Fujirebio expands its Alzheimer’s disease test menu with the much awaited and fully automated Lumipulse® G pTau 217 Plasma assay for Research Use Only (RUO)

Gent, Belgium, Malvern PA, United States, and Tokyo, Japan, December 22nd, 2023 – H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

“The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”

About pTau 217

Current research indicates that plasma pTau, including pTau 217, is a predictor of amyloid status determined either by CSF1 or PET2, and therefore able to differentiate between Alzheimer’s disease (AD) and non-AD neurodegenerative diseases3,4 and to predict progression to AD.5,6 Blood-based biomarkers, such as plasma pTau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy in clinical trials, and could further advance the development and implementation of disease-modifying treatments in the field of AD and related disorders.7 This assay is designed to measure specifically the phosphorylation on position threonine 217 in human plasma.

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information at Fujirebio Alzheimer. - Fujirebio's Press Release  – H.U. Group's press Release [PDF] -

LEQEMBI® to be launched in Japan for Alzheimer’s disease on December 20

Stockholm, Sweden, December 13, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced that LEQEMBI (lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) drug price list.

LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan’s NHI drug price list, the products Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Heath, Labour and Welfare, held today. The launch, planned for December 20, will make Japan the second country to have the product on the market, following the U.S.

"This is a great Christmas present! Alzheimer's disease patients in Japan will now have access to the first disease modifying treatment. This gives hope for the large aging population in Japan with a great need for new treatment options," says Gunilla Osswald, CEO of BioArctic.

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, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

Eisai will conduct a post-marketing special use results survey in all patients who are administered LEQEMBI (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and the Optimal Clinical Use Guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (ARIA).

Eisai serves as the lead of LEQEMBI 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, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region... BioArctic's Press Release - Eisai's Press Release- Biogen's Press Release -

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.

Agitation symptoms negatively impact functioning, disease progression, quality of life and care for about half of Alzheimer’s dementia patients – and are a consistent predictor of nursing home admission.

REXULTI® is the first drug approved by the FDA for agitation associated with dementia due to Alzheimer’s disease.

November 06, 2023 - PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce that treatment with REXULTI® (brexpiprazole) resulted in statistically significant and clinically meaningful improvements in adult patients with agitation associated with dementia due to Alzheimer’s disease, according to the complete results of the placebo-controlled pivotal phase 3 Study 213 (NCT03548584), published today in JAMA Neurology.1 In May 2023, brexpiprazole became the first and only drug to receive approval from the Food and Drug Administration for this indication. REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Study 213 is the second pivotal phase 3 study, in addition to Study 283 (NCT01862640), to report positive efficacy and good tolerability for brexpiprazole, compared to a placebo, when used to treat patients with agitation associated with dementia due to Alzheimer’s disease.2 The JAMA Neurology publication is the first to report the efficacy of brexpiprazole to significantly improve each of three classifications of agitation symptoms: aggressive behaviors, physically nonaggressive behavior and verbally agitated behavior... Otsuka and Lundbeck's Press Release -  TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03548584

 

Alzheon Announces Phase 1 Results of ALZ-801, a First-in-Class Inhibitor of Amyloid Formation and Neurotoxicity for Alzheimer’s Disease

March 20, 2015 - LEXINGTON, Mass.- Alzheon, Inc., a clinical-stage biopharmaceutical company focused on brain health, memory and aging, today announced that the company presented Phase 1 clinical data for ALZ-801, a first-in-class small molecule inhibitor of amyloid formation and neurotoxicity for the treatment of Alzheimer’s disease. As additional support to the clinical program for ALZ-801, Alzheon presented expanded post-hoc analyses of Phase 3 data with tramiprosate, the parent molecule of the optimized prodrug ALZ-801, which demonstrated sustained efficacy on cognition and function in a population of patients with Alzheimer’s disease that are positive for the ε4 gene variant of apolipoprotein E (ApoE4), associated with increased risk of Alzheimer’s disease. The Phase 1 results and Phase 3 post-hoc clinical analyses were presented at a poster session today at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases in Nice, France... [PDF] Alzheon's Press Release -

Higher dose of Novartis drug Exelon® Patch approved by FDA for patients with mild to moderate Alzheimer's disease

Sept. 4, 2012 - The US Food and Drug Administration has approved a higher dose of Exelon® Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease. The new 13.3 mg/24 h dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition. 

"Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver," said Jeffrey Cummings, MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."... Novartis' Press Release -

ReproCELL launches Alzheimer’s disease model based on iPS-derived human neuronal cells

7th June 2012 - ReproCELL, Inc. (CEO: Chikafumi Yokoyama PhD) announces that the company will start commercializing human iPS-derived neurons in which an Alzheimer’s disease related gene has been incorporated.

ReproCELL’s scientists have successfully incorporated a gene related to Alzheimer’s disease using homologous recombinant genetic engineering technology into undifferentiated human iPS cells and then differentiated them into neurons. In these cells, it has been confirmed that amyloid beta 42 is accumulated at higher levels compared to normal neurons. This phenomena is similar to what is observed in neurons of Alzheimer’s patients. Accordingly, ReproCELL’s scientists believe the newly developed iPS cells can be useful for drug screening to identify new therapeutic molecules to treat Alzheimer’s disease patients.... ReproCELL's Press Release -

Axerion Therapeutics and AstraZeneca to Develop and Commercialize a Biologic Approach for the Treatment of Alzheimer’s Disease

May 1, 2012 - Axerion Therapeutics, Inc., a private Connecticut-based biotechnology company, and MedImmune the global biologics arm of AstraZeneca, announced that they have entered into a research collaboration and sublicense arrangement to develop and commercialize a biologic approach for the treatment of Alzheimer's disease.

The agreement with Axerion is the first collaboration signed within the new Neuroscience Innovative Medicines Unit that AstraZeneca announced in February 2012. Under this model, AstraZeneca and MedImmune will conduct neuroscience discovery research and early development for small and large molecules by tapping into the best available external science and sharing cost, risk and reward with other research partners active in psychiatry, neurology and pain research.

Under the terms of the agreement, Axerion has granted the AstraZeneca Neuroscience Innovative Medicines Unit an exclusive sublicense* to research, develop and commercialize a pre-clinical biologic that targets the binding of A-beta oligimers to prion proteins.

In exchange, the AstraZeneca Neuroscience Innovative Medicines Unit will provide Axerion with certain upfront and milestone payments plus research and development (R&D) funding during the time both companies are working together on the program. Additionally, Axerion will earn royalties on product sales. The financial terms of the deal have not been disclosed... Axerion Therapeutics' Press Release -

Piramal Healthcare : Encouraging Phase III Study Results Show PET Imaging with Florbetaben Reliably Detects Beta-Amyloid in the Brain

April 16, 2012 - Lead Compound in newly created subsidiary Piramal Imaging SA - Piramal Imaging SA (“Piramal”), a newly formed subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], announced positive results from a Phase III study that showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease. The study results will be featured as part of the Emerging Science Program on April 25th at the American Academy of Neurology’s 64th Annual Meeting in New Orleans.

Historically, the only way to definitively diagnose Alzheimer’s disease has been after death – at autopsy – through analysis and identification of beta-amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).

Piramal has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG through its newly created subsidiary – Piramal Imaging SA. Florbetaben is the lead compound in the portfolio... Piramal Healthcare's Press Release -