Celgene International Sarl (Nasdaq: CELG) announced that REVLIMID (lenalidomide) has been granted full marketing authorization by the European Commission 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 Europe, and REVLIMID represents the first breakthrough oral therapy in Europe 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 EU approval of REVLIMID is an especially important and positive milestone for Celgene, as well as a substantial step forward 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 local regulatory authorities to determine next steps for pricing, reimbursement and distribution plans for all EU member states so that REVLIMID is available for eligible patients 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), and 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, but not in the EU, 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 by the FDA. In the EU, the Marketing Authorization Application for this indication is currently under review by the EMEA's Committee for Medicinal Products for Human use (CHMP).
About REVLIMID(R)
REVLIMID is an IMiDs(R) 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 Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Canton of Neuchatel, 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 http://www.celgene.com.- PR Newswire, UK
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