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Biogen readies for U.S. launch of Alzheimer's drug ahead of FDA meeting

(Reuters) - Biogen Inc BIIB.O said on Wednesday it was diverting part of its budget and resources for blockbuster multiple sclerosis drug Tecfidera towards a potential launch of its Alzheimer's disease drug, aducanumab.

FILE PHOTO: A sign marks a Biogen facility in Cambridge, Massachusetts, U.S. January 26, 2017. REUTERS/Brian Snyder

With Tecfidera’s dominance under threat from recently launched generic versions, the drugmaker is throwing its weight behind U.S. approval of aducanumab. A closely watched U.S. Food and Drug Administration’s expert panel meeting next month will discuss potential approval of the drug.

Chief Executive Officer Michel Vounatsos believes a decision by the FDA, due by March 7, could influence other regulators as well. Biogen has filed for European review of the drug and is also preparing to file for approval in Japan.

“We are reallocating some Tecfidera resources to support the launch of (MS drug) Vumerity as well as aducanumab,” Vounatsos added.

Biogen said it was confident the Alzheimer’s disease drug would be approved, despite one study of the drug failing to meet its main goals.

Wall Street analysts remain largely divided on the drug’s approval due to mixed data in late-stage studies.

If approved, the drug would be the first treatment designed to delay progression of Alzheimer’s disease and possibly bring in billions of dollars in sales.

Tecfidera has come under pressure from cheaper generic drugs priced at about 90% discount on average. Biogen expects its sales to decline further next quarter from a 15% drop to $953 million in the third quarter. The drug brought in $4.3 billion in sales in 2019.

Biogen now expects full-year adjusted profit of $32.50 to $33.50 per share, down from its prior estimate of $34 to $36 per share.

Total revenue fell 6.2% to $3.38 billion in the third quarter.

Biogen’s shares fell nearly 1% to $264.66.

Reporting By Manas Mishra and Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli

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