Anavex Life Sciences Appoints Senior VP of Regulatory Affairs
November 06 2023 - 8:00AM
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 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 DevelopmentToll-free:
1-844-689-3939Email: info@anavex.com
Investors:Andrew J.
BarwickiInvestor RelationsTel: 516-662-9461Email:
andrew@barwicki.com
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