Lil
03-23-2006, 08:47 AM
Business Editors / Health/Medical Writers
VERNON HILLS, Ill.--(BUSINESS WIRE)--March 23, 2006--
Applied NeuroSolutions, a biopharmaceutical company
focused on diagnostics and novel therapeutic targets for treatment of
Alzheimer's disease (AD), today announced results for the full-year
ended December 31, 2005. Total revenues for the twelve months ended
December 31, 2005 increased 90% to $480,000 compared to $253,000 in
2004. Net loss for the 2005 full-year was $2.62 million, or $0.028 per
share, versus $2.80 million, or $0.032 per share, in 2004. Applied
NeuroSolutions ended the year with $1.66 million in cash. The company
currently spends approximately $675,000 each quarter.
John F. DeBernardis, Ph.D., President and Chief Executive Officer
of Applied NeuroSolutions, said, "Our continued focus this year is to
advance our cerebrospinal fluid (CSF) diagnostic test for Alzheimer's
disease towards commercialization both in the U.S. and overseas, and
further advance our serum-based diagnostic test to the point of
commercial viability. There is currently no FDA-approved diagnostic
test to detect Alzheimer's disease. Today, the only definitive way to
diagnose AD is from an autopsy. We continue to see promise in our
technology and believe it has the potential to diagnose AD early so
that the patients can have the best chance to treat the symptoms of
the disease."
Dr. DeBernardis continued, "Our long-range goal is to discover
novel targets for AD therapeutics based on what we believe is a common
intracellular phosphorylation pathway leading to the development of
abnormal, destructive brain structures characteristic of AD. We have
also developed proprietary reagents that allow us to identify and
validate appropriate, disease-specific intervention points in this
pathway that may suggest novel therapeutic approaches." Dr.
DeBernardis further commented that the company intends to partner its
discovery capabilities with pharmaceutical companies to further their
AD therapeutic development programs.
Applied NeuroSolutions' technology is based on discoveries made by
Dr. Peter Davies, Professor of Pathology and Neuroscience at the
Albert Einstein College of Medicine and the company's founding
scientist. Applied NeuroSolutions has patents on the AD-related
discoveries that are derived from Dr. Davies' lab.
Corporate
-- The company appointed Jay B. Langner and Robert S. Vaters to
the Board of Directors. Jay has been the Chairman of the Board
of Trustees of Montefiore Medical Center for the past 21
years. Robert S. Vaters was the Executive Vice President of
Strategy and Corporate Development of Inamed Corporation
(NASDAQ:IMDC).
-- Applied NeuroSolutions renewed agreements with founding
scientist, Dr. Peter Davies.
-- Applied NeuroSolutions raised awareness of the importance of
diagnosing Alzheimer's disease early and has received
extensive media attention over the past year.
Regulatory
-- Management continued its discussions with the FDA. Applied
NeuroSolutions has already submitted its pre-Investigational
Device Exemptions (IDE) package to the FDA and had its pre-IDE
meeting with the FDA. Applied NeuroSolutions is currently
working with its regulatory consultants and Alzheimer's
disease experts to incorporate FDA feedback from this meeting
that would lead toward an IDE filing.
-- The company is pursuing a CE mark in Europe, which would allow
the test to be marketed in Europe.
Research
-- Researchers worldwide, in collaboration with Applied
NeuroSolutions and Dr. Peter Davies, published four studies in
peer-reviewed scientific journals in 2005; two additional
studies conducted in 2005 were published in peer-reviewed
scientific journals in early 2006. There were four studies
initiated in 2005, which are currently ongoing, including a
longitudinal mild cognitive impairment (MCI) study and a study
of MCI and p-tau 231 levels.
-- Applied NeuroSolutions entered into a research agreement with
Nanosphere, Inc., a nanotechnology-based molecular diagnostics
company, to assist in the development of a second-generation
diagnostic test for AD, utilizing other bodily fluids, such as
serum.
-- bioMerieux, S.A., a leading international diagnostics group,
continued to evaluate Applied NeuroSolutions' technology. As
announced in December 2004, Applied NeuroSolutions established
a non-exclusive license agreement with bioMerieux, which
allowed them to evaluate the technology before it elects to
continue the agreement.
-- Applied NeuroSolutions continued to hold ongoing discussions
with large pharmaceutical companies, diagnostic companies and
reference laboratories on potential applications of Applied
NeuroSolutions' technologies.
