1664391649 Biogen and Eisai go public after announcing success in trials

Biogen and Eisai go public after announcing success in trials of an Alzheimer’s drug

The logo of the pharmaceutical company Biogen at its headquarters in Cambridge, Massachusetts in an image file.The logo of pharmaceutical company Biogen at its headquarters in Cambridge, Massachusetts in a file image Brian Snyder (Portal)

Shares in American pharmaceutical company Biogen and Japan’s Eisai soared on Wednesday after both companies announced on Tuesday evening the success of clinical trials of a drug known to cause Alzheimer’s, the most common disease cognitive deterioration, which causes dementia and affects about 50 million people worldwide (about 800,000 in Spain).

Biogen shares opened the session up 45% and remains up for the day with gains of nearly 40%. That equates to an appreciation of about $12,000 million in a single day. The company is worth around $40 billion on the stock market.

For its part, Eisai’s stock price has soared more than 60%, valuing the company by more than $7,500 million to roughly $19,000 million. Shares in Roche and Eli Lilly, which develop drugs using the same principle as Biogen and Eisai, are also up around 7%.

Biogen and Eisai announced this Tuesday that they will apply for regulatory approval of the compound from the US Food and Drug Administration (FDA), following the results of the clinical trials of their drug lecanemab, and will also seek approvals for its marketing in Europe and Japan by the end of the first quarter 2023. Lecanemab is already under review by US regulators under a special accelerated approval process.

Data on the price at which the product would be marketed is not yet known. Both companies secured approval for another Alzheimer’s drug — aducanumab, marketed as Aduhelm — in 2021 despite inconclusive study results. The US health authorities refused to fund it (it cost $56,000 per patient per year) and the European Medicines Agency rejected the application for approval, making it a clinical and commercial failure despite being the first drug to be approved in almost two years Years against the disease has been approved for decades.

Biogen’s shares took a hit, falling from around $400 in June 2021 when the drug was approved to less than $200 when trading Tuesday ahead of announcing the success of the lecanemab trials. In fact, last May the company announced that it was beginning to replace its CEO, Michel Vounatsos, who is still at the helm of the company. Eisai stock, too, had lost more than half of its value in just over a year, also from the June 2021 highs.

Now the companies say a phase 3 study of 1,795 early-stage Alzheimer’s patients shows that giving lecanemab twice a week for 18 months reduced the rate of cognitive decline by 27% compared with those given a placebo. To measure impairment, doctors assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, household and hobbies, and personal hygiene.

The drug is a monoclonal antibody that attacks the amyloid plaques in patients’ neurons, one of the main hypotheses for causing the as-yet-unproven disease. In no case does it cure Alzheimer’s or make it go away. What the tests show is that it stops its effects.

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