Limited therapies are available to treat this rare, chronic inflammatory disorder of unknown cause. The treatment options depend largely on the manifestations of the different organ systems involved. Treatment options recommended by physicians are largely aimed at alleviating specific patient symptoms and may include non-steroidal anti-inflammatory drug (NSAIDS), immunosuppressive medications and disease-modifying antirheumatic drugs (DMARDS) approved for other indications.These results are from investigational studies. Apremilast is not an approved product for any indication. The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, is on-track for the fourth quarter of 2013. The Company is currently exploring opportunities to submit for an indication in Behçet’s disease in a number of countries. About BCT-001 BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a four-week post-treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study was the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.
About ApremilastApremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10. About Behçet’s Disease Behçet’s disease is a chronic inflammatory vasculitis of unknown cause characterized by recurrent oral and genital ulcers, multiple skin lesions ranging from acne to vasculitic ulcerations, vascular involvement, including venous thrombosis and aneurysms which may be life threatening, and inflammatory disease of the eye manifesting as uveitis (may lead to blindness), neurologic involvement and gastrointestinal involvement. Prevalence of Behçet’s disease is highest in the Middle East, Asia and Japan, but it is classified as a rare or “orphan” disease by the NIH in the United States. At this time, there are limited therapies for this orphan indication in the United States or throughout Europe. In some cases, uncontrolled inflammation may lead to blindness, intestinal perforations, stroke, and even aneurismal bleeding which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. To learn more about the role of PDE4 in inflammatory diseases, visit www.discoverpde4.com. About Celgene Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. Forward-Looking Statements This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.