) recently announced results from a phase III study (PALACE 3:
n=495) on its pipeline candidate apremilast. The study evaluated
apremilast in patients suffering from psoriatic arthritis at 20
mg and 30 mg dosages (twice daily). Results were presented at the
annual meeting of the European Congress of Rheumatology held in
Results from the multi-center, double-blind, placebo-controlled,
parallel-group phase III study showed that treatment with
apremilast caused significant improvements in the symptoms of the
disease compared to placebo in psoriatic arthritis patients
across both dosage strengths.
We note that the primary endpoint of the study was the proportion
of patients who reached the criteria laid down by the American
College of Rheumatology of 20% improvement (ACR20) in disease
symptoms compared to baseline at week 16. Moreover, patients
undergoing apremilast therapy demonstrated improvement across key
secondary objectives of the phase III study.
Besides the PALACE 3 study, the PALACE program also consists of
three more phase III studies (PALACE 1, PALACE 2 and PALACE 4) on
apremilast in the psoriatic arthritis indication. At the EULAR,
Celgene also presented results after an analysis of pooled safety
data from the PALACE 1, 2 and 3 studies.
Earlier this year, Celgene made 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
We note that apart from psoriatic arthritis, apremilast is also
being developed for other indications including psoriasis.
Celgene intends to seek US approval for the psoriasis indication
in the latter half of the year. European approval for apremilast
in the psoriasis and psoriatic arthritis indications (combined)
is expected to be sought in the second half of 2013. Apremilast,
on approval, would compete with drugs such as
) Enbrel in the market for inflammatory diseases.
Celgene carries a Zacks Rank # 3(Hold). Companies such as
Biogen Idec Inc.
), appear to be favorably placed with a Zacks Rank #1 (Strong
AMGEN INC (AMGN): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
To read this article on Zacks.com click here.