2024-07-30 20:12:00
CAMBRIDGE, Massachusetts. & BREA, California & TOKYO –
Biogen Inc. (Nasdaq: BIIB), Beckman Coulter, Inc. and Fujirebio announced a collaboration to identify and develop potentially blood-based biomarkers for Tau pathology in the brain and to potentially advance and commercialize new tests for Tau pathology in Alzheimer’s Disease (AD). The development of tau-specific blood-based biomarkers that can measure a patient’s tau burden could provide crucial insights into the underlying pathological processes of Alzheimer’s Disease and facilitate the development of a new generation of therapies targeting tau pathology.
As part of this collaboration, the companies will work to identify new blood-based biomarkers and enhance known blood-based biomarkers for tau pathology in Alzheimer’s. The goal of the collaboration is to develop and clinically validate new tools to measure tau pathology in the brain to stratify patients or to monitor responses to treatment in clinical trials. The partnership has the potential to advance tau-specific blood-based biomarkers and diagnostic tools that could be used not only in clinical trials but also in clinical practice to enable the application of future therapies targeting tau pathology.
“The stratification and monitoring of patients regarding tau pathology is a growing need for the next generation of Alzheimer’s therapies, such as our pipeline of tau-targeted therapies, including tau-targeted ASOs,” said Jane Grogan, Ph.D., Head of Research at Biogen. “Through this collaboration, we aim to leverage our comprehensive scientific expertise in the development and use of biomarkers alongside our partners’ diagnostic capabilities to accelerate the development timeline for blood-based diagnostics that can measure the degree of a patient’s tau pathology.”
“The collaboration between Biogen, Beckman Coulter, and Fujirebio combines the strength of leading biomarker development with innovative potential treatments focused on the tauopathy aspect of neurodegeneration, bringing us closer to effective solutions,” said Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay at Beckman Coulter Diagnostics. “This collaboration with Biogen and Fujirebio underscores our commitment to work with leading companies in the field of neurodegenerative diseases to provide fully automated, high-throughput blood-based Alzheimer’s tests for the millions of dementia patients worldwide.”
“Blood-based biomarkers for tau pathology could accelerate the development and implementation of disease-modifying therapies for neurodegenerative diseases like Alzheimer’s,” said Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc. “This partnership will help us expedite our efforts to develop novel diagnostics for neurodegenerative diseases and deliver them to laboratories and clinicians around the world through our global diagnostics partners to meet the unmet medical need for blood-based biomarkers.”
Under the collaboration, Biogen will provide data from clinical Alzheimer’s studies and its expertise in biomarker research to prioritize the markers for tau pathology. Fujirebio and Beckman Coulter will be responsible for the development, manufacturing, and marketing of the diagnostics.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company pioneering innovative science to develop new medications that improve the lives of patients and create value for shareholders and society. We have a deep understanding of human biology and leverage multiple modalities to develop best-in-class treatments or therapies that deliver outstanding results. Our approach is to take bold risks aligned with return on investment to achieve long-term growth.
We regularly post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Facebook, LinkedIn, X, YouTube.
About Beckman Coulter, Inc.
Beckman Coulter is a global leader in modern diagnostics and has been committed for over 80 years to enhancing the role of the diagnostic laboratory in improving patient health. Our mission is to redefine healthcare—one diagnosis at a time—and we do this by harnessing the power of science, technology, and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing and can be found in hospitals, reference labs, and physician offices around the globe. Our goal is to offer smarter and faster diagnostic solutions that facilitate the transition from present to future. We do this by accelerating the supply of a comprehensive clinical menu, scalable laboratory automation technologies, insightful clinical informatics, and laboratory performance services. Beckman Coulter is headquartered in Brea, California, and employs more than 11,000 people worldwide. 2024-13330.
Stay connected with Beckman Coulter and follow the company on LinkedIn, X, and Facebook.
About Fujirebio
Fujirebio, a company of H.U. Group Holdings Inc., is a global leader in high-quality in vitro diagnostics (IVD). The company has over 50 years of experience in designing, developing, manufacturing, and globally marketing robust IVD products. Fujirebio delivers new technologies and novel diagnostic markers to the global diagnostics industry through material supply, contract development, and manufacturing.
Fujirebio was the first company to develop and market liquor biomarkers under the Innogenetics brand more than 25 years ago. Fujirebio continues to be the only company with such a comprehensive range of manual and fully automated tests for neurodegenerative diseases and continuously collaborates with organizations and clinical experts around the world to innovate earlier, simpler, and more comprehensive neurodegenerative diagnostics. For more information, visit www.fujirebio.com/alzheimer.
