Leqembi® (lecanemab) launched in China

Rhea-AI Summary

BioArctic AB's partner Eisai has announced the launch of Leqembi® (lecanemab) in China on June 28, 2024. Approved in January 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD), Leqembi is now available in the United States, Japan, and China. Eisai estimates there are 17 million early AD patients in China. The drug will be available in the private market with a 200 mg vial priced at CNY 2,508. A specialized healthcare insurance plan partially covering the drug cost has been introduced. Leqembi, which reduces amyloid-beta (Aβ) plaques in the brain, is the first treatment shown to slow disease progression. BioArctic will receive milestone payments and a 9% royalty on global sales, with plans to commercialize the drug in the Nordic region pending European approval.

Positive

• Leqembi launched in China, third country after the US and Japan.
• 17 million estimated early AD patients in China.
• 200 mg vial priced at CNY 2,508.
• Healthcare insurance plan launched for partial drug cost coverage.
• Leqembi reduces amyloid-beta plaques, slowing disease progression.
• BioArctic to receive milestone payments and 9% royalty on global sales.
• Plans for joint commercialization in the Nordic region pending European approval.

Negative

• None.

Financial Analyst

The launch of Leqembi in China represents a significant milestone for BioArctic and its partner Eisai. Financially, this could mean a noteworthy boost to revenue streams, especially given the estimated 17 million potential patients in China. BioArctic's entitlement to a 9% royalty on global sales, without assuming the development costs, places the company in a favorable financial position. Investors should monitor the uptake of Leqembi in the private market and track subsequent performance metrics. The collaboration with a major Chinese medical insurance company to include the drug in their insurance plan is a strategic move likely to increase market penetration. However, the price point of CNY 2,508 per 200 mg vial could limit accessibility initially, possibly hindering widespread adoption in a low-income segment. Long-term, broader insurance coverage could alleviate this.

Oncology Doctor

The introduction of Leqembi offers an innovative approach to Alzheimer’s treatment by selectively binding to soluble and insoluble amyloid-beta aggregates, which are core components of Alzheimer's pathology. This mechanism of action is unique and holds promise for reducing the rate of disease progression. The scientific community has long sought treatments that offer not just symptomatic relief but also a deceleration in cognitive decline. The dual targeting of protofibrils and plaques is a comprehensive strategy that may set new benchmarks in Alzheimer’s therapy. Clinicians should stay informed about results from the ongoing evidence-building efforts, particularly focusing on how well patients respond to early diagnosis and treatment facilitated by emerging blood biomarkers. This could eventually lead to more personalized treatment regimens.

Market Research Analyst

From a market perspective, entering the Chinese market is a strategic move for Eisai and BioArctic. China's rapidly aging population and the substantial number of early Alzheimer's disease cases present a massive untapped market. The blend of online and offline services for diagnosis and treatment could serve as a model for other markets, emphasizing the importance of integrating technology with traditional healthcare services. However, the effectiveness of these channels and the actual demand within the private sector will need close monitoring. A potential challenge could be navigating the complex regulatory landscape and achieving widespread acceptance among healthcare providers and patients. The collaboration with a major insurance player is a positive signal but will need to be expanded to ensure broader market engagement.

STOCKHOLM, June 28, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai today announced today that Leqembi^® (brand name in China:  "乐意保^®", generic name: lecanemab) has been launched in China. Leqembi received approval in January 2024 as a treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. China is the third country to launch Leqembi following the United States and Japan.

Eisai estimates there are 17 million patients with MCI or mild dementia due to AD (collectively referred to as early AD) in China in 2024, which is expected to increase as the population ages.  Eisai is distributing the product in China and conducting information provision activities through specialized Medical Representatives, while also working to build a unique early AD diagnosis and treatment pathway that combines online and offline services. Eisai is also working to build evidence for the implementation of definitive diagnosis of early AD using blood biomarkers.

In China, Leqembi will first be launched in the private market and the price for a 200 mg vial will be CNY 2,508. In collaboration with Eisai, a major Chinese medical insurance company has developed and launched a healthcare insurance plan specifically for AD including partial coverage of the drug cost. Through these efforts, Eisai is committed to promoting the early detection, diagnosis, and treatment of AD in China.

Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils^[1]), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the world's first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has no development costs for Leqembi in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalty of 9 percent on global sales. In addition, BioArctic has the right to commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on June 28, 2024, at 01.30 a.m. CET.

For further information, please contact: 
Oskar Bosson, VP Communications and IR
E-mail:  oskar.bosson@bioarctic.com
Phone: +46 70 410 71 80 

Jiang Millington, Director Corporate Communication and Social Media
E-mail: jiang.millington@bioarctic.com
Phone: +46 79 33 99 166

About lecanemab (generic name, brand name: Leqembi^®)
Lecanemab (Leqembi) is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the U.S., Japan, China, and South Korea with the following indications:            

• U.S.: For the treatment of Alzheimer's disease (AD). It should be initiated in patients with mild cognitive impairment or mild dementia stage of disease. See full US prescribing information including boxed waring.
• Japan: For slowing progression of mild cognitive impairment (MCI) and mild dementia due to AD.
• China: For the treatment of MCI due to AD and mild AD dementia.
• South Korea: For treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD (early AD)

Lecanemab approvals were based on the large global Phase 3 Clarity AD study. In the Clarity AD study, lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai has also submitted applications for approval of lecanemab in 14 countries and regions, including the European Union (EU). A supplemental Biologics License Application (sBLA) for intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024. The rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous injection formulation, which is being developed to enhance convenience for patients, was initiated in the U.S. under Fast Track status in May 2024. 

Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

^[1] Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.

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Leqembi® (lecanemab) launched in China

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SOURCE BioArctic

FAQ

When was Leqembi launched in China?

Leqembi was launched in China on June 28, 2024.

What is Leqembi used for?

Leqembi is used for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD).

How many early AD patients are there in China?

There are an estimated 17 million early AD patients in China.

What is the price of Leqembi in China?

The price of a 200 mg vial of Leqembi in China is CNY 2,508.

Is there any insurance coverage for Leqembi in China?

Yes, a specialized healthcare insurance plan has been launched that partially covers the cost of Leqembi.

How does Leqembi work?

Leqembi selectively binds to and reduces amyloid-beta (Aβ) plaques in the brain, slowing cognitive and functional decline.

What are BioArctic's financial benefits from Leqembi sales?

BioArctic will receive milestone payments and a 9% royalty on global sales of Leqembi.

Are there plans to commercialize Leqembi in other regions?

BioArctic plans to commercialize Leqembi in the Nordic region pending European approval.