nih.
"Life threatening infections are a growing concern globally
," says Dr.S.
Actual results may vary materially from the forward-looking statements.
yersinia vibrio
The antibodies
will be produced under
Good Manufacturing Practices (cGMP) at XOMA's manufacturing facility. Department
of Health and Human Services., The U.V. Antibiotic resistance costs U. In fact, development and approvals
of new antibacterial agents have decreased by 56 percent over the past 20
years (1998-2002 vs
. constellatus), Bacteroides
fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides
vulgatus, Clostridium perfringens, and Peptostreptococcus micros.pinworms clostridium
S. The company pipeline includes
products from collaborative
product development programs with Chiron Corporation, Millennium
Pharmaceuticals
, Inc.S. in the near future. The
safety and effectiveness of TYGACIL in patients below age 18 and
lactating
women have not been established.
For a copy of TYGACIL Prescribing Information,
please visit
http://www. The
Company assumes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or
otherwise.noroviruses cyclosporiasis
citizens from
the harmful effects of biological agents
used as instruments of terror. SRI's Biosciences Division
works with
government agencies and commercial pharmaceutical and biotechnology
companies to provide
a broad range of preclinical drug discovery and
development services, including medicinal chemistry
, custom synthesis,
regulatory support, efficacy and safety evaluations, pharmacokinetics
and metabolism
studies, analytical chemistry and formulation design in
production in GLP and cGMP environments.
The Australian Therapeutic Goods Administration and the South
African Medicines Control
Council (MCC) granted priority evaluation to
TYGACIL.S.
TYGACIL may cause fetal harm when
administered to a pregnant woman.spoilage noroviruses
HHSN266200500004C. For more information
about XOMA's product pipeline
and antibody product development
capabilities and technologies, please visit XOMA's website at
http:
//www.
A Clinical Challenge
The U. According to the CDC, antibiotic
resistance
has become so widespread that many significant bacterial infections
in the world are becoming resistant
to commonly used antibiotics.5 percent) and vomiting (19.
There is also information about
poisonings from toxic animals and plants.
staphylococcal cyclosporiasis
government to develop new
therapies to counter these biological
threats.xoma. These risks, including those
related to the results of pre-clinical testing, the timing
or results
of pending and future clinical trials (including the design and
progress of clinical
trials; safety and efficacy of the products being
tested; action, inaction or delay by the FDA, European
or other
regulators or their advisory bodies; and analysis or interpretation
by, or submission
to, these entities or others of scientific data),
changes in the status of the existing collaborative
relationships, the
ability of collaborators and other partners to meet their obligations,
market
demand for products, scale up and marketing capabilities,
competition, uncertainties regarding the
status of biotechnology
patents, uncertainties as to the cost of protecting intellectual
property
and risks associated with XOMA's status as a Bermuda company,
are described in more detail in the
Company's most recent annual
report on Form 10-K and in other SEC filings. The overall
discontinuation
rate for TYGACIL (5.flukes poisoning
"Numerous events in the United States over the past few years
serve as a
stark reminder that the use of biological agents remains a
real threat," said John L. Actual results
could differ
materially from those anticipated due to certain risks inherent in the
biotechnology
industry and for companies engaged in the development of
new products in a regulated market. Food
and Drug
Administration (FDA) today approved Tygacil(TM) (tigecycline), a novel I. Antibiotic development
has slowed to the point that FDA has had
few opportunities to approve new agents. New classes of
antibiotics are needed to
address increasing antibiotic resistance among common pathogens. intermedius
, and S. The Company's major divisions
include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare,
and Fort Dodge
Animal Health.poisoning caliciviruses
S. News releases, fact sheets and other
NIAID-related materials are
available on the NIAID Web site at
http://www.J. Wyeth anticipates that TYGACIL will be available
to hospitals in the
U.
Important Safety Information
TYGACIL is contraindicated
in patients with known hypersensitivity to
tigecycline. It is a leader in the
discovery, development
, manufacturing, and marketing of pharmaceuticals,
vaccines, biotechnology products and nonprescription
medicines that improve
the quality of life for people worldwide.clostridium spoilage
"Bacterial infections are becoming
more difficult to treat,
with resistant strains on the increase.salmonellosis tapeworms
"As an industry leader in developing
monoclonal antibodies, XOMA
is committed to working with the U. NIAID
supports basic and applied
research to prevent, diagnose and treat
infectious diseases such as HIV/AIDS and other sexually transmitted
infections, influenza, tuberculosis, malaria and illness from
potential agents of bioterrorism
. These statements are based on
assumptions that may not prove accurate.FDA APPROVES TYGACIL(TM)
FIRST-IN-CLASS ANTIBIOTIC
TYGACIL is approved for adults with complicated skin and skin
structure
infections (cSSSI) caused by Escherichia coli, Enterococcus faecalis
(vancomycin-susceptible
isolates only), Staphylococcus aureus (methicillin-
susceptible and -resistant isolates), Streptococcus
agalactiae, Streptococcus
anginosus grp.
