COLLEGEVILLE, Pa., May 29 /PRNewswire-FirstCall/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the
U.S. Food and Drug Administration (FDA) has issued an approvable letter for
the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of
adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requested that Wyeth provide
additional analyses to support the safety and efficacy of TYGACIL for the
treatment of patients with CAP with illness severe enough to require
hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk
of TYGACIL for any potential of liver toxicity. Wyeth recently provided
that information to the agency during the review period and believes that
its response adequately addresses the issues raised by the FDA. However,
the agency acknowledged in its letter that it had not yet reviewed that
information.
"We believe the data from our current clinical development program
support TYGACIL as a potential therapeutic option for patients with CAP,"
says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer,
Wyeth Pharmaceuticals. "Wyeth is committed to working with the FDA to
resolve the outstanding issues for TYGACIL in order to gain approval."
TYGACIL was approved by the FDA in June 2005 for the treatment of adult
patients with complicated intra-abdominal infections (cIAI) and complicated
skin and skin structure infections (cSSSI).
Wyeth has achieved significant success in bringing new products to
market. Year to date, the Company has obtained three new product approvals
in the following therapeutic areas: major depressive disorder, Hemophilia A
and opioid-induced constipation.
About Community-Acquired Pneumonia
CAP is defined as pneumonia acquired outside a hospital or long-term
care facility. It is an infection of the lungs that results in decreased
ability to function normally. Although pneumonia is not a reportable
illness, it appears that up to 5.6 million cases of community-acquired
pneumonia occur annually. In addition, hospitalization rates among patients
with CAP are approximately 20 percent. Symptoms of CAP include cough,
fever, chills, fatigue, shortness of breath, and chest pain.
About the CAP Clinical Trials
TYGACIL was evaluated in adults for the treatment of CAP in two phase
3, multicenter, randomized, double-blind studies. The two studies (N=418,
N=434) were conducted at 116 sites in 28 countries across the globe and
evaluated the efficacy and safety of tigecycline compared with levofloxacin
in subjects hospitalized with CAP.
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 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 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 IV 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 (26.4%) and vomiting
(18.1%)
-- 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 http://www.Wyeth.com.
About Wyeth Pharmaceuticals
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, nutritionals 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 that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied by such statements. In particular, there can be no assurance that
our pending supplemental new drug application for TYGACIL for the CAP
indication will be approved or that the product will ever be successfully
commercialized for CAP or other indications. Other risks and uncertainties
that could cause actual results to differ materially from those expressed
or implied by forward-looking statements include, without limitation, the
inherent uncertainty of the timing and success of, and expense associated
with, research, development, regulatory approval and commercialization of
our products and 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; emerging data on our products and pipeline 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" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
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.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
CONTACT:
Media Contacts: Sal Foti, +1-484-865-3490, or
Gwen Fisher, +1-484-865-5160; or Investor Contact: Justin
Victoria, +1-973-660-5340, all of Wyeth Pharmaceuticals
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