Anavex Life Sciences Corp. (OTCBB: AVXL)
 |
Website:
www.anavex.com |
| Read our report on Anavex Life Sciences Corp. (OTCBB: AVXL) |
Anavex Life Sciences Corp. (OTCBB: AVXL)
is utilizing its proprietary SIGMACEPTOR™ Discovery Platform to
discover and develop new drugs for the treatment of Central Nervous
System (CNS) diseases and cancer.
The Anavex portfolio comprises novel, wholly owned sigma receptor
agonists and antagonists in clinical and preclinical stages that
target neurodegenerative diseases and cancer. AVXL’s lead drug
candidate for Alzheimer’s Disease, ANAVEX 2-73, has successfully
completed a Phase 1 single ascending dose (SAD) clinical trial.
Results regarding the compound’s safety profile are very
encouraging.
AVXL has also started scale-up manufacturing of ANAVEX 1-41, its
second lead compound, targeting depression and Alzheimer’s Disease.
In our opinion, with sufficient quantities of ANAVEX 1-41 in hand,
AVXL will be in a position to advance the program and begin
preclinical studies on large animals in the near term. Another three
compounds (for malignant melanoma, prostatic cancer and epilepsy)
will complete preclinical testing soon. Additionally, further
compounds, which target conditions such as stroke, depression and
neuropathic pain, as well as various types of cancer, are in
preclinical development and will potentially enter clinical trials
over the following years.
We also believe that AVXL utilizes an innovative and radically
different approach, which in Alzheimer’s Disease emphasizes tackling
some of the potential upstream causes of Alzheimer’s Disease and may
be disease-modifying, unlike the currently available
symptomatic-only treatments.
AVXL’s work is led by a strong, proven Board of Directors and management team and supported by a highly experienced Scientific Advisory Board and skilled biochemists, medicinal chemists, pharmacologists, toxicologists and molecular biologists, who work in collaboration with leading research and academic institutions. In our opinion, AVXL is much further along than is reflected by its stock price.
Robust
Drug Pipeline
Anavex’s proprietary SIGMACEPTOR™ Discovery Platform has resulted
in, and continues to generate, small molecule drug candidates with
unique modes of action targeting sigma receptors in many
neurological diseases (such as Alzheimer’s Disease, depression,
epilepsy) and cancer. When bound by Anavex’s specifically designed
compounds, sigma receptors influence the functioning of multiple
biochemical signals that are involved in the pathogenesis (origin or
development) of a disease.
With its SIGMACEPTOR™-N program, Anavex is focused on developing the
first of a new class of disease-modifying treatments for CNS and
neurological diseases.
AVXL’s lead Alzheimer’s Disease drug candidate is ANAVEX 2-73. This
compound has preclinical pharmacological, behavioral and
histological evidence as a potentially effective antiamnesic,
neuroprotective (i.e. protects nerve cells from degeneration or
death) and anti-depressive agent, due to its potent affinity for
sigma-1 receptors and moderate affinities for M1-4 muscarinic
receptors. ANAVEX 19-144 is AVXL’s lead drug candidate for the
potential treatment of epilepsy.
Preclinical data reveals that these compounds exhibit significant
anti-amnesic, neuroprotective and anticonvulsant properties in a
variety of in vitro systems and specialized animal models. These
activities involve sigma-1, muscarinic and NMDA receptor components,
in addition to positively impacting ion channels, indicating a
unique mode of action.
During animal studies in epilepsy, ANAVEX 19-144 has shown it may
help control seizures and the epileptogenesis process. Moreover, its
neuroprotective properties may prevent the process that causes
longterm damage to tissue and cells as well as biochemical and
physiological alterations in the brain resulting from seizures. AVXL
has also reported promising
preclinical developments with ANAVEX 1-41, a sigma-1 receptor
agonist and a lead compound to treat depression. It may also be a
potential back-up compound to ANAVEX 2-73 for Alzheimer’s Disease.
