Dive Brief:
- Japanese drug producer Eisai followed in the footsteps of partner Biogen on Monday, highlighting an increased focus and investment in its Alzheimer's disease programs.
- In treating Alzheimer's, CEO Haruo Naito said his company would investigate holistic approaches and continue development of its beta-amyloid antibody 2401 and BACE inhibitor 2609 programs. Eisai has an ongoing Phase 2 trial for the former drug and two upcoming Phase 3 studies, one of which has completed enrollment, for the latter.
- Eisai's drugs work to inhibit the production of (or detoxify) amyloid beta proteins. Researchers believe the build-up of those proteins can kill neurons and impair signaling across the brain in Alzheimer's patients. Many AD treatments have been based on this hypothesis, but the failure rate is extremely high.
Dive Insight:
Eisai teamed up with Cambridge, MA-based Biogen in a 2014 deal aimed at developing Alzheimer's treatments. Each company brought two candidates to the table and allowed the other access to manufacture and market those candidates. Biogen's contributions included an anti-tau monoclonal antibody and BIIB037 (aducanumab), an anti-amyloid beta antibody.
During an October 31 earnings call, Eisai mirrored comments Biogen made last week regarding Eli Lilly's competing Alzheimer's drug solanezumab, which is currently in a Phase 3 trial called Expedition-3, and could justify a long-standing hypothesis about the disease.
"Shall the solanezumab E-3 study be positive, of course, it's a very strong validation to the amyloid hypothesis. And I believe our confidence to our programs will certainly increase," Naito said in the call. "Now, if somehow that study is not positive, we still believe we are very confidence about our programs, because even though these antibodies target the amyloid cascade, they do act on quite different mechanisms."
Eisai reported second quarter earnings on Monday, as its fiscal year begins April 1. R&D spending was lower for the company in the first half of the fiscal year due to flux in foreign exchange rates and spending cuts from its partnership with Biogen. Eisai expects higher R&D expenses during the second half of the fiscal year, however.
In an October 31 investor note for Biogen, Jefferies analysts highlighted the potential for Eisai's two Alzheimer's programs.
"As there is less attention on this asset — with aducanumab titration data appearing qualitatively supportive and all eyes on the forthcoming solanezumab data — the ’2401 program could provide an interesting additional potential shot on goal for the [Biogen]/Eisai collaboration," said an October 31 investor note from Jefferies.