Stephen
Damment, Senior Vice President of Biosciences R+D, Shire, UK.5
mg/dL, the blood phosphorus
levels of many patients on dialysis exceed 6.
urethra digestive
Other side effects
reported in trials included dialysis
graft complications, headache, abdominal
pain and hypotension. For further information about
FOSRENOL
(R), please visit the FOSRENOL(R) Web site at http://www.peptic tract
When assessed at pH 5 to 7, the affinity of
FOSRENOL(R) was four-fold higher compared to sevelamer HCl.D.S. Despite the
availability of these
agents, it remains a challenge for some ESRD patients to
maintain target ranges.
Forward
-Looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Act of 1995.genitourinary ulcer
intestinal urticaria
Once bound, the FOSRENOL(R)/phosphate complex cannot
pass
through the intestinal lining into the blood and is eliminated from the body,
which decreases
the overall phosphate absorption from food," said Dr.FOSRENOL. In the event such
risks or uncertainties
materialize, Shire's results could be materially
affected.Corgentech Presents Preclinical Data Demonstrating
Reduction of Inflammation Using New Drug Candidate for Inflammatory Bowel Disease
bacterial bowel
In fact, by the
fifth year no patients reported treatment-related
adverse events.
Of the approximately 20
million Americans who have some form of kidney
disease, as of 2002, more than 512,000 have developed
ESRD, a figure that has
grown 400 percent over the last 20 years.com. These include without
limitation
all statements related to our clinical trials and progress with
developing product candidates.genitourinary urinary
In
addition, FOSRENOL(R)-treated patients maintained serum
phosphorus reductions for up to five years
.
Managing Hyperphosphatemia
Phosphorus, an element found in nearly all foods, is absorbed
from the
gastrointestinal tract into the bloodstream.
The K/DOQI Clinical Practice Guidelines
for Bone Metabolism and Disease
also note in Guideline 5, Use of Phosphate Binders in Chronic Kidney
Disease
(CKD), that non-calcium and non-aluminum phosphate binders are a preferred
first-line
treatment option in lowering serum phosphorus levels.S.uterus uterine
The clinical relevance of the effect of pH
on in
vitro binding of FOSRENOL(R) has not been established. All forward-looking statements are
qualified
in their entirety by this cautionary statement, and Corgentech
undertakes no obligation to revise
or update any forward-looking statements to
reflect events or circumstances after the date hereof
.brucellosis genitourinary
will
develop hyperphosphatemia and therefore require a phosphate-binding drug. FOSRENOL(R) launched
in January 2005 and is available in 250 milligram (mg) and 500 mg strengths. The most
common
side effects leading to discontinuation in clinical trials were
gastrointestinal events (nausea,
vomiting, and diarrhea). NF-kappaB
Decoy was shown to be efficiently delivered to inflamed areas
of the gut,
significantly reduced inflammatory cell infiltrates and expression of
proinflammatory
genes, and reversed disease-associated weight loss and tissue
damage in multiple chronic and acute
preclinical models of IBD.inflammatory bowel
"Based on the results reported, we're able to further reinforce the
safety
and efficacy profile for FOSRENOL(R)."
Without effective treatment, hyperphosphatemia (high levels
of phosphorus
in the blood) can lead to renal osteodystrophy in end stage renal disease
(ESRD
) patients, and an increased risk of bone pain, skeletal deformities and
fractures., Canada, UK, France
, Italy, Spain and Germany) as well as a specialist
drug delivery unit in the U. These forward-looking
statements are based upon our current expectations.undulant genitourinary
,
showed that, in vitro, FOSRENOL(R) (lanthanum
carbonate) binds phosphate
across a broad pH range with higher affinity than sevelamer hydrochloride
. When the kidneys fail, they no
longer effectively remove phosphorus, even with the help of blood
-cleansing
dialysis machines. Such levels have been linked to a significantly higher illness and
death
risk for patients who have undergone at least one year of dialysis. FOSRENOL(R) should not be taken
if you are under
18 years of age. "Based on these data, we believe that
NF-kappaB Decoy could
someday have therapeutic potential as a novel
cross-functional drug in both Crohn's disease and ulcerative
colitis.urinary stomach
D.shire.
