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LEDERLE TO MARKET ZOSYN(TM), A POWERFUL NEW HOSPITAL IV ANTIBIOTIC AND A THERAPEUTIC ADVANCE FOR THE TREATMENT OF POTENTIALLY LIFE-THREATENING INFECTIONS

-- FDA Approves First Intravenous Antibacterial Combination in Six Years
 And the First To Contain Tazobactam --
 WAYNE, N.J., Oct. 25 /PRNewswire/ -- Lederle Laboratories, a division of American Cyanamid Company (NYSE: ACY), announced today that it has received Food and Drug Administration approval to market ZOSYN(TM) (piperacillin sodium/tazobactam sodium), a powerful new antibiotic for hospital use. ZOSYN combines Lederle's piperacillin, a broad-spectrum antibiotic, with tazobactam, a powerful beta-lactamase inhibitor. ZOSYN is indicated as presumptive therapy before the specific cause of an infection has been identified, and for the treatment of mixed (polymicrobial) infections caused by microorganisms that produce beta-lactamases, enzymes which enable certain bacteria to resist many antibiotics.
 ZOSYN is more effective than two therapies that have been considered, until now, as primary therapies for the treatment of these particular infections, according to recent multicenter clinical trials conducted in the U.S. and Canada. ZOSYN cured or improved 84 percent of patients with community-acquired lower respiratory tract infections, compared to 64 percent for SmithKline Beecham's Timentin(R) (ticarcillin/clavulanate), according to a study presented in October 1993 at the 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in New Orleans. ZOSYN cured or improved 88 percent of patients with serious intra-abdominal infections, compared to 77 percent for combination therapy of clindamycin phosphate plus gentamicin, according to a study reported in the September 1993 issue of The American Surgeon. Clindamycin phosphate plus gentamicin is considered the "gold standard" therapy for intra-abdominal infections.
 During the last year, the compound was launched under the brand name TAZOCIN(TM) in France, Germany, The Netherlands, Spain, Switzerland, United Kingdom and Scandinavia, where the product was extremely well- received and quickly gained widespread hospital use.
 POSITIVE RESPONSE BY HOSPITALS ANTICIPATED
 "In this challenging era of healthcare reform, ZOSYN is ideally positioned to enter the hospital antibiotic market. ZOSYN, with its unique combination and extended spectrum of activity against resistant bacteria, has shown excellent efficacy in key areas of infectious disease therapy," said Edward Fritzky, President of Lederle Laboratories. "ZOSYN approval has been eagerly anticipated by the hospital infectious disease community, and we believe ZOSYN will swiftly find a place in the infectious disease armamentarium of most hospitals. We believe this important new product has the potential to help alleviate part of the Centers for Disease Control's estimated $4.5 billion healthcare costs of hospital-acquired infections."
 Clinical studies prove ZOSYN to be an effective monotherapy for many polymicrobic infections that previously have required multiple antibiotics. The ability of ZOSYN to control or destroy normally resistant bacteria can potentially result in lower treatment costs and shorter hospital stays. Administering ZOSYN as a monotherapy may be less costly than administering combination therapy, since fewer pharmacy and nursing services may be required.
 "While piperacillin's broad spectrum of activity makes ZOSYN effective against a wide range of infectious bacteria, the inclusion of tazobactam, one of the most powerful beta-lactamase inhibitors available, separates it from other antibiotics," says Linda Wase, M.D., Vice President of Scientific Affairs and Medical Director, Lederle Laboratories. "Many resistant bacteria produce beta-lactamase enzymes that inactivate antibiotics by breaking an essential link in their molecular structure. The tazobactam component of ZOSYN inactivates these enzymes before they can destroy the piperacillin antibiotic component, thereby allowing the piperacillin to effectively target and destroy infectious bacteria."
 HOSPITALS TEST ZOSYN IN LARGEST MULTICENTER IN VITRO TRIAL TO DATE
 ZOSYN is currently being tested in the largest, multi-center in vitro trial of intravenous antibiotics conducted to date. Over one hundred leading academic medical centers throughout the United States are conducting this multicenter microbiology trial to measure the susceptibility of bacteria to ZOSYN versus 18 other intravenous antibiotics. The study involves more than 55,000 isolates of different bacteria. Lederle anticipates that results of the trial, which will be available later this year, will help hospitals gain confidence that clinical efficacy of ZOSYN is comparable to that of agents currently used in practice.
 ZOSYN is indicated for the treatment of the following infections caused by susceptible organisms:
 -- Intra-abdominal infections (e.g., appendicitis complicated by rupture or abscess; peritonitis).
 -- Community-acquired pneumonia.
 -- Skin and skin structure infections (e.g., cellulitis, cutaneous abscess, ischemic diabetic foot infection).
 -- Gynecologic infections (e.g., post-partum endometritis, pelvic inflammatory disease).
 Due to its broad spectrum of activity, ZOSYN is also indicated as presumptive therapy for the above conditions.
 CLINICAL TRIALS SHOW SAFETY AND EFFICACY
 Extensive Phase III clinical trials conducted with more than 3,400 patients worldwide at leading, geographically diverse medical institutions, including Massachusetts General Hospital in Boston, Baylor College of Medicine in Houston and San Francisco General Hospital, show that ZOSYN has excellent efficacy and is safe and well tolerated.
 The most common side effects reported were diarrhea, nausea or headache. The use of ZOSYN is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins or beta-lactamase inhibitors.
 Lederle Laboratories, a division of American Cyanamid Company, is a research-intensive pharmaceutical organization with a major focus on anti-infective products. Lederle has a tradition of developing landmark antibiotics, including AUREOMYCIN(R) (chlortetracycline), the world's first broad spectrum antibiotic; MINOCIN(R) (minocycline), a semi- synthetic tetracycline derivative; SUPRAX(R) (cefixime), the first oral once-a-day cephalosporin; and, PIPRACIL(R) (piperacillin), a semi- synthetic broad spectrum penicillin.
 NOTE: Please consult full prescribing information for ZOSYN(TM) - (piperacillin sodium/tazobactam sodium)
 -0- 10/25/93
 /CONTACT: Pat Fiaschetti of Lederle Laboratories, 201-831-4684/
 (ACY)


CO: Lederle Laboratories ST: New Jersey IN: MCT SU: PDT

WB-TM -- NY010 -- 6269 10/25/93 11:28 EDT
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Date:Oct 25, 1993
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