The phase II trial (BCT-001) in patients with Behçet’s disease achieved its primary endpoint of demonstrating a statistically significant improvement in the number of oral ulcers at day 85 between apremilast and placebo. Behçet’s disease is a rare chronic inflammatory disorder with high unmet medical need that is characterized by recurrent oral and genital ulcers. We are currently reviewing future regulatory and clinical strategies in light of these data.
Results from the phase III ESTEEM program (ESTEEM 1 and 2) in moderate-to-severe psoriasis are expected by year-end and early 2013.
We plan to submit a NDA for PsA in the first quarter of 2013 followed by a sNDA for moderate-to-severe psoriasis in the second half of 2013 pending positive results from the ESTEEM program. A combined Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) for PsA and moderate-to-severe psoriasis is planned for the second half of 2013.
Third Quarter 2012 Conference Call and Webcast InformationWe are hosting a conference call to discuss the third quarter 2012 operating and financial performance on Thursday, October 25, 2012, at 9:00 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon October 25, 2012, until midnight ET November 1, 2012. To access the replay, in the U.S. dial 800-585-8367; international dial 404-537-3406; and Participant Passcode 38153623. Our fourth quarter 2012 financial and operational results are expected to be reported in late January 2013. About REVLIMID In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy. REVLIMID is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.