Celgene Announces New Data for OTEZLA® (Apremilast) Will Be Presented at European Academy of Dermatology and Venereology Congress

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation

, today announced that the latest research on Otezla® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), will be presented at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015. Nine abstracts (one oral presentation and eight e-posters) evaluating the use of OTEZLA in plaque psoriasis and pre-clinical data in atopic dermatitis will be presented at the meeting. Data to be presented include pre-specified analyses of the LIBERATE study assessing the impact of either oral OTEZLA 30 mg twice daily or weekly subcutaneous (SC) etanercept 50 mg, each compared with placebo, on changes in patient-reported pruritus (itching) and health-related quality of life through 32 weeks of treatment in patients with moderate to severe plaque psoriasis. Efficacy and safety results from the LIBERATE study were previously presented at this year's Annual Meeting of the American Academy of Dermatology in San Francisco, California. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept. A retrospective analysis of results from the ESTEEM 1 trial will examine the potential of an alternate tool to measure psoriasis disease severity, particularly in patients with moderate psoriasis. This composite tool, called Physician's Global Assessment and Body Surface Area (PGAxBSA), will be compared with the Psoriasis Area and Severity Index (PASI) in its ability to measure the effect of treatment with OTEZLA in patients with plaque psoriasis. Improvement in PASI scores is a measurement typically used in registrational trials to examine the effectiveness of plaque psoriasis treatments. Results from pre-clinical studies assessing the potential of apremilast, the active ingredient in OTEZLA, as a treatment for atopic dermatitis will also be presented. The data will evaluate the effect of apremilast on gene expression in human epidermal keratinocytes (skin cells) that have been stimulated by T helper 2 (Th2) and Th17 cytokines – proteins thought to be associated with skin inflammation. The impact of apremilast treatment on gene expression and skin symptoms in two mouse models of dermatitis will also be investigated. A phase II trial of apremilast in moderate to severe atopic dermatitis is ongoing. "New data to be presented at EADV will not only further evaluate OTEZLA's clinical benefit in plaque psoriasis, but also highlight our ongoing commitment to uncovering the potential of OTEZLA in other immune-related dermatologic diseases, such as atopic dermatitis," said Scott Smith, President, Celgene Inflammation & Immunology. "Furthermore, we are eager to assess the use of alternative endpoints in patients with moderate plaque psoriasis, for which PASI may be a less sensitive measure." The following abstracts will be presented at EADV as an exchange of scientific and clinical information (all times, CEST): Abstracts at a Glance Oral Presentation FC08.05; Saturday October 10, 2015, 3:36 - 3:45 PM Apremilast Regulates Human Keratinocyte Gene Expression in Vitro and Reduces Antigen-driven Dermatitis in Vivo; Mary Adams Location: B3M1-4 Poster Number 1652 Metabolic and Weight Changes with Apremilast in Patients with Psoriasis: Pooled Laboratory Analysis of the Phase 3 ESTEEM 1 and 2 Trials; April Armstrong, MD Location: e-Poster area Poster Number P1653 Efficacy of Apremilast or Etanercept Compared with Placebo in Patients with Moderate to Severe Psoriasis: Results From the LIBERATE Study; Jennifer Soung, MD Location: e-Poster area Poster Number P1655 Evaluation of the Physician's Global Assessment and Body Surface Area Composite Tool for Assessing Psoriasis Response to Apremilast Therapy: Results from the ESTEEM 1 Study; Kristina Callis Duffin, MD Location: e-Poster area Poster Number 1656 Analysis of Psoriasis Area and Severity Index and Weight Change During Long-term Treatment with Apremilast in Patients with Moderate to Severe Plaque Psoriasis (ESTEEM 1); Kristian Reich, MD Location: e-Poster area Poster Number P1658 Safety of Apremilast and Etanercept Compared with Placebo in Patients with Moderate to Severe Psoriasis: Results From the LIBERATE Study; Melinda Gooderham, MD Location: e-Poster area Poster Number P1668 Impact of Apremilast or Etanercept on Pruritus and Health-Related Quality of Life in Patients with Moderate to Severe Psoriasis: Results From the LIBERATE Study; Kim Papp, MD Location: e-Poster area Poster Number P1706 Cost per Responder of Apremilast Versus Etanercept in Patients with Moderate to Severe Psoriasis Using Results From LIBERATE; Tom Tencer, MD Location: e-Poster area Poster Number P1771 Effect of Apremilast and Etanercept on Patient-Reported Outcomes in Patients with Moderate to Severe Plaque Psoriasis in the LIBERATE Study; Melinda Gooderham, MD Location: e-Poster area The views expressed and the techniques presented by the speakers at the 24th EADV Congress in Copenhagen, Denmark are not necessarily shared or endorsed by the European Academy of Dermatology and Venereology. About ESTEEM ESTEEM 1 and 2 are two large pivotal phase III randomized, placebo-controlled studies evaluating OTEZLA in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. Approximately 1,250 patients were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo patients were switched to OTEZLA 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial OTEZLA randomization and Psoriasis Area and Severity Index (PASI)-75 response (ESTEEM 1) or (PASI)-50 (ESTEEM2).