging data on the candidate in the psoriatic arthritis indication. Earlier this year, Celgene made regulatory submissions for the approval of apremilast (psoriatic arthritis) in the US and Canada. Approvals of apremilast in the US and Canada for the psoriasis indication are expected to be sought in the latter half of the year. Moreover, the biopharmaceutical company intends to seek European approval for apremilast for the psoriatic arthritis and psoriasis indications on a combined basis in the second half of the year.
Celgene carries a Zacks Rank #3 (Hold). Stocks such as Biogen Idec Inc. (BIIB), Jazz Pharmaceuticals Public Limited Company (JAZZ) and Santarus, Inc. (SNTS) appear to be more favorably placed. All three companies carry a Zacks Rank #1 (Strong Buy).
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