Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the
U.S. Food and Drug Administration (FDA) has accepted for filing the
Company's supplemental New Drug Application (sNDA) for its first-in-class
antibiotic Tygacil(R) (tigecycline) for the treatment of patients with
community-acquired pneumonia (CAP). The FDA now will complete its review of
the application. The FDA may approve or disapprove the application, request
additional data or take other administrative actions.
"CAP is a serious respiratory disease that affects millions of
Americans," says Gary L. Stiles, M.D., Executive Vice President, Chief
Medical Officer, Wyeth Pharmaceuticals. "The acceptance of this sNDA is an
important event as it brings Wyeth closer to providing physicians with a
new option for the treatment of CAP."
The sNDA submission included integrated data from two investigational
clinical studies that included 846 patients. Study data showed that Tygacil
cured 89.7 percent of patients hospitalized with CAP, and levofloxacin - an
existing treatment option for CAP - cured 86.3 percent of studied patients.
The most common adverse events for Tygacil were nausea (24.3 percent),
vomiting (16.0 percent) and abdominal pain (5.7 percent). The
discontinuation rates due to adverse events for Tygacil and levofloxacin
were similar (6.1 percent and 8.3 percent, respectively).
"As antibiotic resistance continues to be a concern for many strains of
the most common bacteria causing CAP, there is a growing need for new
options," says Thomas File, M.D., Chief of Infectious Disease Services for
Summa Health System in Akron, Ohio.
About Community-Acquired Pneumonia
CAP is defined as pneumonia not acquired in a hospital or long-term
care facility. It is a bacterial infection in the lung and is a common, but
serious, respiratory disease affecting approximately 5.6 million Americans
each year. The cost of treating patients with CAP is about $10 billion per
year, with inpatient costs representing 92 percent of the total sum and
hospitalized patients accruing nearly $7,500 each. CAP also is thought to
account for 10 million physician visits per year in the United States.
Symptoms of CAP include cough, fever, chills, fatigue, shortness of breath
and chest pain.
About the Clinical Trials
Phase 3 clinical trials of Tygacil for CAP were conducted over a
24-month period in more than 200 countries across the globe. The first of
their kind for Tygacil in the area of pneumonia, the clinical trials were
multicenter, multinational, double-blind, randomized, controlled studies
designed to compare cure rates between Tygacil and levofloxacin.
About Tygacil
Tygacil was first approved by the FDA in June 2005 for the treatment of
complicated intra-abdominal infections (cIAI) and complicated skin and skin
structure infections (cSSSI) in adults.
Indications
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 group
(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 group (includes S. anginosus, S. intermedius
and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron,
Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens and
Peptostreptococcus micros.
Tygacil can be used as an empiric monotherapy to treat a variety of
cIAI and cSSSI, both hospital- and community-acquired, including
complicated appendicitis, intra-abdominal abscesses, infected burns, deep
soft-tissue infections and infected ulcers.
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 and -susceptible Staphylococcus
aureus, (MRSA and MSSA) and vancomycin-resistant enterococci (VRE); Tygacil
is unaffected by extended-spectrum beta-lactamases (ESBLs).
In addition, Tygacil has been shown to have in vitro activity against
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 and Pasteurella multocida. The
clinical significance of in vitro activity is unknown.
Tygacil provides clinicians with an 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 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.
-- Anaphylaxis/anaphylactoid reactions have been reported with nearly all
antibacterial agents, including tigecycline, and may be life
threatening.
-- 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 and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis and hyperphosphatemia). As with tetracyclines, pancreatitis
has been reported with the use of Tygacil.
-- The safety and efficacy of Tygacil in patients with hospital-acquired
pneumonia have not been established.
-- In clinical trials, the most common treatment-emergent adverse events
in patients treated with Tygacil were nausea (29.5 percent) and
vomiting (19.7 percent).
-- 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.
-- Clostridium difficile-associated diarrhea (CDAD) has been reported
with use of nearly all antibacterial agents, including Tygacil, and
may range in severity from mild diarrhea to fatal colitis.
-- 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 and diazepam.
For a copy of Tygacil Prescribing Information, please visit
wyeth.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products.
Wyeth is one of the world's 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 non-prescription medicines that improve the
quality of life for people worldwide. The Company's major divisions include
Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
The statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events
and are subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such statements.
These risks and uncertainties include the inherent uncertainty of the
timing and success of, and expense associated with, research, development,
regulatory approval and commercialization of our products, including with
respect to our pipeline products; government cost-containment initiatives;
restrictions on third-party payments for our products; substantial
competition in our industry, including from branded and generic products;
data generated on our products; the importance of strong performance from
our principal products and our anticipated new product introductions; the
highly regulated nature of our business; product liability, intellectual
property and other litigation risks and environmental liabilities;
uncertainty regarding our intellectual property rights and those of others;
difficulties associated with, and regulatory compliance with respect to,
manufacturing of our products; risks associated with our strategic
relationships; economic conditions including interest and currency exchange
rate fluctuations; changes in generally accepted accounting principles;
trade buying patterns; the impact of legislation and regulatory compliance;
risks and uncertainties associated with global operations and sales; and
other risks and uncertainties, including those detailed from time to time
in our periodic reports filed with the Securities and Exchange Commission,
including our current reports on Form 8-K, quarterly reports on Form 10-Q
and annual report on Form 10-K, particularly the discussion under the
caption "Item 1A, RISK FACTORS." The forward-looking statements in this
press release are qualified by these risk factors. We assume no obligation
to publicly update any forward-looking statements, whether as a result of
new information, future developments or otherwise.
Wyeth
wyeth
View drug information on Tygacil; Warfarin Sodium tablets.