Preclinical tests revealed significant neuroprotective benefits
through the prevention of endoplasmic reticulum stress,
mitochondrial stress and oxidative stress, which damage and destroys
cells and may be involved in primary causes of Alzheimer’s Disease.
In addition, ANAVEX 1-41 prevented the expression of caspase-3 in
animal models. Caspase-3 is an enzyme that plays a key role in
apoptosis (programmed cell death) and in the loss of cells in the
hippocampus, the part of the brain that regulates learning, emotion
and memory. These activities involve both muscarinic and sigma-1
receptor systems. Potentially, ANAVEX 1-41 may offer
disease-modifying options that reverse memory and learning deficits
and protect nerve cells from death through its anti-amnesic and
neuroprotective actions, as well as anti-depressive effects.
Both ANAVEX 2-73 and ANAVEX 1-41 may slow the progression of
Alzheimer’s Disease and potentially improve the quality of life of
those impacted by the disease.
The SIGMACEPTOR™-C program leverages some unique properties of sigma
receptor compounds, which allows Anavex to create the first of a new
class of drug candidates designed to combat various types of solid
cancers. Sigma receptors are highly expressed in different tumor
cell types and binding by sigma receptor binding
compounds may induce selective apoptosis.
In addition, through tumor cell membrane reorganization and
interactions with ion channels, AVXL’s cancer drug candidates may
play an important role in inhibiting the processes of metastasis
(spreading of cancer cells from the original site to other parts of
the body), angiogenesis (the formation of new blood vessels) and
tumor cell proliferation.
ANAVEX 1079, ANAVEX 1007 and ANAVEX 1519 are AVXL’s drug candidates
for the treatment of melanoma and prostate cancers. These are low
molecular weight, synthetic compounds exhibiting high (nanomolar)
affinity for sigma-1 and
moderate (micromolar) affinity for sigma-2 receptors and sodium
channels. In advanced preclinical studies, these compounds have
revealed anti-tumor potential with no toxic side effects to date in
animal models. They have also been shown to selectively kill human
cancer cells in xenograft models without affecting normal, healthy
cells and significantly suppressed tumor growth in immune-deficient
mice. These results have been reported in several scientific
publications.
ANAVEX 1066 is AVXL’s novel drug candidate for the potential
treatment of pancreatic and prostate cancers and neuropathic pain.
Numerous additional compounds are currently in the early discovery
and lead optimization stages of Anavex’s SIGMACEPTOR™-N and
SIGMACEPTOR™-C programs.
Potential Market
The financial potential of compounds that successfully tackle these
conditions is substantial. IMS Health estimates that the annual
sales in the markets for drugs that combat Alzheimer’s Disease,
epilepsy and depression are projected to reach $8 billion, $13
billion, and $14 billion respectively in 2012. The market for cancer
drugs will reach $75-$80 billion annually by 2012, almost double the
2007 value of $41 billion, according to the 2008 IMS Global Oncology
Forecast.
Market Position
AVXL’s 11,000-square-foot research laboratory in Athens, Greece is
the home base for a core team of researchers with expertise in
medicinal chemistry, molecular biology, biochemistry, toxicology and
pharmacology. In addition, Anavex boasts a network of strategic
collaborations with ABX-CRO, Syntagon, Cerep, Oncodesign, Eurogenet
Laboratories, FORENAP Pharma EURL, Amylgen SAS and leading academic
institutions, such as Université Montpellier, Université Nice and
Sophia Antipolis in France. These collaborations make it possible
for Anavex to outsource parts of its R&D process to drive capital
efficiency while maintaining control of its research initiatives and
intellectual property.
Biopharmaceuticals Sector
The global pharmaceutical market continues to experience high
growth. Significant R&D efforts and innovative new treatments from
smaller biotech companies are fuelling innovation for big
pharmaceutical firms and for the market in general.
