In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial
Infarction Trial) trial, patients were followed for 28 days. ACS is a major cause of emergency medical
care and hospitalization in
the United States(5). TTP has been reported rarely following use of
PLAVIX,
sometimes after a short exposure (<2 weeks). Antman et al.
4. Addition of
clopidogrel to
aspirin and fibrinolytic therapy for myocardial infarction with ST-
segment elevation.geoghegan@sanofi-aventis.com
Collaboration Aims to Improve Dosing
Convenience for Patients Treated for
Neovascular Age-Related Macular Degeneration (neovascular
AMD)
FORT COLLINS, Colo. "We are proud to
partner with OSI.hallervorden porphyrias
The companies have also submitted
a filing to the
European Medicines Evaluation Agency (EMEA) for a STEMI indication in the
European
Union. (See
CONTRAINDICATIONS and PRECAUTIONS. Sanofi-aventis is listed in
Paris (EURONEXT:
SAN) and in New York (NYSE: SNY). PRP's lead products
under development are InsuLAR(TM), a once
-a-week basal insulin injection and
PulmoLAR(TM), a sustained release preparation for the treatment
of Pulmonary
Arterial Hypertension.acidemia vegetative
About STEMI and Acute Coronary Syndrome
Acute
ST-segment elevation myocardial infarction (STEMI), along with
unstable angina (UA) and non-ST segment
elevation myocardial infarction
(NSTEMI), are the three conditions classified as acute coronary syndrome
(ACS). **)
* As part of the worldwide postmarketing experience with PLAVIX, suspected
cases of thrombotic thrombocytopenic purpura (TTP), some with fatal
outcome, have
been reported at a rate of about 4 cases per million
patients exposed. OSI will reimburse
PRP for efforts carried out by PRP in support of the collaboration.rombergs pyromania
TTP is a serious condition
and requires urgent referral to a hematologist for prompt treatment."
PRP received an undisclosed
upfront payment from (OSI) Eyetech and also
will receive payments for achieving certain milestones
and royalties on net
sales of any products resulting from the collaboration.pseudomembranous pernicious
PLAVIX is marketed
worldwide by sanofi-aventis (Paris Bourse: EURONEXT:
SAN; New York: NYSE: SNY) and Bristol-Myers
Squibb Company (NYSE: BMY) as
PLAVIX(R) and Iscover(R).phenylketonuria acidemia
The FDA has designated the filing
for priority review, which is granted to
applications in which a new indication or new drug product
, if approved, would
present a significant improvement compared to currently available therapies or
marketed products(3). Sabatine MS, Cannon CP, Gibson CM, et al. VEGF is a protein that plays a critical
role in angiogenesis (the
formation of new blood vessels) and increased permeability (leakage from
blood
vessels), two pathological processes that contribute to the vision loss
associated with
neovascular AMD. (OSI) Oncology is focused on developing molecular targeted
therapies designed to
change the paradigm of cancer care.porphyrias pallister
Food and Drug
Administration, PLAVIX has been used to treat millions
of patients
worldwide(5).com.
* Acute Coronary Syndrome (ACS)
For patients with
ACS (unstable angina/non-Q-wave MI), including
patients who are to be managed medically and
those who are to be managed
with percutaneous coronary intervention (with or without stent
) or
coronary artery bypass graft surgery (CABG), PLAVIX has been shown to
decrease
the rate of a combined end point of cardiovascular death, MI,
or stroke as well as the rate
of a combined end point of cardiovascular
death, MI, stroke, or refractory ischemia.**)
* The rates of major and minor bleeding were higher in patients treated
with PLAVIX
plus aspirin compared with placebo plus aspirin in a
clinical trial., chief executive officer
of (OSI) Eyetech and executive vice president of OSI Pharmaceuticals. OSI markets Tarceva through
partnerships with Genentech, Inc.
The company has unique sustained release injectable technologies
and uses
these primarily to develop its own proprietary products.acidemia pickwickian
J.
The FDA filing is based
on the findings of two recent clinical trials that
treated STEMI patients with PLAVIX administered
on a background of standard
therapy.
PLAVIX has demonstrated early and long term risk reduction
for patients at
risk for atherothrombotic events in important clinical trials.acc.htm.lauscher@sanofi
-aventis.PR Pharmaceuticals (PRP) Announces Collaboration With OSI Pharmaceuticals to Develop Sustained
Release Formulation of Macugen(R) (pegaptanib sodium injection)
The agreement gives OSI and its
development
and marketing partner Pfizer access to a proprietary method for encapsulating
Macugen
for use in ophthalmology.D.
OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered
and developed by OSI to obtain FDA approval and the only EGFR inhibitor to
have demonstrated the
ability to improve survival in both non-small cell lung
cancer and pancreatic cancer patients.
PRP is a Fort Collins, CO based privately held Biopharmaceutical Company.phenylketonuria platelet
(See ADVERSE REACTIONS
.
