) recently announced positive top-line results on its candidate
apremilast from a phase III study (PALACE-1: n~500), which is
evaluating 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
Top-line results from the randomized, placebo-controlled, pivotal
study revealed that patients treated with apremilast achieved the
primary endpoint defined by the American College of Rheumatology
criteria for 20% improvement (ACR20) compared to baseline at week
Top-line data also revealed that treatment with apremilast
resulted in significant improvements in arthritis-related endpoints
(including ACR50 and ACR70) through week 24 across the evaluated
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Moreover, apremilast also resulted in improvements in various
measures of physical function. 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.
We note that apart from the PALACE-1 study, the PALACE program
consists of two more phase III studies (PALACE 2 and PALACE 3).
Celgene intends to present top-line data from both studies in the
third quarter of 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. Data from two ongoing phase III
studies (ESTEEM 1 and 2) evaluating apremilast in patients
suffering from moderate-to-severe psoriasis are expected by year
end. Celgene intends to seek US approval for apremilast in the
psoriasis indication in the second half of 2013.
European approval is expected to be sought in the second half of
2013. Other indications for which apremilast is being studied
include rheumatoid arthritis and ankylosing spondylitis. Successful
development of apremilast would boost the stock. Apremilast, on
approval, would compete with drugs such as
) Enbrel in the market for inflammatory diseases.
We currently have a Neutral recommendation on Celgene. The stock
carries a Zacks #3 Rank (Hold rating) in the short-run.