The global market for pharmaceuticals is expected to reach $1.1
trillion in 2014, according to a report published in April 2010 by
IMS Health. Drug companies have enjoyed extremely high returns on
investment capital in recent years as well as a favorable company
survivorship rate compared with many other industries, notes
investment author and economist Larry MacDonald. “Demographic trends
suggest the need for growth in the pharmaceutical sector to support
future medical needs – particularly in Anavex’s areas of focus. In
North America, the aging of the “baby boom” generation is already
enhancing the demand for new, diseasemodifying treatments for
serious age-related diseases such as Alzheimer’s and cancer.
Meanwhile, the rise of new middle class populations in emerging
markets, such as China, India, Russia and Brazil, has created a vast
new international market for the best medications available. In our
opinion, companies that can help to satisfy needs to meet the
treatments required by these populations will fare very well in the
stock market.
Alzheimer’s Disease
According to the Alzheimer’s Association, by 2030, it is estimated
one out of eight people over age 65 will have
ALZHEIMER’S DISEASE.and nearly 50% of those over 85 will be
affected. Now it is critical for researchers, industry drug
developers and regulators to work together in order to bring disease
modifying therapies for Alzheimer’s Disease to market. According to
a study of the University of Connecticut, the successful development
of disease modifying drugs for Alzheimer’s Disease could potentially
save the U.S. healthcare system an estimated $4 trillion.
Alzheimer’s Disease is a healthcare system ‘time-bomb.’ Medications
today only treat the symptoms, not having the ability to stop the
onset nor progression of the disease. Meanwhile, the majority of
Alzheimer’s Disease treatments in development are focused on
reducing or dissolving amyloid-beta plaques.
There have been many well-publicized failures of those potential
amyloid removal therapies, including Neurochem’s Alzamed, Myriad
Genetics’ Flurizan and Lilly’s semagacestat. Vaccines that clear
amyloid-beta plaques, such as Wyeth/Elan’s AN-1792, have also failed
to impact the disease, while tau therapy is considered by many to be
not reproducible and fails to impact the disease. Monoclonal
antibodies have also failed to show compelling and statistically
significant benefit in Phase 2 studies across the range of
Alzheimer’s patients.
Recently, Medivation/Pfizer’s
Dimebon, an off-patent antihistamine, failed in Phase 3
clinical trials. While approximately 50 novel compounds are being
studied, most are in big pharma pipelines or are tied up under
existing partnership agreements. Typically, no small companies with
compounds that have successfully cleared
Phase 2 clinical trials are left unpartnered with big pharma. Anavex
was recognized in January 2011 by the independent publication
Alzheimer’s Weekly as ‘the most promising drug in Alzheimer’s
disease’ after their analysis of more than 100 studies and over
10,000 articles.
Epilepsy Treatment
It is estimated that 50 million people are living with epilepsy
worldwide, according to the International Bureau for Epilepsy. New
drugs that could potentially modify the onset and progression of
epilepsy are needed and may have blockbuster potential. Such drugs
would have a novel mode of action that combines anti-amnesic,
anxiolytic and neuroprotective properties, as well as excellent
safety and tolerability profiles. Anavex is currently developing
drug candidates seeking to deliver these properties.
Cancer
Cancer is a leading cause of death around the world, according to
the World Health Organization. Cases of cancer doubled globally
between 1975 and 2000, will double again by 2020, and will nearly
triple by 2030, says the report.
There were an estimated 12 million new cancer diagnoses and more
than seven million deaths worldwide this year. The projected numbers
for 2030 are 20 to 26 million new diagnoses and 13 to 17 million
deaths. Currently available treatments are not accessible nor
effective for many patients, and have limited impact on survival for
patients with metastatic disease. New treatments with novel
mechanisms of action that can overcome resistance mechanisms,
inhibit tumor cell proliferation, and trigger tumor cell death could
offer greater therapeutic benefit and improved survival. The Anavex
program is seeking to deliver such profiles within its drug
candidates. Given the substantial unmet need in cancer, such agents
may have the potential to become blockbusters.
