AML. THALOMID (thalidomide): THALOMID, sold as THALOMID or Thalidomide Celgene outside of the United States, is administered orally for the treatment of patients with various indications, such as multiple myeloma and erythema nodosum leprosum. ISTODAX (romidepsin): ISTODAX is administered by intravenous infusion for the treatment of patients with the diseases (such as cutaneous T-cell lymphoma and peripheral T-cell lymphoma) and has received orphan drug designation for the treatment of non-Hodgkin’s T-cell lymphomas, including cutaneous T-cell lymphoma and peripheral T-cell lymphoma. REVLIMID, POMALYST, and THALOMID are distributed in the United States primarily through contracted pharmacies under the REVLIMID Risk Evaluation and Mitigation Strategy (REMS), POMALYST REMS and THALOMID REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of REVLIMID, POMALYST, and THALOMID. Internationally, REVLIMID, THALOMID/Thalidomide Celgene and IMNOVID are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the product’s safe and appropriate distribution and use. VIDAZA, ABRAXANE, ISTODAX and OTEZLA are distributed through the more traditional pharmaceutical industry supply chain and are not subject to the same risk-management distribution programs as REVLIMID, POMALYST/IMNOVID and THALOMID/Thalidomide Celgene. Preclinical and Clinical-Stage Pipeline The company’s preclinical and clinical-stage pipeline of new drug candidates and cell therapies is highlighted by multiple classes of both small molecule and biologic therapeutic agents designed to selectively regulate disease-associated genes and proteins. These product candidates are at various stages of preclinical and clinical development. Immune-Inflammatory Diseases: OTEZLA (apremilast) a novel PDE4 inhibitor, is being studied in clinical trials in ankylosing spondylitis, Behçet's disease, atopic dermatitis, and ulcerative colitis, and is approved in psoriasis and psoriatic arthritis. Differentiated oral therapies are advancing through mid to late stage trials in inflammatory diseases, including GED-0301, a potential smad7 anti-sense treatment, with a phase III program in CD underway, and a phase II trial in UC initiated. In addition, ozanimod is a potential S1P receptor modulator, with a phase III trial in UC underway, and a phase II trial in CD initiated. Other oral therapies include, for rheumatology, OTEZLA, CC-220, and CC-292; for dermatology, OTEZLA; and for neuro-inflammation and MS, ozanimod and ABX-1431. Sotatercept (ACE-011) and luspatercept (ACE-536): The company has collaborated with Acceleron Pharma, Inc. to develop sotatercept and luspatercept. A phase II trial is in progress to evaluate the use of sotatercept in the treatment of patients with chronic kidney disease and phase III and phase II trials, respectively are evaluating luspatercept in the treatment of patients with beta-thalassemia and MDS. Epigenetics: The company markets two epigenetic modifiers, VIDAZA and ISTODAX. The company has two phase III trials of CC-486 enrolling to evaluate CC-486 in the treatment of MDS and AML and two on-going phase II trials of CC-486 in solid tumors. The company acquired the IDH2 inhibitor (AG-221/CC-90007) from Agios Pharmaceuticals, Inc. (Agios) and is evaluating its activity in a phase III trial in AML. The company is also evaluating AG-120 (IDH1 inhibitor) and AG-881 (IDH1 and IDH2 inhibitor) in AML and solid tumors, in partnership with Agios. Protein Homeostasis: CC-122 (a PPM Pleiotropic Pathway Modifier) and CC-220 represent novel compounds that are in phase I and phase II clinical trials, both as single agents and in combination, for hematological and solid tumor cancers and inflammation and immunology diseases. Immuno-Oncology: The strategic collaboration with Astra Zeneca/ MedImmune Limited has provided the company with the opportunity to evaluate durvalumab, an anti-PDL-1 antibody, in hematological cancers in combination with REVLIMID, POMA
(CELG:Consolidated Issue Listed on NASDAQ Global Select )
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