04.09.2007 11:30:00

Oral Cancer Drug REVLIMID(R) Receives Swissmedic Approval in Switzerland for Treatment of Multiple Myeloma

Celgene International Sàrl (NASDAQ: CELG) announced today that its innovative oral cancer drug REVLIMID (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. This approval represents the first regulatory approval for Celgene in Switzerland, and REVLIMID represents the first breakthrough oral therapy in Switzerland for multiple myeloma patients in more than forty years. Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide. There are more than 85,000 men and women in Europe currently undergoing treatment for multiple myeloma, and 25,000 people are expected to die from this blood cancer in 2007. "The opportunity to offer REVLIMID as an oral therapy to our patients, gives a new structure to the way multiple myeloma is treated and means important progress”, says Dr. Taverna, Head of Oncology, at the hospital of Münsterlingen. "For us as treating physicians it is of high importance that companies such as Celgene support clinical research. For the treatment of patients with multiple myeloma we have now two multinational, randomized trials, demonstrating the superior efficacy of REVLIMID in combination with Dexamethasone, compared to Dexamethasone alone.” "The Swiss approval of REVLIMID is an especially important and positive milestone for Celgene, as well as an important step toward achieving our global mission of making innovative oral therapies available to patients with significant unmet medical needs worldwide,” said Aart Brouwer, President of Celgene International. We are working diligently with Swissmedic to determine next steps for pricing, reimbursement and distribution so that REVLIMID is available for eligible patients in Switzerland as quickly as possible.” The Marketing Authorization Application (MAA) for REVLIMID was based upon the safety and efficacy results of two large, randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating REVLIMID plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. "REVLIMID represents a significant advancement in the treatment of multiple myeloma and we are fully committed to swiftly bringing this new oral therapeutic option to patients in need across Europe,” said Graham Burton, M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene. "We remain committed to the broad and global clinical development of our investigational therapies being studied in blood and solid tumor cancers, and we are grateful that our collaborative efforts have resulted in this approval of REVLIMID.” REVLIMID has obtained Orphan Drug designation in the EU, US and Australia for treatment of multiple myeloma. REVLIMID is approved for use as an oral treatment in combination with dexamethasone by the European Commission, following the recommendation from the European Medicines Agency (EMEA). REVLIMID is currently approved in the US by the U.S. Food and Drug Administration (FDA) for multiple myeloma patients who have received at least one prior therapy. REVLIMID is also approved in the US, by the FDA, for treatment of 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. About REVLIMID® REVLIMID is an IMiDs® compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 75 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of-matter and use patents. About Multiple Myeloma Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown. About Swissmedic Swissmedic is the central Swiss supervisory authority for therapeutic products. To protect humans and animals, Swissmedic ensures that only high-quality, safe and effective medicines and medical devices are placed on the market in Switzerland. Swissmedic is a public service organization of the federal government with headquarters in Bern. It is independent in its organization and management and has its own separate budget. Swissmedic is linked to the Federal Department of Home Affairs (FDHA). The Agency Council is its highest body and represents Swissmedic in contacts with the FDHA and the Federal Council (the Swiss government). It also approves Swissmedic's annual budget, annual accounts, and annual report. About Celgene International Sárl Celgene International Sárl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative 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. REVLIMID® is a registered trademark of Celgene Corporation. 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.

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