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Anavex Life Sciences Appoints Senior VP of Regulatory Affairs



NEW YORK – November 6, 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) diseases, today announced the appointment of David Goldberger, RPh, MLS as Senior Vice President Regulatory Affairs. Mr. Goldberger brings over 40 years of pharmacy practice and pharmaceutical industry experience and has most recently been with Otsuka Pharmaceuticals Research and Development (Otsuka) as Vice President Global Regulatory Affairs, U.S. and Europe. Mr. Goldberger will succeed retiring Senior Vice President Regulatory Affairs, Emmanuel O Fadiran, RPh, MS, PhD.


“We are delighted to welcome Mr. Goldberger to the Anavex team,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Mr. Goldberger has an impressive background in leading the regulatory strategies for numerous product developments including subsequent NDA submissions and helping to deliver drug candidates to patients worldwide in addition to expertise in overseeing global regulatory interactions for CNS development projects. We also want to express our gratitude to Dr. Fadiran for his years of outstanding leadership and contributions to Anavex.”


Before joining Anavex Mr. Goldberger has most recently been with Otsuka where he led the Regulatory Affairs efforts to gain approval for multiple CNS products, including ABILIFY MAINTENA®, REXULTI®, new indications for ABILIFY® as well other product and therapeutic area approvals. Prior to Otsuka he held senior level positions in Global Regulatory Affairs for Johnson and Johnson (J&J) Pharmaceutical Research and Development in Global Regulatory Affairs. Throughout his career he has covered the full range of investigational products development and marketed products across multiple therapeutic areas including psychiatry and neurology. Mr. Goldberger has extensive experience in working with the U.S. FDA, EMA, Health Canada, and other global health authorities. In addition, he led CMC Regulatory Affairs, Labeling, Regulatory Operations/Technology and Medical Writing areas. Mr. Goldberger holds bachelor’s and master’s degrees from Rutgers University.


“I am very excited to be working with the Anavex portfolio, which has great potential to significantly impact the treatment of patients with neurodevelopmental, neurodegenerative and psychiatry disorders,” said Mr. Goldberger. “I believe that I can help build upon the work done to date and move the products toward regulatory approval for the patients who need them.”


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


Investors:

Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com


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