Tokyo, Oct 26, 2009 - (JCN Newswire) - Eisai Co., Ltd. and TSD Japan, Inc. today announced that they had concluded a license and joint development agreement for the development of denileukin diftitox (generic name) in Japan. Under the terms of the agreement, Eisai shall grant TSD the exclusive right to co-develop the drug in Japan, while Eisai will retain the exclusive right to market the product once marketing authorisation has been granted.
Denileukin diftitox is a solution for intravenous injection for the treatment of patients with cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+). In February 1999, the drug was granted accelerated approval as a biological product in the United States by the U.S. Food and Drug Administration under Subpart E, an FDA regulation. It has been made available for healthcare professionals since then, and in October 2008, the accelerated approval was converted to full approval. Denileukin diftitox has been granted orphan drug status in the U.S. and is currently marketed by Eisai's U.S. subsidiary under the brand name of ONTAK(R).
CTCL is a type of cutaneous non-Hodgkin's lymphoma that comes in a variety of forms. In CTCL, T cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions. The quality of life (QOL) of patients with this disease is greatly reduced due to severe pain and pruritus. While CTCL is often regarded as a low-grade lymphoma, it is slowly progressive and can take anywhere from several years to upwards of ten to reach tumour stage. By the time it has reached this stage, the cancer is highly malignant and has usually spread to the lymph nodes and internal organs, which may lead to a poor prognosis. There has been no known cure for CTCL as yet and treatment of this disease can still be very difficult.
Eisai and TSD will work closely together in an effort to meet unmet medical needs and will expedite the development of the drug so as to bring a new treatment option to patients with CTCL and healthcare professionals as early as possible.
Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a type of cutaneous non-Hodgkins lymphoma that comes in a variety of forms. Mycosis fungoides (MF) and Sezary Syndrome are the most common forms of this disease. While CTCL is often regarded as a low-grade lymphoma, it is slowly progressive and can take anywhere from several years to upwards of ten to reach tumour stage (stage IIB - IVB by tumour-node-metastasis classification). By the time it has reached this stage, the cancer is highly malignant, and has usually spread to the lymph nodes and internal organs, which may lead to a poor prognosis. There has been no known cure for CTCL as yet and treatment of this disease can still be very difficult.
About TSD Japan, Inc.
TSD Japan, Inc. ("TSD") was set up in 2005 to develop drugs, especially for oncology, refractory diseases and its adjuvant treatments, which have not been on the Japanese market and are required by the patients as soon as possible. To develop new and innovative pharmaceutical products, TSD has established a unique business model combining expertise in partnering between pharmaceutical companies in Japan and domestic or foreign drug-discovery bio-venture companies, in clinical studies with in-house clinical development functions, and in consulting of clinical development.
In January 2009, TSD entered into a license agreement with GenomIdea Inc. to develop, manufacture and distribute HVJ envelope for the treatment of prostate cancer in Japan, which is currently under co-development of its non-clinical studies with GenomIdea Inc. On August 31, 2009, this HVJ-E project was approved by the government-financed aid project for strategic sophistication of Basic Manufacturing Technology by Ministry of Economy, Trade and Industry (METI). More information about TSD is available on the following Web site http://www.tsd-japan.co.jp.
About Eisai
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 8,000 people worldwide. For more information, please visit www.eisai.co.jp .
Contact:
Eisai Co., Ltd.
Public Relations Department
Tel: +81-3-3817-5120
TSD Japan, Inc.
Partnering
Tel: +81-6-6309-5214
Oct 26, 2009
Source: Eisai
Eisai (TSE: 4523) (U.S: ESALY)
From the Japan Corporate News Network
http://www.japancorp.net
Topic: Press release summary
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