Biogen Safe Harbor
This press release contains forward-looking statements regarding: our strategy and plans; the potential and prospects for our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data evaluations and presentations; the potential for blood-based Alzheimer biomarker tests; regulatory discussions, submissions, applications and approvals; the potential benefits, safety, and efficacy of our and our collaboration with Beckman Coulter Diagnostics and Fujirebio;. These forward-looking statements may be accompanied by terms such as “aiming,” “anticipating,” “believing,” “estimating,” “expecting,” “projecting,” “targeting,” “intending,” “may,” “planning,” “potential,” “possible,” “foreseeing,” “will,” “would,” and other similar words and phrases. The development and marketing of drugs involve substantial risks, and only a small number of research and development programs result in the commercialization of a product. Results from early clinical studies may not be indicative of the full results or the outcomes of later or larger clinical studies and do not guarantee regulatory approval. You should not place undue reliance on these statements.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in these statements, including: our reliance on revenues from our products; the uncertainty of achieving long-term success in developing, licensing, or acquiring additional product candidates or indications for existing products; failure to compete; failure to successfully implement or realize the anticipated benefits of our strategic and growth initiatives; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; our reliance on collaborative partners and other third parties in the development, regulatory approval, and commercialization of products and other aspects of our business beyond our full control; risks related to current and potential future healthcare reforms; risks related to the commercialization of biosimilars; risks related to obtaining, protecting, and enforcing our data, intellectual property, and other proprietary rights as well as risks and uncertainties related to claims and disputes concerning intellectual property; the risk that positive results in one clinical study may not be repeated in subsequent or confirmatory studies or that success in early clinical studies may not be predictive of results in later or larger clinical studies or studies in other potential indications; risks related to clinical studies, including our ability to manage clinical activities appropriately, unexpected concerns that may arise from additional data or analyses obtained during clinical studies, regulatory authorities may require additional information or further studies or fail to grant or delay the approval of our drug candidates; the occurrence of adverse safety events, restrictions on the use of our products, or product liability claims; risks related to technological failures or breaches; issues with our manufacturing processes; risks related to management, personnel, and other organizational changes, including the recruitment and retention of personnel; non-compliance with legal and regulatory requirements; risks of international operations, including currency fluctuations; risks related to investments in our manufacturing capabilities; risks related to the distribution and sale of counterfeit or inappropriate versions of our products by third parties; risks associated with the use of social media and AI-based software for our business; operational results and financial condition; fluctuations in our operating results; risks associated with real estate investments; risks associated with access to capital and credit markets; risks related to debt; market, interest, and credit risks associated with our investment portfolio; risks related to stock buyback programs; terms regarding change of control in certain of our collaboration agreements; fluctuations in our effective tax rate; environmental risks; and all other risks and uncertainties described in other reports we file with the U.S. Securities and Exchange Commission.
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Source: Business Wire
Future Trends in Alzheimer’s Disease Biomarker Development
In an exciting development for Alzheimer’s research, Biogen Inc., Beckman Coulter, and Fujirebio have announced a collaboration aimed at identifying and developing blood-based biomarkers for tau pathology in the brain. This advancement highlights a significant trend towards creating innovative, less invasive diagnostic tools that could streamline the detection and monitoring of Alzheimer’s disease (AD). As the understanding of tau’s role in neurodegeneration deepens, tailored therapies centered on tau pathology are likely to emerge as a focal point in treatment strategies.
The collaboration aims to accelerate the identification and clinical validation of blood-based biomarkers. Blood tests specifically targeting tau pathology could potentially allow clinicians to stratify patients based on their disease progression, ultimately leading to more personalized treatment options. Such advancements echo a broader industry trend where precision medicine is becoming central to patient care, particularly in complex neurodegenerative disorders.
As these partnerships between biotechnology and diagnostic companies unfold, we can anticipate the emergence of high-throughput, automated diagnostic tests for Alzheimer’s. This would not only facilitate clinical studies but may also transition to widespread clinical practice, democratizing access to crucial diagnostic tools. Furthermore, the integration of big data analytics and artificial intelligence in biomarker research will likely enhance predictive capabilities, improving how clinicians assess treatment responses for Alzheimer’s therapies.
The convergence of cutting-edge research with diagnostic innovation holds the promise of advancing our understanding of Alzheimer’s disease significantly. As patients increasingly seek earlier diagnoses and effective treatments, blood-based biomarkers for tau pathology could emerge as a game-changing element in Alzheimer’s management, setting a precedent for future neurodegenerative disease diagnostics.
Continued collaboration across leading biotech and diagnostic firms will be instrumental in pioneering these efforts, paving the way for the development of novel diagnostics that enhance patient outcomes globally.