Celgene phase 3 – Oral Apremilast Achieves Statistical Significance for the Primary Endpoint of PASI-75 in the First Phase III Study in Patients with Psoriasis

New Drug Approvals

APREMILAST, N-{2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide

mar02,2013

Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today presented the results from ESTEEM 1, the Company’s first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida.

“I see this as a prime candidate for future management of psoriasis that allows us to treat a range of patients, including more moderate cases earlier on”

The company previously announced statistical significance for the primary and major secondary endpoint of PASI-75 at Week 16 and the Static Physician Global Assessment for patients receiving apremilast in the ESTEEM 1&2 phase III studies. ESTEEM 1&2 are the phase III registrational randomized, placebo-controlled studies evaluating the Company’s oral small-molecule inhibitor of phosphodiesterase-4 (PDE4) in patients with moderate-to-severe chronic plaque psoriasis.

ESTEEM 1, presented today, evaluated efficacy and safety in a range of patients. Approximately one-third of the study…

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PHARMA PROFESSIONAL, ITALY
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