FDA Approves New Indication For Schering-Plough Corporation's AVELOX(R) For Treatment Of Complicated Intra-Abdominal Infections

KENILWORTH, N.J., Nov. 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) today announced that the U.S. Food and Drug Administration (FDA) has approved the once-daily, broad-spectrum antibiotic AVELOX® (moxifloxacin HCl) for a new use -- the treatment of complicated intra-abdominal infections (cIAI) in adults. AVELOX is the only marketed fluoroquinolone antibiotic approved by the FDA as monotherapy to treat this indication. The FDA approval to treat cIAI is the sixth indication for AVELOX.

AVELOX, available in tablet and intravenous (I.V.) formulations, was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough.

Intra-abdominal infections are caused by disease, trauma or surgery in the abdomen that cause bacteria to leak from the gastrointestinal tract into adjacent tissue. There are approximately 3.5 million cases in the United States each year, with many patients contracting the infection secondary to appendicitis.(1)

"The FDA approval of AVELOX to treat complicated intra-abdominal infections is welcome news, providing doctors with an effective treatment option for their patients, and giving patients convenient once-daily dosing and an easy transition from I.V. to oral therapy when they leave the hospital," said Joseph S. Solomkin, M.D., professor in the department of surgery and director of research of the division of trauma/critical care at the University of Cincinnati College of Medicine.

With this FDA approval, AVELOX is indicated for the treatment of adults with 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.

The FDA approval was based on results from clinical studies in cIAI patients showing that sequential I.V. or oral monotherapy with AVELOX once daily was as effective as the widely used I.V. therapy piperacillin-tazobactam four times daily followed by oral amoxicillin-clavulanate twice daily. AVELOX was effective at eradicating key pathogens, including E. coli and the anaerobe B. fragilis, which are the most commonly encountered bacteria in cIAI.

"This FDA approval signals yet another important milestone for AVELOX, following the approval of AVELOX for treatment of complicated skin and skin structure infections in June," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "By adding two new indications this year, AVELOX has successfully expanded its utility as a broad-spectrum antibiotic. This will help toward AVELOX becoming a fluoroquinolone of choice for its approved indications."

Patients taking AVELOX for cIAI treatment benefit from the convenience of once-daily therapy and not requiring dosage adjustments when switching from I.V. to oral therapy. Dosage adjustments also are not required for AVELOX patients suffering from renal impairment.

In October 2004, Schering-Plough acquired exclusive U.S. rights to market, sell and distribute AVELOX from Bayer Pharmaceuticals Corporation. As holder of the New Drug Application (NDA) and patents for AVELOX, Bayer completed the research and FDA submission related to this new indication.

The FDA approval to treat cIAI is the sixth indication for AVELOX, which is already approved in the United States to treat acute bacterial sinusitis (ABS); acute bacterial exacerbation of chronic bronchitis (ABECB); community acquired pneumonia (CAP) -- including CAP caused by multi-drug resistant Streptococcus pneumoniae (MRSP) and penicillin-resistant Streptococcus pneumoniae (PRSP); uncomplicated skin and skin structure infections (uSSSI); and complicated skin and skin structure infections (cSSSI).

AVELOX Studies in cIAI

Two randomized, active-controlled trials in cIAI were performed. In a double-blind trial conducted primarily in North America, the efficacy of sequential I.V. or oral (PO) monotherapy with AVELOX 400 mg once daily (QD) for 5-14 days was compared to I.V. piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of patients with cIAI, including peritonitis, abscesses, appendicitis with perforation and bowel perforation. This study enrolled 681 patients, 379 of which were considered clinically evaluable. In this study, the overall success rates in evaluable patients for AVELOX versus the comparator were 79.8 percent and 78.1 percent, respectively.

About Complicated Intra-Abdominal Infections (cIAI)

Complicated intra-abdominal infections arise from the hollow organs of the peritoneal 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.

About AVELOX

AVELOX is approved to treat: Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis; Acute Bacterial Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae 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," such as levofloxacin 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. These medications include quinidine, procainamide, amiodarone and sotalol.

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 http://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 30,000 people around the world. The company's Web site is http://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 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, current and future branded, generic or over-the-counter competition and the regulatory process, 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 the company's third quarter 2005 10-Q.

Reference (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.)

AVELOX is a registered trademark of Bayer AG and is used under license by Schering-Plough.

Source: Schering-Plough Corporation