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SkyePharma and Nippon-Shinyaku Announce Distribution Agreement For DepoCyt(TM) in Japan (PR Newswire)... need for surgical insertion of a reservoir into the brain that is often necessary for frequent administration......Prevalence is dependent on tumor type and is estimated at up to 25% of patients with...... estimated at up to 25% of patients with late-stage solid tumors and up to 20% of patients with certain types of lymphoma....- Jul 02 7:30 AM ET


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Posted on: 07/02/2001

"Yahoo - SkyePharma and Nippon-Shinyaku Announce Distribution Agreement For DepoCyt(TM) in Japan"
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Monday July 2, 7:30 am Eastern Time

Press Release

SOURCE: SkyePharma PLC

SkyePharma and Nippon-Shinyaku Announce Distribution Agreement For DepoCyt(TM) in Japan

LONDON, and KYOTO, Japan, July 2 /PRNewswire/ -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announced today that the marketing and distribution rights to Japan and Taiwan for DepoCyt (cytarabine liposome injection) have been granted to Nippon-Shinyaku Co Ltd. DepoCyt is for the treatment of lymphomatous and neoplastic meningitis, a serious disabling and potentially fatal complication of cancer.

Nippon-Shinyaku currently markets immediate release cytarabine in Japan and therefore has significant experience and in-depth understanding of the market for neoplastic meningitis. Nippon-Shinyaku will be responsible for further clinical development, regulatory approval as well as marketing and distribution of DepoCyt in Japan. DepoCyt will be supplied from SkyePharma's San Diego facility.

Michael Ashton, Chief Executive Officer of SkyePharma stated: "The Japanese distribution of DepoCyt is yet another exciting milestone for SkyePharma and further underlines the value of our DepoFoam(TM) technology. We have also had considerable interest from potential European marketing partners and physicians for DepoCyt and anticipate to be able to announce a licensee for Europe near-term."

DepoCyt is an injectable, sustained-release formulation of the chemotherapeutic agent, cytarabine. Using SkyePharma's proprietary lipid-based drug delivery technology, DepoFoam, DepoCyt 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. DepoCyt 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, DepoCyt provides higher drug levels for a prolonged period and results in better clinical response and prolonged time to disease progression in lymphomatous meningitis.

DepoCyt is already approved for marketing in the U.S. and Canada under the trademark DepoCyt® and in April 2001 received recommendation from the European Committee on Proprietary Medicinal Products (CPMP) for the granting of marketing authorization in Europe. Final approval is anticipated in the next few months. Chiron Corporation holds the marketing rights for DepoCyt in the U.S. and Paladin Labs Inc. in Canada.

About Neoplastic Meningitis: Neoplastic meningitis (NM) is a condition that occurs when a patient's primary cancer metastasizes or spreads to the membranes and CSF surrounding the brain and spinal cord. Prevalence is dependent on tumor type and is estimated at up to 25% of patients with late-stage solid tumors and up to 20% of patients with certain types of lymphoma. The number of patients developing NM in Japan is estimated at 15,000 - 20,000 per annum.

SkyePharma PLC, one of the world's leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug discovery through the approval process. Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilization encompass the vast majority of delivery systems in use by the pharmaceutical industry. For more information, visit SkyePharma's web site at http://www.skyepharma.com.

Nippon Shinyaku Co., Ltd., founded in the famous ancient capital Kyoto in 1919, a R&D-oriented pharmaceutical company focusing its R&D on the development of products in urology, cardiovascular, cancer, gastrointestinal, and inflammation & allergy fields and marketing unique ethical drugs such as remedies for pollakiuria, prostatic hypertrophy, prostatic cancer, leukaemia and hypertension/angina pectoris. For more information, visit Nippon Shinyaku's web site at http://www.nippon-shinyaku.co.jp.

This press release may contain forward-looking statements regarding SkyePharma PLC. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that any product in the SkyePharma product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved. The Company undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.

SOURCE: SkyePharma PLC

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