The company along with Eisia, its Japanese partner in the project, made a decision to halt the trial after the data analysis team determined that the trials will not meet their primary deadline and immediately, both firms lost money after their shares plummeted.
The ENGAGE and EMERGE trials were created to evaluate the efficacy and safety of aducanumab in people with a confirmed diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's disease.
Major pharmaceuticals have developed dementia treatments based on the assumption that Alzheimer's was associated with the accumulation of beta-amyloid, and eliminating or suppressing it would treat or prevent Alzheimer's.
This disappointing news confirms the complexity of treating Alzheimer's disease and the need to further advance knowledge in neuroscience.
Over the past three years, Biogen has spent $743 million on the research and development of aducanumab, and an additional $93 million on sales and marketing of the drug, with contributions of $30.2 million and $23.3 million from Eisai, respectively, according to a Securities and Exchange Commission filing.
The development is a "transformative failure for Biogen's pipeline", said Brian Abrahams, an analyst at RBC Capital Markets, who had the equivalent of a hold rating on the stock.
Biogen noted that there was no safety issue in the discontinued trials, leaving possibilities for aducanumab's effect on dementia prevention.
Pfizer past year ended research on therapies for Alzheimer's and Parkinson's diseases, the latter of which limits a person's motor functions. Samsung BioLogics, however, said the company suffered no damage. Inc., and Johnson & Johnson, have all previously abandoned Alzheimer drug trials over lack of effectiveness or due to safety concerns. "Aducanumab is dead, and we'd argue so is the beta-amyloid hypothesis".
Many companies are pursuing alternative theories for attacking Alzheimer's, such as focusing on tau, another Alzheimer's-linked protein, or on inflammation, which is believed to play a role in the very early formation of the disease.
Eisai Co., Ltd. announced that a total of seven presentations highlighting the latest data on its Alzheimer's disease/dementia pipeline, including anti-amyloid beta (Abeta) protofibril antibody BAN2401 and oral beta amyloid cleaving enzyme (BACE) inhibitor elenbecestat will be given at the 14th International Conference on Alzheimer's & Parkinson's Diseases (AD/PD) from March 26 to 31 in Lisbon, Portugal.
Biogen said researchers will share data from the two ended trials at future medical meetings so that others can learn from them.
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