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Eisai stands firm on Alzheimer's drug outlook amid analysts' concerns

During Eisai Co. Ltd.'s earnings call for the nine-month period ended Dec. 31, 2017, analysts jumped at the opportunity to ask the company about its investigational Alzheimer's disease drug BAN2401, which failed to meet a primary endpoint in December 2017.

The monoclonal antibody drug works by binding to and clearing beta-amyloid, which are abnormal proteins that accumulate in the brain of Alzheimer's patients.

Currently being co-developed with Biogen Inc., BAN2401 did not meet the criteria of success at 12 months in its 18-month-long phase 2 study, an independent data monitoring board determined.

According to the Japanese drugmaker, two out of the 856 patients enrolled in the trial dropped out, which raised more questions than answers for analysts, despite the fact that both patients showed a reduction in the level of amyloid.

Studies on amyloid over the last decade have so far failed to prove a strong correlation between its accumulation level in the brain and the severity of Alzheimer's.

However, Eisai remains confident with BAN2401, urging analysts to wait for the study's comprehensive readout at 18 months.

"That hurdle was very high," said Ivan Cheung, president of Eisai's neurology business group.

"The 12-month analysis is to allow us to be able to start the phase 3 earlier given the need for this population. It did not happen from our perspective [but] from everything we have seen so far we are still confident about the 18-month analysis," Cheung said. "The truth will be unveiled in a few months but I am definitely very excited and looking forward to that."

Lenvima's China approval on the horizon

Eisai is also expecting its cancer drug Lenvima to be approved in 2018.

In December 2017, the China Food and Drug Administration granted Lenvima priority review for treating hepatocellular carcinoma, a type of liver cancer.

"Within one year or so, we expect approval to be obtained," said Yasunobu Kai, chief planning officer of Eisai's oncology business group.

The drug manufacturer said it will continue to work with the Chinese regulator ahead of the drug's anticipated approval, though it does not have a set date yet.

"The regulatory environment in China is evolving very fast," said Takashi Owa, chief medicine creation officer and chief discovery officer of Eisai's oncology business group.