Board and Management
Harvey Lalach—President, Secretary and Director:
Mr. Lalach is a senior-level executive with over 24 years of
experience. A co-founder of Anavex Life Sciences Corp., he has
served as President, Secretary and Director since AVXL’s inception
in 2007. He played an instrumental role in the development and
successful growth of numerous start-up ventures. He has spent many
years focused on the corporate governance and management of public
companies, serving in both Director and Officer capacities. He has
vast experience in corporate finance activities and strategic
initiatives, including several M&A transactions and raising equity
in North America and Europe.
George Tidmarsh, MD, PhD—Executive Director:
Dr. Tidmarsh has more than 20 years of experience and brings to
Anavex a significant track record in clinical trials, FDA drug
approvals and corporate growth. He has founded several successful
companies including Horizon Therapeutics (now Horizon Pharma)
(NASDAQ: HZNP). From 2005 through 2008 Dr. Tidmarsh served as
Horizon’s Chief Executive Officer, successfully completing four
Phase 1 and two large Phase 3 trials, including the registration
trials for Duexa, now FDA approved.
Prior to Horizon, Dr. Tidmarsh founded Threshold Pharmaceuticals
(NASDAQ: THLD) where he served as AVXL’s President and as a Director
from 2001 to 2006. Most recently, Dr. Tidmarsh served as Chief
Scientific Officer at Spectrum Pharmaceuticals as a part of their
acquisition of Metronome Therapeutics, a novel cancer drug
development company that Dr. Tidmarsh founded in 2007. In addition,
Dr. Tidmarsh’s background includes various positions at Coulter
Pharmaceuticals, including Chief Medical Officer, and SEQQUS where
he played a key role in the approval of Doxil. He has also held
scientific and clinical positions at Gilead Sciences and SyStemix.
Dr. Tidmarsh has published 25 peer-reviewed articles in leading
journals and authored 15 U.S. patents. He received his Bachelor of
Science, M.D., and Ph.D. from Stanford University, where he also
completed Residency and Fellowship training. In addition, Dr.
Tidmarsh is currently an Associate Professor of Pediatrics and
Neonatology at Stanford University School of Medicine.
Sean Lowry—Director:
Since 2001, Mr. Lowry has been president of Wm. Lowry Consulting, a
management consulting company. He has been a partner and portfolio
manager in Gulfstream Ventures, a venture capital firm, since 2006.
He has served as an officer and director of several private
companies, and was director of investor relations for the publicly
traded Workbrain Inc. between 2004 and 2006. He has financial
oversight responsibilities.
Robert Chisholm—Director:
A finance and administration executive with more than 25 years of
experience, Robert Chisholm has significant expertise in corporate
finance, strategic business initiatives and growth-oriented public
companies. Mr. Chisholm is currently an officer and partner of
Emprise Capital Corp, a private company focused on advising
portfolio companies on managing finances, including development and
implementation of comprehensive budgeting processes, public market
listings and oversight of contract negotiations. He is CFO and a
director of Savary Capital Corp., Windamere Ventures Ltd. (formerly
Advanced Vision Systems Corp.) and Brookwater Ventures. Mr. Chisholm
is also a member of the Board of Directors for Seymour Ventures.
Alexandre Vamvakides, Ph.D.—Scientific Founder, Chief Scientific
Officer, and Chairman of the Scientific Advisory Board.:
Dr. Vamvakides has spent 30 years in research, focusing on the
therapeutic/pharmacological areas of anti-neurodegenerative,
antiepileptic and anti-depressive molecules. The author of more than
80 scientific papers, he has worked at the Institut national de la
santé et de la recherche médicale (INSERM), the University of
Athens, Ciba-Geigy (now Novartis), Sanofi and many other research
laboratories throughout Europe, for the discovery and development of
new concepts in the therapeutic areas of CNS, oncology, as well as
anti-inflammatory diseases.
