Where are we standing today in the fight against Alzheimer's?
We are in a period brimming with hope and on the cusp of significant change. Many of us have personal connections to the devastating impacts of both cancer and Alzheimer's disease, which drives Eisai’s focus on these critical areas. A few years back, I shared insights on the hopeful trajectory of Alzheimer's treatment, emphasizing the pivotal moment when products cross regulatory thresholds and begin commercialization. Despite challenges and some companies exiting the space due to low returns on their investments, Eisai has committed over four decades to this cause, starting with a breakthrough symptomatic treatment, continuing to significantly advance the science of Alzheimer’s, and through our collaborations, such as with Biogen, bringing forth new therapies.
Our global CEO often reflects on the delay in arriving at this juncture, sharing his views openly with shareholders. However, we are now witnessing unprecedented mobilization across neurology and community settings in the fight against Alzheimer’s, bolstered by investments in diagnostics and patient support mechanisms. These developments are converging to expedite the patient journey, highlighted by the rapid advancement of blood-based biomarkers for confirmatory testing, which were once thought to be years away. Our recent $15 million investment in C2N, for instance, is aimed at supporting the patient journey through simplification of the diagnostic process. Such initiatives underscore Eisai's commitment to simplifying and enhancing the patient experience through innovative diagnostic technologies.
Is the widespread impact of Alzheimer's and oncology the rationale behind Eisai's choice of therapeutic areas?
The pervasive nature of diseases like Alzheimer's and cancer indeed plays a role in our decision-making process regarding therapeutic areas. Eisai is inspired by the Japanese philosophy known as “Ricchi”, which metaphorically suggests building one's house where no others exist. This approach encapsulates our mission to venture into areas with significant, unaddressed medical needs, thereby bringing value to society through innovative healthcare solutions.
Regarding the pricing of high-impact drugs like Leqembi, how does Eisai approach this sensitive issue?
We care about societal value, endeavoring to distribute the benefits of our innovations across society. This involves a holistic approach and rigorous process of defining the value LEQEMBI brings to patients and the broader community, a task Eisai has undertaken with the utmost seriousness. We assess the simulated impact of our medicines on reducing demand for health services and global burden of disease as potential “economic value” while enhancing further innovations in AD.
We estimate that over 10 years cumulatively, the gradual adoption of LEQEMBI treatment at this pricing approach could give back about 60% of the potential positive social impact of several tens of billion dollars to the U.S. society.
Our strategy has been to be as transparent as possible, detailing our pricing philosophy and the rationale behind it on public platforms. This transparency has been well-received, earning us recognition for our forthrightness and clarity in sharing our pricing strategy. Our approach is underpinned by a desire to foster dialogue and understanding around the assumptions and calculations that guide our pricing decisions, with the aim of sharing the benefits of LEQEMBI as widely as possible.
Looking ahead, what is the next significant innovation in Eisai's pipeline?
A new age of Alzheimer’s stands before us and Eisai remains invigorated by the prospects within our pipeline. Our journey with LEQEMBI, from its conceptual stages through to clinical trials, has been marked by innovation and a commitment to excellence. The accolades received for our clinical program underscore our expertise and the potential impact of our upcoming therapies. We aim to seek approval for a subcutaneous formulation of LEQEMBI that if approved by the FDA will provide appropriate patients with the opportunity to use an autoinjector at home for both therapy initiation and maintenance dosing further simplifying the treatment pathway for patients and their families.
Our ambition extends beyond current treatment paradigms, aiming to intervene at the earliest disease stages to halt progression and, ultimately, prevent the onset of symptoms. The use of LEQEMBI in people who may be at risk for Alzheimer’s disease, but who are not experiencing the clinical symptoms is being explored in the AHEAD 3-45 clinical trial. Beyond amyloid, Eisai’s investigational anti-microtubule binding region tau antibody being developed as a disease-modifying agent for tauopathies has the potential for use as an independent therapy or in combination with LEQEMBI.
This vision is supported by the advancement of diagnostic tools, such as blood-based biomarkers, which are essential for identifying preclinical cases. Through these efforts, Eisai aspires to fundamentally alter the trajectory of Alzheimer's, offering hope for earlier and more effective intervention.
