Remicade

Remicade has been developed for the treat- of TNF a leads to inflammation. TNF a has
ment of Crohn’s disease, rheumatoid arthri- effects on various organs and cells, and it
tis, and Behçet’s disease. Tanabe began plays a main role in various inflammatory
full-scale clinical trials of Remicade in conditions, such as Crohn’s disease and
Japan in 1995 and launched the product in rheumatoid arthritis. In clinical trials,
the domestic market in May 2002 after it Remicade has shown significant efficacy in
was approved for active Crohn’s disease. the treatment of inflammatory diseases, and
Remicade was subsequently approved for it is considered to be an important advance
rheumatoid arthritis in July 2003. We will in the treatment of Crohn’s disease and
devote resources to the development of rheumatoid arthritis.
Remicade as a new drug that meets medical
needs and has a high growth potential. DISTINCTIVE EFFICACY
CHARACTERISTICS
There are three distinct characteristics of
Remicade’s efficacy that account for its high
HIGHLY EVALUATED AROUND evaluation in the marketplace. First, it is
THE WORLD highly effective and has a fast onset acting,
Overseas, Remicade has already been with peak efficacy reaching about two to
approved in Europe, the United States, and four weeks after administration. Second, it
many other regions for Crohn’s disease and has a long half-life, which makes it effective
rheumatoid arthritis, and its efficacy has for extended periods. Generally, the effects
been highly evaluated. As of July 2003, of a single IV administration last for more
Remicade has been approved and launched
in 70 countries. In the United States, sales of
Remicade by Johnson & Johnson totaled
$1,580 million in 2002.

REMICADE’S DISTINCT
MECHANISM OF ACTION
Remicade is an anti-TNF (tumor necrosis
factor) a chimeric monoclonal antibody that
combines with TNF a and inhibits its action.
TNF a, a cytokine produced by white blood
cells, has an important role in the body’s
protective function, but the overproduction

10 Tanabe Seiyaku Co., Ltd.

than two months. Third, it has an action that
destroys the cells that produce TNF a, and as
a result it can prevent the root cause of
inflammation. Due to these distinct charac-
teristics, Remicade is expected to show
superior efficacy in comparison with other
anti-inflammatory agents. In particular, its
efficacy in controlling the progress of
rheumatoid arthritis (structual damage) has
been confirmed, relieving patients and their
families from concern about the future and
improving patients’ quality of life.
INFORMATION ACTIVITIES FROM
THE PATIENT’S POINT OF VIEW
Remicade’s unique efficacy has been recog-
nized overseas, and it quickly became the
focus of attention in Japan. Accordingly,
many doctors and patients awaited its
launch. However, as a therapeutic antibody,
Remicade is an entirely new type of drug,
and to avoid serious side effects, extra care is
essential when it is prescribed. In July 2003,
we established the Remicade Division and
assigned approximately 70 Remicade area
managers to our branches. We will promote
Remicade carefully, providing specialists
with accurate information about proper
usage and ensuring that they have a thor-
ough understanding of Remicade’s efficacy
and risks.
In Japan, there are an estimated 700,000
to 800,000 patients with rheumatoid arthri-
tis, and about 20,000 patients with Crohn’s
disease. Tanabe will work to enable more
patients to use Remicade with confidence by
providing accurate information so that
Remicade’s efficacy can be used to con-
tribute appropriately to improving patients’
quality of life.

REMICADE’S MECHANISM OF ACTION

Binds to and neutralizes Dissociates receptor- Attacks cells producing TNF

soluble TNF bound TNF

TNF producing cells

TNF (activated macrophages, etc.)
receptor

TNF target cell

(vascular endothelial
cells, immune
system cells) Membrane-
bound TNF

Attack

Remicade Soluble TNF

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