DepoCyte (Cytarabine Liposome Injection) Receives European Commission Marketing Approval
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DepoCyte (Cytarabine Liposome Injection) Receives European Commission Marketing Approval

LONDON, ENGLAND -- August 8, 2001 -- SkyePharma PLC announced today that the European Commission has granted marketing authorisation for DepoCyte™ (cytarabine liposome injection) throughout the European Union (EU) for the treatment of lymphomatous meningitis, a serious disabling and potentially fatal complication of cancer.
On July 25, 2001, SkyePharma announced that it had licensed the marketing rights for DepoCyte in Europe and the Philippines to Elan Pharma International Limited, an affiliate of Elan Corporation PLC, for a potential total of $23 million milestones and signing fees of which $10 million was received on signing. The granting of marketing approval triggers a significant additional milestone payment under the licensing agreement with Elan.

This receipt of marketing approval ratifies the positive recommendation received from the European Committee on Proprietary Medicinal Products (CPMP) in April 2001. It is believed that DepoCyte is the first treatment for lymphomatous meningitis approved by the CPMP centralised approval procedure.

DepoCyte is 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., Paladin Labs Inc. in Canada and Nippon Shinyaku in Japan.

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) over a two-week period and extends the dosing interval to one injection every two weeks instead of twice a week.

DepoCyte can be given by a simple spinal injection and also avoids the need for surgical insertion of a reservoir into the brain that is often necessary for frequent administration with standard cytarabine. For patients, this means a better quality of life, fewer injections and hospital visits and the opportunity to avoid invasive and costly surgery. In addition, DepoCyte provides higher drug levels for a prolonged period and results in better clinical response and prolonged time to disease progression in lymphomatous meningitis.

Lymphomatous meningitis (LM) is a condition that occurs when a patient’s primary cancer spreads to the membranes and CSF surrounding the brain and spinal cord. Current incidence figures from the Lymphoma Research Foundation in the U.S. estimate that between 7 and 15 percent of individuals with lymphoma and up to 20 percent of patients with Aids related lymphoma develop LM.

SOURCE SkyePharma PLC

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