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Leqembi® launched in South Korea

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Eisai has launched Leqembi® in South Korea following its approval in May 2024 for treating early Alzheimer's disease (AD). The drug targets approximately 900,000 dementia patients in South Korea, where about 70% have Alzheimer's dementia. Leqembi, developed through collaboration between BioArctic and Eisai, is the first approved treatment that reduces disease progression by targeting amyloid-beta aggregates. The initial launch will be in the private market, with BioArctic retaining rights for joint commercialization in the Nordic region pending European approval.

Eisai ha lanciato Leqembi® in Corea del Sud dopo la sua approvazione nel maggio 2024 per il trattamento dell'Alzheimer nelle fasi iniziali (AD). Il farmaco si rivolge a circa 900.000 pazienti affetti da demenza in Corea del Sud, dove circa il 70% ha demenza di Alzheimer. Leqembi, sviluppato attraverso la collaborazione tra BioArctic ed Eisai, è il primo trattamento approvato che riduce la progressione della malattia puntando agli aggregati di amiloide-beta. Il lancio iniziale avverrà nel mercato privato, con BioArctic che mantiene i diritti per la commercializzazione congiunta nella regione nordica in attesa dell'approvazione europea.

Eisai ha lanzado Leqembi® en Corea del Sur tras su aprobación en mayo de 2024 para el tratamiento de la enfermedad de Alzheimer en sus etapas tempranas (AD). El medicamento está dirigido a aproximadamente 900,000 pacientes con demencia en Corea del Sur, donde alrededor del 70% tiene demencia tipo Alzheimer. Leqembi, desarrollado mediante la colaboración entre BioArctic y Eisai, es el primer tratamiento aprobado que reduce la progresión de la enfermedad al dirigirse a los agregados de beta-amiloide. El lanzamiento inicial se realizará en el mercado privado, con BioArctic manteniendo los derechos para la comercialización conjunta en la región nórdica a la espera de la aprobación europea.

이사이가 2024년 5월 초기 알츠하이머 병(AD) 치료를 위한 승인을 받은 후 한국에서 Leqembi®를 출시했습니다. 이 약물은 한국의 약 90만 명의 치매 환자를 대상으로 하며, 이 중 약 70%가 알츠하이머형 치매에 해당합니다. LeqembiBioArctic와 이사이의 협업을 통해 개발된 최초의 승인을 받은 치료제로, 아밀로이드 베타 집합체를 타겟으로 하여 질병 진행을 줄이는 염두에 두고 있습니다. 초기 출시가 민간 시장에서 진행되며, BioArctic는 유럽의 승인을 기다리면서 북유럽 지역에서의 공동 상용화를 위한 권리를 유지합니다.

Eisai a lancé Leqembi® en Corée du Sud après son approbation en mai 2024 pour le traitement de la maladie d'Alzheimer à un stade précoce (AD). Ce médicament cible environ 900 000 patients atteints de démence en Corée du Sud, où environ 70 % souffrent de démence de type Alzheimer. Leqembi, développé grâce à une collaboration entre BioArctic et Eisai, est le premier traitement approuvé qui réduit la progression de la maladie en ciblant les agrégats d'amyloïde-beta. Le lancement initial se fera sur le marché privé, BioArctic conservant les droits de commercialisation conjointe dans la région nordique en attente de l'approbation européenne.

Eisai hat Leqembi® in Südkorea eingeführt, nachdem es im Mai 2024 zur Behandlung der frühen Alzheimer-Krankheit (AD) genehmigt wurde. Das Medikament richtet sich an etwa 900.000 Demenzpatienten in Südkorea, von denen etwa 70 % an Alzheimer-Demenz leiden. Leqembi, das in Zusammenarbeit zwischen BioArctic und Eisai entwickelt wurde, ist die erste zugelassene Behandlung, die das Fortschreiten der Krankheit durch gezielte Wirkung auf amyloid-beta-Aggregate verringert. Der anfängliche Launch erfolgt im Privatmarkt, wobei BioArctic die Rechte für die gemeinsame Vermarktung in der nordischen Region bis zur europäischen Genehmigung erhält.

Positive
  • First approved treatment showing disease progression reduction in Alzheimer's
  • Market expansion into South Korea, accessing a potential market of ~630,000 Alzheimer's patients
  • Maintains rights for Nordic region commercialization
Negative
  • initial launch to private market only in South Korea

Insights

The launch of Leqembi in South Korea represents a significant market expansion for BioArctic and Eisai in a country with substantial market potential. With approximately 900,000 dementia patients and 70% being Alzheimer's cases, the addressable market is considerable. The private market launch strategy suggests a premium pricing approach, which could drive meaningful revenue.

The drug's unique mechanism targeting both soluble and insoluble amyloid-beta aggregates positions it favorably in the market. South Korea's aging population and high dementia prevalence rate of 10% in people over 65 presents a growing opportunity. This expansion follows successful launches in other markets and strengthens BioArctic's global commercial presence in the Alzheimer's treatment space.

STOCKHOLM, Nov. 27, 2024 /PRNewswire/ - BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai today announced today that Leqembi® (generic name: lecanemab) has been launched in South Korea. Leqembi received approval in South Korea in May 2024 for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia (early AD).

Eisai estimates there were approximately 900,000 dementia patients in South Korea in 2021, with one in ten people over the age of 65 suffering from dementia, and one in five from mild cognitive impairment (MCI). It is reported that Alzheimer's dementia patients account for about 70 percent of all dementia patients.[1] In South Korea, Eisai will first launch Leqembi in the private market.

Leqembi selectively binds to soluble amyloid-beta (Aβ) aggregates (protofibrils[2]), 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 first 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 the right to jointly commercialize Leqembi in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

The information was released for public disclosure, through the agency of the contact persons below, on November 28, 2024, at 00.30 CET.

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

About lecanemab (Leqembi®)

Lecanemab 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, South Korea, Hong Kong, Israel, United Arab Emirates and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

Eisai has also submitted applications for regulatory approval of lecanemab in 17 other countries and regions, including the European Union. In November 2024, the treatment received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval. A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was submitted to the U.S. Food and Drug Administration (FDA) in March 2024, which was accepted in June 2024. In October 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 completed in the U.S. under Fast Track status.

Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study 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] Korean dementia observatory 2022: National Institute of Dementia (Korean)

[2] 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® launched in South Korea

Cision View original content:https://www.prnewswire.com/news-releases/leqembi-launched-in-south-korea-302317977.html

SOURCE BioArctic

FAQ

When did Leqembi (BIOA) receive approval in South Korea?

Leqembi received approval in South Korea in May 2024 for treatment of early Alzheimer's disease.

What is the target market size for Leqembi (BIOA) in South Korea?

There were approximately 900,000 dementia patients in South Korea in 2021, with Alzheimer's dementia patients accounting for about 70% of all cases.

How does Leqembi (BIOA) work in treating Alzheimer's disease?

Leqembi works by binding to and reducing both soluble amyloid-beta aggregates (protofibrils) and insoluble Aβ aggregates (fibrils) in the brain, which are major components of Aβ plaques in Alzheimer's disease.

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