) announced encouraging data from two phase III studies (PALACE-2,
PALACE-3), which evaluated its candidate apremilast in patients
suffering from psoriatic arthritis at 20 mg and 30 mg
The encouraging pipeline-related news had a positive impact on
Celgene's stock price. Psoriatic arthritis refers to a painful,
chronic inflammatory disease, associated with psoriasis (a
The randomized, placebo-controlled studies are evaluating patients
suffering from psoriatic arthritis, who had a history of failed
treatment by oral disease-modifying antirheumatic drugs (DMARDs)
and/or an anti-tumor necrosis factor (TNF) agent. The patients were
treated with apremilast either as a monotherapy or in conjunction
with other antirheumatic therapies. We note that positive results
from the other phase III study (PALACE-1) of the program were
disclosed by Celgene in July 2012.
Results from all three studies revealed that treatment with
apremilast resulted in improvements in various measures of physical
function through week 24. Furthermore, treatment with the candidate
was found to be safe. Celgene stated that the extension phase of
the study will remain blinded until all patients have completed
week 52. Celgene intends to present complete data from the studies
at appropriate medical conferences.
Celgene intends to seek US approval for apremilast in the psoriatic
arthritis indication based on data from the PALACE program in the
first half of 2013. Celgene is also evaluating apremilast in
patients suffering from moderate-to-severe psoriasis.
Celgene intends to seek EU approval for apremilast in the
psoriasis and psoriatic arthritis indications in the second half of
2013. Apremilast, on approval, would compete with drugs such as
) Enbrel in the market for inflammatory diseases.
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Moreover, Celgene also presented positive data from a phase II
study, which evaluated apremilast as a treatment for Behcet's
disease. Celgene intends to submit marketing applications for
apremilast in Behcet's disease, a rare inflammatory disorder, in
We currently have a Neutral recommendation on Celgene. The stock
carries a Zacks #3 Rank (Hold rating) in the short-run.