D.
"This approval is the most recent example of Abbott's significant strides
against cancer
through advanced molecular diagnostics and new treatments to
help patients live longer, healthier
lives."
About Fluorescence in situ Hybridization
The FISH technology platform is a
system in which genes and chromosomes
are probed by fluorescent-labeled DNA and then illuminated
to allow for
clearer identification.
Antares Pharma currently distributes its needle-free
injector systems in
more than 30 countries and markets the same technology for use with human
growth
hormone through licensees in most major regions of the world.
gvs elmsford
Abbott is a global, broad-based
health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals
and
medical products, including nutritionals, devices and diagnostics.com .dma gvs
The FDA based
its approval on a Premarket Approval Application (PMA) filed
by Abbott in December 2003.7 percent
.5 percent. The
company employs more than 60,000 people and markets its products in more than
130
countries.
Based on the evidence provided by the Company in its pre-IND meeting with the
FDA,
the Company was granted the right to proceed directly into a Phase II
dose ranging study upon concurrence
with the protocol submitted, as well as
conduct only a single Phase III study."
Dr.
Licensees
also market an ibuprofen gel using Antares Pharma's ATD(TM)
technology in several major European
countries.sanofi sutures
"UroVysion is significantly more sensitive than conventional methods for
the detection
of bladder cancer," said Michael Sarosdy, M., of San Antonio,
Texas, a urologic oncologist and lead
investigator of the UroVysion study. Abbott scientists are also exploring FISH's
diagnostic capabilities
for cervical, esophageal, melanoma and hematological
cancers.
For more information, visit
Antares Pharma's web site at
http://www.antarespharma.cpg elmsford
Prior to that,
monitoring was done primarily
by cystoscopy and urine cytology.g."
OAB is characterized by involuntary muscle contractions
leading to loss of
urine, with symptoms including urinary frequency, urgency and urge
incontinence
. Securities and
Exchange Commission.yms cpg
Included in that filing were the results of a 23-
site study
of 497 patients presenting with hematuria. "This is an important new tool for clinicians
to fight
bladder cancer. It has been shown that by identifying abnormalities in
chromosomal DNA, clinicians
can effect better treatments.uvex cpg
S.com and its needle-free product website,
http://www.compresses transdermal
, ureter, urethra
,
renal, and/or prostate in males, and further patient follow-up is justified. Over 500,000 people
in the United
States have a history of this cancer.
Currently, the market for OAB is dominated
by major pharmaceutical companies
such as Pfizer and Ortho-McNeil Pharmaceuticals, a division of
Johnson +
Johnson.uvex welbeck
S. Positive FISH
results in the absence of other signs or symptoms of bladder
cancer recurrence
may be evidence of other urinary tract related cancers, e. In 2005
there will
also be about 13,000 deaths from bladder cancer in the United
States (about 9,000 men and 4,000 women
).abbott. A
SCRIPT report in 2004 highlighted that OAB is the fastest growing
pharmaceutical sector
, which will exceed $11 billion by the year 2008. The Company's AP-1034 formulation is a cosmetic
quality
, clear and odorless gel designed to be rapidly absorbed through the
skin following a once-a-day application
on the abdomen, shoulders or thighs
with reduced side effects.transdermal crutches
supllies masterplan
About Bladder Cancer
The American Cancer Society estimates that in 2005 there will be about
63,000 new cases of bladder
cancer diagnosed in the United States (about
47,000 men and 16,000 women). While it can affect a
person at any age, it is most common
among the elderly, with a prevalence of 33% to 61% in people
over age 65.
Statements included in this press release that are not historical in
nature
are "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act
of 1995.com.tyrite stopcocks
The test is designed to detect genetic changes in bladder cells in urine
specimens
using a proprietary technology known as fluorescence in situ
hybridization or FISH. Urine cytology
was also performed and demonstrated a relative
sensitivity of 39.2 percent and a relative specificity
of 91.D.Antares Pharma Files IND for Its First Proprietary Pharmaceutical Product - Transdermal Gel
to Treat Overactive Bladder Syndrome
forceps stopcocks
FDA Approves First Gene-Based Test UroVysion(TM) for Diagnosis
of Patients Suspected of Having Bladder Cancer
Food and
Drug Administration has approved Abbott
's UroVysion(TM) DNA probe assay for
use as an aid in the initial diagnosis of bladder cancer in patients
with
hematuria (blood in urine) suspected of having bladder cancer.
