) 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.
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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.
Jazz Pharmaceuticals Public Limited Company
) appear to be more favorably placed. All three companies carry a
Zacks Rank #1 (Strong Buy).