"We are pleased with the additional data presented today suggesting that
our
NF-kappaB Decoy significantly reduces the inflammatory response associated
with inflammatory bowel
disease," said Leslie M. You are cautioned not to
place undue reliance on these forward-looking statements
, which speak only as
of the date of this press release.urethra bowel
WASHINGTON, Data presented today at the
National Kidney Foundation (NKF) 2005 clinical meeting in Washington, D.
In addition to the
binding affinity data, another study presented at the
NKF clinical meeting found that FOSRENOL(R
) continued to demonstrate sustained
efficacy, tolerability and safety in patients (n=33) treated
for up to five
years.
Most patients require a total daily dose between 1,500 mg and 3,000 mg to
achieve serum phosphorus control, which equates to one to two FOSRENOL(R)
tablets per meal. FOSRENOL
(R) should not be taken if
you're nursing or pregnant.
THE "SAFE HARBOR" STATEMENT UNDER
THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not
historical facts are forward-
looking statements. Corgentech is currently conducting a
multi
-center, Phase 1/2 clinical trial of NF-kappaB Decoy for eczema in the
United States involving approximately
75 patients, and a second trial of
approximately 120 patients will begin enrolling patients imminently
and will
be conducted in Australia and Switzerland.uterine urethra
The phosphate-binding affinity of FOSRENOL
(R) was more than 200 times
higher compared to sevelamer HCl at pH 3, which simulates the acidic
environment
of the stomach. Accumulating evidence also shows that hyperphosphatemia may
contribute to cardiovascular
disease, which accounts for almost half of all
deaths among dialysis patients.
However, control
of serum phosphorus to the National Kidney Foundation's new
Kidney Disease Outcomes Quality Initiative
(K/DOQI) Clinical Practice
Guidelines for Bone Metabolism and Disease target, high pill burden, and
poor
patient compliance remain significant problems with currently available
therapies. According
to the K/DOQI Clinical Practice Guidelines
for Bone Metabolism and Disease, Guideline 3, Evaluation
of Serum Phosphorus
Levels, fewer than 30 percent of dialysis patients are able to maintain serum
phosphorus levels in the target range. SOUTH SAN FRANCISCO, Calif. McEvoy, Ph.urticaria fibroids
Even with
a low phosphorus diet, most ESRD patients in the U. Caution should
be used in patients with these
conditions.com.
Forward-looking
statements involve risks and uncertainties.ulcers ulcerative
New In Vitro
Data Show That FOSRENOL(R) May Have Greater Phosphate Binding Affinity Than Sevelamer Hydrochloride
In addition, the
presence of bile acids did not affect the stability of the
FOSRENOL(R)/phosphate
complex, whereas bile acids led to a more than 20-fold
reduction in phosphate-binding affinity of
sevelamer HCl with the consequent
release of its phosphate.
Diet restrictions alone generally
cannot control phosphorus levels and
patients traditionally manage hyperphosphatemia by taking phosphorus
-binding
agents at every meal.
The recommended initial daily dose of FOSRENOL(R) is 750-1,500 mg
for adults;
physicians should adjust the dose to reach target serum phosphorus levels.
Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty
pharmaceutical company with a strategic focus on meeting the needs of the
specialist physician
and currently has a range of projects and products in the
areas of central nervous system (CNS),
gastrointestinal (GI), and renal
disease. IBD
represents a new therapeutic target for NF-kappaB
Decoy that, similar to
atopic dermatitis where we currently have trials underway, represents a
significant
unmet medical need.ulcers uterine
For further information on Shire, please visit
the Shire Web site: http://www
. Such forward-looking statements involve a number of risks
and uncertainties and are subject to change
at any time.
These data further corroborate preclinical data presented last month which
showed
NF-kappaB Decoy's ability to dramatically decrease inflammation and
swelling in preclinical models
of atopic dermatitis, a chronic inflammatory
skin disease also known as eczema. For more information
on the company and its technologies, please
visit http://www.hives ulcerative
5 to 4. Such binders "soak up" phosphorus
in the
gastrointestinal tract, before it can be absorbed into the blood.S., senior vice
president
of research at Corgentech. We are creating a pipeline of novel therapeutics focused
initially on
the treatment of inflammatory diseases, infectious diseases and
cancer.corgentech.B Decoy,
progress
, timing and results of our clinical trials for NF-.urticaria inflammatory
While the normal adult range for phosphorus is
2.com.urethra ulcer
C.
