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Recently Approved I.V. Antibiotic Demonstrates Expanded Broad Spectrum
In Vitro Activity
WASHINGTON, Dec. 16 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), presented data today from multiple studies that
indicate the in vitro activity of TYGACIL(R) (tigecycline) against many
resistant Gram-negative bacteria, including Extended-Spectrum Beta-Lactamase
(ESBL)-producing organisms. Nearly 99 percent of Acinetobacter isolates
tested were susceptible to TYGACIL. These data were among 39 tigecycline
abstracts and posters presented at the 45th Annual Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C., U.S.A.
"While much has been reported on the rising rates of Gram-positive
organisms, such as methicillin -resistant Staphylococcus aureus (MRSA), there
is increasing concern throughout the global medical community over resistant
Gram-negative organisms, especially those that are ESBL producing," says David
Wu, M.D., Assistant Vice President, Clinical Affairs, Global Medical Affairs
at Wyeth.
Extended-Spectrum Beta Lactamases, known as ESBLs, are enzymes produced by
Gram-negative bacteria that make the organisms drug resistant.
Tigecycline is not affected by these enzymes.
Among the data presented are results from the Tigecycline Evaluation
Surveillance Trial (T.E.S.T.) demonstrating tigecyclines in vitro activity
against commonly encountered Gram-negative bacteria strains, such as
Acinetobacter baumannii, that are found in certain community- and hospital-
acquired infections. Other data demonstrated tigecyclines in vitro activity
against important ESBL-producing bacteria such as Klebsiella pneumoniae and
Escherichia coli isolates.
About Resistant Gram-Negative Bacteria
Data have shown a marked rise in resistant strains of Gram-negative
bacteria such as Klebsiella, Enterobacter, and E. coli over the past decade. A
high rate of ESBL-producing Gram-negative bacteria has been detected in Latin
America, and, since 2001, ESBL production has risen sharply in the UK and
Ireland. According to data from the Centers for Disease Control and
Prevention, Klebsiella pneumoniae isolates resistant to certain antibiotics
have increased in the U.S. within the past few years.
About TYGACIL
TYGACIL, a first-in-class glycylcycline, is an I.V. antibiotic with an
expanded broad spectrum of in vitro activity against Gram positives, Gram
negatives, anaerobes, methicillin-resistant Staphylococcus aureus (MRSA) and
vancomycin-resistant enterococci (VRE); TYGACIL is unaffected by Extended-
Spectrum Beta Lactamases (ESBLs).
TYGACIL is indicated for the treatment of 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. (includes S.
anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, and
Bacteroides fragilis.
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. (includes S. anginosus, S. intermedius, and S.
constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides
uniformis, Bacteroides vulgatus, Clostridium perfringens, and
Peptostreptococcus micros.
TYGACIL was approved in the United States on June 16, 2005, and 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.
In addition, TYGACIL has been shown to have in vitro activity against the
indicated organisms above and the following organisms: Enterococcus avium,
Enterococcus casseliflavus, Enterococcus faecalis (vancomycin-resistant
isolates), Enterococcus faecium (vancomycin-susceptible and
-resistant isolates), Enterococcus gallinarum, Listeria monocytogenes,
Staphylococcus epidermidis (methicillin-susceptible and -resistant isolates),
Acinetobacter baumannii, Aeromonas hydrophila, Citrobacter koseri,
Enterobacter aerogenes, Pasteurella multocida. The clinical significance of in
vitro activity is unknown.
TYGACIL provides clinicians with a novel, expanded broad-spectrum
antibiotic option that can be used at the onset of treatment when the specific
bacteria present are not yet known. In addition, TYGACIL does not require
dosage adjustment in patients with impaired renal function, and is
conveniently dosed every 12 hours.
Important TYGACIL Safety Information
* To reduce the development of drug-resistant bacteria and maintain the
effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should
be used only to treat infections proven or strongly suspected to be
caused by susceptible bacteria.
* TYGACIL is contraindicated in patients with known hypersensitivity to
tigecycline.
* TYGACIL should be administered with caution in patients with known
hypersensitivity to tetracycline class antibiotics.
* Glycylcycline class antibiotics are structurally similar to
tetracycline class antibiotics and may have similar adverse effects.
Such effects may include: photosensitivity, pseudotumor cerebri,
pancreatitis, and anti-anabolic action (which has led to increased BUN,
azotemia, acidosis, and hypophosphatemia).
* In clinical trials, the most common treatment-emergent adverse events
in patients treated with TYGACIL were nausea (29.5%) and vomiting
(19.7%).
* TYGACIL may cause fetal harm when administered to a pregnant woman.
* The safety and effectiveness of TYGACIL in patients below age 18 and
lactating women have not been established.
* Pseudomembranous colitis has been reported with nearly all
antibacterial agents and may range in severity from mild to life
threatening.
* Concurrent use of antibacterial drugs with oral contraceptives may
render oral contraceptives less effective.
* The use of TYGACIL during tooth development may cause permanent
discoloration of the teeth. TYGACIL should not be used during tooth
development unless other drugs are not likely to be effective or are
contraindicated.
* Prothrombin time or other suitable anticoagulant test should be
monitored if TYGACIL is administered with warfarin.
* Monotherapy should be used with caution in patients with clinically
apparent intestinal perforation.
* In patients with severe hepatic impairment (Child Pugh C), the initial
dose of TYGACIL should be 100 mg followed by 25 mg every 12 hours.
Patients should be treated with caution and monitored for treatment
response.
* The following drugs should not be administered simultaneously through
the same Y-site as TYGACIL: amphotericin B, chlorpromazine,
methylprednisolone, and voriconazole.
For a copy of TYGACIL Prescribing Information, please visit http://www.wyeth.com
About Wyeth
Wyeth is one of the worlds largest research-driven pharmaceutical and
health care products companies. 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. The Companys major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of womens health care, cardiovascular disease, central nervous system,
inflammation, transplantation, hemophilia, oncology, vaccines and nutritional
products.
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 Companys 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.
Actual results may vary materially from the forward-looking statements. The
Company assumes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or
otherwise.
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