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Biogen Shares Fall As Late-stage Trials Of Alzheimer's Drug Discontinued

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Shares of Biogen Inc. (BIIB) are falling almost 28 percent in Thursday's trading after the company and Japanese drugmaker Eisai Co. Ltd. (ESALY.PK) said they will discontinue two late-stage trials for their experimental Alzheimer's drug, Aducanumab.

The two Phase 3 trials, ENGAGE and EMERGE, are multi-center, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of Aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.

Biogen and Eisai said they decided to trials after results of a futility analysis conducted by an independent data monitoring committee indicated the trials were unlikely to meet their primary endpoint upon completion. The companies added that the decision to stop the studies was not based on safety concerns.

"This disappointing news confirms the complexity of treating Alzheimer's disease and the need to further advance knowledge in neuroscience," said Michel Vounatsos, Chief Executive Officer at Biogen.

Biogen and Eisai have collaborated since October 2017 on the development and commercialization of Aducanumab globally.

The U.S. Food and Drug Administration has granted Fast Track designation for the development of Aducanumab, a process that allows priority reviews for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.

Alzheimer's disease is an irreversible, progressive brain disorder causing problems with memory, thinking and behavior. An estimated 5.7 million Americans are said to have Alzheimer's disease, and this number is projected to exceed 7.1 million by 2025.

Biogen and Eisai plan to present detailed data from the two Phase 3 studies at future medical meetings to inform ongoing research.

The primary objective of the study was to evaluate the efficacy of monthly doses of Aducanumab as compared with placebo in slowing cognitive and functional impairment. Secondary objectives were to assess the effect of monthly doses of Aducanumab as compared to placebo on clinical progression.

Further, Biogen and Eisai said they will discontinue the EVOLVE Phase 2 safety study and the long-term extension of the PRIME Phase1b study of Aducanumab.

The companies will assess initiation of the Aducanumab Phase 3 secondary prevention trial while evaluating data from the ENGAGE and EMERGE trials.

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