Eisai Announces Launch of Higher-Dose Aricept(R) 23mg Tablet for

Eisai Announces Launch of Higher-Dose Aricept(R) 23mg Tablet for
Moderate-to-Severe Alzheimer's Disease in South Korea 
Realizes Further Contribution to Patients with Dementia in Asia Region 
Tokyo, Aug 27, 2013 - (JCN Newswire) -  Eisai Co., Ltd. announced today that
its marketing subsidiary in South Korea, Eisai Korea Inc., has launched a
higher-dose, once-daily Aricept(R) (donepezil hydrochloride) 23 mg tablet
formulation for treatment of moderate-to-severe Alzheimer's disease (AD)
in South Korea. 
South Korea is the first country in the Asia region to launch the formulation.
More than 9% of South Korea's population, or approximately 540,000
patients, are reported to be living with AD, with approximately 220,000
patients of that number estimated to be living with moderate-to-severe stages
of the disease(1). Eisai Korea has been locally marketing Aricept 5 mg and 10
mg tablet formulations since 1998 and Aricept Evess 5 mg and 10 mg orally
disintegrating formulations since 2008. The launch of the Aricept 23 mg tablet
will provide a more beneficial treatment option for patients with
moderate-to-severe AD, including patients who have stopped treatment with
existing formulations due to reduced drug efficacy as the disease progresses. 
Eisai has already received approval for the formulation in Hong Kong and is in
the process of submitting further applications in India, Indonesia, Malaysia,
Thailand, the Philippines and other countries in the Asia region. In a
head-to-head trial (Study 326), the Aricept 23 mg tablet was shown to possess
superior benefit in cognitive function of patients with moderate-to-severe AD.
The formulation was subsequently approved in the United States in July 2010 as
a treatment option for patients with moderate-to-severe AD. 
There are approximately 15,940,000 patients with dementia in the Asia region
and it is estimated that this number will significantly increase to
approximately 33,040,000 patients by 2030(2). As the originator and developer
of Aricept, Eisai is a leader in AD treatment and the company remains actively
committed to the development of AD treatments in the Asia region and their
promotion and widespread use through disease and diagnosis education, with the
aim of making further contributions to increasing the benefits provided to
patients with AD and their families. 
(1) Korea Ministry of Health and Welfare, 2012
(2) Dementia: A Public Health Priority 2012, World Health Organization 
About Aricept(R) 
Aricept is an acetylcholinesterase inhibitor discovered and developed by
Eisai. It increases brain levels of the neurotransmitter acetylcholine by
inhibiting its breakdown by acetylcholinesterase to slow the overall
progression of symptoms associated with AD. Aricept is currently approved in
more than 90 countries and territories around the world for the treatment of
mild-to-moderate AD. It is also approved as a treatment for patients with
severe AD in Japan, the United States, Canada, countries in Central and South
America, South Korea and other Asian countries, and other regions. 
About Study 326 
The approval of the Aricept 23 mg tablet in the United States is based on data
from a head-to-head study (Study 326) of 1,467 patients with moderate-to-severe
AD. In evaluations of cognitive function, the Aricept 23 mg tablet was shown to
possess superior benefit over the existing Aricept tablet 10 mg formulation.
The study was conducted with two primary endpoints: Severe Impairment Battery
(SIB), which evaluates severely impaired cognitive function, and
Clinician's Interview-Based Impression of Change Plus Caregiver Input
(CIBIC plus), which evaluates changes in overall clinical symptoms. SIB results
of the study demonstrated that the 23 mg tablet possessed statistically
significant benefit versus the Aricept tablet 10 mg formulation. On the other
hand, the 23 mg tablet did not exhibit a statistically significant level of
difference in CIBIC plus results. The SIB results (higher scores are better)
were 2.6 +/- 0.58 in the 23 mg group and 0.4 +/- 0.66 in the 10 mg group, with
a difference of 2.2 (p = 0.0001). The CIBIC plus results (lower scores are
better) were 4.23 +/- 1.07 in the 23 mg group and 4.29 +/- 1.07 in the 10 mg
group, with a difference of 0.06 (p = 0.1789).
The most frequently observed adverse effects (5% or more) in the study
included nausea, vomiting, diarrhea, anorexia, and other digestive symptoms
commonly seen in patients taking acetylcholine esterase inhibitors. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Contact: 
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120 
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