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ANAVEX Announces New U.S. Intellectual Property Compositions Patent for ANAVEX®2-73 (blarcamesine)



NEW YORK – June 1, 2023

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 awarded new U.S. Patent No. 11,661,405 entitled “CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof.


Anavex’s newest patent will be expected to remain in force at least until October 2036, not including any patent term extensions. The new patent will expand the coverage of certain ANAVEX®2-73 (blarcamesine) crystals covered by U.S. Patent No. 10,413,519, to methods of their making. The ANAVEX®2-73 (blarcamesine) compound in one of its crystal forms has been used in various preclinical and clinical trials, for a broad range of CNS disorders, including but not limited to, Alzheimer’s disease, Parkinson’s disease, Parkinson’s disease dementia, Rett syndrome, Fragile X syndrome, Infantile spasms, Angelman syndrome and other undisclosed rare CNS disorders.


“This new patent relating to ANAVEX®2-73 is exceptionally important for ANAVEX, because all clinical trials with ANAVEX®2-73 (blarcamesine), including Alzheimer’s disease Phase 2b/3 ANAVEX®2-73-AD-004 study are using the patent protected crystal forms as the active pharmaceutical ingredient,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We are extremely pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine) which demonstrates our continued commitment to protecting all aspects of the Anavex product portfolio.”


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 recently 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


Investors:

Andrew J. Barwicki Investor Relations Tel: 516-662-9461


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