Eisai Company, Ltd. is Granted Favorable Preliminary Injunction Ruling in Aricept(R) Patent Infringement Lawsuit Against TEVA Pharmaceuticals USA
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.
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.
CONTACT: Corporate Communications Department, Eisai Co., Ltd.,
+81-3-3817-5120; Judee Shuler, Eisai Inc., +1-201-746-2241
Web site: http://www.eisai.com/