All eyes on Biogen and Eisai’s potential Alzheimer’s breakthrough

Biogen and Eisai are working together on an Alzheimer’s disease treatment, and despite a chequered history, are hoping trial results announced today will convince regulators that they have a breakthrough drug.

Two pharmaceutical giants released a joint statement at the beginning of this month revealing a few, promising details from their 18-month long study of BAN2401 used to treat patients with early Alzheimer’s disease.

The placebo-controlled trial achieved statistical significance on key predefined endpoints evaluating efficacy on slowing progression in Alzheimer’s Disease Composite Score and on reduction of amyloid accumulated in the brain after 18 months of treatment.

Biogen and Eisai are going to lay out all details of their clinical study results today during a live webcast from the Alzheimer’s Association International Conference in Chicago.

Ahead of the presentation, a representative from Eisai said the companies will try to accelerate development as much as possible using measures such as the FDA’s “Breakthrough Therapy” pathway, which allows for a fast six-month review if trial results look promising.

Lynn Kramer, chief medical officer at Eisai, told Reuters: “We are certainly considering ‘prime’ status in Europe, ‘breakthrough’ in the United States and ‘sakigake’ in Japan.”

The Alzheimer’s disease treatment has a potential to become a multi-billion dollar seller with nearly 50 million people affected worldwide and the estimate to cross the 130 million mark by 2050.

The positivity mirrored investors’ enthusiasm on the stock exchange, bumping Eisai and Biogen’s shares values as much as 14.6% and 7% respectively, on the heels of this statement.

However, there have been mixed reviews about details from the trial results from the drug published so far.

Many specialists in the field are sceptical indicating that after the first year of trial has not met endpoints and was measured using predictive “Bayesian” statistical method and then switched to traditional statistical model after 18th month.

Others said the news was welcome in the field of Alzheimer’s research after a string of pharma giants like Merck & Co, Eli Lilly and Boehringer failed to find an effective treatment and axed their trials.

 

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