Eisai Submits New Drug Application For Rheumatoid Arthritis Drug Adalimumab (D2E7) In Japan

(JCN Newswire) - Eisai Co., Ltd, Tokyo, Japan (TSE: 4523) and Abbott Japan Co., Ltd. today submitted a new drug
application (NDA) to the Minister of Health Labour and Welfare (MHLW) for
the manufacturing and marketing for the rheumatoid arthritis drug
adalimumab (D2E7), which is co-developed by the two companies in Japan.


Adalimumab (D2E7) resembles antibodies normally found in the human body.
It works by neutralizing TNF-, a protein that plays a central role in the
inflammatory responses of autoimmune disease such as rheumatoid arthritis.


Clinical trials for adalimumab (D2E7) have been conducted in Japan since
2000. The clinical trials have explored 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.


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 rheumatic disease as soon as possible.


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-


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- 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.


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.
For more information, please visit abbott.


About Eisai Co., Ltd.


Eisai Co., Ltd. (TSE: 4523)(OTC: 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
eisai.co.jp.


Eisai Co., Ltd.

Eisai Co., Ltd. (TSE: 4523) (U.S.: ESALY)

eisai.co.jp/index-e.html


From the Japan Corporate News Network

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View drug information on Humira.