Anavex Life Sciences Appoints Former FDA Officer as Senior Vice President of Regulatory Affairs
May 01 2017 - 7:00AM
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
diseases including Alzheimer’s disease, other central nervous
system (CNS) diseases, pain and various types of cancer, today
announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as
Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24
years of regulatory experience within the U.S. Food and Drug
Administration (FDA), having held leadership positions at the FDA’s
Center for Drug Evaluation and Research (CDER).
“Dr. Fadiran 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 manage the considerable number of regulatory
filings that Anavex has planned.”
Prior to joining Anavex, Dr. Fadiran served as a Clinical
Pharmacology Team Leader at the FDA’s CDER. During his 24-year
(1993-2017) tenure at the FDA, Dr. Fadiran reviewed hundreds of New
Drug Applications (NDAs), supplemental New Drug Applications
(sNDAs), Biologics License Application (BLAs), Abbreviated New Drug
Applications (ANDAs) and Investigational New Drug applications
(INDs) for approval and made strategic recommendations for the
development of several products across many therapeutic categories.
He was on review teams for several novel therapies including
first-in-class approvals. Dr. Fadiran also led a cross-disciplinary
NDA review team and authored the first Cross-Discipline Team Leader
(CDTL) review for the Division of the Pulmonary and Allergy
Products, Office of Drug Evaluation II, CDER. He was actively
involved in the writing, internal/external training and
implementation of the U.S. FDA Guidance for Industry for population
pharmacokinetics.
“I am very pleased to be joining Anavex at this important and
exciting time for the company,” stated Dr. Fadiran. “There are
tremendous opportunities ahead, and I look forward to working with
the Anavex team to deliver on the corporate objectives for 2017 and
beyond.”
Dr. Fadiran has been involved in the formulation of significant
strategic FDA regulatory initiatives including serving as a member
of the Senior Management Teams for the Data Standard (Janus) and
Sentinel Initiatives. He was an active member of the FDA Senior
Science Council working group for the creation and launching of the
FDA’s Strategic Plan for Regulatory Science in 2012. Recently, he
has played an active role in the development of the Comprehensive
in vitro Proarrhythmia Assay (CiPA) for future replacement of the
thorough QT studies. As a long-term member of the FDA Institutional
Review Board (IRB), he actively contributed to the development of
standard operating procedures (SOP) for the committee.
Dr. Fadiran holds a BS (Pharmacy) and MS from Obafemi Awolowo
University, Ile-Ife, Nigeria and a PhD in Pharmaceutical Sciences
from the University of Strathclyde, Glasgow, UK. Dr. Fadiran
is a recipient of the prestigious Fogarty International Fellowship
of the National Institutes of Health (NIH) (1991-1993) as well as
numerous awards from the FDA, among them the Commissioner’s Award
of Excellence, in recognition of his outstanding contributions to
regulatory review of applications and development of regulatory
guidance and policies.
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
diseases including Alzheimer’s disease, other central nervous
system (CNS) diseases, pain and various types of cancer. Anavex’s
lead drug candidate, ANAVEX 2-73, recently successfully completed a
Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an
orally available drug candidate that restores cellular homeostasis
by targeting sigma-1 and muscarinic receptors and successfully
completed Phase 1. Preclinical studies demonstrated its potential
to halt and/or reverse the course of Alzheimer’s disease. ANAVEX
2-73 has also exhibited anticonvulsant, anti-amnesic,
neuroprotective and anti-depressant properties in animal models,
indicating its potential to treat additional CNS disorders,
including epilepsy and others. The Michael J. Fox Foundation for
Parkinson’s Research has awarded Anavex a research grant to develop
ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund
a preclinical study, which could justify moving ANAVEX 2-73 into a
Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting
sigma-1 and M1 muscarinic receptors, is a promising preclinical
drug candidate demonstrating disease modifications against the
major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including
cognitive deficits, amyloid and tau pathologies, and also with
beneficial effects on neuroinflammation and mitochondrial
dysfunctions. Further information is available
at www.anavex.com. You can also connect with the company on
Twitter, Facebook and LinkedIn.
Forward-Looking StatementsStatements 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:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
203-258-0159
dennisdobsonjr@dobsonmediagroup.com
Social Media:
Bill Douglass
Gotham Communications
646-504-0890
bill@gothamcomm.com
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