Positive Data on Celgene's Apremilast - Analyst Blog
May 09 2013 - 12:00PM
Zacks
Celgene
Corporation (CELG) recently announced positive results
from the PALACE 4 study on apremilast. The study is evaluating
apremilast (20 mg and 30 mg), a novel, oral small-molecule
inhibitor of phosphodiesterase 4 (PDE4), in patients suffering from
psoriatic arthritis.
Results from the phase III study
showed that apremilast achieved statistical significance for ACR 20
at week 16 in psoriatic arthritis patients across both dosage
strengths. Results also revealed that the candidate showed benefit
over placebo in other secondary objectives of the study. We note
that the 52-week PALACE 4 study is currently underway.
Besides the PALACE 4 study, the
PALACE program also consists of three more phase III studies
(PALACE 1, PALACE 2 and PALACE 3) on apremilast in the psoriatic
arthritis indication. We remind investors that Celgene presented
encouraging data from the PALACE-2 and PALACE-3 studies in Sep 2012
and from the PALACE 1 study in Nov 2012. Top-line results from
PALACE 3 study and 52-week results from PALACE 1 study are expected
in June this year.
Earlier this year, Celgene
submitted regulatory submissions for the approval of apremilast
(psoriatic arthritis) in the US and Canada, based on the positive
results from PALACE 1, 2 and 3 studies.
We note that apart from psoriatic
arthritis, apremilast is also being developed for the treatment of
psoriasis, ankylosing spondylitis, and Behçet’s disease.
Celgene intends to seek US approval
for the psoriasis indication in the latter half of the year.
European approval of psoriatic arthritis and psoriasis indications
is expected to be sought in the second half of the year on a
combined basis.
Celgene, a biopharmaceutical
company, currently carries a Zacks Rank #2 (Buy). Other biopharma
stocks, such as Athersys Inc. (ATHX), XOMA
Corporation (XOMA) and Santarus, Inc.
(SNTS) are comparatively well placed and carry a Zacks Rank #1
(Strong Buy).
ATHERSYS INC (ATHX): Free Stock Analysis Report
CELGENE CORP (CELG): Free Stock Analysis Report
SANTARUS INC (SNTS): Free Stock Analysis Report
XOMA CORP (XOMA): Free Stock Analysis Report
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