Eisai inaugurates new US HQ as closely watched FDA Alzheimer's decision draws near

Eisai officially launched its new U.S. headquarters just as the Japanese pharma looks to expand its commercial presence with an Aduhelm follow-up in Alzheimer’s disease by “building trust with the public.”

Eisai is bringing about 800 employees with it to the new head office. The 332,800-square-foot facility is located on the ON3 Campus in Nutley, New Jersey, an old Roche site.

But back when the company announced the move two years ago, it said the plan was to transfer up to 1,200 U.S. corporate and R&D functions to the new site.

“It’s only always been 800,” an Eisai spokesperson told Fierce Pharma. The company had less than 800 staffers at the old Woodcliff Lake site, and Eisai is now also bringing together people in the metropolitan New Jersey area, the spokesperson added. The site has capacity to house 1,300 staffers.

Eisai has been increasing its headcount in North America in the past few years. As of the end of March, the company recorded 1,982 employees in North America, up from 1,820 a year ago and 1,682 in 2020.

But the company did recently unveil plans to shut down its H3 Biomedicine oncology R&D wing in Massachusetts, laying off 88 people stationed there. Besides the corporate headquarters and H3, Eisai also operates a dementia discovery center in Cambridge, Massachusetts, plus an Exton, Pennsylvania, facility, which holds a biologics plant and a cancer and neurodegenerative disease biologics discovery center.

The relocation comes as Eisai is gearing up for an all-important FDA decision on Biogen-partnered Alzheimer’s candidate lecanemab. The beta-amyloid antibody, a follow-up to the pair’s ill-fated Aduhelm, is under FDA priority review for a decision by Jan. 6, 2023.

After a negative Medicare coverage decision that basically nixed Aduhelm’s commercial prospects at least for the next few years, Eisai in March handed its partial stake in Aduhelm to Biogen to focus on lecanemab, on which the Japanese pharma is taking the lead.

In preparation for lecanemab’s potential rollout, Eisai recently brought on former Eli Lilly exec Thomas Fagan Jr. to the new role of vice president, U.S. Alzheimer’s disease commercial. It’s not immediately clear how big an Alzheimer’s commercial team Eisai is building.

While Eisai is anticipating an accelerated approval based on biomarker data, the 1,795-subject phase 3 Clarity AD trial is expected to read out how lecanemab could slow dementia symptoms in this September. If successful, the results could support a full approval.

The Centers for Medicare & Medicaid Services (CMS) only covers beta-amyloid antibodies cleared under the FDA’s accelerated approval pathway when they are used in a clinical trial setting. Eisai has already started discussions with the CMS about using data from Clarity AD to enable fast reconsideration for broader access for lecanemab once a full approval comes through, Ivan Cheung, Eisai’s U.S. head and global neurology business chief, said during an investor call two weeks ago.

“Foundational to our launch preparation for lecanemab is building trust with the public about lecanemab’s clinical data and value,” Cheung said during the call.

Aiming to avoid some of the mistakes Biogen made with Aduhelm, Eisai will publish lecanemab clinical data in a peer-reviewed journal in a timely manner, according to Cheung. Biogen was criticized for its delay in disclosing full Aduhelm data from two phase 3 trials, and when it finally did in March—nine months after the FDA nod—it chose a small journal.

Without giving Eisai’s final pricing strategy, Cheung pointed to an early evaluation of lecanemab’s value, suggesting it could potentially be priced up to $38,000 a year.