Tangui Nicolas Maurice, Ph.D.—Scientific Advisory Board:
Dr. Maurice has spent 15 years in the field of neurosciences,
including behavioral and molecular neuropharmacology, sigma
receptors, neuropeptides, neurosteroids, neurotrophic factors,
normal pathological aging models for Alzheimer’s and related
disorders, and behavioral phenotyping of rodent models. He is a
researcher at the Institut national de la santé et de la recherche
médicale (INSERM) U710 at Montpellier. He has also held research
positions at the Centre National de la Recherche Scientifique
(CNRS), INSERM U336, the department of neuropsychopharmacology and
hospital pharmacy at Meijo University (Nagoya, Japan), and Jouveinal
Research Institute (Fresnes, France).
Paul Aisen, MD—Scientific Advisory Board – Clinical Expert:
Dr. Aisen is a leading clinician and researcher in Alzheimer’s
disease clinical trials and is on the faculty of the University of
California, San Diego School of Medicine’s Department of
Neurosciences. Since 2007, he has been Director of the Alzheimer’s
Disease Cooperative Study, funded by the National Institute on Aging
to develop assessment instruments and conduct clinical trials. He is
Associate Editor of Alzheimer’s Research and Therapy, and sits on
the editorial board of BMC Medicine. He has published more than 180
peer-reviewed papers.
Rachelle Doody, MD, PhD—Scientific Advisory Board – Clinical Expert:
Dr. Doody is the Effie Marie Cain Chair in Alzheimer’s Disease
Research and Professor of Neurology at Baylor College of Medicine,
where she directs the Alzheimer’s Disease and Memory Disorders
Center (ADMDC), which was the lead developer of the most widely
prescribed Alzheimer’s disease drug worldwide. She has published
over 135 original articles, receiving multiple research grants. She
participates in a wide range of collaborative efforts and boards,
including Steering Committees.
Jeffrey Cummings, MD—Scientific Advisory Board – Clinical Expert:
Christopher Shackleton, MD—Scientific Advisory Board –
Advisor: Dr. Shackleton is a prominent, uniquely
qualified physician and surgeon, clinical investigator, information
technologist, and corporate finance and healthcare solutions
consultant. He holds triple specialist credentials in medical and
surgical disciplines. He has a strong publication record and is a
renowned innovator, pioneer and leader in the development and
deployment of new clinical techniques and treatment modalities.
Obtaining medical education and training from the Universities of
British Columbia, Toronto and Harvard, he also studied corporate
finance, financial markets and derivatives at The London School of
Economics, reaching the rank of full professor at the University of
Los Angeles (UCLA). He is also on the Board of Trustees of the
Fraser Institute.
Summary
Opportunities in the stock market are not always so clear cut and
certainly do not happen often. In our opinion, timing is everything
in the biotech industry. Those who get in earliest often reap the
biggest rewards. AVXL's management has continued to develop and
advance its lead drug ANAVEX 2-73 to the point where it is ready for
the ever important Phase 1 trials. The company's capital structure
has remained very tight with only 27.2 million shares outstanding
and roughly 19.5 million in the float. Anavex's market cap is
exceptionally small in respect to many other junior biotech's at or
near the same stage of development. With roughly a $45 million
market cap AVXL could be an easy acquisition target for a company
like Pfizer or Merck. In our opinion, investors have a tremendous
opportunity to make a major stock market score with AVXL.
OTCBB Symbol:
AVXL
Current Price:
$1.70
Shares Outstanding: 27.2
million
Public Float:
19.5 million
Market Cap:
$45 million
52 Week Trading Range:
52-Week Low: $1.05
52-Week High: $4.29
Corporate Offices:
50 Harrison Street
Suite 315A
Hoboken, NJ 07030
Phone:
416-489-0092
Website:
www.anavex.com
AVXL has a
Strong Pipeline of 30+ novel candidate drugs that address urgent
unmet medical needs for treating major
devastating diseases including Alzheimer’s Disease, epilepsy,
depression, stroke, neuropathic pain and other types of cancer.
Anavex is led by
a seasoned Board and management team and has access to leading
scientists and clinicians through its Scientific
Advisory Board.