MADISON, N.J., Sept. 29 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), presented data today from Phase III studies in patients with community-acquired pneumonia (CAP) at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, California. Community-acquired pneumonia is defined as pneumonia not acquired in a hospital or long-term care facility. CAP affects approximately 5.6 million Americans each year.
According to the integrated data from two investigational clinical studies that included 846 patients, TYGACIL(R) cured 89.7 percent of patients hospitalized with CAP, compared to levofloxacin - an existing treatment option for CAP, which cured 86.3 percent of studied patients. The difference between these cure rates was not statistically significant. Additional data showed that the length of hospital stay for patients treated with TYGACIL was comparable to levofloxacin. The length of stay for both treatment groups totaled 6.3 days. The most common adverse events for TYGACIL were nausea (24.3%), vomiting (16.0%) and abdominal pain (5.7%). The discontinuation rates due to adverse events for TYGACIL and levofloxacin were similar (6.1% and 8.3%, respectively).
"The need for a new option is especially critical as many strains of the most common bacteria causing CAP are now resistant to certain antibiotics and can complicate treatment. Additionally, new treatment options are always welcome for important atypical microbes," says Thomas File, M.D., Chief of Infectious Disease Services for Summa Health System in Akron, Ohio.
David Wu, M.D., Assistant Vice President, Clinical Affairs, Global Medical Affairs at Wyeth says, "This data is especially notable as we prepare to submit a supplemental New Drug Application for TYGACIL that would include CAP. CAP is a potentially fatal ailment and the hope is that TYGACIL will provide the medical community with another treatment option.
Carol J. Baker, President, National Foundation for Infectious Diseases said, "At a time when new antimicrobials are so desperately needed, Wyeth's work to explore the utility of TYGACIL across other infectious diseases is especially helpful considering the limited treatment options available to health care providers."
Wyeth plans to file globally for this indication in 2007. To date, TYGACIL has been approved in 40 countries including: the United States, Canada, Argentina, Brazil, Colombia, Ecuador, Mexico, Peru, Philippines and the European Union for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI).
MORE ABOUT CAP:
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 is also 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.
According to the American Academy of Family Physicians, the mortality in CAP may increase if antibiotic therapy is delayed. Therefore, diagnostic and treatment decisions need to be made accurately and efficiently.
About TYGACIL
TYGACIL is indicated for the treatment of adults with:
Complicated skin and skin structure infections 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 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, Bacterioides 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.
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, 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 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, 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.
* 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 www.wyeth.com.
About Wyeth
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 nonprescription 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.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth has leading products in the areas of women's 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 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 risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, 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, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, 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." 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