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| |  Europe Recommends Approval Of Depocyte (Cytarabine Liposome) For Lymphomatous Meningitis LONDON, UK -- April 2, 2001 -- SkyePharma PLC announced that the European Committee on Proprietary Medicinal Products (CPMP) has recommended the granting of marketing authorization for DepoCyte™ (cytarabine liposome injection) for the treatment of lymphomatous meningitis, a serious disabling and potentially fatal complication of cancer. The CPMP's recommendation for approval will be forwarded to the European Commission and when ratified SkyePharma will receive a single license for marketing throughout the European Union (EU). It is believed that DepoCyte will be the only intrathecal treatment for lymphomatous meningitis approved by the CPMP centralized approval procedure. SkyePharma is currently seeking a European marketing partner. Michael Ashton, chief executive officer of SkyePharma stated: "The European approval of DepoCyte is an exciting further milestone for SkyePharma following on from the recent re-launch of the product in the U.S. We are delighted that this significant advancement in therapy will now soon be available in Europe. We have already had substantial interest from potential European marketing partners and physicians for DepoCyte and hope to be able to announce a licensee in the near future. In addition we are continuing to make progress on the introduction of DepoCyte in Japan and other parts of the world." DepoCyte is an injectable, sustained-release formulation of the chemotherapeutic agent, cytarabine. Using SkyePharma's proprietary lipid-based drug delivery technology, DepoFoam™, DepoCyte gradually releases cytarabine into the cerebral spinal fluid (CSF) and extends the dosing interval to once every two weeks as compared to the standard intrathecal chemotherapy dosing of two times per week. By providing continuous delivery of cytarabine over a two-week period, DepoCyte offers patients the advantages of fewer injections and less frequent hospital visits. DepoCyte is already approved for marketing in the U.S. and Canada under the trademark DepoCyt®. Chiron Corporation holds the marketing rights for DepoCyt in the U.S. and Paladin Labs Inc. in Canada. Lymphomatous meningitis is a condition that occurs when a patient's primary cancer metastasizes or spreads, by way of malignant cells, to the membranes and CSF surrounding the brain and spinal cord. Current incidence figures from the Lymphoma Research Foundation in the U.S. state that 7 to 15 percent of individuals with lymphoma, or approximately 6,000 people per year are diagnosed with lymphomatous meningitis. However, many patients remain undiagnosed due to the disease's wide-ranging symptoms. If left untreated, patients usually die within four to six weeks.
SOURCE SkyePharma PLC
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