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March 2, 2013
16:09 EDTCELGCelgene presents results from 1st phase III study in psoriasis ESTEEM 1
Celgene International Sŕrl, a subsidiary of Celgene 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. 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 in patients with moderate-to-severe chronic plaque psoriasis. Statistical significance at week 16 was also demonstrated in the major secondary endpoint, Static Physician Global Assessment (sPGA) of clear or almost clear (P<0.0001), and other key secondary endpoints (change in BSA, Pruritus VAS, DLQI), as well as in assessments of difficult to treat areas (nail and scalp psoriasis). An NDA submission to the U.S. Food and Drug Administration, based on the combined ESTEEM 1&2 studies for psoriasis, is expected in the second half of 2013. The Company previously announced it expects to file a separate NDA for psoriatic arthritis in the first quarter of 2013. A combined PsA/psoriasis MAA submission in Europe is also planned for the second half of 2013.
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