BioArctic: Lecanemab receives priority review status in Japan - Yahoo Finance

1 year ago 38

, /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) spouse Eisai announced contiguous that the exertion for manufacturing and selling support for lecanemab (generic name, U.S. marque name: LEQEMBI™) successful Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Lecanemab is an anti-amyloid-β (Aβ) protofibril[1] antibody for attraction of Alzheimer's illness (AD). Priority Review successful Japan is granted to caller medicines recognized arsenic having precocious aesculapian inferior for superior diseases, and erstwhile designated for Priority Review, the people full reappraisal play is shortened.

In Japan, Eisai submitted the manufacturing and selling support for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) connected January 16, 2023. This exertion is based connected the results of the Phase 3 Clarity AD survey and the Phase 2b objective study, which demonstrated that lecanemab attraction showed a simplification of objective diminution successful aboriginal AD.

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to lend to the neurotoxicity successful AD. As such, lecanemab whitethorn person the imaginable to person an effect connected illness pathology and to dilatory down the progression of the disease. The Clarity AD survey of lecanemab met its superior endpoint and each cardinal secondary endpoints with highly statistically important results. In November 2022, the results of the Clarity AD survey were presented at the 2022 Clinical Trials connected Alzheimer's Disease (CTAD) league and simultaneously published successful the New England Journal of Medicine, a peer-reviewed aesculapian journal.

In the U.S., lecanemab was granted accelerated support arsenic a attraction for AD by the U.S. Food and Drug Administration (FDA) connected January 6, 2023. On the aforesaid day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for support nether the accepted pathway. In Europe, Eisai submitted a selling authorization exertion (MAA) to the European Medicines Agency (EMA) connected January 9, 2023, which was accepted connected January 26, 2023. In China, Eisai initiated submission of information for a BLA to the National Medical Products Administration (NMPA) successful December 2022.

Eisai serves arsenic the pb of lecanemab improvement and regulatory submissions globally with some Eisai and Biogen co-commercializing and co-promoting the merchandise and Eisai having last decision-making authority. BioArctic has close to commercialize lecanemab successful the Nordic nether definite conditions and is presently preparing for commercialization successful the Nordics unneurotic with Eisai. BioArctic has nary improvement costs for lecanemab successful Alzheimer's illness and is entitled to payments successful transportation with regulatory filings, approvals, and income milestones arsenic good arsenic royalties connected planetary sales.

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This accusation is accusation that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The accusation was released for nationalist disclosure, done the bureau of the interaction idiosyncratic below, connected January 30, 2023, astatine 00.30 a.m. CET.

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

About Priority Review successful Japan
Priority reappraisal is granted to medicines that conscionable each of the pursuing requirements. In addition, medicines designated arsenic orphan drugs and pioneering medicines volition beryllium fixed precedence for review.
i. the qualifying illness is deemed to beryllium serious; and
ii. the efficacy oregon information of the merchandise is recognized to beryllium intelligibly superior to that of existing medicines, aesculapian devices, oregon regenerative aesculapian products oregon attraction methods from a aesculapian constituent of view.

About lecanemab
Lecanemab (Brand Name successful the U.S.: LEQEMBI™) is the effect of a strategical probe confederation betwixt BioArctic and Eisai. Lecanemab is simply a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid-beta (Aβ). Lecanemab selectively binds and eliminates Aβ protofibrils that are thought to lend to the neurotoxicity successful Alzheimer's disease. As such, lecanemab whitethorn person the imaginable to person an effect connected illness pathology and to dilatory down the progression of the disease. In the U.S., LEQEMBI was granted accelerated support by the U.S. Food and Drug Administration (FDA) connected January 6, 2023. LEQEMBI is indicated for the attraction of Alzheimer's illness successful the U.S. Treatment with LEQEMBI should beryllium initiated successful patients with mild cognitive impairment oregon mild dementia signifier of disease, the colonisation successful which attraction was initiated successful objective trials. There are nary information oregon effectiveness information connected initiating attraction astatine earlier oregon aboriginal stages of the illness than were studied. This denotation is approved nether accelerated support based connected simplification successful Aβ plaques observed successful patients treated with LEQEMBI. Continued support for this denotation whitethorn beryllium contingent upon verification of objective payment successful a confirmatory trial. The Clarity AD survey of lecanemab met its superior endpoint and each cardinal secondary endpoints with highly statistically important results. Please spot LEQEMBI US Prescribing Information.

Eisai has completed a lecanemab subcutaneous bioavailability survey and subcutaneous dosing is presently being evaluated successful the Clarity AD unfastened statement hold study.

Since July 2020 Eisai's Phase 3 objective survey (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically mean and person intermediate oregon elevated levels of amyloid successful their brains, is ongoing. AHEAD 3-45 is conducted arsenic a public-private concern betwixt the Alzheimer's Clinical Trial Consortium that provides the infrastructure for world objective trials successful AD and related dementias successful the U.S, funded by the National Institute connected Aging, portion of the National Institutes of Health and Eisai.

Since January 2022, the Tau NexGen objective survey for Dominantly Inherited AD (DIAD) is ongoing, wherever lecanemab is fixed arsenic a inheritance anti-amyloid attraction erstwhile exploring operation therapies with anti-tau treatments. The survey is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine successful St. Louis.

About the collaboration betwixt BioArctic and Eisai
Since 2005, BioArctic has a semipermanent collaboration with Eisai regarding the improvement and commercialization of drugs for the attraction of Alzheimer's disease. The astir important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed successful December 2007, and the Development and Commercialization statement for the antibody BAN2401 back-up for Alzheimer's disease, which was signed successful May 2015. In March 2014, Eisai and Biogen entered into a associated improvement and commercialization statement for lecanemab. Eisai is liable for the objective development, exertion for marketplace support and commercialization of the products for Alzheimer's disease. BioArctic has close to commercialize lecanemab successful the Nordic nether definite conditions and is presently preparing for commercialization successful the Nordics unneurotic with Eisai. BioArctic has nary improvement costs for lecanemab successful Alzheimer's illness and is entitled to payments successful transportation with regulatory filings, approvals, and income milestones arsenic good arsenic royalties connected planetary sales.

About BioArctic AB
BioArctic AB (publ) is simply a Swedish research-based biopharma institution focusing connected disease-modifying treatments for neurodegenerative diseases, specified arsenic Alzheimer's disease, Parkinson's illness and ALS. BioArctic focuses connected innovative treatments successful areas with precocious unmet aesculapian needs. The institution was founded successful 2003 based connected innovative probe from Uppsala University, Sweden. Collaborations with universities are of large value to the institution unneurotic with its strategically important planetary spouse Eisai successful Alzheimer disease. The task portfolio is simply a operation of afloat funded projects tally successful concern with planetary pharmaceutical companies and innovative in-house projects with important marketplace and out-licensing potential. BioArctic's Class B stock is listed connected Nasdaq Stockholm Large Cap (ticker: BIOA B). For much accusation astir BioArctic, delight sojourn www.bioarctic.com.

^[1] Protofibrils are ample Aβ aggregated soluble taxon of 75-500 Kd

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