Eisai is Granted Favorable Preliminary Injunction Ruling in Aricept(R) Patent Infringement...
Eisai is Granted Favorable Preliminary Injunction Ruling in Aricept(R) Patent
Infringement Lawsuit Against Teva Pharmaceuticals
TOKYO and WOODCLIFF LAKE, N.J., March 28 /PRNewswire/ -- Eisai Co., Ltd.
and its U.S. subsidiary Eisai Inc. (collectively "Eisai") today announced that
the United States District Court for the District of New Jersey has ruled in
Eisai's favor with respect to Eisai's motion for a preliminary injunction in
its patent infringement lawsuit against Teva Pharmaceuticals and its division
Gate Pharmaceuticals (collectively "Teva"), concerning Aricept(R) (generic
name: donepezil hydrochloride tablets).
As previously announced, Eisai filed the infringement actions in December
2005 contesting Teva's submission of an abbreviated new drug application
(ANDA) to the FDA for Aricept(R).
"We are pleased with the court's preliminary injunction decision to
prevent the sale of Teva's generic product before the expiration of the
donepezil composition of matter patent," said Mr. Hajime Shimizu, Chairman &
CEO of Eisai Corporation of North America and Eisai Inc. "We will continue to
actively protect our intellectual property throughout the world."
Aricept(R), an acetylcholinesterase inhibitor developed by Eisai Co., Ltd.
in Japan, increases the concentration of acetylcholine, a neurotransmitter, in
the brain. Aricept(R) was launched in the United States in 1997 and is
indicated for the treatment of mild, moderate, and severe dementia of the
Alzheimer's type. In the United States, Eisai Inc. copromotes Aricept(R) with
Pfizer Inc.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that
discovers, develops and markets products throughout the world. Eisai's
corporate human health care (hhc) mission is to give first thought to patients
and their families, and to increase the benefits that health care provides.
The company believes that increasing patient satisfaction through the
development of innovative new medicines exemplifies its important mission. For
more information about Eisai Co., Ltd., please visit
www.eisai.co.jp/index-e.html.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd.
Established in 1995, Eisai Inc. began marketing its first product in the
United States in 1997 and has rapidly grown to become an integrated
pharmaceutical business with sales of approximately $2.6 billion in fiscal
year 2006 (year ended March 31, 2007). For more information about Eisai Inc.,
please visit www.eisai.com.
About Aricept(R)
Aricept(R) is well tolerated but may not be for everyone. People at risk
for stomach ulcers or who take certain other medicines should tell their
doctors because serious stomach problems, such as bleeding, may get worse.
Some people who take Aricept(R) may experience fainting. Some people may have
nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have
muscle cramps or loss of appetite or may feel tired. In studies, these were
usually mild and temporary.
In a progressively degenerative disease such as Alzheimer's, improvement,
stabilization or a less-than-expected decline over time is considered a
positive response to treatment. These types of responses have been observed in
patients treated with Aricept(R) in clinical trials for Alzheimer's disease.
Individual responses to treatment vary. For more information about Aricept(R),
see accompanying full prescribing information or call (888) 999-9616 or visit
www.aricept.com.
Safe Harbor Statement
This press release may contain so-called "forward-looking statements."
These statements are based on current expectations, forecasts and assumptions
that are subject to risks and uncertainties which could cause actual outcomes
and results to differ materially from these statements. Risks and
uncertainties include general industry and market conditions, and general
domestic and international economic conditions such as interest rate and
currency exchange fluctuations. Risks and uncertainties particularly apply
with respect to product-related forward-looking statements. Product risks and
uncertainties include, but are not limited to, technological advances and
patents attained by competitors; challenges inherent in new product
development, including claims and concerns about product safety and efficacy;
domestic and foreign healthcare reforms; trends toward managed care and
healthcare cost containment; and governmental laws and regulations affecting
domestic and foreign operations. Also, there are manufacturing and marketing
risks and uncertainties, which include, but are not limited to, inability to
build production capacity to meet demand, unavailability of raw materials, and
failure to gain market acceptance. The Company disclaims any intention or
obligation to update or revise any forward-looking statements whether as a
result of new information, future events or otherwise.
SOURCE Eisai Co., Ltd.
Corporate Communications Department, Eisai Co., Ltd., +81-3-3817-5120; Judee
Shuler, Eisai Inc., +1-201-746-2241
© Thomson Reuters 2008 All rights reserved



