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News Release

April 2, 2004

Eisai's German Pharmaceuticals Marketing Subsidiary and GlaxoSmithKline Sign a Promotion Agreement for IMUREK(R), an Immunosuppressant

Eisai Co., Ltd.
Eisai GmbH

Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that Eisai GmbH (hereinafter "EDG", Headquarters: Frankfurt, President: Andreas N. Wiegand), a German subsidiary of Eisai, and GlaxoSmithKline Germany (hereinafter "GSK") entered into a promotion agreement for GSK's IMUREK(R) (generic name: azathioprine), an immunosuppressive agent, in the German market. Under the agreement, from April 1, 2004, EDG will solely promote the 25mg and 50mg tablet and intravenous formulation of IMUREK(R) which is currently marketed in the region by GSK GmbH & Co. KG.

IMUREK(R) functions by suppressing the immune response. The indications approved in Germany are moderate and severe inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis, acute exacerbations of multiple sclerosis, autoimmune diseases including chronic active hepatitis, systemic lupus erythematosus, haemolytic anaemia or severe rheumatoid arthritis, idiopathic thrombocytopenic purpura, polyarteritis nodosa and immunosuppression after organ transplants.

EDG currently markets PARIET(R) (rabeprazole sodium), a proton pump inhibitor in the gastroenterology therapeutic area, and will now add IMUREK(R) with its indication for IBD to EDG's gastroenterology lineup. Both PARIET(R) and IMUREK(R) will enable EDG to strengthen its position in the therapeutic area through efficient promotion, and Eisai hopes to contribute to improving the quality of life for a wider range of patients.

[The explanations of terms are attached below for reference]


[ Eisai GmbH ]
    President : Andreas N. Wiegand
Headquarters : Frankfurt, Germany
Establishment : 1996
Capital : 7,669 thousand euros (as of January 31, 2004)
Employees : 112 (including approximately 80 medical representatives)

[ Explanations of Terms ]
    1. Immunosuppressant
  Immunosuppressants are agents that can suppress immune responses, and are used to prevent rejection of transplanted organs as well as to treat allergic reactions and autoimmune diseases.

2. Autoimmune Disease
  An illness that occurs when normal body tissues are attacked by its own immune system resulting from an improper, excessive, or deficient immune response. The attack causes destruction of the body tissues, overgrowth or malfunction of organs, which may involve either a single type of tissue or organ, or multiple organs.
Autoimmune disease also develops when the immune control system that is responsible for distinguishing 'self' cells and molecules from foreign invaders is disrupted, or occasionally when abnormally transformed body tissues cannot yet be recognized as 'self'.
Following are examples of autoimmune or autoimmune-related diseases:
  - Chronic hepatitis
- Chronic rheumatoid arthritis
- Autoimmune haemolytic anaemia
- Idiopathic thrombocytopenic purpura
- Dermatomyositis
- Systemic lupus erythematosus
- Polyarteritis nodosa

  3. Inflammatory Bowel Disease (IBD)
  Immunosuppressants A group of chronic intestinal diseases of unknown cause which result in inflammation or ulcers in the lining of the large or small intestine. IBD generally refers to ulcerative colitis and Crohn's disease.

i) Ulcerative Colitis (UC)
UC is a diffuse nonspecific disease that causes chronic inflammation of the lining of the colon, frequently leading to erosions or ulcers. The rectum is primarily involved in UC and the inflammation may extend to the whole of the colon. Bloody stool, mucous tool, diarrhea and abdominal pain can be symptoms of UC. This disease characteristically waxes and wanes.
Although the causes of UC are not entirely known, it is currently thought that under the influence of complicatedly linked genetic and environmental factors, the onset and duration of inflammation is probably associated with overreaction of immune cells in the intestine against some kind of antigen.

ii) Crohn's Disease (CD)
CD is an inflammatory disease that is usually diagnosed in persons in their teens or twenties, commonly involving the small and large intestine, but which can affect other parts of the digestive system from the mouth to the anus. The disease may cause elongated or irregular-shaped ulcers, swelling in the lining or narrowing of the inner surface of the bowels. Abdominal pain, diarrhea, fever, and lesions in the anus are common symptoms, but CD can be sometimes associated with complications outside the digestive system.
Although no specific cause has ever been clearly proven, according to recent studies, genetic factors are a probable cause of the disease. This hypothesis ascribes the onset to an abnormal response by immune system cells like lymphocytes against invaders such as food ingredients, foreign subjects, or viruses.

  4. Multiple Sclerosis (MS)
  MS is an autoimmune disease in which the immune system destroys the myelin sheath of the central nervous system (CNS) including the brain and the spinal cord.

The disease causes a large variety of symptoms in various parts of the body, ranging from ophthalmic problems such as impaired vision, double vision (polyopia), rapid repetitious eye movements (nystagmus) and eye pain to numbness, weakness, difficulty in discharge of urine or feces, incontinence, dizziness, and difficulty in speaking or swallowing.

MS can gradually progress while recurrently waxing (exacerbation) and waning (regression). Although the causes of MS are not well known, it probably results from abnormalities in the immune system that produce antibodies which attack the myelin in the CNS.