Apremilast Meets Endpoints in Phase 3 Psoriasis Trials

Celgene International Sàrl, a subsidiary of Celgene Corporation, announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 Phase 3 studies. ESTEEM 1 & 2 are the two pivotal Phase 3 randomized, placebo-controlled studies evaluating apremilast, the company's oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with moderate to severe chronic plaque psoriasis. Patients on apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment. An NDA submission for psoriasis, based on ESTEEM 1 & 2 data, is expected in the second half of 2013. The company previously announced it expects to file an NDA for psoriatic arthritis in the first quarter of 2013 and a combined MAA for psoriasis and psoriatic arthritis in Europe in the second half of the year. To date, the five positive Phase 3 studies from the ESTEEM and PALACE programs represent the most comprehensive clinical data for submission for patients with psoriatic disease. Clinical data from ESTEEM 1 & 2 are planned for presentation at upcoming major medical meetings.