Eisai's 2020 financial report: China continues to grow, lenvatinib and perampanel enter the national medical insurance

Recently, Eisai announced its fiscal year 2020 (April 1, 2020-March 31, 2021) performance: total revenue was 645.
9 billion yen, a year-on-year decrease of 7.
1%, of which pharmaceutical business revenue was 586.
1 billion yen, an increase from the same period last year.
1.
5%
.

Japan's pharmaceutical business declines, China, the United States and Europe maintain growth

In terms of regions, Japan, the United States, and China ranked the top three in terms of revenue from the pharmaceutical business, but Japan's revenue has declined compared with 2019
.

The decline in revenue from the pharmaceutical business in Japan was due to Lyrica (pregabalin), Methycobal (methcobalamin), Aricept (donepezil), Halaven (eribulin), Pariet (rabeprazole), Treakisym (bendamustine) Product sales fell, among which Lyrica's sales fell most obviously due to the impact of generic drugs
.

In addition, the sales of Eisai's blockbuster oncology drug Lenvima (lenvatinib) have also declined in Japan, but have maintained a growth trend in the United States, China and other regions

The growth of the pharmaceutical business in China was mainly due to the sales of Lenvima, Halaven and Fycompa.
The sales of Lenvima (levatinib) increased from 13.
3 billion yen in 2019 to 18.
5 billion yen.
Halaven Lin) sales increased from 400 million yen in 2019 to 1.
6 billion yen, and Fycompa (perampanel) sales increased from 100 million yen in 2019 to 500 million yen
.

It is worth mentioning that in 2020, lenvatinib was approved in China for the second indication-radioactive iodine refractory differentiated thyroid cancer, and entered the 2020 national medical insurance through medical insurance negotiations
.

Eribulin was approved in China in July 2019 for the treatment of locally recurring or metastatic breast cancer that has received at least two chemotherapy regimens (including anthracyclines and taxanes) in the past.

Lenvima sales continued to rise, Aricept sales fell significantly

From the perspective of global sales of major products, most of Eisai's major product sales declined in 2020, and the neurological drug Aricept (donepezil) declined the most
.

Aricept is a second-generation central acetylcholinesterase (AchE) inhibitor.
It was approved by the FDA in November 1996 and became the second Alzheimer's disease (AD) drug approved worldwide.
It reached its peak sales in 2009.
After the patent expired in 2010, sales declined year by year
.

Fycompa is a first-in-class anti-epileptic drug developed internally by Eisai.
It is a highly selective and non-competitive AMPA-type glutamate receptor antagonist and has been used in more than 70 countries around the world.
Approved as an adjuvant therapy for the treatment of partial-onset epilepsy (POS, with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older.
It has been approved as an adjuvant therapy in more than 65 countries around the world.
Used for the treatment of primary general tonic clonus (PGTC) seizures in patients with epilepsy of 12 years and older.
It is approved as a monotherapy and adjuvant therapy in Japan, the United States and South Korea, and is used in patients with epilepsy of 4 years and older.
Treatment of epilepsy (with or without secondary generalized seizures)
.

In addition, Fycompa has also been developed to treat epilepsy associated with Lennox-Gastaut syndrome

       The sales of Lenvima/Kisplyx (lenvatinib), a major anti-tumor product, still maintains a growth trend, which is mainly due to the expansion of indications
.

At present, Eisai and Merck are using the LEAP (LEnvatinib and Pembrolizumab) clinical development projects in 13 different types of tumors (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma).

       A variety of drugs under development, the future can be expected

       In addition to these products, Eisai as well as a variety of investigational drugs, such as aducanumab, lecanemab, lorcaserin, denileukin diftitox , tazemetostat, amatuximab and so on
.

       aducanumab is the first biological agent to target AD-related clinical symptom decline and pathological mechanisms to be submitted to the regulatory agency.
It is an antibody that targets beta amyloid (Aβ) and has been proven in clinical trials to remove Aβ in the brain.
, And significantly reduce the mild cognitive impairment (MCI) caused by AD and mild AD dementia.
The drug is currently under review in Europe, America and Japan
.

Evaluate Vantage predicts that if it is successfully listed, aducanumab's global sales in 2026 are expected to reach 4.

       Lecanemab is an experimental humanized monoclonal antibody for Alzheimer’s disease introduced by Eisai from BioArctic.
It can selectively bind to neutralize and eliminate soluble and toxic β (Aβ) amyloid aggregates (fibrils).
), Eisai and Bojian reached a cooperative development and commercialization agreement on the drug in March 2014
.

Currently, researchers are conducting an open-phase extension trial (OLE) for the phase 2 study of lecanemab for early AD, an exploratory phase 3 clinical trial (Clarity AD), and another phase 3 clinical trial for preclinical AD (AHEAD 3-45)

       Lorcaserin is a selective serotonin 5-hydroxytryptamine 2C (5-HT2c) receptor agonist, which selectively activates 5-HT2c receptors in the brain and activates GABAergic inhibitory interneurons.
It is expected that lorcaserin can increase GABAergic The synaptic inhibition of Dravet syndrome reduces seizures in patients with Dravet syndrome
.

Currently, the Phase 3 study of lorcaserin for the indication of Dravet syndrome is underway, and the FDA has granted it an orphan drug designation for this indication

       denileukin diftitox (genetic recombinant) is a fusion protein of interleukin 2 (IL-2) and the receptor binding part of diphtheria toxin, which specifically binds to the IL-2 receptor on the surface of tumor lymphocytes.
It was submitted in April 2020 in Japan for the treatment of relapsed Or refractory cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) listing applications
.

       Tazemetostat is an oral, pioneering EZH2 inhibitor developed by Epizyme
.

EZH2 is a histone methyltransferase.

       Amatuximab is a chimeric immunoglobulin G-1-κ (IgG1/κ) monoclonal antibody with high affinity and specificity for mesothelin
.
Mesothelin is a glycoprotein that is overexpressed on the surface of mesothelioma cells
.
In January 2014, it was granted the orphan drug qualification for the treatment of malignant mesothelioma by the EC
.