Healthcare Industry News: Cytogen
News Release - November 30, 2007
Lenalidomide (REVLIMID(R)) Receives Orphan Medicinal Product Designation from the European Commission for Chronic Lymphocytic LeukemiaBOUDRY, Switzerland--(HSMN NewsFeed)--Celgene International Sàrl (NASDAQ: CELG ) announced that lenalidomide (REVLIMID) has been granted orphan medicinal product designation by the European Commission (EC) for treatment of chronic lymphocytic leukemia (CLL) following the favorable opinion of the European Medicines Agency’s (EMEA) Committee for Orphan Medicinal Products (COMP).
Orphan medicinal product designation is granted by the EC to promote development of drugs to treat rare diseases or conditions. Orphan designation will give lenalidomide (REVLIMID) access to the Centralized Procedure for the application for marketing approval; reduce fees associated with applying for marketing approval and protocol assistance; and provide ten years of market exclusivity once approved for treatment of chronic lymphocytic leukemia.
Chronic lymphocytic leukemia is a hematological cancer that affects approximately 165,000 people in the European Union, based on an estimated prevalence 3.5 per 10,000.
“The decision by the European Commission to designate REVLIMID as an orphan medicinal product for treatment of chronic lymphocytic leukemia supports our efforts to move REVLIMID as quickly as possible through the clinical and regulatory development process worldwide,” said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation. “We continue to be encouraged by the growing body of published and presented data on REVLIMID by key opinion leaders at major medical meetings, and based on these findings, we are committed to accelerating wherever possible our efforts to help address the unmet medical needs of patients with chronic lymphocytic leukemia worldwide.”
Within the EU, Iceland and Norway, REVLIMID® (lenalidomide) is authorized for marketing and, in combination with dexamethasone, is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
REVLIMID is also currently approved in the United States by the U.S. Food and Drug Administration (FDA) and in Switzerland for multiple myeloma patients who have received at least one prior therapy. Additionally, REVLIMID is approved in the United States for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk Myelodysplastic Syndrome (MDS) associated with a deletion 5q Cytogenetic abnormality with or without additional Cytogenetic abnormalities. REVLIMID has already obtained Orphan Drug designation in the EU, United States, Switzerland and Australia for the treatment of multiple myeloma and in the EU, Australia and United States for treatment of MDS.
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 100 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 United States and foreign issued and pending patent applications including composition-of- matter and use patents.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia results from an acquired (not inherited) injury to the DNA of a single cell, a lymphocyte, in the bone marrow. This injury is not present at birth. Scientists do not yet understand what produces this change in the DNA of CLL patients. This change in the cell's DNA confers a growth and survival advantage on the cell, which becomes abnormal and malignant (leukemic). The result of this injury is the uncontrolled growth of lymphocytic cells in the marrow leading invariably to an increase of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.
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 twenty-seven 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, (4) To support the European pharmaceutical research and development industry by developing efficient, effective and responsive operating procedures.
About Celgene International Sárl
Celgene International Sárl, located in Boudry, 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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