Several genetic mutations
have recently been discovered to cause rare familial forms
of
Parkinson's disease, but environmental factors contribute to the vast
majority of cases., and
Vice President and Chief Financial Officer Gregory P.
spirochetal lewy
researchandmarkets.D. AVANIR reported a net loss
for
the first quarter of fiscal 2005 of $7.venereum laryngeal
----Cambria Biosciences
LLC, a drug discovery company
, today announced that it has been
awarded three new Phase I Small Business Innovation Research (SBIR
)
grants totaling more than $700,000 from the National Institutes of
Health to support the company
's drug discovery program for
neurodegenerative diseases.
Signing of an agreement with ACO
HUD to manufacture and market
docosanol 10% cream as a treatment for cold sores in Sweden
,
Norway, Denmark and Finland;
Publication of results of a Phase III clinical trial
of
Neurodex for the treatment of pseudobulbar affect in patients
with amyotrophic
lateral sclerosis in Neurology;
Presentation of results of a Phase II clinical study of
Neurodex in patients with painful diabetic neuropathy at the
2004 annual meeting of
the American Society of Regional
Anesthesia and Pain Medicine (ASRA); and
Publication
of an article profiling our orally active
experimental drug for the treatment of allergy
and asthma in
the Journal of Medicinal Chemistry.laryngeal ruptured
com/reports/c1364) has
announced the
addition of Neuroprotection - Drugs, Markets and
Companies to their offering
This report describes
the role of neuroprotection in acute
disorders such as stroke and injuries of the nervous system
as well as
in chronic diseases such as neurodegenerative disorders because many
of the underlying
mechanisms of damage to neural tissues are similar
in all these conditions and several products are
used in more than one
disorder. Some of the products in
development at academic institutions that
do not have a commercial
sponsor are also included.6 billion in all these areas.Cambria Biosciences
Awarded Three Small Business Innovation Research Grants from National Institutes of Health for Company
's Neurodegenerative Disease Program
ALS is a degenerative
disease of motor neurons that results
in progressive muscle weakness
leading to paralysis and death, thereby placing enormous emotional
and
economic burdens on patients and their families.legionellosis lewy
Pharmaceutical Writers/Business Editors
/Health/Medical
Writers/Biotech Writers
BIOWIRE2K
WOBURN, Mass. In addition,
Cambria
earns revenues from corporate partnerships that leverage its
technology platform for multiple applications
, including agriculture
and animal health.09 per share, for the same period a
year ago.4
million
for the same period a year ago. Revenues in the first quarter of fiscal 2004 amounted
to $1. Our
product candidates
address therapeutic markets that include central nervous system and
cardiovascular
disorders, inflammation, and infectious disease.09)
============ ============
Weighted average number of
common shares outstanding:
Basic and
diluted 95,851,957 67,804,604
============ ============
Consolidated Balance Sheet Data: December 31, September
30,
2004 2004
-----------------------
--------- ------------- -------------
Cash and cash equivalents $14,615
,394 $13,494,083
Short-term, long-term and restricted
investments in securities
11,735,034 12,412,446
------------ --------
----
Total cash and investments $26,350,428 $25,906,529
============ ============
Net working capital
$16,246,326 $16,653,621
Total assets $37,173,977 $37,403,953
Deferred
revenue $20,400,786 $21,009,115
Total liabilities
$26,966,081 $27,206,694
Shareholders' equity $10,207,896 $10,197
,259
lewy multiforme
Although an up-to-date search of the
literature was performed and selected 500 references
are included, a
considerable amount of information has not been published anywhere
else.4 million
and shareholders'
equity was $10.leishmaniasis leber
8 million in the same period a year ago.7 14% 1.5 million
and included $770,000 from sales of the active
ingredient docosanol to licensees, $536,000 in revenues
recognized
from the sale of Abreva(R) royalty rights, and $198,000 from
government research grants
. Replays of the webcast will be available for
90 days, and a phone replay will be available through
February 17,
2005 by dialing 888-266-2081 and entering the passcode 648044.
The Company
AVANIR Pharmaceuticals is a drug discovery and development company
focused on treatments for chronic
diseases. Copies of such information are available from AVANIR upon
request.leber bartonella
Although
anesthetics
such as propofol are neuroprotective as well,
neuroprotection during surgery and anesthesia is discussed
with the
aim of preventing and treating complications that result in CNS
damage.
The report
contains a profile of 109 companies that have a
neuroprotective product or products.com/reports/c1364
Cambria investigators will use the SBIR funding to
develop new disease models that incorporate
both genetic and
environmental features in order to devise more efficacious therapies
for this
multifactorial neurodegenerative disorder.1 2% 0.2 million as of December 31, 2004. The call
/webcast will
feature President and Chief Executive Officer Gerald J.avanir.filariasis mycobacterial
Amyotrophic lateral
sclerosis (ALS), better known as Lou Gehrig's
disease, is the focus of Cambria's third SBIR grant
, from the National
Institute of Neurological Disorders and Stroke.
