Celgene Corporation Release: REVLIMID(R) Marketing Authorization Application Accepted By EMEA For Review
SUMMIT, N.J., Oct. 26 /PRNewswire-FirstCall/ -- Celgene Corporation announced that the European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for REVLIMID (lenalidomide), submitted in August 2005. The application is based on clinical data from an open-label Phase II trial, evaluating REVLIMID in the largest clinical trial to date of MDS patients with deletion 5q chromosomal abnormality. Celgene is seeking authorization to market REVLIMID as a treatment for 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.
MDS is a malignant disorder of blood cell production that affects approximately 67,000 people throughout Europe. The most common clinical manifestation associated with MDS is chronic refractory anemia, and the multiple complications that stem from frequent blood transfusions. REVLIMID has been designated as an Orphan Medicinal Product in the European Union (EU) for the treatment of MDS.
REVLIMID also has been designated as an Orphan Medicinal Product in the EU for the treatment of multiple myeloma (MM). Celgene expects to file its supplemental New Drug Application (sNDA) and MAA for REVLIMID in previously treated patients with relapsed and refractory MM to the FDA in fourth quarter 2005, and to the EMEA in first quarter 2006.
"Celgene looks forward to working with the EMEA as it begins the review process for REVLIMID. We appreciate the efforts of all the people who made this filing possible, and acknowledge the commitment from all participants in these MDS studies, who helped REVLIMID get to this stage in the European regulatory process." said Graham Burton, M.D., Sr.VP, Regulatory Affairs and Pharmacovigilence for Celgene Corporation.
About REVLIMID(R)
REVLIMID is a member of a new group of proprietary compounds of Celgene Corporation. These novel compounds or IMiDs(R) are compounds that have diverse biological properties, including immunomodulatory properties. Celgene continues to evaluate treatments with REVLIMID for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukemia as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, 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.
REVLIMID is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are hematologic malignancies that affect approximately 300,000 people worldwide. MDS occurs when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the World Health Organization, 15,000 to 25,000 new cases of MDS are diagnosed each year in Europe, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients often must rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with MDS, and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in 20 percent to 30 percent of all MDS patients. The World Health Organization also has recently identified a unique subset of MDS patients with a "5q-Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.
About EMEA
The European Medicines Agency (EMEA) is the European regulatory body responsible for the authorization and supervision of medicinal products for human and veterinary use in member European countries, approximately fifteen to date. The agency has four key objectives: (1) To protect public health by mobilizing the best scientific resources existing within the European Union; (2) To promote health care through the effective regulation of new pharmaceuticals and better information for users and health professionals; (3) To facilitate quicker access and the free circulation of pharmaceuticals within the European single market; and (4) to support the European pharmaceutical research and development industry by developing efficient, effective and responsive operating procedures.
About Celgene
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.
This release contains forward-looking statements which are subject to 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 expressed or 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 other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
Celgene CorporationCONTACT: Robert J. Hugin, Senior VP and CFO, Celgene Corporation,+1-908-673-9102, or Brian P. Gill, Director PR, IR, Celgene Corporation,+1-908-673-9530
Web site: http://www.celgene.com/