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Pharmaceuticals

Eisai to apply for Alzheimer's treatment approval in fiscal 2022

CEO Naito says trials go 'smoothly' and sees candidate as growth driver

A retirement home in Germany: Eisai's Alzheimer's treatment is undergoing final clinical trials in Japan, the U.S., Europe and China.   © Reuters

TOKYO -- The head of Japanese pharmaceutical company Eisai plans to submit an application for approval in fiscal 2022 for a new Alzheimer's treatment being developed with U.S. partner Biogen.

"One clinical trial was delayed due to the impact from the novel coronavirus, but it has largely gone smoothly," Eisai CEO Haruo Naito told Nikkei in an interview. "We'll compile the final results during the July-September quarter in 2022."

Naito said an application for approval would come in fiscal 2022, which ends in March 2023.

The candidate, called BAN2401, is undergoing final clinical trials in Japan, the U.S., Europe and China.

Alzheimer's cases are linked to the accumulation of protein pieces called beta-amyloid, which form plaques in the brain. The plaques lead to the death of nerve cells. BAN2401 is an antibody designed to bind to beta-amyloid plaques, tagging them so the immune system can eliminate the formations.

Beta-amyloid begins accumulating 15 to 20 years before Alzheimer's symptoms appear. If BAN2401 is administered during the early stages of the disease, the treatment has the potential to delay the progress of symptoms over a long period.

Eisai CEO Haruo Naito says the final results of the Alzheimer's treatment trials will be published in the second half of 2022.

Eisai started selling the separate Alzheimer's drug Aricept in the U.S. in 1997. The company has invested resources to maintain "a research and development structure in the sector that surpasses major Western competitors," Naito said.

Eisai gained access to the base technology for BAN2401 through its partnership with BioArctic, a Swedish biopharma startup. Since 2014, Eisai has developed the candidate with Biogen, which has an extensive track record in neurological diseases.

If BAN2401 is commercialized, Eisai and Biogen will jointly market the regimen globally. All revenue will go to Eisai, with the two companies splitting the profits.

Eisai and Biogen also are developing aducanumab, another Alzheimer's treatment. The U.S. Food and Drug Administration recently granted the regimen priority review, and final approval is expected by March. Like BAN2401, aducanumab targets beta-amyloid for elimination, although the antibodies are different. Eisai once halted trials on this therapy candidate, but additional data revived the company's interest.

Eisai posted 695.6 billion yen ($6.65 billion) in sales for the fiscal year ended March 31, generating a net profit of 121.7 billion yen. Though the company's anti-cancer agents have attained growth, revenue is down more than 10% from its fiscal 2009 peak due to expired patents.

Naito positions the new Alzheimer's treatment candidates as a source of earnings on par with the anti-cancer drugs.

"We're prepared to live alongside the Alzheimer's remedies," he said.

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