Recently, Celgene Corporation (CELG) 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 psoriasis indication.
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 biologic therapy.
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 Array Biopharma (ARRY), Celldex Therapeutics, Inc. (CLDX) and Kythera Biopharmaceuticals, Inc. (KYTH) are comparatively well placed and carry a Zacks Rank #2 (Buy).
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