TYGACIL is also approved for adults with complicated
intra-abdominal
infections (cIAI) caused by Citrobacter freundii, Enterobacter cloacae,
Escherichia
coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus
faecalis (vancomycin-susceptible isolates
only), Staphylococcus aureus
(methicillin-susceptible isolates only), Streptococcus anginosus grp
.7 percent).For information about pathogens transmitted in water or food.
staphylococcal yersinia
S.com) is one of the
world
's leading independent research and technology development
organizations. Founded as Stanford Research
Institute in 1946, SRI has
been meeting the strategic needs of clients for almost 60 years.yersinia salmonellosis
TYGACIL
is indicated for the treatment of complicated intra-
abdominal infections (cIAI) and complicated
skin and skin structure infections
(cSSSI) in adults.com
About Wyeth
Wyeth (NYSE:
WYE) is one of the world's largest research-driven
pharmaceutical and health care products companies
.
The statements in this press release that are not historical facts are
forward-looking
statements based on current expectations of future events that
involve risks and uncertainties including
, without limitation, risks
associated with the inherent uncertainty of the timing and success of
pharmaceutical research, product development, manufacturing,
commercialization, economic conditions
including interest and currency
exchange rate fluctuations, changes in generally accepted accounting
principles, the impact of competitive or generic products, trade-buying
patterns, wars or terrorist
acts, product liability and other types of
lawsuits, the impact of legislation and regulatory compliance
and obtaining
reimbursement, favorable drug pricing, access and other approvals,
environmental
liabilities, and patent, and other risks and uncertainties,
including those detailed from time to
time in the Company's periodic reports,
including current reports on Form 8-K, quarterly reports
on Form 10-Q and the
annual report on Form 10-K, filed with the Securities and Exchange Commission
.
staphylococcus clostridium
Under the 18-month contract, XOMA will develop monoclonal antibody
therapeutics using proprietary
antibody expression systems to produce
anti-type A-botulinum neurotoxin monoclonal antibodies including
a
Master Cell Bank (MCB), Manufacturer's Working Cell Bank (MWCB) and
other designated deliverables
. Castello, president, chairman and CEO of
XOMA. TYGACIL provides clinicians with a novel,
broad
-spectrum option that can be used at the onset of treatment when the
specific bacteria present are
not yet known.
In clinical trials, empiric monotherapy with TYGACIL provided comparable
clinical
cures rates in cSSSI to vancomycin and aztreonam, a combination
treatment.caliciviruses poisoning
"
"We have previously
stated that an important part of our strategy
for achieving profitability is increased utilization
of our process
development and manufacturing assets," continued Castello.4 percent).rwis gastroenteritis
"
TYGACIL
can be used as an empiric monotherapy to treat a variety of cIAI
and cSSSI, both hospital- and community
-acquired, including complicated
appendicitis, infected burns, intra-abdominal abscesses, deep soft
tissue
infections, and infected ulcers. The increasing
prevalence of resistant bacteria often
necessitates the use of combinations of
antibiotics to fight infections. intermedius, and S.
(includes S. Use of TYGACIL during tooth development may
cause permanent discoloration of the teeth
.flukes staphylococcus
niaid. Centers for Disease Control and Prevention (CDC) states that
persons infected with drug-resistant
organisms are more likely to have longer
hospital stays and require treatment with multiple drugs
. TYGACIL was accepted by the European Medicines
Agency (EMEA) for review, and Wyeth has filed for
approval in other countries,
including Brazil, Canada, Colombia, Mexico, Switzerland, Taiwan, and
Venezuela.safefood cryptosporidiosis
Botulinum neurotoxins are one of these
biological threats and new vaccines, therapies
and diagnostics are
needed to counter the potential terrorist use of these toxins.sri.
antibiotic
with a broad spectrum of antimicrobial activity, including activity
against the drug-resistant bacteria
methicillin-resistant Staphylococcus
aureus (MRSA).
