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Eisai Co., Ltd. announced that Eisai Medical Research Inc., the U.S. clinical research subsidiary of Eisai, received a notification from the FDA that it may proceed with the clinical study for E2012
TOKYO, Japan | April 2, 2008 | Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on April 2, 2008 (the U.S. Eastern Time), Eisai Medical Research Inc. (Headquarters: New Jersey, President: Masanori Tsuno), the U.S. clinical research subsidiary of Eisai, received a notification from the U.S. Food and Drug Administration (FDA) that it may proceed with the clinical study for E2012. E2012 is Eisai's potential next generation Alzheimer's disease treatment. The company had suspended the Phase I study for E2012 in the United States in February, 2007 and has been requesting for resuming the study with data required by the FDA. With this response from the FDA, Eisai will start preparations for resuming the study.
The need for a next generation disease modifying treatment that improves the underlying Alzheimer's disease is increasing. E2012, a novel compound discovered by Eisai, is a gamma-secretase modulator that suppresses the production of beta-amyloid, which is believed to be one of the causes of Alzheimer's disease.
As the leader in Alzheimer's disease therapy with its marketed product, Aricept® (donepezil hydrochloride), Eisai is pursuing the development of new therapies for the disease through multi-faceted approaches including investigation of genes responsible for the onset of the disease, immunotherapy and vaccine therapy. Through these efforts, the company is committed to contributing to increasing the benefit to Alzheimer's disease patients and their families.
SOURCE: Eisai Co., Ltd. |
