MW Biogen's stock rises after E.U. regulator reverses negative view of Alzheimer's drug

By Ciara Linnane

EMA issues positive opinion on Leqembi, albeit for a limited patient group

Biogen Inc.'s stock rose 1% Thursday, after Europe's pharmaceutical regulator issued a positive opinion on the Alzheimer's disease drug that the company developed with Japanese partner Eisai - reversing an earlier decision not to approve the drug.

The European Medicines Agency had issued a negative opinion on the drug, called Leqembi, in July, citing a side effect that involves swelling and potential bleeding in the brain.

"After re-examining its initial opinion, EMA's human-medicines committee $(CHMP)$ has recommended granting a marketing authorization to Leqembi (lecanemab) for treating mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer's disease," the EMA said in a statement.

But the drug is only being recommended for patients who are not carriers of Apoe4, a protein involved in the metabolism of fats in humans that is known to be a risk factor in Alzheimer's.

Eisai had requested that the EMA revisit its negative opinion. The European Commission is now expected to make a final decision on the marketing-authorization application within 67 days.

Alzheimer's affects an estimated 6.9 million people in Europe, and that figure is expected to nearly double by 2050 given demographic trends.

"There is a significant unmet need for new treatment options that slow down the progression of early AD and reduce the overall burden on people affected by AD and society," Biogen $(BIIB)$ and Eisai (JP:4523) $(ESAIY)$ said in a joint statement.

Eisai is the lead for the development of the drug, while Biogen and Eisai are jointly commercializing and promoting it.

Biogen's third-quarter sales were weighed down by weak uptake of Leqembi, which chalked up just $39 million worth in the third quarter, while FactSet was expecting $55 million.

On a call with analysts, Chief Executive Christopher A. Viehbacher acknowledged sales of Leqembi were still below the company's expectations. "The prescriber base is not expanded to the extent that we had anticipated," he said, according to a FactSet transcript.

But the company is seeing the benefits from an increased sales force, he added, and is optimistic about markets such as Japan and China.

Biogen's stock has fallen 35% in the year to date, while the SPDR S&P Biotech exchange-traded fund XBI has gained 10% and the S&P 500 SPX has gained 25%.

-Ciara Linnane

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November 14, 2024 13:21 ET (18:21 GMT)

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