WOODCLIFF LAKE, N.J., April 20, 2012 /PRNewswire/ -- Eisai announced today that the company has amended the licensing agreement with Teikoku Pharma USA, Inc. (TPU), a subsidiary of Teikoku Seiyaku Co., Ltd., pertaining to exclusive overseas marketing rights for the Aricept® patch (once weekly donepezil HCl transdermal system).
The amendment allows TPU to be solely responsible for making all decisions regarding future development activities for the Aricept patch. Eisai has the option to obtain exclusive worldwide marketing rights. The license agreement was amended as a result of TPU's decision to withdraw the New Drug Application (NDA) for the approval of the Aricept patch in the United States.
In June 2010, TPU submitted the NDA to the U.S. Food and Drug Administration (FDA) for approval of the Aricept patch in the United States. The FDA issued a Complete Response Letter and after careful evaluation, TPU decided to withdraw the NDA on April 17, 2012 after determining that it would be difficult to respond to all the issues within the designated timeframe.
Eisai and Teikoku Seiyaku will continue to move forward with the development of a once daily Aricept patch for the Japanese market based on the exclusive license agreement between the two companies concerning research, development and marketing rights in Japan.
About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.
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. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. Eisai employs approximately 11,000 employees worldwide.