SkyePharma given EU licence for DepoCyte cancer treatment

SkyePharma has announced that the European Commission has given the go-ahead for DepoCyte (cytarabine liposome injection) to be marketed throughout the EU to treat lymphomatous meningitis, a potentially fatal complication for cancer sufferers.

This follows an announcement by the company on 25 July that it had licensed the marketing rights for DepoCyte in Europe and the Philippines to Elan Pharma International in a deal that could reach US$23m (€26m).

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

DepoCyte has been approved for marketing in the US and Canada since 1999. Chiron Corp holds the marketing rights for DepoCyte in the US, Paladin Labs in Canada and Nippon Shinyaku in Japan.

SkyePharma's ceo, Michael Ashton, said, 'The licensing and marketing approval of DepoCyte in Europe represented the largest challenge for SkyePharma towards achieving its principal financial objective to operate profitably by the end of the financial year. We are very excited that this internally developed product, which is a significant advancement in therapy, should soon be available throughout Europe to treat patients with this serious complication of cancer.'

DepoCyte is an injectable, sustained-release formulation of the chemotherapeutic agent, cytarabine. Using SkyePharma's 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.

It 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.