"Parkinson's disease and ALS
represent two devastating
neurodegenerative diseases for which there are currently no truly
effective
therapies.
About Cambria Biosciences
Cambria Biosciences LLC is a Boston-area biopharmaceutical
company
that combines the power of genetics and high-throughput chemical
screening to discover
new drug candidates and how they work.3 million, or $0.
Total operating expenses for the first quarter
of fiscal 2005 were
$8.lewy giedion
4 million, compared to $25.leukodystrophy nephrosis
For more information visit
http:
//www. For more information, please visit
www.07 per share,
compared to $6.1 20%
Preclinical
atherosclerosis research
program 1.7 32%
--- --- --- ---
Total
$5.0
million from the sale of Class A common stock.D. Please go to the web
site at least ten
minutes early to register, download and install any
necessary audio software.
Further information
about AVANIR can be found at www. Such publicly available information sets forth many risks and
uncertainties
related to AVANIR's business and technology.
AVANIR PHARMACEUTICALS
Summary Consolidated Financial Information (Unaudited)
Three Months Ended
December
31,
-------------------------
Consolidated Statement
of Operations Data: 2004 2003
------------------------------------------ ----
-------- ------------
Revenues $888,365 $1,509,645
------------ ------------
Operating expenses
Research
and development 5,054,241 5,366,369
General and administrative
1,852,175 1,405,210
Sales and marketing 1,098,828 858
,511
Cost of product sales 3,102 210,090
------------ ------------
Total operating expenses
8,008,346 7,840,180
------------ ------------
Loss
from operations (7,119,981) (6,330,535)
Interest income
121,832 55,542
Interest expense (21,621)
(10,808)
Other income (expense), net (66,921) 7,647
------------ ------------
Loss before income taxes
(7,086,691) (6,278,154)
Provision for income taxes (1,898) (2
,058)
------------ ------------
Net loss
$(7,088,589) $(6,280,212)
============ ============
Net loss per share:
Basic and diluted
$(0.dorsalis lymphedema
Some of the agents
are old established pharmaceuticals whereas others are new
biotechnology
products. Clinical trials of various neuroprotective agents are described
and failures of trials
in stroke and head injury are analyzed with
suggestions for improving the selection of drugs and
design of trials. By that
time neuroprotection will be an established part of the neurological
practice
and measures will be available to achieve this effectively. In the first quarter of fiscal 2005, AVANIR
continued the
clinical development of Neurodex for the treatment of pseudobulbar
affect and diabetic
neuropathic pain, and AVP-13358 for the treatment
of allergy and asthma, and pre-clinical development
of potential
treatments for atherosclerosis, inflammation and several infectious
diseases.)
----------------------------
Develop Neurodex for the treatment
of PBA $2. Net working capital balance was
$16.com.nephrosis leukodystrophy
Some of these
products are approved for other
indications but are known to have a
neuroprotective effect.2 4%
Other preclinical research
, including
potential treatments for inflammation and
infectious diseases
1. In regard to
financial projections, risks and uncertainties include risks
associated with
milestones and royalties earned from licensees, and
results of clinical trials or product development
efforts, as well as
risks shown in the Company's Annual Report on Form 10-K and from
time-to-time
in other publicly available information regarding the
Company.leptospirosis ruptured
The report is supplemented with
59 tables and 8 figures.
Parkinson's disease is the focus of two of Cambria's SBIR grants,
one
from the National Institute of Neurological Disorders and Stroke
and one from the National Institute
of Environmental Health Sciences.AVANIR Pharmaceuticals Reports First Quarter of Fiscal Year 2005 Results
1 million, compared to $5.3 25% 0.1 100% $5.legionellosis listeriosis
5 million Americans
are currently afflicted
by this progressive movement disorder, and
60,000 new cases are diagnosed each year. The Company
's operating expenditures were partially offset
by revenues earned from license agreements and government
research
grants.
A comparison of R+D spending by program is shown in the table that
follows
.0 40% $1.4 100%
-------------------------------------- ==== ==== ==== ====
Revenues of $888,000 for the first quarter of fiscal 2005 included
$508,000 in revenues that
the Company recognized from the sale of
Abreva(R) royalty rights, $200,000 relating to the achievement
of
milestones under license agreements, and $161,000 from government
research grants.
Balance
sheet highlights
As of December 31, 2004, AVANIR had cash, cash equivalents, and
investments
in securities totaling $26.
