) announced positive results on its candidate apremilast from a
phase III study (ESTEEM 1), which evaluated patients suffering
from moderate-to-severe chronic plaque psoriasis. The data was
presented at the annual meeting of the American academy of
dermatology. ESTEEM 1 is Celgene's first phase III study in the
The study evaluated efficacy and safety of the candidate in a
range of psoriasis patients. Approximately 33 % of the study
population was systemic and/or phototherapy treatment-naïve.
Almost 30% of the overall study population had undergone prior
Data from the study revealed that approximately 33.1% patients in
the apremilast arm demonstrated a 75% reduction in their PASI
(psoriasis area and severity index) score at week 16 as opposed
to only 5.3% in the placebo arm. Moreover, the candidate was well
tolerated in the study and was found to be safe
Celgene intends to seek US approval for apremilast in the
psoriasis indication in the second half of 2013. The company is
also evaluating apremilast in patients suffering from psoriatic
arthritis. It intends to seek US approval for apremilast in the
psoriatic arthritis indication shortly.
European approval for apremilast in the psoriasis and psoriatic
arthritis indications (combined) is expected to be sought in the
second half of 2013. The candidate is also undergoing phase III
studies in the ankylosing spondylitis indication. The data is
expected in 2014.
Celgene, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma stocks, such as
Celldex Therapeutics, Inc.
Kythera Biopharmaceuticals, Inc.
) are comparatively well placed and carry a Zacks Rank #2
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