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News Release

January 25, 2002


Salzburg (January 25, 2002) - Eisai Co., Ltd. of Tokyo (President and CEO: Haruo Naito) announced results of the first of two phase three clinical trials conducted by Eisai Inc. (President: William Sheldon) involving vascular dementia (VaD) for ARICEPTR which were presented at the Second International Congress on Vascular Dementia (ICVD) in Salzburg, Austria. Treatment with ARICEPTR significantly improved the cognitive and global (overall) function of patients with vascular dementia compared with placebo in this double-blind study.

VaD, cognitive decline caused by cerebrovascular disease, is second only to Alzheimer's disease as a cause of dementia representing up to one-third of all diagnosed cases. VaD is directly correlated with such risk factors as high blood pressure, diabetes, elevated cholesterol levels, and smoking and incidence increases with age. In Europe, the prevalence of VaD is estimated to be 1.5 to 4.8 percent for people 70 to 80 years of age; of the patients over 65 years old diagnosed with dementia in the United States, it is estimated 9 to 39 percent have VaD.

The 24-week double-blind randomized study involved patients who received daily doses of either 5 milligrams (mg) ARICEPTR (donepezil hydrochloride), 10 mg ARICEPTR or placebo. Participant eligibility was defined by the NINDS-AIREN criteria to exclude patients with Alzheimer's disease, and in almost all cases evidence of cerebrovascular disease was apparent by computed tomography (CT) or magnetic resonance imaging (MRI).

The study included 616 men and women with VaD, with an average age of 75 years. Most all participants took one or more medications, most frequently to prevent cardiovascular disease, with over 80 percent receiving some form of medication to prevent strokes. Patients who received ARICEPTR 5 mg or 10 mg showed significant improvement in their cognitive function compared to those taking placebo as measured by the Alzheimer's Disease Assessment Scale (ADAS-cog). Evaluation of global function also revealed significant improvements for patients at both ARICEPTR doses compared to patients who received placebo as measured by the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC plus), a standard global assessment tool.

Overall adverse events did not differ significantly in frequency between the ARICEPTR groups and the placebo group. As expected and consistent with the drug's known mechanism of action, side effects related to the digestive system (including diarrhea and nausea) occurred more frequently in ARICEPTR treated patients than placebo treated patients.

Of the 125 patients who discontinued the study, 73 did so due to an adverse event. This study is one of two conducted to examine the efficacy and safety of ARICEPTR in patients with VaD for the purpose of filing with regulatory authorities in the U.S. and Europe for an indication to treat VaD. The results of the second study are expected to be released in mid 2002. In addition, Eisai Co., Ltd. will work with its strategic alliance partner, Pfizer Inc., to file both studies in their respective territories.

ARICEPTR is an acetylcholinesterase inhibitor and was discovered and developed by Eisai Co., Ltd. ARICEPTR increases a neurotransmitter in the brain, acetylcholine serving to improve the symptoms associated with Alzheimer's disease. ARICEPTR has been launched in over 50 counties worldwide including Japan, the U.S., the U.K., Germany, and France. Sales are forecast for this fiscal year ending in March 2002 to be approximately yen89.5 billion.

Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisiai actively participates in all aspects of the worldwide health care system. The Company reported sales of over $2.9 billion in 2000 with approximately 14 percent of sales spent for research and development.

ARICEPTR is a registered trademark of Eisai Co., Ltd.


NINDS-AIREN Criteria : National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences Criteria
Criteria to define vascular dementia as involving memory loss, as w_ell as impairment in at least two other cognitive domains, including orientation attention, language-verbal skills, visuo-spatial abilities, calculations, executive functions, motor control, praxis, abstraction, and judgment, that interfere with activities of daily life over and above other consequences of cerebral vascular disease (CVD).
ADAS-cog :Alzheimer's Disease Assessment Scale
Frequently used 11-item scale developed to assess the severity of cognitive impairment and the cognitive items include: spoken language ability, comprehension of spoken language, word-finding difficulty in spontaneous speech, following commands, naming objects and fingers, constructional praxis, ideational praxis, orientation, word-recall task, word recognition task, and recall of test instructions. Scores range from 0 to 70 points and lower scores indicate less severe impairment.
CIBIC plus :Clinician's Interview-Based Impression of Change with caregiver input
Semi-structured interview, performed first with the caregiver and then with the patient, to provide an overall (global) assessment of change from baseline; allows physicians to assess the patient's overall (global) response to treatment. This instrument examines the four major areas of patient function: general, cognitive, behavioral, and activities of daily living. Subsequent to baseline, the CIBIC plus change scores are rated on a 7-point scale where 1 equals marked improvement, 2 equals moderate improvement, 3 equals minimal improvement, 4 equals no change, 5 equals minimal worsening, 6 equals moderate worsening, and 7 equals marked worsening.