Data from Studies of Amrubicin in Small?Cell Lung Cancer Presented at the 2008 American Society of Clinical Oncology Meeting Demonstrate Single Agent Anti?Tumor Activity in Western Patient Population

Celgene Corporation (Nasdaq:CELG) today announced physicians from leading medical centers presented data from two Phase II clinical studies of amrubicin in patients with extensive–disease small–cell lung cancer (SCLC) either sensitive to platinum–based first–line therapy or refractory to platinum–based first–line therapy. Results of the studies demonstrated improved overall response rates that compare favorably with topotecan, as well as no evidence of anthracycline–induced cardiotoxicity with cumulative dosing up to 1,000 mg of amrubicin. In the first study, a randomized, multi–center U.S. study involving 48 centers, patients with SCLC and sensitive to previous first–line platinum–based chemotherapy received either intravenous (IV) amrubicin 40 mg/m2/day on days 1 to 3 of a 21–day cycle or IV topotecan 1.5 mg/m2/day on days 1 to 5 of a 21–day cycle. The primary endpoint was response rate, and secondary endpoints were time to disease progression, progression–free survival, overall survival and safety. The primary endpoint of the study was met with patients receiving amrubicin demonstrating an overall response rate of 34 percent, compared to 3.8 percent of patients receiving topotecan (p<0.004). Additionally, the median progression–free survival time for amrubicin patients is 138 days compared to 106 days for topotecan. Amrubicin was well tolerated in patients with advanced SCLC, with myelosuppression as the main dose–limiting toxicity. The most common grade three or higher adverse events in the study for patients receiving amrubicin were neutropenia (44.9%), thrombocytopenia (26.5%) and leukopenia (20.4%). In the second multi–center international study, patients with SCLC who were refractory to first–line platinum based chemotherapy were treated with IV amrubicin 40 mg/m2/day on days 1 to 3 of a 21–day cycle. The primary endpoint was response rate, and secondary endpoints were time to disease progression, progression–free survival, overall survival and safety. Of the 69 patients treated, overall response rate for the study was 17.4 percent with one complete response. These rates compare favorably with those seen historically with topotecan. Additionally, median progression–free survival is 97 days. Amrubicin is generally well tolerated in the study. Reversible myelosuppression is the main dose limiting toxicity and there is no evidence of anthracycline–induced cardiotoxicity. The most common grade three or higher adverse events in the study were neutropenia (62.3%), thrombocytopenia (36.2%) and anemia (27.5%). "The impressive response rates seen in these studies of Amrubicin demonstrate a favorable comparison to results in patients treated with topotecan and warrant further study of this promising new anthracycline," said Dr. Robert M. Jotte of the Rocky Mountain Cancer Centers in Denver, Co. and the lead investigator of one of the studies. "The continuing flow of information from these clinical studies are leading the way to new options for patients with this critical disease." These results build upon the increasing body of research and create a foundation for ongoing Phase III clinical studies of Amrubicin in small cell lung cancer. About Amrubicin Amrubicin is a third–generation, synthetic anthracycline analogue that has demonstrated substantial clinical efficacy in the treatment of small cell lung cancer. Amrubicin is a potent topoisomerase II inhibitor and is being studied as a single agent and in combination with anti–cancer therapies for a variety of solid tumors. Amrubicin is currently approved and marketed in Japan for the treatment of small cell lung cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on oncology, which licensed Japanese marketing rights from Dainippon Sumitomo, the original developer of the therapy. Dainippon Sumitomo also licensed the U.S. and European rights of Amrubicin to Pharmion Corporation, which was acquired by Celgene Corporation in 2008. About Small Cell Lung Cancer Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung, and which occurs almost exclusively in people who smoke. While small cell lung cancer constitutes approximately 15 percent of all lung cancers, SCLC tends to be more aggressive and fast growing than the more common non–small cell lung cancer. Of the estimated 65,000 patients diagnosed with SCLC each year in the US and EU, approximately 60 percent of patients have extensive disease at diagnosis, and the remaining 40 percent present with localized, or limited stage, disease. About Celgene Celgene Corporation, based in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company´s website at www.celgene.com. This release contains certain forward–looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company´s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward–looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company´s filings with the Securities and Exchange Commission such as Form 10–K, 10–Q and 8–K reports.