New Long-Term Apremilast Data to Be Presented at American College of Rheumatology Annual Meeting New analyses of PALACE clinical trial program assess long-term efficacy and safety profiles of apremilast for the treatment of psoriatic arthritis Phase II trial results evaluate apremilast in Behçet’s disease—a rare disease with limited therapies in the U.S. or Europe Business Wire BOUDRY, Switzerland -- September 26, 2013 Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the latest research findings on apremilast, the Company’s novel, oral small-molecule selective inhibitor of phosphodiesterase 4 (PDE4), will be presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego, October 25-31. Data to be presented include long-term (52-week) results from two Phase III investigational trials evaluating the treatment with apremilast for patients with psoriatic arthritis (PALACE 2) and in patients with psoriatic arthritis with skin involvement (PALACE 3). Additional analyses from the PALACE program will be presented demonstrating the effect of apremilast treatment on the signs and symptoms characteristic of psoriatic arthritis, including swollen joints, painful/tender joints, enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (inflammatory swelling of a finger or toe) and impairments of physical function. Scheduled presentations will include long-term safety findings from three PALACE trials. Results will also be presented from BCT-001, a Phase II trial evaluating apremilast in patients with Behçet’s Disease with active oral ulcers. No therapies have been approved in the U.S. or in Europe to treat this rare, chronic inflammatory disorder of unknown cause. The approved treatment options depend largely on the manifestations of the different organ systems involved. “There is a clear need for new treatment options for both psoriatic arthritis and Behçet’s disease, and the apremilast data being presented at the upcoming ACR meeting reinforces Celgene’s commitment to the development of options for people living with these diseases,” said Peter Callegari, M.D., Global Medical Affairs Vice President of Inflammation and Immunology for Celgene Corporation. “We are pleased by the continued success of the clinical development program for apremilast in both more common inflammatory as well as orphan diseases.” The following abstracts on apremilast will be presented in oral and/or poster sessions as an exchange of scientific and clinical information by clinical investigators (all times, PDT): Plenary Presentation Abstract 761; Oral; Sunday, October 27, 11:15 AM Location: Hall B1 Apremilast for the Treatment of Behçet’s Syndrome: A Phase II Randomized, Placebo-Controlled, Double-Blind Study; Hatemi, et al. Oral Presentations Abstract 815; Sunday, October 27; 2:45 PM Location: Room 33A Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis (PALACE 2); Cutolo, et al. Abstract 816; Oral; Sunday, October 27, 3:00 PM Location: Room 33 A Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results From Three Phase 3, Randomized, Controlled Trials; Gladman, et al. Posters Abstract 311; Sunday, October 27, 8:30 AM - 4:00 PM Location: Exhibit Hall B2-C-D Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis and Current Skin Involvement (PALACE 3); Edwards, et al. Abstract 310; Sunday, October 27, 2013, 8:30 AM - 4:00 PM Location: Exhibit Hall B2-C-D Long-term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials; Mease, et al. Abstract 317; Sunday, October 27, 2013, 8:30 AM - 4:00 PM Location: Exhibit Hall B2-C-D Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvement in Tender and Swollen Joint Counts in Patients with Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled Trials; Cutolo, et al. Abstract 331; Sunday, October 27, 2013, 8:30 AM - 4:00 PM Location: Exhibit Hall B2-C-D Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvement in Physical Function in Patients with Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled Trials; Schett, et al. Abstract 348; Sunday, October 27, 2013, 8:30 AM - 4:00 PM Location: Exhibit Hall B2-C-D Laboratory Abnormalities in Patients with Psoriatic Arthritis Receiving Apremilast, an Oral Phosphodiesterase 4 Inhibitor: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials; Mease, et al. About PALACE Program PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent extension in which all patients are treated with apremilast. The three PALACE studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed an anti-tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis. The primary endpoint of the PALACE 1, 2 3 and 4 studies is the proportion of patients in each treatment group who achieved the American College of Rheumatology criteria for 20 percent improvement (ACR20) compared to baseline at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at week 24. There is a subsequent extension in which all patients are treated with apremilast. In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks. Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission. 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. The NDA for psoriasis was submitted to health authorities in the US in the third quarter of 2013. The Company previously announced it expects to submit a separate NDS in Canada for psoriasis and a combined psoriatic arthritis/psoriasis MAA in Europe in the second half of 2013. 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 4-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 is 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 Apremilast Apremilast, an oral small-molecule specific inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates a network of pro-inflammatory and anti-inflammatory mediators. 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 Psoriatic Arthritis Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. More than a million people in the U.S. and Europe are diagnosed with this arthritic condition. Approximately 30 percent of people with psoriasis eventually develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn about psoriatic arthritis and the role of PDE4, go to www.discoverpsa.com and www.discoverpde4.com. 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 aneurysms and venous thrombosis, and inflammatory disease of the eye manifesting as uveitis. 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 complications, stroke, and even meningitis, which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. 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 our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission. 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New Long-Term Apremilast Data to Be Presented at American College of Rheumatology Annual Meeting
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