Anavex Received Agreement from the Committee for Medicinal Products for Human Use (CHMP) for the Submission of a Marketing Authorisation Application of Oral Blarcamesine for Alzheimer’s Disease
- Oral blarcamesine for Alzheimer’s disease is eligible for submission of a Union Marketing Authorisation in the EU under the centralised procedure
- Blarcamesine addresses a broader Alzheimer’s disease population compared to monoclonal antibodies
- Significant improvement in dementia symptoms and reduction of pathological aggregation of amyloid in early Alzheimer’s disease
- None.
Insights
The eligibility of Anavex's blarcamesine for a centralised review by the EMA's CHMP is a pivotal development for the company. It simplifies the regulatory pathway across EU member states, which is a significant advantage for a clinical-stage biopharmaceutical company. The potential of blarcamesine as a convenient oral therapy for Alzheimer's disease, not requiring invasive diagnostic procedures, positions it favorably against more intrusive treatments like monoclonal antibodies.
From an investment perspective, this eligibility may signal a reduced risk profile for Anavex's pipeline and can potentially lead to a re-evaluation of the company's market valuation. The addressable market for Alzheimer's treatments is substantial and growing, which could result in considerable revenue streams if blarcamesine is approved and successfully commercialized.
However, the market for Alzheimer's treatments is highly competitive and subject to rigorous regulatory scrutiny, given past challenges in drug development for this disease. Investors should monitor the progress of the Marketing Authorisation Application and any emerging efficacy and safety data, which will be crucial for the drug's market prospects.
Blarcamesine's potential impact on Alzheimer's disease treatment is noteworthy. The Phase 2b/3 trial results indicating not only symptomatic improvement but also a reduction in amyloid aggregation and brain volume loss are promising. These findings suggest a dual action of blarcamesine on both the symptoms and the pathophysiology of Alzheimer's disease, which is a significant breakthrough if validated by further research.
For healthcare providers and patients, the ease of diagnosis without the need for PET scans or lumbar punctures could lead to broader accessibility and adoption of the treatment. This is especially important considering the anticipated doubling of Alzheimer's cases in Europe by 2030. The potential for blarcamesine to treat a larger patient population than current therapies could have a profound impact on public health and healthcare systems.
The strategic implications for Anavex within the EU market are substantial. By leveraging the centralised procedure, Anavex can streamline the marketing application process, which could lead to faster access to the market and a unified marketing strategy across EU countries. This is a crucial step for a clinical-stage company transitioning to commercial phases.
For stakeholders, including investors and potential partners, the CHMP's decision enhances the attractiveness of Anavex's portfolio. The broader treatment population for blarcamesine compared to competitors' therapies could lead to higher market penetration and stronger negotiating power with payers. The anticipated publication in a peer-reviewed journal will further validate the scientific community's acceptance of the research.
However, the long-term success of blarcamesine will depend on its clinical efficacy, safety profile and the ability of Anavex to effectively manage the commercialization process, including manufacturing, distribution and marketing. These factors will ultimately determine the return on investment for stakeholders.
NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, announced today that the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of an application for a Union Marketing Authorisation in the EU under the European Medicines Agency’s centralised procedure.
The granting of the eligibility from the CHMP under the centralised procedure allows for submission of a single Marketing Application to the European Medicines Agency that, if approved, would allow blarcamesine to be marketed in all EU member states. Anavex is aiming to submit the Marketing Authorisation Application as early as possible in 2024.
“We appreciate the CHMP/EMA’s decision to deem blarcamesine eligible for a centralised regulatory review,” said Anavex’s Christopher U Missling, PhD, President and Chief Executive Officer. “We understand that there is a need for scalable and accessible treatments options which can be pragmatically administered like oral blarcamesine not requiring any complex additional procedures for the treatment of people with Alzheimer’s disease.”
There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 20301, which could be addressed by blarcamesine.
Since blarcamesine requires only a physician assessed diagnosis of Alzheimer’s disease and not any invasive amyloid positron emission tomography (PET) scans or lumbar punctures (spinal tap), the potential addressable market for blarcamesine consist of a broader Alzheimer’s disease population compared to the class of drugs called monoclonal antibodies, which require a minimum threshold of amyloid measured by PET or spinal tap. According to a recent NIH-funded analysis, applying the clinical trial eligibility criteria for monoclonal antibodies resulted in only a small fraction of participants with Alzheimer’s disease being eligible to receive treatment.2
The ANAVEX®2-73-AD-004 Alzheimer’s disease placebo-controlled Phase 2b/3 trial showed that in addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.
Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized, placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
2 Pittock RR, Aakre JA, Castillo AM, et al. Eligibility for Anti-Amyloid Treatment in a Population-Based Study of Cognitive Aging. Neurology. 2023;101(19):e1837-e1849. doi:10.1212/WNL.0000000000207770
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