(See WARNINGS.**)
* In clinical trials, the most common clinically important side
effects
were pruritus, purpura, diarrhea, and rash; infrequent events included
intracranial
hemorrhage (0.
Accessed December 8, 2005
3.pdf.orthostatic acidemia
, PR Pharmaceuticals, Inc. Macugen
(R) (pegaptanib sodium injection) is approved in
the United States for the treatment of neovascular
age-related macular
degeneration.pyromania pickwickian
FDA Grants Priority Review to PLAVIX(R) (Clopidogrel Bisulfate)
Supplemental New Drug Application (sNDA) for Additional Type of Heart Attack
com. Lancet 2005; 366:
1622-32
2.fda. The Company operates
through three business teams, (OSI) Oncology, (OSI
) Eyetech and (OSI)
Prosidion. For
additional information about OSI, please visit http://www.com
vegetative pseudomembranous
STEMI is a heart attack in
which an artery is generally blocked completely for sufficient
time to cause
heart muscle damage.
Both studies were presented at the 54th Annual Scientific Session
of the
American College of Cardiology (ACC) in March 2005 and subsequently published
in the Lancet
(1) and the New England Journal of Medicine(4), respectively. Since
its initial approval on November
17, 1997, by the U. In the CURE
trial, patients with unstable angina (UA) and non-ST segment elevation
myocardial infarction (NSTEMI) were followed for up to one year, and in the
CAPRIE trial, patients
with recent MI, recent ischemic stroke, or established
peripheral artery disease were followed for
up to three years. Center for Drug Evaluation and Research.
announced today an exclusive agreement
with OSI Pharmaceuticals to collaborate
on the development of a sustained release formulation of
Macugen(R)
(pegaptanib sodium injection), a novel treatment for neovascular age-related
macular
degeneration (neovascular AMD), using PRP's proprietary ProPhase(TM)
encapsulation technology.
Increases in intraocular pressure (IOP) have been seen within 30 minutes
of injection with Macugen
.prpharm.hallervorden pernicious
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical
and related health care
products company whose mission is to extend and enhance human life. Available
at
http://www. PLAVIX Prescribing Information.3-mg dose once every six weeks by intravitreal
injection.com. OSI commercializes Macugen in partnership with Pfizer Inc.osip.hallervorden orthostatic
This blockage is caused
by clot formation in the
arteries, which is also known as atherothrombosis. In the CURE trial, patients
with unstable
angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) were
followed
for up to one year, and in the CAPRIE trial, patients with recent MI,
recent ischemic stroke, or
established peripheral artery disease were followed
for up to three years.
For full prescribing
information about Macugen, please visit
http://www.proteinuria vegetative
Backed by a world-class R+D organization,
sanofi
-aventis is developing leading positions in seven major therapeutic
areas: cardiovascular, thrombosis
, oncology, metabolic diseases, central
nervous system, internal medicine, and vaccines., Management
of Patients With STEMI: Executive Summary J
Am Coll Cardiol 2004;44:671-719. N Engl J Med
2005;352:1179-1189
5.macugen.
Intravitreal injections including those with Macugen
have been associated
with endophthalmitis. (OSI) Prosidion is committed to the generation of
novel
, targeted therapies for the treatment of type 2 diabetes and obesity.pemphigus pernicious
plavix.gov/cder/mapp/6020-3.com
Tricia Geoghegan Felix Lauscher
sanofi-aventis
sanofi-aventis
908-243-2064 212-551-4018
tricia.
Most frequently reported adverse events in patients treated for up to two
years were anterior chamber
inflammation, blurred vision, cataract,
conjunctival hemorrhage, corneal edema, eye discharge, eye
irritation, eye
pain, hypertension, increased IOP, ocular discomfort, punctate keratitis,
reduced
visual acuity, visual disturbance, vitreous floaters, and vitreous
opacities. These events occurred
in approximately 10% to 40% of patients. in the U.poliodystrophy phenylketonuria
- Filing for STEMI Indication Also Submitted
in Europe -
PARIS, and PRINCETON, N. Food and Drug Administration (FDA) has accepted
for
review a supplemental new drug application (sNDA) for the antiplatelet
agent PLAVIX(R) (clopidogrel
bisulfate) for treatment of patients with acute
ST-segment elevation myocardial infarction (STEMI
).05%).**)
** Please see full prescribing information by visiting
http://www.
Under the terms of the collaboration, PRP grants OSI Pharmaceuticals an
exclusive license to use
PRP's ProPhase(TM) technology with respect to Macugen
in the treatment of eye diseases. and with
Roche throughout the
rest of the world.pterygium proteinuria
, Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) and Bristol
-Myers Squibb Company (NYSE: BMY)
announced today that the U. COMMIT (ClOpidogrel and Metoprolol in
Myocardial Infarction Trial)
collaborative group.
