Stockholm, May 17, 2023 /PRNewswire/ -- BioArctic AB's
(publ) (Nasdaq Stockholm: BIOA
B) partner Eisai today announced the publication of results from
a simulation study evaluating the societal value of lecanemab
(brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid
beta (Aβ) protofibril[1] antibody,
for the treatment of early Alzheimer's
disease[2], in the context of the Japanese
health care system in the peer-reviewed journal Neurology
and Therapy. The paper concluded that lecanemab treatment
would improve health and humanistic (quality of life) outcomes and
reduce medical costs, public care costs and caregiver burden for
individuals with early AD and their caregivers in Japan.
More details of the results of the simulation can be found in
the paper or in Eisai's press release.
Eisai serves as the lead of lecanemab development and regulatory
submissions globally with both Eisai and Biogen co-commercializing
and co-promoting the product and Eisai having final decision-making
authority. BioArctic has the right to commercialize lecanemab in
the Nordic region 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 person below, on May 17, 2023, at 01.30
a.m. CET.
For further information, please contact:
Oskar Bosson, VP Communications and
IR
E-mail: oskar.bosson@bioarctic.se
Phone: +46 70 410 71 80
About lecanemab
Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a
strategic research alliance between BioArctic and Eisai. Lecanemab
is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody
directed against aggregated soluble and insoluble forms of
amyloid-beta (Aβ). In the US, LEQEMBI was granted accelerated
approval by the US Food and Drug Administration (FDA) on
January 6, 2023 and was launched in
the U.S. on January 18, 2023. LEQEMBI
is indicated for the treatment of Alzheimer's disease (AD) in the
U.S. Treatment with LEQEMBI should be initiated in patients with
mild cognitive impairment or mild dementia stage of disease, the
population in which treatment was initiated in clinical trials.
There are no safety or effectiveness data on initiating treatment
at earlier or later stages of the disease than were studied. The
accelerated approval was based on Phase 2b data that demonstrated that lecanemab reduced
the accumulation of Aβ plaque in the brain, a defining feature of
AD, and its continued approval may be contingent upon verification
of lecanemab's clinical benefit in a confirmatory trial. The U.S.
Food and Drug Administration (FDA) determined that the results of
Clarity AD can serve as the confirmatory study to verify the
clinical benefit of lecanemab.
Please see LEQEMBI US Prescribing Information.
In the U.S., Eisai submitted a supplemental Biologics License
Application (sBLA) to the FDA for approval under the traditional
pathway on January 6, 2023. On
March 3, 2023, the FDA accepted
Eisai's sBLA based on the Clarity AD clinical data, and the
lecanemab application has been granted Priority Review, with a
Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to
hold an Advisory Committee to discuss this application on
June 9, 2023. Eisai submitted an
application for manufacturing and marketing approval to the
Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023, in Japan. Priority Review was granted by the
Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the prior
assessment consultation system of PMDA, with the aim of shortening
the review period for lecanemab. In Europe, Eisai submitted a marketing
authorization application (MAA) to the European Medicines Agency
(EMA) on January 9, 2023, which was
accepted on January 26, 2023. In
China, Eisai initiated submission
of data for a BLA to the National Medical Products Administration
(NMPA) of China in December 2022, and Priority Review was granted on
February 27, 2023.
Eisai has completed a lecanemab subcutaneous bioavailability
study, and subcutaneous dosing is currently being evaluated in the
Clarity AD open label extension study. 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
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 in December
2007, and the Development and Commercialization agreement
for the antibody BAN2401 back-up for Alzheimer's disease, which was
signed in May 2015. In March 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 and currently Eisai and BioArctic are preparing for a joint
commercialization in the region. 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 disease-modifying treatments for
neurodegenerative diseases, such as Alzheimer's disease,
Parkinson's disease, and ALS. BioArctic focuses on innovative
treatments in areas with high unmet medical needs. The company was
founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are
of great importance to the company together with its strategically
important global partner Eisai in Alzheimer disease. The project
portfolio is a combination of fully funded projects run in
partnership with global pharmaceutical companies and innovative
in-house projects with significant market and out-licensing
potential. BioArctic's Class B share is listed on Nasdaq Stockholm
Large Cap (ticker: BIOA B). For more information about BioArctic,
please visit www.bioarctic.com.
[1] Protofibrils are large Aβ aggregated soluble
species of 75-5000 Kd
[2] Mild cognitive impairment due to Alzheimer's
disease (AD) and mild AD dementia
The following files are available for download:
https://mb.cision.com/Main/9978/3771004/2065864.pdf
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Societal value of
lecanemab in Japan published in Neurology and Therapy
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