Anavex Life Sciences Announces Grant of U.S. Patent Covering Blarcamesine (ANAVEX®2-73) for Treatment of Neurodevelopmental Disorders
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Insights
The granting of U.S. Patent No. 11,839,600 to Anavex Life Sciences Corp. for ANAVEX®2-73 (blarcamesine) represents a significant bolstering of the company's intellectual property rights, particularly in the competitive field of neurologic therapeutics. This patent not only extends the exclusivity period for ANAVEX®2-73 until at least January 2037 but also covers a broad spectrum of neurodevelopmental and neurological conditions associated with MeCP2 gene mutations. The patent's scope, encompassing various symptoms and conditions, may deter competitors from entering the space and provides Anavex with a strategic advantage in terms of market exclusivity.
From a patent landscape perspective, the breadth of this patent is noteworthy. It covers a range of symptoms across multiple disorders, which could potentially reduce the risk of infringement by ensuring the uniqueness of the therapy. Moreover, the patent's longevity implies sustained revenue potential for Anavex, assuming successful commercialization and market adoption of ANAVEX®2-73. This can be particularly attractive to investors who are looking for companies with a strong defensive moat in the form of intellectual property.
The impact of ANAVEX®2-73 on Anavex's clinical pipeline cannot be overstated. The compound's expanded indication for various symptoms related to MeCP2 gene mutations could address a significant unmet medical need in neurodevelopmental disorders. The specificity of targeting loss-of-function mutations suggests potential for a personalized medicine approach, which is at the forefront of modern therapeutics. The clinical efficacy of ANAVEX®2-73 in ameliorating symptoms such as abnormal breathing, seizures and sleep disturbances will be critical in determining the drug's value proposition and its adoption by healthcare providers.
Furthermore, the potential for ANAVEX®2-73 to treat a range of disorders, from Rett syndrome to autism spectrum disorder and multiple sclerosis, indicates a wide target market. The success of the drug will hinge on the outcomes of clinical trials and subsequent FDA approval processes. Positive trial results could lead to considerable market penetration and revenue generation, while any setbacks could significantly impact the company's financial health and stock performance.
Anavex's strategic positioning in the neurologic therapeutics market is poised to strengthen with the addition of this patent. The market for treatments of the covered disorders, especially those with genetic underpinnings like Rett syndrome and certain autism spectrum disorders, is growing as awareness and diagnosis rates increase. The patent's protection of ANAVEX®2-73's use in a wide array of symptoms implies potential for capturing a significant share of this niche market.
Investors should monitor the progression of ANAVEX®2-73 through the clinical trial phases, as each phase's success can lead to incremental increases in the company's valuation. It is also essential to consider the competitive landscape; while the patent provides protection, the emergence of alternative therapies or changes in treatment guidelines can influence Anavex's market share. The long-term exclusivity granted by the patent is a crucial factor in forecasting the company's revenue streams and evaluating its investment potential.
Grant of Its Newest U.S. Patent Expands Anavex’s Intellectual Property Portfolio in Neurologic Indications
NEW YORK, Jan. 08, 2024 (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 including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2).
The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension.
“This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.”
About Neurodevelopmental Disorders
Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2
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.empowerbh.com/blog/what-are-neurodevelopmental-disorders/
2 https://ourworldindata.org/neurodevelopmental-disorders
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