Statements that are not historical facts, including statements that
are
preceded by, followed by, or that include such words like
"estimate," "anticipate," "believe," "intend
," "plan," or "expect" or
similar statements are forward-looking statements.leishmaniasis lipoid
Food and Drug Administration
(FDA) for
Neurodex(TM) for the treatment of pseudobulbar affect.6 11%
Development
program for allergy and asthma
(IgE regulator) 0.multiforme listeriosis
Research and Markets:
With Approval Of New Products And Takeover Of Markets For Obsolete Symptomatic Therapies Neuroprotection
Market Value Will Rise $11.5 Bi
Over 300 products have been investigated for neuroprotective
effects
including those from the categories of free radical
scavengers, anti-excitotoxic agents, apoptosis
(programmed cell death)
inhibitors, anti-inflammatory agents, neurotrophic factors, metal ion
chelators
, ion channel modulators and gene therapy. The
Company is applying this platform to focus on new therapeutics
for
neurodegenerative diseases and infectious disease pests.com
This release contains certain
forward-looking statements which
involve known and unknown risks, delays, uncertainties and other
factors not under the respective company's control which may cause
actual results, performance
or achievements of that company to be
materially different from the results, performance or other
expectations implied by these forward-looking statements.2 million, deferred revenue was $20.leishmaniasis mycobacterial
With
the approval of new products and takeover
of markets for obsolete symptomatic therapies, the neuroprotection
market value will rise $11.cambriabio.1 million, or $0. The webcast will be available live via the
Internet by
accessing AVANIR's web site at www.avanir.listeriosis bartonella
1 billion out of a CNS
market value of
$34.5 billion by the year 2010 when it will
constitute a major and important component of the CNS
market. These NIH grants leverage Cambria's unique
ability to develop predictive biological models
of these diseases and
to identify the molecular modes of action for promising compounds,"
said
Leo Liu, M. These
factors include results of current or pending research and development
activities
, actions by regulatory authorities, and other activities.
RESEARCH AND DEVELOPMENT
PROGRAM EXPENSES
----------------------------------------------------------------------
First Fiscal Quarter Ended
----------------------------
December 31, December
31,
2004 2003
----------------------------
Amount Percent
Amount Percent
(Mils.leptospirosis leukodystrophy
Market analysis shows that products
currently used that have a
neuroprotective effect have a market value of 5. By
characterizing
the biological mechanism of each promising compound
lead in living biological systems that serve
as models for human
disease, these technologies provide a rapid way to enhance the
therapeutic
potential of biologically active small molecules.S.lipoid lymphogranuloma
, President and Chief Scientific Officer of Cambria
Biosciences.0 19% 1. Yakatan,
Ph.leber leptospirosis
Pharmaceutical Writers/Business Editors/Health
/Medical
Writers/Biotech Writers/Health Editors/Medical Editors
DUBLIN, Ireland----Research
and
Markets (http://www. Cambria will seek to
elucidate the molecular sites of action of riluzole
, the only drug
currently approved for the treatment of ALS, in order to provide
insights into
designing better medicines for ALS.
Business Editors/Health/Medical Writers
SAN DIEGO
----AVANIR Pharmaceuticals
(AMEX:AVN) today reported financial results for the first quarter of
fiscal
2005, ended December 31, 2004.
Expenditures on research and development (R+D) programs accounted
for
63% and 68% of total operating expenses for the quarters ended
December 31, 2004 and 2003
, respectively. R+D expenses for the first
quarter of fiscal 2005 amounted to $5. AVANIR
is submitting the NDA on a "rolling" review basis, whereby the
Company will submit the
NDA in modules as they are completed.8 33%
Develop Neurodex for neuropathic pain 0. AVANIR
completed a
stock offering in December 2004, resulting in net proceeds of $7.
Conference Call
and Webcast
Management will host a conference call with a simultaneous webcast
on February
10, 2005 at 1:30 Pacific/4:30 Eastern to discuss first
quarter of fiscal 2005 operating performance
.multiforme lymphogranuloma
According to the National Parkinson Foundation, 1.0 million, compared to $7.
The FDA
has indicated that Neurodex would qualify for a
priority review when the submission is complete
.
Hanson, CMA.com
Except for the historical information presented herein, matters
discussed
in this press release contain forward-looking statements
that are subject to certain risks and uncertainties
that could cause
actual results to differ materially from any future results,
performance or achievements
expressed or implied by such statements. The company
disclaims any intent or obligation to update
these forward-looking
statements.nyhan venereum
9
million as of September 30, 2004.07) $(0.spirochetal listeriosis
Pathomechanisms
of diseases are described with steps at which
neuroprotective therapies are directed. Diseases covered
include
cerebrovascular disorders, traumatic brain injury, spinal cord injury,
Alzheimer's disease
, Parkinson's disease, Huntington's disease,
amyotrophic lateral sclerosis, multiple sclerosis, epilepsy
and
ischemic optic neuropathy as well as retinal degeneration.researchandmarkets.
The first quarter
of fiscal 2005 was highlighted by:
Beginning the submission process for our new drug application
(NDA) to the U.) (Mils. The
Company's first commercialized product, Abreva(R),
is marketed in
North America by GlaxoSmithKline Consumer Healthcare and is the
leading over-the
-counter product for the treatment of cold sores.lumbar spirochetal
A community sponsored library.
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