Anavex Life Sciences Announces Grant of U.S. Patent Covering Blarcamesine (ANAVEX®2-73) for Treatment of Insomnia or Anxiety

Grant of Its Newest U.S. Patent Expands Anavex’s Compounds Intellectual Property Portfolio

NEW YORK, Nov. 22, 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 including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 11,813,242 entitled “A2-73 AS A THERAPEUTIC FOR INSOMNIA, ANXIETY, AND AGITATION”. This patent expands Anavex’s existing patent coverage of ANAVEX^®2-73 (blarcamesine), including U.S. Patent No. 11,337,953 to cover Anavex’s leading drug candidate, ANAVEX^®2-73 (blarcamesine), ANAVEX^®1-41 and ANAVEX^®19-144, for treating insomnia, anxiety or agitation.

Insomnia-related costs in the U.S. have been estimated in 2020 to exceed $100 billion per year.¹ The economic burden of anxiety in the U.S. was estimated in 2019 to be over $46.4 billion.² The total incremental cost of just institutionalization of Alzheimer’s disease patients associated with agitation was estimated in 2019 at $4.3 billion in the U.S.³

This newest patent is expected to remain in force at least until July 2037, not including any patent term extension. Together with Anavex U.S. Patent No. 11,337,953, which is expected to remain in force at least until 2038, not including any patent term extension, the two patents provide extensive coverage of ANAVEX^®2-73 (blarcamesine) for use in treating either insomnia or anxiety, used alone or in combination with ANAVEX^®19-144 or ANAVEX^®1-41. The two patents broadly cover a range of dosage forms in treating known co-morbidities in Alzheimer’s disease including but not limited to oral, injectable, topical, inhalable, subcutaneous, intranasal and sublingual dosage forms.

“This granted USPTO patent is not only another important milestone in protecting the commercial potential of ANAVEX^®2-73 (blarcamesine) and Anavex’s other lead compounds with the practical value of delivering holistic care for patients with Alzheimer’s dementia or Parkinson’s diseases, who often concurrently suffer from insomnia and/or anxiety, but along with other recent allowances, demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our entire product portfolio,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

About Insomnia and Anxiety

Insomnia – Left untreated, insomnia can affect memory and concentration, and raises health risks in many areas, such as high blood pressure, coronary heart disease, diabetes, cancer, depression. According to the CDC, about 1 out of 3 U.S. adults complain of poor sleep. Growing evidence shows that sleep deprivation can affect buildup of beta-amyloid in the brain, a pathological link to dementia, Alzheimer’s disease, and Parkinson’s disease.⁴

Anxiety – Symptoms of anxiety characterize several neurological conditions. Anxiety is particularly common in individuals with symptoms of dementia and/or Alzheimer’s disease, especially for those patients who retain self-awareness of their condition. Anxiety can make certain symptoms of dementia worse, by affecting cognitive function such as attention, planning, organizing and decision-making.⁵

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
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¹ https://www.ajmc.com/view/economic-burden-and-managed-care-considerations-for-the-treatment-of-insomnia
² https://pubmed.ncbi.nlm.nih.gov/31646432/
³ https://alz-journals.onlinelibrary.wiley.com/doi/10.1016/j.trci.2019.10.004
⁴ https://www.nih.gov/news-events/nih-research-matters/sleep-deprivation-increases-alzheimers-protein
⁵ https://www.alzheimers.org.uk/about-dementia/symptoms-and-diagnosis/anxiety-dementia#:~:text=It%20is%20common%20for%20people,%2C%20organising%20and%20decision%2Dmaking.