Study met primary objective using 20 mg of apremilast twice per day with superior ACR20 of 43.5% (p<0.0001) compared to placebo (11.8%) after 12 weeks of oral treatment

Impressive safety and tolerability profile

Efficacy and adverse event profile supports initiation of pivotal phase III studies in the first half of 2010

Celgene Corporation (NASDAQ: CELG) announced the preliminary results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast - a novel, orally available small molecule that exhibits anti- inflammatory activities through the suppression of multiple pro-inflammatory mediators and cytokines - in adult patients with psoriatic arthritis (CC-10004-PSA-001). The study met its primary objective of assessment of ACR20 at 12 weeks. ACR20 is defined as the percentage of patients achieving a 20% or better improvement according to the American College of Rheumatology (ACR) criteria. ACR20 is the primary assessment utilized by the U.S. Food and Drug Administration for assessment of efficacy in psoriatic arthritis, as well as rheumatoid arthritis.

The study sought to determine the efficacy and safety of apremilast in 204 patients at two different dose regimens - 20mg twice per day and 40mg once per day - compared to placebo after 12 weeks. In the study, both apremilast treatment arms had a significant improvement in their ACR20 outcome versus placebo: 43.5% of patients in the 20 mg twice daily arm and 35.8% of patients in the 40 mg once daily arm achieved an ACR20 compared to 11.8% of patients in the placebo arm.

In addition, the study measured secondary 12-week endpoints including ACR50 and ACR70, defined as the percentage of patients achieving 50% and 70% improvements respectively according to ACR criteria. These measures are utilized to demonstrate clinical benefit for patients in addition to the primary regulatory measure of ACR20. The 12-week ACR50 was 17.4% in the 20mg twice daily arm, 13.4% in the 40 mg once daily arm, and 2.9% in the placebo arm. The 12-week ACR70 was 5.8% in the 20 mg twice daily arm, 7.5% in the 40 mg once daily arm, and 1.5% in the placebo arm.

The five most common adverse events reported in the study were nausea, diarrhea, headache, nasopharyngitis and fatigue. Additionally, there was not a significant difference in infections between apremilast and placebo.