) recently announced encouraging results on its candidate
apremilast from a phase III study (PALACE-1: n~500), which
evaluated patients suffering from psoriatic arthritis at 20 mg
and 30 mg dosages. We note that psoriatic arthritis refers to a
painful, chronic inflammatory disease, associated with psoriasis
(a skin-related disorder). Results were presented at the annual
conference of the American College of Rheumatology (ACR).
Data from the randomized, placebo-controlled, multi-center
study revealed that patients treated with apremilast achieved
statistically significant and higher ACR20 responses at week 16
compared to those in the placebo arm
We note that apart from the PALACE-1 study, the PALACE program
consists of two more phase III studies (PALACE 2 and PALACE 3).
We remind investors that Celgene presented encouraging data from
the PALACE-2 and PALACE-3 studies in September 2012.
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, US approval is expected to be sought in the second
half of 2013.
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
) Enbrel in the market for inflammatory diseases. Moreover,
Celgene is also evaluating apremilast as a treatment for Behcet's
We currently have a Neutral recommendation on Celgene. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
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