Eisai uses 40 years to reach a new milestone in the treatment of Alzheimer’s disease | Insight Research

Eisai and Biogen jointly announced that Lecanemab, an investigational therapy for Alzheimer’s disease (AD) jointly developed by the two parties, is being used in the treatment of mild Alzheimer’s disease and Clarity AD, a Phase 3 validation clinical trial in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease, met its primary endpoint, significantly improving patients’ CDR-SB scores, while the trial met all key secondary endpoints. The effective date of the Lecanemab PDUFA (Prescription Drug User Fee Act) is set for January 6, 2023.

Lecanemab binds to soluble amyloid-beta (A[beta]) aggregates and promotes their clearance. It has the potential to change disease pathology and slow disease progression. According to the data, the drug slowed the cognitive decline of patients in the early stage of the trial by 27% compared with the control group within 18 months.

Notably,this is the first time in Alzheimer’s research that a drug has been definitively found to slow the disease. This is also a major breakthrough that Eisai has brought to the industry after nearly 40 years in the field of Alzheimer’s disease.

Eisai’s strength is even more evident in the collaboration between Eisai and Biogen’s Alzheimer’s drug

Lecanemabis the second drug jointly developed by Eisai and Biogen for Alzheimer’s disease. The first drug was approved last year and has been controversial. Aducanumab.

Wall Street Insights & Wisdom Research noted that , the cooperation between Eisai and Biogen on Alzheimer’s disease is somewhat Different, Aducanumab was developed by Biogen, Eisai participated in the share, and Biogen led the commercialization. As for Lecanemab, Eisai leads the global development and registration. Both parties are jointly responsible for the commercialization of Lecanemab, while Eisai retains the final decision-making power.

The principle of the two drugs is basically the same, Lecanemaband Aducanumab are both anti-amyloid beta. But from the data point of view, the difference is huge. The success of the Lecanemabdata will prove that the beta amyloid theory may become a feasible solution for the treatment of Alzheimer’s disease.

See Wisdom Research in last year’s article New Drug Approval Brings Major Changes to Alzheimer’s Treatment, Early Detection Bears the brunt? It is mentioned in “Seeing Wisdom Research” that the difficulty in the treatment of Alzheimer’s disease is that its pathogenesis is not completely clear. At present, it is widely accepted theories that the imbalance between the production and clearance of amyloid-β (Aβ) in the brain is the initiating factor of neuronal degeneration and dementia. Aducanumab is a high affinity, fully human IgG1 monoclonal antibody targeting the Aβ conformational epitope. It can theoretically selectively bind to the amyloid deposits in the brains of AD patients, and then by activating the immune system, to a certain extent clear the deposited proteins in the brain.

Although the same target is also developed, Eisai is clearly superior this time. Not only is the efficacy significant, but it is also the first time that a drug can slow down Alzheimer’s disease.

strong>.

However, Eisai’s success in Alzheimer’s disease is not due to luck. Eisai has been researching Alzheimer’s disease for nearly 40 years since it first entered the field of Alzheimer’s disease in 1983. And the company has been focusing its business resources on the field of dementia.

Eisai successfully developed Aricept in 1997 as a standard treatment for Alzheimer’s disease. It is a symptomatic treatment that can temporarily improve cognitive function, but it cannot be caused by the disease itself. Aspects of treatment, and the available period of treatment is short. It is worth noting that the drugs currently on the market are symptomatic treatment and cannot alleviate the symptoms of Alzheimer’s disease.

This success of Lecanemab will make up for the company’s losses on Aducanumab. Wisdom Research learned that Eisai was confident in the effect of Lecanemabin May of this year, and earlier in March, Eisai andBiogen revised the cooperation agreement on Aducanumab, no longer bears losses, and withdrew from the development decision and commercialization of Aducanumab, while Aducanumab will continue to complete more data validation of clinical trials in the next 8 years .

Aducanumab has twists and turns, and the future market will be handed over to other products

Aducanumab has been controversial since its approval, there is no clear evidence that the drug slows clinical cognitive decline in Alzheimer’s patients, although an independent expert at the time The panel voted almost unanimously against approving the drug, but the FDA accelerated its approval anyway.

After being approved for marketing, Aducanumab still could not be approved by doctors, and its sales in the United States were dismal. In order to save sales, Biogen also priced it from $56,000/ It fell to $28,200/year in 2018, a drop of nearly half, but the Centers for Medicare and Medicaid Services (CMS) still hasn’t fully covered it. At the same time, Biogen China, which had hoped for the Chinese market, also laid off the commercialization team established for the Chinese market of Aducanumab.

During the development of Aducanumab, Biogen had initially declared that the clinical study had failed, but after analyzing a larger data set, the company’s medical data statistician found that in the EMERGE study, patients receiving high doses of Aducanumab-treated Alzheimer’s patients achieved the primary endpoint with a significant 23% reduction in the Clinical Cognitive Disability Rating Score (CDR-SB) at Week 78 compared with the control group. In addition, in several other secondary endpoints, the high-dose aducanumab treatment group also showed a sustained reduction effect compared with placebo.

At the same time, the imaging data also showed that the amyloid plaque burden in the Aducanumab treatment group was significantly reduced at 26 and 78 weeks compared with the placebo group. Although full of controversy, the FDA combined the above data and finally decided to approve Aducanumab The emergence of Aducanumab has increased the clinical means to delay the progression of Alzheimer’s disease, but so far there is no evidence that this drug has the potential to reverse lesions and relieve symptoms.

And with Lecanemab showing for the first time that it can slow the symptoms of Alzheimer’s disease, it is clear that the market will shift to Eisai.

Alzheimer’s has the highest incidence of neurodegenerative diseases(10% of people over age 65 in the US), according to NCBI In 2021, 6.2 million people over the age of 65 in the United States will suffer from Alzheimer’s disease. Relevant forecasts show that the global Alzheimer’s disease drug market will be $4 billion in 2021, will grow at a compound annual growth rate of 16.2% from 2022 to 2030. Therefore, drugs for this disease have always attracted the participation of global pharmaceutical companies, but there are countless cases of failure. Today’s success of Eisai also inspires the industry.

With the success of Eisai, Lilly and Roche’s hopes for Alzheimer’s success have increased, with two drugs currently in clinical pipelines with excellent data targeting Aβ. The announcement of the Eisai data also sent Eli Lilly’s shares up more than 7% after the market.

Currently, Donanemab from Eli Lilly has met its primary endpoint in a Phase II clinical trial, slowing clinical progression by 32% in patients with early-stage Alzheimer’s disease. A head-to-head Phase III trial of Donanemab versus Aduhelm, which assesses how quickly amyloid deposits are cleared from a patient’s brain, could be announced in the third quarter of this year. At the same time, the China Food and Drug Administration also approved the clinical trial of Donanemab in China in June this year.

And Roche has said that gantenerumab significantly reduced sporadic Alzheimer’s disease in open-label extension studies of SCarlet RoAD and Marguerite RoAD of amyloid plaques; in the DIAN-TU-001 study, gantenerumabreduced rates of amyloid plaques in patients with dominantly inherited Alzheimer’s disease< /strong>. Based on these data, the FDA has granted breakthrough therapy designation to gantenerumab.

To sum up, Alzheimer’s disease, which has plagued the medical industry for decades, has finally ushered in the dawn. The process of Alzheimer’s disease drug research and development is a typical feature of the innovative drug industry. Years of accumulation have resulted in a success. Eisai’s success in Alzheimer’s disease is not accidental. It is the result of nearly 40 years of perseverance.

© 2021 All Rights Reserved. Design & Developed By Besticoder