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News Release

FOR IMMEDIATE RELEASE
December 26, 2005
For Print (PDF 135KB)

New Drug Application for Rheumatoid Arthritis Drug Adalimumab (D2E7) Submitted in Japan

Eisai Co., Ltd.
Abbott Japan Co., Ltd.

Eisai Co., Ltd, Tokyo, Japan (President : Haruo Naito) and Abbott Japan Co., Ltd, Osaka, Japan (President : Zahir Lavji) today submitted a new drug application (NDA) to the Minister of Health Labour and Welfare (MHLW) for the manufacturing and marketing of the rheumatoid arthritis drug adalimumab (D2E7), which is co-developed by the two companies in Japan.

Adalimumab (D2E7) is a human monoclonal antibody. It works by neutralizing TNF-alpha, a protein that plays a central role in the inflammatory responses of autoimmune diseases such as rheumatoid arthritis.

Clinical trials for adalimumab (D2E7) have been conducted in Japan since 2000 to explore adalimumab's (D2E7) effectiveness in treating autoimmune disorders such as rheumatoid arthritis. Approximately 400 Japanese patients have participated in the trials.

Adalimumab (D2E7) is the only fully human monoclonal antibody approved by the United States Food and Drug Administration and the European Medicines Agency for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Abbott markets adalimumab (D2E7) in the U.S. and European Union under the brand name of HUMIRA(R).

In Japan, there are estimated to be approximately 700,000 patients with rheumatoid arthritis. Eisai and Abbott Japan are making every effort to obtain early approval for the drug in order to bring the benefits of adalimumab (D2E7) to patients with rheumatoid arthritis as soon as possible.


(Please see the attached glossaries for reference.)
Please contact the following departments regarding this topic.
Corporate Communications Dept.
Eisai Co., Ltd.
Phone: 81-3-3817-5120
Public Affairs
Abbott Laboratories
Phone: 1-847-938-8848



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About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries. In Japan, 1,900 employees are dedicated to manufacture and development of the products, as well as the sales and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics, with the corporate base in Tokyo, Osaka, Fukui, and Matsudo.

Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for autoimmune diseases.


<Glossaries>
•  Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease that causes inflammation and swelling of many joints. Long-term progression of joint damage may often cause deformation and dysfunction of joints.
Although the exact cause of this disease remains unknown, it is believed that factors such as microbial infection stimulate overgrowth of synovial cells lining the joint cavities. This change is accompanied by an increase in blood vessels in joints and migration of blood cells such as lymphocytes and macrophages from vessels to synovial tissues. Immune response in joints and inflammation caused by cytokines released by lymphocytes and macrophages may trigger destruction of cartilage and bone.

•  TNF-alpha
The tumor necrosis factors (TNFs) are a group of cytokines (i.e., substances mediating cell-cell interactions) that have been found to damage tumor cells.
TNF-alpha is produced by many types of cells such as macrophages, lymphocytes, and vascular endothelial cells, and is known to cause and enhance inflammatory responses and to activate inflammatory cells.

•  Monoclonal antibody
A monoclonal antibody is a protein produced from clones of a single antibody-producing cell (called monoclones). Using the monoclonal antibody technique, we can obtain a homologous population of antibody molecules identical in amino acid sequence and other characteristics.