Anavex Life Sciences Announces Issuance of Blarcamesine (ANAVEX®2-73) Composition of Matter U.S. Patent Expanding its Intellectual Property Portfolio

NEW YORK, Jan. 27, 2025 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer’s disease, Parkinson’s disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, announced today it was issued a new U.S. Patent No. 12,180,174 entitled “A2-73 CRYSTALLINE POLYMORPH COMPOSITIONS OF MATTER AND METHODS OF USE THEREOF” from the United States Patent and Trademark Office (USPTO) for its U.S. Patent Application Serial Number USSN: 17/978,818. This new patent claims crystalline forms of the dihydrogen phosphate salt of ANAVEX®2-73 (blarcamesine), freebase, transdermal patches and enteric coated oral dosage forms including the same for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer’s disease, Parkinson’s disease and other disorders.

Anavex’s newest patent will be expected to remain in force at least until July 2039, not including any patent term extensions. It will expand and supplement the current ANAVEX®2-73 (blarcamesine) patent portfolio, which includes several U.S. Patents, including U.S. Patent Nos. 10,413,519; 10,966,952; 11,661,405; and 11,498,908.

“The issuance of this U.S. Patent again showcases our expertise in identifying and pursuing novel therapeutic forms and formulations that are rooted in science,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We believe the unique properties of the dihydrogen phosphate crystals make it possible in addition to convenient once daily oral dosing to also deliver the active (ANAVEX®2-73 freebase) in transdermal patches, which could simplify further the administration and boost patients’ compliance. As such, we believe that the addition of the dihydrogen phosphate crystals to our platform could greatly benefit the patients at large.”

About Crystal Forms

Crystal polymorphism is a unique phenomenon related to chiral compounds, wherein the compounds may crystallize into different crystal structures or crystal forms under different conditions and/or processes. Specifically for pharmaceuticals, polymorphic forms of drug substances ‘exist in different crystalline forms which differ in their physical properties’.¹ These property differences may result in direct medical implications, such as ease of formulation, increased efficacy, and reduced side effects. For example, the widely used analgesic drug, acetaminophen has three polymorphic forms, I, II, and III, among which only Form I is made into commercial dosage forms as the other two forms are either meta-stable or unstable.² Nonetheless, uncovering an optimal crystal form is NOT an easy or straightforward task, because there are so many variables and possibilities involved, and chance of success lies heavily on the researcher’s experience and insights into the compounds in question. Both ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 have the potential to form different crystal forms. Through its deep understanding and abundance experience with these two compounds, Anavex was successful in discovering crystal forms of ANAVEX®2-73 (blarcamesine) and ANAVEX®19-144 that have advantageous physiochemical and/or pharmacological properties.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

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, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, 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 and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 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. We believe that ANAVEX®3-71, which targets SIGMAR1 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 ICH HARMONISED TRIPARTITE GUIDELINE, SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES Q6A, Current Step 4 version dated 6 October 1999, page 8.

² Lee E.H., “A practical guide to pharmaceutical polymorph screening & selection,” Asian Journal of Pharmaceutical Sciences, Vol 9, Issue 4, August 2014, Pages 163-175.