"I believe it is important for a binder to trap dietary phosphorus in the
acidic
environment of the stomach and duodenum, before it can be absorbed in
the small intestine. As patients
continued on therapy, the number of adverse events
decreased. Shire has operations in the world
's key pharmaceutical markets
(U.digestive urethra
"The comprehensive data were thoroughly evaluated on several
parameters
over a number of years," said Ghodrat Siami, M.5
mg/dL.
ABOUT FOSRENOL(R
)
FOSRENOL(R) is indicated to reduce serum phosphate. The daily dose should be divided and taken
with meals.
The most common adverse events were gastrointestinal, such as nausea and
vomiting
, and generally abated over time with continued dosing. Although studies were not designed to detect
differences in risk of fracture and mortality, there were no differences
demonstrated in patients
treated with FOSRENOL(R) compared to alternative
therapy for up to three years.
NF-kappaB
Decoy is a selective and potent inhibitor of the transcription
factor NF-kappaB, which is implicated
in inflammatory diseases such as eczema,
asthma and IBD.inflammatory urinary
FOSRENOL(R) is marketed by Shire Pharmaceuticals
Group plc (LSE: SHP,
Nasdaq: SHPGY, TSX: SHQ)., Corgentech
Inc. The company has not yet forecasted
its plans relating to a clinical trial for IBD."
About Corgentech
Corgentech is
a biopharmaceutical company focused on the development and
commercialization of DNA-based novel therapeutics
for significant unmet
medical needs.B Decoy,
intellectual property matters, difficulties or delays
in obtaining regulatory
approval, manufacturing our product candidates, competition from other
pharmaceutical
or biotechnology companies, our ability to obtain additional
financing to support its operations
and other risks detailed in relevant
filings with the Securities and Exchange Commission, including
our Annual
Report on Form 10-K/A for the year ended December 31, 2004, and our quarterly
report
on 10-Q for the quarter ended March 31, 2005.
hives bowel
, professor of
medicine at Vanderbilt University
and assistant chief of the nephrology
medical service at the Veterans Administration Medical Center
in Nashville,
TN. FOSRENOL(R), which
received FDA approval in October 2004, is formulated as
an easy to use,
chewable only tablet that can be taken without water, an important advantage
for
ESRD patients who must restrict their fluid intake. The duration of treatment exposure and time of
observation in the clinical program are too short to conclude that FOSRENOL(R)
does not affect
the risk of fracture or mortality beyond three years.
Patients with acute peptic ulcer, ulcerative
colitis, Crohn's disease or bowel
obstruction were not included in FOSRENOL(R) clinical studies.
(Nasdaq: CGTK) today announced that its NF-kappaB Decoy (NF-kappaB Decoy)
drug candidate was effective
in preclinical studies in reducing disease
activity in acute and chronic models of Crohn's disease
and ulcerative
colitis-both also referred to as inflammatory bowel disease (IBD). Words such as
"believes," "anticipates,"
"plans," "expects," "intend," "will," "slated," "goal" and similar expressions
are intended to identify forward-looking statements.bowel ulcerative
, Ph.D. Our actual results and the timing
of
events could differ materially from those anticipated in such forward-
looking statements as a result
of these risks and uncertainties, which
include, without limitation, risks related to the development
of NF-.bowel undulant
FOSRENOL(R)
does not contain calcium or aluminum; it meets the K/DOQI recommendations as
one of the preferred first-line treatment options in lowering serum phosphorus
levels. The risks
and uncertainties include, but are not limited to, risks
associated with the inherent uncertainty
of pharmaceutical research, product
development, manufacturing and commercialization, the impact
of competitive
products, including, but not limited to, the impact on Shire's Attention
Deficit
+ Hyperactivity Disorder (ADHD) franchise, patents, including but not
limited to, legal challenges
relating to Shire's ADHD franchise, government
regulation and approval, including but not limited
to the expected product
approval dates of METHYPATCH(R) (methylphenidate), XAGRID(R) (anagrelide
hydrochloride) and BIPOTROL(R) (carbamazepine), the implementation of Shire's
planned reorganization
and other risks and uncertainties detailed from time to
time in Shire's filings with the Securities
and Exchange Commission, including
Shire's most recent annual report on Form 10-K. These data
were
presented today at the 12th International Congress of Mucosal Immunology
in Boston, MA.digestive usher
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