About Applied NeuroSolutions' Alzheimer's Disease Diagnostic Test
Increased amounts of the altered tau protein in cerebrospinal
fluid (ptau-231) distinguish AD patients from those with other forms
of cognitive impairment, providing an early diagnostic test and a
method for following disease progression. Applied NeuroSolutions has
developed an antibody-based test measuring the protein in the CSF of
AD patients and is working on a second-stage blood serum-based test
that is expected to be easier to perform and less expensive.
Currently there is no FDA-approved diagnostic test to detect AD
and follow its progression. Confirmation of diagnosis is performed
through a series of behavioral measurements and brain scans.
Definitive diagnosis can be made only from examination of postmortem
brain tissue samples. Applied NeuroSolutions' test would provide a
significant breakthrough in supporting definitive early diagnosis.
About Applied NeuroSolutions
Applied NeuroSolutions, Inc. (OTCBB:APNS) is developing products
to both diagnose and discover novel therapeutic targets for
Alzheimer's disease. The company's technology is based on discoveries
originating from the Albert Einstein College of Medicine. Applied
NeuroSolutions has developed a cerebrospinal fluid (CSF) test to
detect early-stage Alzheimer's disease with a 85%-95% accuracy in more
than 3,500 patient samples. There are approximately 2 million new
patients annually worldwide who are candidates for an AD CSF
diagnostic test, according to the research firm Datamonitor. The
company is also developing a blood serum-based screening test, as well
as novel therapeutic targets for treatment of AD. Alzheimer's disease
currently afflicts over 4 million Americans, and the market for AD
therapy is expected to grow to 21 million patients by 2010 in the
seven major pharmaceutical markets (USA, France, Germany, Italy,
Spain, U.K. and Japan) according to BioPortfolio, Ltd. There is
currently no FDA-approved diagnostic test to detect Alzheimer's
disease. For more information, visit www.appliedneurosolutions.com.
KEYWORD: NORTH AMERICA ILLINOIS UNITED STATES
INDUSTRY KEYWORD: SENIORS HEALTH BIOTECHNOLOGY CLINICAL TRIALS GENETICS MEDICAL DEVICES MENTAL HEALTH PHARMACEUTICAL RESEARCH & SCIENCE CONSUMER EARNINGS
SOURCE: Applied NeuroSolutions, Inc.
CONTACT INFORMATION:
Applied NeuroSolutions, Inc.
David Ellison, CFO, 847-573-8000
or
Financial Dynamics
Julie Huang (Investors), 212-850-5600
or
Monarch Communications
Jeff Siegel (media), 516-569-4271
VERNON HILLS, Ill.--(BUSINESS WIRE)--March 23, 2006--
Applied NeuroSolutions, a biopharmaceutical company
focused on diagnostics and novel therapeutic targets for treatment of
Alzheimer's disease (AD), today announced results for the full-year
ended December 31, 2005. Total revenues for the twelve months ended
December 31, 2005 increased 90% to $480,000 compared to $253,000 in
2004. Net loss for the 2005 full-year was $2.62 million, or $0.028 per
share, versus $2.80 million, or $0.032 per share, in 2004. Applied
NeuroSolutions ended the year with $1.66 million in cash. The company
currently spends approximately $675,000 each quarter.
John F. DeBernardis, Ph.D., President and Chief Executive Officer
of Applied NeuroSolutions, said, "Our continued focus this year is to
advance our cerebrospinal fluid (CSF) diagnostic test for Alzheimer's
disease towards commercialization both in the U.S. and overseas, and
further advance our serum-based diagnostic test to the point of
commercial viability. There is currently no FDA-approved diagnostic
test to detect Alzheimer's disease. Today, the only definitive way to
diagnose AD is from an autopsy. We continue to see promise in our
technology and believe it has the potential to diagnose AD early so
that the patients can have the best chance to treat the symptoms of
the disease."
Dr. DeBernardis continued, "Our long-range goal is to discover
novel targets for AD therapeutics based on what we believe is a common
intracellular phosphorylation pathway leading to the development of
abnormal, destructive brain structures characteristic of AD. We have
also developed proprietary reagents that allow us to identify and
validate appropriate, disease-specific intervention points in this
pathway that may suggest novel therapeutic approaches." Dr.
DeBernardis further commented that the company intends to partner its
discovery capabilities with pharmaceutical companies to further their
AD therapeutic development programs.
Applied NeuroSolutions' technology is based on discoveries made by
Dr. Peter Davies, Professor of Pathology and Neuroscience at the
Albert Einstein College of Medicine and the company's founding
scientist. Applied NeuroSolutions has patents on the AD-related
discoveries that are derived from Dr. Davies' lab.
