Eisai, the partner of BioArctic AB’s (publ), an emerging life sciences company listed on NASDAQ Stockholm, has just taken a major step towards realizing their goal of providing a new treatment for early-stage Alzheimer’s disease.
The duo have submitted a Marketing Authorisation Application (MAA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody.
Lecanemab has been designated by the MHRA to be part of the Innovative Licensing and Access Pathway (ILAP) which, if approved, will see it become a much needed treatment option for those with confirmed amyloid pathology in the brain.
The groundbreaking Clarity AD study of lecanemab has shown a promise in slowing down the progression of Alzheimer’s disease. By selectively binding and eliminating the toxic Aβ aggregates associated with the disease, lecanemab achieved highly statistically significant results across its primary and secondary endpoints.
The results of this study have led to the filing of a Marketing Authorisation Application with the MHRA – a validating process that could see lecanemab providing hope to those living with Alzheimer’s.
Eisai is leading the charge in the development and global submission of lecanemab, while collaborating with Biogen to co-commercialize and promote this revolutionary product. With Eisai in the driver seat, having final decision-making authority, BioArctic holds the exclusive rights to commercialize lecanemab in the Nordic region. The two have joined forces in preparation for a joint commercial presentation in the region, getting ready to revolutionize the healthcare landscape.
About the Innovative Licensing and Access Pathway (ILAP) in the UK
The Innovative Licensing and Access Pathway (ILAP) from the Medicines and Healthcare products Regulatory Agency (MHRA) is an exciting program designed to provide a faster route to market for life-saving and seriously debilitating medicines.
It works by improving communication and coordination between pharmaceutical companies, the MHRA and reimbursement bodies like NICE, leading up to Marketing Authorisation Application (MAA) submissions. This is great news for patients in desperate need of innovative treatments, allowing them to gain access to cutting-edge care faster than ever before.
BioArctic and Eisai have joined forces to create Lecanemab, a revolutionary humanized monoclonal antibody designed to target forms of the protein amyloid-beta (Aβ). This immunoglobulin gamma 1 (IgG1) has the potential to be a highly effective solution for those suffering from Alzheimer’s and other related diseases. Lecanemab will be able to interact with both the soluble and insoluble forms of Aβ, presenting an innovative and promising treatment for the future.
On January 6, 2023, the US Food and Drug Administration (FDA) granted accelerated approval for lecanemab in the treatment of Alzheimer’s disease. This was swiftly followed by a supplemental Biologics License Application (sBLA), submitted by Eisai on the same day, which was granted priority review and is due for a US action date of July 6, 2023.
This was swiftly followed by submissions to medical authorities in Europe, Japan, China and Canada for similar reviews and approval; the most recent of which being the New Drug Submission (NDS) to Health Canada which was accepted on May 15, 2023. Overall, a tremendous effort by Eisai has accelerated the approval of lecanemab around the world.
Eisai has pulled out all the stops with the submission and approval of Lecanemab for the treatment of Alzheimer’s disease. On January 6, 2023, the US Food and Drug Administration granted accelerated approval, swiftly followed by a priority review from the US with an action date of July 6, 2023.
This momentum was then carried around the world with medical authorities in Europe, Japan, China and Canada all accepting submissions. Most recently, the New Drug Submission to Health Canada was accepted on May 15, 2023. Through their collaborative efforts, Eisai has greatly speeded up the approval process of such an important drug.
Eisai has put in tireless work and dedication to achieve accelerated approval for the Lecanemab drug in the treatment of Alzheimer’s disease from US Food and Drug Administration on January 6, 2023.
Subsequently, the US granted a priority review with a deadline of July 6, 2023 that resulted in global acceptance of the drug by medical authorities in countries such as Europe, Japan, China and Canada. Most recently, the New Drug Submission to Health Canada was accepted on May 15, 2023 – an achievement that has been made possible through Eisai’s hard work and collaboration in accelerating the approval process of this life-changing drug.
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) is ongoing, where lecanemab is given as a background anti-amyloid treatment when exploring combination therapies with anti-tau treatments. The study is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis.
About the collaboration between BioArctic and Eisai
For over a decade, BioArctic has pursued a strong partnership with Eisai to bring effective therapies to Alzheimer’s disease. The two companies formally confirmed their collaboration with key contracts in 2007 and 2015.
After further development, Eisai and Biogen joined forces in 2014 with the goal of bringing lecanemab to market. By collaborating together, they are striving to turn the tide in the battle against Alzheimer’s disease by providing treatments that improve the lives of all those affected.
BioArctic and Eisai are on the brink of a joint commercial venture to bring lecanemab to the Nordic region. There are no development costs for BioArctic, and they are entitled to rewards upon gaining regulatory approvals and sales milestones- not to mention the royalties they will receive on global sales. This is a momentous partnership that could be a groundbreaking breakthrough in the field of Alzheimer’s disease!
About BioArctic AB
BioArctic AB (publ) is a pioneering Swedish biopharma company that strives to develop cutting-edge disease-modifying treatments for neurodegenerative disorders like Alzheimer’s, Parkinson’s and ALS. Based on world-class research from Uppsala University, BioArctic is dedicated to find solutions in areas with urgent unmet medical needs.
Working closely with renowned universities and their global partner Eisai in Alzheimer disease, the company leverages a project portfolio fueled by both fully funded partnerships with global pharmaceutical companies and innovation driven in-house projects with potential for market and out-licensing. BioArctic’s Class B share is traded on Nasdaq Stockholm Large Cap (ticker: BIOA B).