About TYGACIL
TYGACIL, the
first antibiotic approved in a new class called
glycylcyclines, was developed by Wyeth to overcome
key mechanisms of
resistance that have affected antibiotic use.
Wyeth now awaits decisions
on approval of TYGACIL from other regulatory
bodies around the world. Pseudomembranous colitis has
been
reported with nearly all antibacterial agents and may range from mild to life
threatening
.noroviruses schistosomiasis
About XOMA
XOMA develops and commercializes antibody and other protein-based
biopharmaceuticals
for cancer, immune disorders and infectious
diseases. society
between $4 billion and $5 billion
annually.trichinosis staphylococcal
XOMA Awarded $15 Million Contract from NIAID to Help Fight Bioterrorism; XOMA to Develop Three
Anti-Botulinum Neurotoxin Monoclonal Antibodies
----XOMA Ltd.
This project will be 100% funded
with Federal funds from NIAID under
Contract No.gov
About SRI
Silicon Valley-based
SRI International (www. The division specializes in
cancer, infectious disease and neurobiological
research. Provides Physicians With Treatment Alternative
for Complicated
Skin and Intra-abdominal Infections
MADISON, N. 1983-1987). Empiric monotherapy with TYGACIL
also provided clinical cure rates
comparable to imipenem/cilastatin, an empiric treatment for cIAI
.0 percent) was comparable to vancomycin
and aztreonam (5.schistosomiasis flukes
About NIAID
NIAID is a component
of the National Institutes of Health, an
agency of the U.S.com/
Certain statements contained
herein concerning current
collaborations and product development or that otherwise relate to
future
periods, are forward-looking statements within the meaning of
Section 27A of the Securities Act of
1933 and Section 21E of the
Securities Exchange Act of 1934. The approval of TYGACIL will provide
physicians with an important option for patients with complicated skin, skin
structure, and intra
-abdominal infections. TYGACIL should be administered with caution in patients with
known hypersensitivity
to, and may have adverse effects similar to,
tetracycline class antibiotics.salmonellosis sood
In addition, TYGACIL
does not
require dosage adjustment in patients with impaired renal function, and is
conveniently
dosed every 12 hours.campylobacteriosis rotavirus
Business Editors/Health/Medical Writers
BIOWIRE2K
BERKELEY, Calif
. citizens against the harmful effects of biological
agents used in bioterrorism. SRI International
, an independent,
nonprofit research institute based in Menlo Park, CA, will be a
subcontractor
under this contract and will develop potency assays to
support antibody characterization."
About
Botulism Neurotoxin (BoNT)
With the recent deliberate exposure of postal workers, other
government
employees, and the American public to Bacillus anthracis
spores, there is an urgent need to devise
effective measures to
protect U. The
nonprofit research institute performs client-sponsored research
and
development for government agencies, commercial businesses and
nonprofit foundations.S.
Additionally, few broad-spectrum antibiotic agents are currently in
development.trichinosis staphylococcus
, and Aphton Corporation
.
Joseph Camardo, Senior Vice President, Global Medical Affairs, Wyeth
Pharmaceuticals. constellatus
),
Streptococcus pyogenes, and Bacteroides fragilis. The submission also included in vitro data
showing
activity against both gram-negative and gram-positive bacteria,
anaerobes, and certain drug-resistant
pathogens. In clinical trials, the most common
treatment-emergent adverse events in patients treated
with TYGACIL were nausea
(29.campylobacteriosis cyclosporiasis
"This
contract with NIAID is an important step forward in achieving
this
objective. (includes S. anginosus, S. anginosus, S.
The TYGACIL New Drug Application
(NDA) submission included data from four
pivotal phase III studies examining the safety and efficacy
of TYGACIL for the
treatment of cIAI and cSSSI. Monotherapy should be used with caution in patients
with
clinically apparent intestinal perforation.pinworms trichinosis
(Nasdaq:XOMA) today announced that it was awarded
a $15 million
contract from the National Institute of Allergy and Infectious
Diseases (NIAID)
, a part of the National Institutes of Health (NIH),
to produce three botulinum neurotoxin monoclonal
antibodies designed
to protect U. NIAID also supports research on
transplantation and immune-related
illnesses, including autoimmune
disorders, asthma and allergies. Approval of this first-in-class
product comes at a time
when the need for new antibiotic options to combat serious, resistant
infections
is increasing.3 percent) and imipenem/cilastatin (4.wyeth.
Wyeth Pharmaceuticals
Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), has leading
products in the areas of women's health
care, cardiovascular disease, central
nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines
and nutritional products.cryptosporidiosis noroviruses
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