Eisai Co., Ltd. has amended the section of the licence agreement with California based, Teikoku Pharma USA Inc., the US subsidiary of Teikoku Seiyaku Co., Ltd. pertaining to exclusive overseas marketing rights for the once weekly transdermal patch system for Aricept (donepezil hydrochloride) for Alzheimer's disease.
The amendment allows TPU to be solely responsible for making all decisions regarding future development activities for Aricept transdermal patch system. 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 transdermal patch system in the United States.
In June 2010, TPU submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of the patch system in the United States. The FDA issued a Complete Response Letter and after careful evaluation, TPU decided to withdrew 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 transdermal system for the Japanese market based on the exclusive license agreement between the two companies concerning Japan research, development and marketing rights.
Eisai will draw on its abundant experience with Aricept accumulated thus far and make further contributions to improve the quality of life of patients, families and caregivers living with Alzheimer's disease.