Corporate
-- The company appointed Jay B. Langner and Robert S. Vaters to
the Board of Directors. Jay has been the Chairman of the Board
of Trustees of Montefiore Medical Center for the past 21
years. Robert S. Vaters was the Executive Vice President of
Strategy and Corporate Development of Inamed Corporation
(NASDAQ:IMDC).
-- Applied NeuroSolutions renewed agreements with founding
scientist, Dr. Peter Davies.
-- Applied NeuroSolutions raised awareness of the importance of
diagnosing Alzheimer's disease early and has received
extensive media attention over the past year.
Regulatory
-- Management continued its discussions with the FDA. Applied
NeuroSolutions has already submitted its pre-Investigational
Device Exemptions (IDE) package to the FDA and had its pre-IDE
meeting with the FDA. Applied NeuroSolutions is currently
working with its regulatory consultants and Alzheimer's
disease experts to incorporate FDA feedback from this meeting
that would lead toward an IDE filing.
-- The company is pursuing a CE mark in Europe, which would allow
the test to be marketed in Europe.
Research
-- Researchers worldwide, in collaboration with Applied
NeuroSolutions and Dr. Peter Davies, published four studies in
peer-reviewed scientific journals in 2005; two additional
studies conducted in 2005 were published in peer-reviewed
scientific journals in early 2006. There were four studies
initiated in 2005, which are currently ongoing, including a
longitudinal mild cognitive impairment (MCI) study and a study
of MCI and p-tau 231 levels.
-- Applied NeuroSolutions entered into a research agreement with
Nanosphere, Inc., a nanotechnology-based molecular diagnostics
company, to assist in the development of a second-generation
diagnostic test for AD, utilizing other bodily fluids, such as
serum.
-- bioMerieux, S.A., a leading international diagnostics group,
continued to evaluate Applied NeuroSolutions' technology. As
announced in December 2004, Applied NeuroSolutions established
a non-exclusive license agreement with bioMerieux, which
allowed them to evaluate the technology before it elects to
continue the agreement.
-- Applied NeuroSolutions continued to hold ongoing discussions
with large pharmaceutical companies, diagnostic companies and
reference laboratories on potential applications of Applied
NeuroSolutions' technologies.
About Applied NeuroSolutions' Alzheimer's Disease Diagnostic Test
Increased amounts of the altered tau protein in cerebrospinal
fluid (ptau-231) distinguish AD patients from those with other forms
of cognitive impairment, providing an early diagnostic test and a
method for following disease progression. Applied NeuroSolutions has
developed an antibody-based test measuring the protein in the CSF of
AD patients and is working on a second-stage blood serum-based test
that is expected to be easier to perform and less expensive.
Currently there is no FDA-approved diagnostic test to detect AD
and follow its progression. Confirmation of diagnosis is performed
through a series of behavioral measurements and brain scans.
Definitive diagnosis can be made only from examination of postmortem
brain tissue samples. Applied NeuroSolutions' test would provide a
significant breakthrough in supporting definitive early diagnosis.
About Applied NeuroSolutions
Applied NeuroSolutions, Inc. (OTCBB:APNS) is developing products
to both diagnose and discover novel therapeutic targets for
Alzheimer's disease. The company's technology is based on discoveries
originating from the Albert Einstein College of Medicine. Applied
NeuroSolutions has developed a cerebrospinal fluid (CSF) test to
detect early-stage Alzheimer's disease with a 85%-95% accuracy in more
than 3,500 patient samples. There are approximately 2 million new
patients annually worldwide who are candidates for an AD CSF
diagnostic test, according to the research firm Datamonitor. The
company is also developing a blood serum-based screening test, as well
as novel therapeutic targets for treatment of AD. Alzheimer's disease
currently afflicts over 4 million Americans, and the market for AD
therapy is expected to grow to 21 million patients by 2010 in the
seven major pharmaceutical markets (USA, France, Germany, Italy,
Spain, U.K. and Japan) according to BioPortfolio, Ltd. There is
currently no FDA-approved diagnostic test to detect Alzheimer's
disease. For more information, visit www.appliedneurosolutions.com.
KEYWORD: NORTH AMERICA ILLINOIS UNITED STATES
INDUSTRY KEYWORD: SENIORS HEALTH BIOTECHNOLOGY CLINICAL TRIALS GENETICS MEDICAL DEVICES MENTAL HEALTH PHARMACEUTICAL RESEARCH & SCIENCE CONSUMER EARNINGS
SOURCE: Applied NeuroSolutions, Inc.
CONTACT INFORMATION:
Applied NeuroSolutions, Inc.
David Ellison, CFO, 847-573-8000
or
Financial Dynamics
Julie Huang (Investors), 212-850-5600
or
Monarch Communications
Jeff Siegel (media), 516-569-4271