Eisai expects 1,500 Alzheimer's patients in China launch, sees ‘huge’ growth

BioArctic AB

05/02/2024 12:57

(Repeats story that was originally published Feb 4 to
additional subscribers. No change to content of story)
    By Julie Steenhuysen and Andrew Silver
       CHICAGO/SHANGHAI, Feb 4 (Reuters) - Japan’s Eisai
 4523.T  aims to roll out its groundbreaking Alzheimer’s drug
Leqembi to 1,500 people in China later this year, but expects
growth to accelerate significantly in 2025 as diagnosis methods
change, a company spokesperson told Reuters.
    More convenient Alzheimer's blood tests expected to be ready
then could help Eisai reach a bigger share of China’s estimated
17 million people with early-stage disease, the spokesperson
said.    
    “China is one of the fastest-aging countries in the world
and is one of the most important countries in the area of
Alzheimer’s disease for Eisai,” a company spokesperson said.
“The potential growth for Leqembi in China is huge.”
    Eli Lilly  LLY.N , which is developing a similar treatment
called donanemab, told Reuters it has filed for approval in
China. The Indianapolis-based company is now testing its drug in
a 1,500-person trial with volunteers in China, Taiwan, South
Korea and the EU, a spokesperson said.
    The size of Eisai's planned China rollout and the filing of
Lilly's approval application have not previously been reported.
    Leqembi, which works by removing a toxic protein called beta
amyloid from the brain, is the first Alzheimer's treatment
proven to alter the course of the fatal, brain-wasting disease.
China approved Leqembi in January. 
    Eisai and U.S. partner Biogen  BIIB.O  have already rolled
out Leqembi in the United States and Japan, and it is under
review in Europe.
    The treatment, given by infusion twice a month, slowed
progression of the disease by 27% for patients in the earliest
stages of Alzheimer's in a clinical trial.
    Current treatments available in China have limited effect,
and Eisai's trial results give patients "a lot of hope," said
Alzheimer's expert Dr. Liu Zhou of Guangdong Medical University.
    Eisai said it expects to start using the drug in China by
September, and forecast a total of 1,500 patients there by March
2025, a number limited by the country's diagnostic capabilities.
    Leqembi's sales could "increase significantly" in 2025, the
company said, with the expected introduction of blood tests to
assess a patient's amyloid burden rather than PET scans or
invasive lumbar punctures, which require access to specialists. 
    “If treatment were to become possible based solely on blood
tests, we think it would generate significant interest,” Citi
analyst Hidemaru Yamaguchi said in a research note. He did not
have an estimate for China but expects Leqembi sales outside of
Japan and the U.S. to peak in 2030 at 126 billion yen ($1.08
billion).
    Rates of Alzheimer's diagnosis and treatment in Asia's
biggest economy remain low, and medical specialists and public
awareness of the disease is limited, according to The China
Alzheimer Report 2022, published in BMJ General Psychiatry.
    China's health ministry did not respond to a request for
comment by the time of publication. 
    Experts said the country has been ramping up imaging
capacity. 
    Siemens Healthineers  SHLG.DE , which sells imaging
equipment in China, said the market in China for molecular
imaging has grown more than 45% over the past four years. 
    
    'ILL PREPARED' 
    Initially, Eisai plans to launch Leqembi on China's private
market, where it is priced at about 200,000 yuan ($28,180) per
year, about $2,000 more than in the U.S.
    Eisai said it will decide whether to seek government
coverage after it assesses private market demand.
    Inclusion on China’s National Reimbursement Drug List
typically means a steep price cut. A 2023 analysis estimated the
average negotiated price cut ranged from 44% to 61%. 
    To be eligible for treatment, patients undergo cognitive
testing, genetic testing to assess whether they carry a gene
that increases the drug's adverse side effects, and testing to
confirm abnormal levels of amyloid, the sticky substance in the
brain targeted by Leqembi.
    Once on treatment, suitable patients undergo a series of MRI
scans to monitor for potentially fatal swelling and bleeding in
the brain. 
    Economist Dr. Soeren Mattke, director of the University of
Southern California Brain Health Observatory who has consulted
for both Eisai and Biogen, said China lacks a system of primary
care physicians to do preliminary testing and refer appropriate
candidates to specialists. 
    Mattke and colleagues published an assessment of China's
readiness for disease-modifying treatments in July in the
Journal Alzheimer's & Dementia that concluded that China is “ill
prepared to provide timely access to an Alzheimer’s treatment.”
    "In China," Mattke said, "specialty care is almost absent in
the rural areas." 
    
    
  

 (Reporting by Julie Steenhuysen in Chicago and Andrew Silver in
Shanghai; Editing by Caroline Humer and Bill Berkrot)
 ((julie.steenhuysen@thomsonreuters.com; 312-408-8131; Reuters
Messaging: Julie.steenhuysen.reuters.com@reuters.net))