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Anavex Life Sciences Announces Issuance of New U.S. Patent ANAVEX®2-73 (blarcamesine)

Intellectual Property Portfolio for the Treatment of Hypertension

NEW YORK – May 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 granted a new U.S. Patent No. 11,622,955 entitled “SIGMA-1 RECEPTOR AGONIST SYSTOLIC BLOOD PRESSURE THERAPY,” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s coverage of treatment methods for ANAVEX®2-73 (blarcamesine), to the treatment of systolic hypertension, or lowering systolic blood pressure.


We are extremely pleased with the expansion of the patent portfolio for ANAVEX®2-73 (blarcamesine) for the indication of hypertension which affects nearly half (47%) of adults in the United States, especially since elevated systolic blood pressure is a major health economy problem within our aging society, said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “This new patent will add to our already robust patent portfolio relating to ANAVEX®2-73, and further demonstrate our strong overall commitment to protecting the full range of commercial opportunities of our product portfolio.”


Anavex’s newest patent will be expected to remain in force at least until November 2038, not including any patent term extensions. The new patent expands existing protections for the use of ANAVEX®2-73 in treating neurodegenerative disorders to the new use for treating systolic hypertension in addition to existing antihypertension therapy. The market for uncontrolled hypertension is 37 million adults in the U.S. alone.


About Hypertension (High Blood Pressure)

The global antihypertensive drugs market size was worth around USD 20.5 billion in 2021 and is predicted to grow to around USD 39.5 billion by 2030.[1] Systolic hypertension is a major health economy problem within our aging society. Elevated systolic blood pressure is even more associated with cardiovascular morbidity and mortality than diastolic blood pressure.[2] According to the U.S. Centers for Disease Control, nearly half (47%) of adults in the United States have hypertension, defined as a systolic blood pressure greater than 130 mmHg or a diastolic blood pressure greater than 80 mmHg, or are taking medication for hypertension. In 2020, more than 670,000 deaths in the United States had hypertension as a primary or contributing cause. Only about 1 in 4 adults (24%) with hypertension have their condition under control. About half of adults (45%) with uncontrolled hypertension have a blood pressure of 140/90 mmHg or higher. This includes 37 million U.S. adults. About 34 million adults who are recommended to take medication may need it to be prescribed and to start taking it. High blood pressure costs the United States about USD 131 billion each year.[3]


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


[1] https://www.fnfresearch.com/antihypertensive-drugs-market [2] Duprez D. Treatment of isolated systolic hypertension in the elderly. Expert Rev Cardiovasc Ther. 2012 Nov;10(11):1367-73. doi: 10.1586/erc.12.117. PMID: 23244357 [3] https://www.cdc.gov/bloodpressure/facts.htm

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