: Biogen and Eisai make plans to take another Alzheimer’s drug to the FDA

by | Oct 25, 2022 | Stock Market

Biogen Inc.
BIIB,
-1.90%
and Eisai Co. Ltd.
4523,
+3.57%
are getting closer to a possible approval of their new treatment for Alzheimer’s disease, with plans to submit the drug for full Food and Drug Administration approval by March of next year. All eyes on lecanemab

The companies have said their experimental therapy, called lecanemab, slowed cognitive decline by 27% in a Phase 3 clinical trial. The drug also appears to help people with day-to-day functions, like managing their finances, taking care of household responsibilities, and being able to leave their homes, executives said Tuesday during an earnings call. “Lecanemab administration showed a highly statistically significant reduction in clinical decline as early as six months which expanded over the 18-month study period on an absolute basis, consistent with a disease-modifying effect,” Michel Vounatsos, Biogen’s outgoing CEO, told investors this week. The new data, which was announced late on Sept. 27, revitalized Biogen’s stock, which closed Sept. 28 at $276.61, a 78% increase over the previous day’s closing price, following the disastrous launch in 2021 of Aduhelm, the controversial treatment for the same disease.  “Lecanemab could be a commercial success,” SVB Securities analyst Danielle Brill told investors on Tuesday, though she cautioned against viewing the drug as a savior for Biogen. “Given [Alzheimer’s disease] is a lower-margin opportunity, and economics are split with partner Eisai, we think it’s unlikely that lecanemab alone can offset the revenue cliff [Biogen] is facing over the next several years.” Aduhelm’s failures Much of Biogen’s stock performance over the last few years has been tied to the therapies the company is developing with Eisai to treat Alzheimer’s disease. Investors first pinned their hopes on Aduhelm, which was approved in 2021. However, Medicare coverage of the drug, as well as others in its therapeutic class, has been restricted amid broader questions about Aduhelm’s price tag — $56,000 a year at launch, now about $28,200 a year — and about how well it works. T …

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