Japan’s Eisai Co. said that an Alzheimer’s drug it is developing with Massachusetts-based Biogen Inc. will enter late-stage trials after getting the green light from the U.S. Food and Drug Administration.
The FDA said in a recent meeting that there was "sufficient data" to move the orally-administered treatment, E2609, to Phase III testing, Eisai said in an e-mailed statement. The drug is believed to block the beta-secretase cleaving enzyme which produces amyloid beta, the build-up of which has been linked to the brain disorder.
More than 40 million people worldwide are living with Alzheimer’s and dementia, and the world’s largest pharmaceutical companies have poured resources into the field. But there is still no cure for Alzheimer’s.
In 2014, Biogen gave Eisai an upfront payment, and a fixed amount of development and milestones for E2609, with the two drugmakers agreeing to share development expenses. Eisai is the maker of Aricept, which was the world’s best-selling Alzheimer’s treatment before it lost patent protection in 2010.
Last July, Biogen said its experimental Alzheimer’s drug BIIB037 failed to show a statistically significant cognitive benefit for patients on a closely watched dose, complicating the company’s quest to develop a treatment.