Celege 2016 Exp. Operational Milestones

Regulatory Submissions/Decisions

Submission for REVLIMID® as maintenance after stem-cell transplant in newly diagnosed multiple myeloma (NDMM) in the U.S. and Europe
Submission of renal impairment data for label update for POMALYST®/IMNOVID® in relapsed/refractory multiple myeloma (RRMM) in the U.S. and Europe
Submission of ABRAXANE® for early-stage breast cancer in Europe
Decision by the Committee for Medicinal Products for Human Use (CHMP) on the submission of REVLIMID® for relapsed/refractory mantle cell lymphoma in Europe
Clinical Data

Data from the phase III REMARC trial with REVLIMID® as maintenance in diffuse large B-cell lymphoma (DLBCL)
Data from the phase III cooperative group ETNA trial with ABRAXANE® as neoadjuvant therapy in HER2-negative high-risk breast cancer
Data from the CLL-002 CONTINUUM® trial with REVLIMID® as maintenance in relapsed/refractory chronic lymphocytic leukemia (CLL)
Data from a phase II trial with CC-122 in non-Hodgkin’s lymphoma (NHL)
Data from phase II trials with motolimod (VTX-2337) in squamous cell carcinoma of the head and neck and ovarian cancer in collaboration with partner VentiRx
Data from the phase II tnAcity® trial with ABRAXANE® in triple-negative breast cancer
Trial Enrollment

Complete enrollment in the phase III AUGMENT® trial with REVLIMID® in relapsed/refractory follicular lymphoma
Complete enrollment in the phase III apact® (PANC-003) trial with ABRAXANE® as adjuvant therapy in surgically resected pancreatic cancer
Complete enrollment in a phase II trial with CC-486 in combination with pembrolizumab in locally advanced or metastatic non-small cell lung cancer
Trial Initiations

Initiate enrollment in a phase I trial of B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy in RRMM in collaboration with partner bluebird bio
Initiate enrollment in six trials in the FUSIONTM program with durvalumab in NDMM, RRMM, NHL, myelodysplastic syndromes and acute myeloid leukemia with partner AstraZeneca/MedImmune
Initiate phase II combination studies with AG-221 and AG-120 in frontline AML in collaboration with partner Agios
I&I

Regulatory Submissions/Decisions

Submission of OTEZLA® for psoriasis in Japan
Clinical Data

Long-term radiographic data from the POSTURE® (AS-001) trial with OTEZLA® in ankylosing spondylitis
Data from the phase III PSA-006 trial with OTEZLA® in patients with active psoriatic arthritis who are biologic-naïve
Data from the phase III PSOR-011 trial with OTEZLA® in Japanese patients with psoriasis
Data from a pharmacokinetic comparability study to support registration of the OTEZLA® once-daily formulation
Data from a phase II trial with OTEZLA® in atopic dermatitis
Data from a phase II trial with CC-220 in systemic lupus erythematosus
Data from a phase II trial with RPC-4046 in eosinophilic esophagitis
Trial Enrollment

Complete enrollment in the phase III RELIEFTM (BCT-002) trial with OTEZLA® in active Behçet's disease
Complete enrollment in a phase II trial with OTEZLA® in ulcerative colitis
Complete enrollment in the phase II STEPSTONE trial with ozanimod in Crohn’s disease
Research and Early Development

File eight Investigational New Drug (IND) applications
Advance at least two compounds to mid-to-late stage development