Important Safety Information
Macugen is contraindicated in patients with ocular or periocular
infections.phenylketonuria pallister
The long
-term efficacy and safety of PLAVIX have been established through
landmark clinical trials in more
than 100,000 patients and in clinical
practice in millions of patients treated worldwide. Accessed
September 5, 2005. Data on file, Sanofi-Synthelabo
6. Sanofi-Synthelabo
MEDIA
INVESTORS
Jeff Macdonald John Elicker
Bristol-Myers Squibb Bristol-Myers Squibb
212-546-4824
212-546-3775
john. PRP is responsible for developing the
formulations and manufacturing
the test article for non-clinical and clinical
trials.
"This collaboration brings together
the scientific and technical expertise
to develop a sustained release formulation of Macugen, our
breakthrough
medicine for neovascular AMD," said David Guyer, M. "Dosing
convenience is important
for retina specialists and patients who are fighting
age-related blindness. Macugen is a
pegylated
anti-VEGF aptamer, which binds to vascular endothelial growth factor
(VEGF). Therefore, IOP as well
as the perfusion of the
optic nerve head should be monitored and managed appropriately.
About PR Pharmaceuticals, Inc.pruritis pinkeye
In the CLARITY -
TIMI 28 (CLopidogrel as Adjunctive ReperfusIon
TherapY - Thrombolysis In
Myocardial Infarction Study 28) trial, patients were followed for 30 days
.
There are approximately ten million heart attacks per year worldwide(1);
in the United States
alone, the estimated 500,000 STEMI events per year
represent one-third of all heart attacks suffered
in the country(2).4%) and severe neutropenia (0.
About sanofi-aventis
Sanofi-aventis
is the world's third largest pharmaceutical company,
ranking number one in Europe.com.proteinuria pemphigus
Patients
who
have experienced STEMI are at high risk of another heart attack, stroke or
death, especially in the
first month following the initial STEMI event.
About PLAVIX
PLAVIX is a prescription
antiplatelet medicine taken once a day that helps
keep platelets in the blood from sticking together
and forming clots.
For more information on PLAVIX visit http://www.
Important Risk
Information:
* PLAVIX is contraindicated in patients with active pathologic bleeding
such as peptic ulcer or intracranial hemorrhage.
(See ADVERSE REACTIONS.elicker@bms.
OSI, through its eye disease unit (OSI) Eyetech, is responsible for
clinical development activities
and has the right to manufacture and
commercialize any resulting product.
About Macugen
Macugen is indicated in the United States for the treatment of neovascular
age-related macular
degeneration (neovascular AMD) and is administered in a
0. In
addition, patients should be monitored
during the week following the injection
to permit early treatment, should an infection occur.S.
More information about PRP on our website http://www.pterygium vegetative
PLAVIX is approved for early and long term
risk reduction in patients at
risk for atherothrombotic events.S.com felix.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicines and changing lives"
by
discovering, developing and commercializing high-quality and novel
pharmaceutical products that extend
life or improve the quality of life for
patients with cancer, eye diseases, and diabetes.proteinuria hallervorden
S.
WHO SHOULD RECEIVE PLAVIX(R)(clopidogrel bisulfate)?(6)
PLAVIX is indicated for the reduction
of atherothrombotic events as
follows:
* Recent Myocardial Infarction (MI), Recent Stroke
, or Established
Peripheral Arterial Disease (PAD)
For patients with a history
of recent MI, recent stroke, or established
PAD, PLAVIX has been shown to reduce the rate of
a combined end point of
new ischemic stroke (fatal or not), new MI (fatal or not), and other
vascular death. Proper aseptic injection technique -- which includes
use of sterile gloves
, a sterile drape, and a sterile eyelid speculum (or
equivalent) -- should always be utilized when
administering Macugen. (OSI) Eyetech
specializes in the development and commercialization of novel
therapeutics to
treat diseases of the eye.pinkeye poliodystrophy
There are approximately
ten million heart attacks
per year worldwide(1); in the United States alone,
the estimated 500,000 STEMI events per year represent
one-third of all heart
attacks suffered in the country(2).plavix. Early intravenous then oral metoprolol
in 45852
patients with acute myocardial infarction randomized placebo-controlled
trial."
"For PRP, this agreement demonstrates the value of our broad intellectual
property
estate and expertise in the formulation of sustained release large
molecules," said Steve Howe, chief
executive officer of PRP.
PRP collaborates with other pharmaceutical companies who desire to
enhance
the benefits of their proprietary molecules through PRP's sustained release
technologies
.phenylketonuria poliodystrophy
PLAVIX should be used
with caution in patients who may be at risk of increased bleeding from
trauma, surgery, or coadministration with NSAIDs or warfarin.
References:
1.
http://www.org/clinical/guidelines/stemi/Guideline1/Pathology.
Serious adverse
events related to the injection procedure occurring in <1%
of intravitreal injections included endophthalmitis
, retinal detachment, and
iatrogenic traumatic cataract.acidemia pseudomembranous
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