SAN FRANCISCO, Sept. 29, 2006 – The efficacy of monotherapy with the once-daily, broad-spectrum antibiotic AVELOX® (moxifloxacin HCl) in the treatment of complicated intra-abdominal infections (cIAI) was highlighted in two clinical data presentations by researchers here at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2006, Schering-Plough Corporation (NYSE: SGP) reported today.
Approximately 3.5 million Americans are diagnosed annually with cIAIs, which are caused by disease, trauma or surgery in the abdomen that can allow bacteria to leak from the gastrointestinal tract into adjacent tissue.(1)
"Complicated intra-abdominal infections often involve several different kinds of bacteria and require broad-spectrum antibiotic therapy for effective treatment," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "The data presented at ICAAC further underscore the efficacy of once-daily AVELOX monotherapy in treating these infections."
AVELOX is the only marketed fluoroquinolone antibiotic approved by the U.S. Food and Drug Administration (FDA) as monotherapy to treat cIAI, and has been shown to be effective at eradicating the most common bacteria that cause cIAI, including E. coli and B. fragilis. AVELOX is indicated to treat polymicrobial cIAI infections, including infections caused by mixed aerobic and anaerobic bacteria (bacteria that thrive without oxygen) commonly seen in patients with cIAI.(2,3)
Robert Consalvo can be reached at (908) 298-7409.
About the ICAAC Data Presentations
Moxifloxacin for the Treatment of Patients with Complicated Intra-Abdominal Infections
(G. Weiss, P. Reimnitz , H. Lippert, and The Aida Study Group)
This prospective, randomized, open-label, multicenter study compared the efficacy and safety of moxifloxacin to that of combination therapy in the treatment of cIAI. Of 595 patients enrolled at 58 international centers, 584 (289 moxifloxacin, 295 control group) were valid for the intent-to-treat analysis. Patients received either intravenous (I.V.) followed by oral moxifloxacin (400 mg, once daily) or a sequential therapy with I.V. ceftriaxone (2 g daily) and metronidazole (0.5 g, three times daily) followed by oral dosing of amoxicillin/clavulanate (625 mg, three times daily) for 14 days. A switch to oral moxifloxacin (400 mg, once daily) or amoxicillin/clavulanate (625 mg, three times daily) was allowed per protocol after the third day of treatment for the two groups, respectively.
In the study, moxifloxacin monotherapy was as effective as the combination regimen in treating patients with cIAI. Overall clinical cure rates were 80.9 percent in the group receiving moxifloxacin and 82.3 percent in the group receiving the combination therapy regimen. Duration of therapy, length of post-operative hospital stay and mortality rates were comparable for the two treatment groups. Both regimens were well tolerated. In the study, 19 percent of the moxifloxacin patients and 12.5 percent of the patients in the comparator arm experienced at least one drug-related adverse event.
Moxifloxacin Efficacy Against Anaerobic Bacteria: Pooled Analysis from Two Complicated Intra-Abdominal Infection Trials (P. Pertel, M. Malangoni , L. Koeth, J. E. Ambler, S. Choudhri)
This analysis, designed to assess the efficacy of moxifloxacin against anaerobic bacteria in cIAI, evaluated pooled data from two large cIAI clinical trials in which the effectiveness of I.V. to oral moxifloxacin (400 mg, once daily) was compared to treatment with combination therapies. In one trial, the comparator treatment was I.V. piperacillin-tazobactam (3.0/0.375 g, every 6 hours) followed by oral amoxicillin-clavulanic acid (800/114 mg, twice daily). In the second trial, the comparator treatment was the combination of I.V. ceftriaxone (2 g, once daily) and metronidazole (500 mg, three times daily) followed by oral amoxicillin-clavulanic acid (500/125 mg, three times daily).
In these studies, clinical efficacy and bacteriological eradication rates were assessed at the test-of-cure visit. The pooled analysis showed that monotherapy with moxifloxacin 400 mg once daily provided clinical and bacteriological success rates against anaerobic pathogens comparable to combination therapy with either piperacillin/tazobactam or ceftriaxone/metronidazole in patients with cIAI. Overall, the combined cure rates were 80.4 percent (345/429) for patients treated with moxifloxacin and 80.4 percent (371/461) for patients in the combination therapy treatment arms.
About Complicated Intra-Abdominal Infections (cIAI)
Complicated intra-abdominal infections arise from the hollow organs of the abdominal cavity, including the stomach, small and large bowel, appendix and biliary system. Types of cIAI include appendicitis with perforation or abscess, intra-abdominal abscess or peritonitis (diffuse inflammation of peritoneum lining the abdominal wall and bowel), perforations of the stomach or bowel, and surgical site infections related to previous intra-abdominal surgery. Generally, cIAI are acquired when the integrity of the gastrointestinal (GI) tract is affected as a result of previous surgery, intrinsic disease or trauma. The leakage of bacteria from within the GI tract into adjacent tissues results in infection. In the case of post-surgical infections, cIAI are caused by nosocomial bacteria specific to the surgical site and to the specific hospital and unit.
AVELOX, available in tablet and I.V. formulations, was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough. AVELOX offers patients a once-daily dosing regimen that does not require dosage adjustment when switching from I.V. to oral therapy. AVELOX patients suffering from renal impairment do not need to have their dosage adjusted.
AVELOX is approved for use in adult patients (18 years of age and older) for the treatment of: Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis; Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis; Community Acquired Pneumonia (CAP) caused by Streptococcus pneumoniae (including multi-drug resistant strains*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae; Uncomplicated Skin and Skin Structure Infections (uSSSI) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes; Complicated Skin and Skin Structure Infections (cSSSI) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae; and Complicated Intra-Abdominal Infections (cIAI) including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.
*MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (Penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotic classes: penicillin (MIC greater than or equal to 2 mcg/mL), second generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
SAFETY INFORMATION about AVELOX
AVELOX is generally well tolerated, with adverse events being similar to standard therapy. The most common side effects caused by AVELOX, which are usually mild, include dizziness, nausea and diarrhea. Patients should be careful about driving or operating machinery until they are sure that AVELOX is not causing dizziness. Patients should inform a health care professional of other side effects.
Patients who have ever had an allergic reaction to AVELOX or any of the other group of antibiotics known as "quinolones" should avoid taking AVELOX.
Patients who have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat should avoid taking AVELOX.
AVELOX is not for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. AVELOX is not for children under the age of 18 years.
Convulsions have been reported in patients receiving quinolone antibiotics. Patients should be sure to let their physician know if they have a history of convulsions.
Many antacids and multivitamins may interfere with the absorption of AVELOX and may prevent it from working properly. Patients should take AVELOX either 4 hours before or 8 hours after taking these products.
Please see full prescribing information for AVELOX available at www.AVELOXUSA.com.
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements related to the potential market for AVELOX. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition and the regulatory process, and any developments following regulatory approval, among other uncertainties.
For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's second quarter 2006 10-Q.
1. The Hospital Antibiotic Market Guide by AMR/Arlington Medical Resources, Inc.; MAT June 2004. (Intra-abdominal Infection cases based on Bayer HealthCare customized definition.)
2. Golan Y, McDermott LA, Jacobus NV, et al. Emergence of fluoroquinolone resistance among Bacteroides species. Journal of Antimicrobial Chemotherapy 2003;52:208-13.
3. Edmiston CE, Krepel CJ, Seabrook GR, et al. In vitro activities of moxifloxacin against 900 aerobic and anaerobic surgical isolates from patients with intra-abdominal and diabetic foot infections. Antimicrobial Agents and Chemotherapy 2004;48:1012-6.
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