BUILDING FOR SUCCESS
Celgene Corporation is delivering the promise of science to patients and their families facing extraordinary challenges with cancer and inflammatory disease through innovative next generation therapies. Driving profitability are marketed products, which include THALOMID (thalidomide), ALKERAN (melphalan), Focalin™, cellular and tissue therapeutics, as well as the Ritalin family of drugs.
Celgene, as a leader in global biotechnology, has built a meaningfully integrated discovery, development and commercialization platform for drug and cell-based therapies that enables the company to continue to develop value within its therapeutic franchise areas of cancer and inflammatory diseases. This target-to-therapeutic platform integrates both small molecule and cell-based therapies and spans the critical functions required to generate a large and diverse pipeline of innovative next generation drugs and cell therapies that address the source of the disease and not just the symptoms.
RECENT PIPELINE HIGHLIGHTS
REVIMID: In February 2003 and April 2003, REVIMID received fast track designation from the FDA for the treatment of multiple myeloma and myelodysplastic syndromes, respectively. REVIMID is currently being tested in two pivotal Phase III FDA SPA trials for the treatment of multiple myeloma and metastatic melanoma. Furthermore, in May, at the International Myelodysplastic Syndromes meeting in Paris, France, REVIMID was the highlight of a study demonstrating medically meaningful erythroid and cytogenic response in MDS patients. That study, initiated by Dr. Alan List of the Moffitt Cancer Center, Tampa Florida, provided the foundation for Celgene to accelerate the potential approval of REVIMID by initiating four Phase II clinical trials; two multicenter Phase II studies in red blood cell transfusion dependent subjects with MDS with or without an associated 5Q minus cytogenetic abnormality and one phase II study in multiple myeloma.
THALOMID: Clinical investigators from leading cancer research centers around the world presented clinical data on THALOMID (thalidomide) in a broad range of hematological malignancies and solid tumor cancers at the Ninth Multiple Myeloma Workshop in Salamanca, Spain and at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, respectively. Several highlighted presentations provided new information on the potential of THALOMID across all stages of multiple myeloma as well as a wide range of solid tumor cancers, including renal cell carcinoma, prostate cancer and malignant melanoma.
ACTIMID™: Our next high-potential orally administered IMiD, is being evaluated in a Phase I/II clinical trial in refractory multiple myeloma and Phase II clinical trial in Prostate cancer. Interim data from an ongoing Phase I/II trial of ACTIMID in 18 relapsed and refractory multiple myeloma patients indicates that ACTIMID has anti-tumor activity in multiple myeloma and has an acceptable toxicity profile.
John W. Jackson - Executive Chairman
Sol J. Barer - Chief Executive Officer
Robert J. Hugin - President and Chief Operating Officer