Anavex Life Sciences Appoints Former FDA Officer as Senior Vice President for Nonclinical Development

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) has appointed Dr. Adebayo Laniyonu as Senior Vice President for Nonclinical Development. Dr. Laniyonu brings over 24 years of FDA experience, previously serving as Supervisory Pharmacologist/Toxicologist at the FDA’s CDER. His expertise encompasses the review of various drug submissions, aiding in regulatory guidance, and addressing issues in rare diseases. Anavex continues to focus on developing drugs for neurodegenerative conditions, with promising clinical results for its lead candidate ANAVEX®2-73 in Alzheimer’s and Parkinson’s diseases.

Positive

• Appointment of Dr. Adebayo Laniyonu as Senior VP, strengthening regulatory expertise.
• Dr. Laniyonu's extensive FDA experience enhances Anavex's strategic capabilities.
• Continued focus on neurodegenerative disorders with promising clinical results.

Negative

• None.

NEW YORK, May 05, 2021 (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) diseases, today announced the appointment of Dr. Adebayo (Bayo) Laniyonu, as Senior Vice President for Nonclinical Development. Dr. Laniyonu has over 24 years’ experience with the US Food and Drug Administration (FDA).

“Dr. Laniyonu has an accomplished track record of working within the FDA,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “His depth of experience makes him an excellent choice to provide objective perspective and manage the continuous nonclinical projects at Anavex.”

Prior to joining Anavex, Dr. Laniyonu served as Supervisory Pharmacologist/Toxicologist at the FDA Center for Drug Evaluation and Research (CDER). He has reviewed hundreds of NDAs, BLAs (including first in class), sNDAs, ANDAs and INDs and provided high impact regulatory and strategic recommendations to the Sponsors of these products. He organized, chaired and presented at FDA workshops and at scientific sessions of professional societies where he presented on FDA current thinking on regulatory issues, he has also presented at FDA Advisory Committee meetings. His review and Supervisory experience span several therapeutics areas including Rare Diseases and Medical Genetics, hematology, Medical Imaging, Radiation Medicine and Medical Counter Measures products. Dr. Laniyonu played pivotal roles in the development of several FDA regulatory guidance documents.

“I am very pleased to be joining Anavex at this important and exciting time for the company,” stated Dr. Laniyonu. “Anavex deep scientific base, innovative and novel approaches to discovery, including use of precision medicine and molecular biology to target a breath of rare diseases, and challenging therapeutic areas such as Rett syndrome, Parkinson’s disease, Parkinson’s disease dementia, Alzheimer’s disease, and other CNS diseases is exciting given the unmet medical needs or orphan nature of some of these diseases. I believe there are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2021 and beyond.”

Dr. Laniyonu holds a PhD in Pharmacology from the University of Glasgow, UK where he was a Commonwealth Scholar. He was also a Canadian Cystic Fibrosis Post-Doctoral Fellow. Dr. Laniyonu was a recipient of many FDA distinguished awards including Department of Health and Human Services Secretary’s Award for Distinguished Service, FDA Award of Merit, FDA Outstanding Service Award, FDA Group Recognition Award, CDER Excellence in Communication Award, CDER Excellence in Mentoring Award.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX^®2-73 (blarcamesine), completed successfully a Phase 2a clinical trials for Alzheimer’s disease and recently a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 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 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 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

FAQ

What is the significance of Dr. Laniyonu's appointment at Anavex?

Dr. Laniyonu's appointment is significant as he brings over 24 years of FDA regulatory experience, which could enhance Anavex's project management and regulatory strategies in drug development.

What drugs is Anavex developing for neurodegenerative disorders?

Anavex is developing ANAVEX®2-73 for Alzheimer’s disease and Parkinson’s disease, with successful results from recent clinical trials.

What achievements does Dr. Laniyonu have in his career?

Dr. Laniyonu has reviewed numerous drug submissions and contributed to FDA regulatory guidance, demonstrating a proven track record in drug development and regulatory affairs.

How does Dr. Laniyonu's experience benefit Anavex?

His experience with the FDA allows him to provide critical insights into nonclinical development, potentially improving Anavex's regulatory submissions and project outcomes.

What is the current status of Anavex's clinical trials?

Anavex recently completed Phase 2 trials for its lead drug candidate ANAVEX®2-73 in Alzheimer’s disease and Parkinson’s disease dementia, showing promising results.