"This new use should allow
physicians to make an earlier diagnosis, with
earlier treatment," Dr. A
negative FISH result does
not rule out all bladder cancer, nor does it
necessarily mean that an individual will not develop
bladder cancer in the
future. This high rate of recurrence requires that patients be
monitored
on a regular basis, including up to four times a year for tumor
recurrence.org
EXTON,
Pa.ouc dma
, The U." Mr. Dario Carrara, Managing Director of Antares Pharma's Pharmaceutical
and Formulation
Division, stated, "Our development team has done an
outstanding job in completing the filing within
the projected timing. I am
confident that they will continue to work with the Agency toward finalizing
the Phase II protocol and then completing the studies with the same diligence
exhibited to date
. The Company's current technology platforms include its Advanced
Transdermal Delivery (ATD(TM))
gels, disposable mini-needle injection systems
(VIBEX(TM)), reusable needle-free injection systems
(VISION(R) and Valeo(TM)),
and fast-melt oral (Easy Tec(TM)) tablets.
compresses welbeck
The study compared UroVysion
performed on
urine samples to cystoscopy/histology testing methods and demonstrated a
clinical
sensitivity of 68.6 percent and a clinical specificity of
77.littmann elmsford
"Studies have shown that early
and accurate detection of bladder cancer is
key as thousands die each year of this disease," said
Mark S., Antares Pharma Inc.forceps elmsford
Approximately 50 percent of patients
will experience a recurrence within
two years after an initial diagnosis of
bladder cancer.
Abbott's news releases and other information
are available at the
company's web site at http://www. We believe this
accomplishment is indicative
of our ability to execute on our commercial plans
and bodes well for our future gel-based products
. Antares Pharma claims the protection of the Safe Harbor
for forward-looking statements contained
in the Private Securities Litigation
Reform Act of 1995.mediject.
uvex cpg
"
In 2001, the
FDA cleared UroVysion for use in conjunction with cystoscopy
to monitor patients for the recurrence
of bladder cancer. Smoking causes nearly half of the
deaths from bladder cancer among men (48 percent
) and less than a third of
bladder cancer deaths in women (28 percent).This category is for suppliers
to the healthcare industry.
dosages medex
Sarosdy said.
Stover added, "It is especially rewarding to have been
granted the right to
proceed expeditiously with our clinical studies.
About Antares Pharma
Antares Pharma is a specialty pharma company focused on the growing
lifestyle products sector
and committed to leveraging its multiple drug
delivery platforms to add value to existing drugs and
to create new products
and devices.
Antares Pharma's corporate headquarters is in Exton, Pennsylvania
, with
subsidiaries performing research, development, manufacturing and product
commercialization
activities in Minneapolis, Minnesota and Basel, Switzerland.dosages littmann
Soloway, M.,
professor, Department of
Urology, University of Miami School of Medicine, and
a leading bladder cancer expert. FISH assay
results may not be informative if the specimen
quality and/or specimen slide preparation is inadequate
.cancer.welbeck forceps
Product Limitations
The clinical interpretation of any test results should
be evaluated within
the context of the patient's medical history and other diagnostic laboratory
test results.secretions welbeck
With this
approval, UroVysion represents the first gene-based test available for
both
diagnosis and monitoring of bladder cancer recurrence. In addition to
UroVysion, FISH is
utilized in an FDA-approved device, PathVysion(R), to
quickly identify which patients with late-stage
breast cancer are suitable
candidates for Herceptin therapy. Stover, President and CEO of Antares
Pharma, commented, "The
submission of Antares Pharma's first proprietary pharmaceutical submission
to
the FDA is an important milestone in our specialty pharma strategy. The Company currently has
active
partnering programs with several pharmaceutical and distribution companies for
a number
of indications and applications, including diabetes, growth
disorders, obesity, female sexual dysfunction
and other hormone therapy.elmsford masterplan
UroVysion shown to be more sensitive than established methods in detecting
bladder cancer
ABBOTT PARK, Ill.
"The FDA's decision
is important because it gives physicians a more
powerful diagnostic test than current methods alone
to detect one of the most
common urological cancers," said Edward Michael, president, Abbott Molecular
.
AP-1034 utilizes Antares Pharma's proprietary Advanced Transdermal
Delivery (ATD(TM)) gel
technology designed to allow delivery of active
substances across the skin.dosages transdermal
The syndrome affects
an estimated 17 million people in the
United States, with the highest incidence of occurrence in
women of post-
menopausal age. The Company cautions readers that
forward-looking statements are
subject to certain risks and uncertainties,
which could cause actual results to differ materially
and which are identified
from time to time in the Company's reports filed with the U. Information
included on the Company's website is not
incorporated herein by reference or otherwise. Suppliers
for a specific specialty may appear in that particular category; general or wider industry suppliers
will be found here.
yms elmsford
Results demonstrated
that UroVysion had greater sensitivity than the most commonly
used testing
method to detect bladder cancer. The chance of a man developing this cancer at
any
time during his life is about 1 in 30 and for a woman, 1 in 90.
Source of bladder cancer
statistics: http://www.
(Amex: AIS), a specialty pharmaceutical company that develops and licenses
drug delivery technology for next-generation lifestyle products, announced
today that it filed
an Investigational New Drug (IND) application on Monday,
March 14, 2005, for the Company's first
proprietary pharmaceutical product
(AP-1034), oxybutynin ATD(TM) gel for overactive bladder syndrome
(OAB).
Jack E. In addition, Antares Pharma
is undertaking development or is conducting research
on several product
opportunities that will form the basis of its specialty pharma program.welbeck yms
Working overtime to stay the Web's best reference!
-> Show SiteSeek's List of Web Sites For This Topic (Not Yet Peer Reviewed)
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)