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AVELOX(R) Monotherapy as Effective as High-Dose Levofloxacin and Ceftriaxone Combination Therapy in Treating Patients With Severe Community-Acquired Pneumonia.

New Head-To-Head Study Presented at 16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

KENILWORTH, N.J., April 7 /PRNewswire-FirstCall/ -- AVELOX(R) (moxifloxacin HCl) monotherapy at 400 mg once daily is as effective as the high-dose combination of levofloxacin (500 mg twice daily) plus ceftriaxone (2 g once daily) in treating patients with severe community-acquired pneumonia (CAP) requiring hospitalization, according to results of a new clinical study presented at the 16th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Nice, France.

Known as the MOTIV (Moxifloxacin Treatment Intravenous) study, the head- to-head comparison of once-daily AVELOX monotherapy to a combination of high- dose levofloxacin plus high-dose ceftriaxone showed no significant difference in clinical cure rates (4-14 days after the last dose), the primary efficacy endpoint for the two per protocol treatment groups (86.9 percent vs. 89.9 percent, respectively), including CAP patients with the most severe pneumonia. The per protocol population consisted of 569 patients. A total of 748 patients were enrolled in the study, of which 738 patients were randomized. Both treatments were well tolerated in the study, with similar adverse event profiles.

"The results of the MOTIV study are important because community-acquired pneumonia is a particular concern for people with chronic illnesses or impaired immune systems, and is a common cause of hospitalization worldwide," said Antoni Torres, M.D., professor of pulmonology at the University of Barcelona in Spain. "CAP can critically affect older patients who may be struggling with existing conditions such as heart disease and diabetes," he added. "These results provide additional evidence that AVELOX is a safe and effective treatment for patients with CAP."

CAP affects approximately 5.6 million adults in the United States each year, with elderly patients (age 65 and above) 60 percent more likely than the general population to develop the infection.(1,2)

AVELOX, a broad-spectrum fluoroquinolone antibiotic, has been shown to be safe and effective as monotherapy in treating patients with CAP and is approved for this indication. (See About AVELOX section below for more information.)

Study Design

The MOTIV study was a prospective, randomized, multicenter, multinational, double-blind, double-dummy comparative study conducted outside the United States designed to determine the efficacy and safety of AVELOX versus a combination of high-dose levofloxacin and high-dose ceftriaxone in treating severe CAP requiring hospitalization and parenteral treatment (treatment by injection). The high-dose of levofloxacin as well as the combination therapy used in the study are not approved in the United States.

Patients in the study were randomized to receive either: AVELOX I.V./oral 400 mg once daily for seven to 14 days; or the combination of ceftriaxone I.V. 2 g once daily plus levofloxacin I.V. 500 mg twice daily, followed by levofloxacin oral 500 mg twice daily, for seven to 14 days. The dose of levofloxacin could be adjusted according to the patient's renal function. Patients in the study were stratified by the Pneumonia Severity Index, with 59.1 percent of the 569 patients in the per protocol population classified as having severe pneumonia (PSI Classes IV-V).

About Community-Acquired Pneumonia (CAP)

Community-acquired pneumonia affects 5.6 million adults in the United States annually, resulting in nearly two million cases of hospitalization.(3,4) It is the fifth leading cause of death among people older than 65 years, and a larger percentage of these patients have frequent co-morbidities and require hospitalization and longer hospital and intensive care unit (ICU) stays.(5,6) The cost of treating CAP patients is estimated at $10 billion per year, with 92 percent of those costs spent on hospitalized care.(7) Community-acquired pneumonia is a particular concern for seniors and people with chronic illnesses or impaired immune systems, although it also affects young and healthy people.

About AVELOX

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 transitioning from I.V. to oral therapy. AVELOX patients suffering from renal impairment do not need to have their dosage adjusted.

AVELOX is indicated for the treatment of adults (18 years of age and older) with infections cause by susceptible strains of the following designated microorganisms: 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. 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 http://www.aveloxusa.com/.

About Schering-Plough

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 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 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 2005 10-K.

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

Levofloxacin is marketed as LEVAQUIN in the United States. LEVAQUIN is a registered trademark of Ortho-McNeil Pharmaceutical.

Ceftriaxone is marketed as ROCEPHIN in the United States. ROCEPHIN is a registered trademark of Roche Laboratories Inc.
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 August 30, 2005.
 3. Centers for Disease Control and Prevention. Premature deaths, monthly
 mortality and monthly physician contacts: United States. MMWR
 1997;46:556.
 4. Niederman MS, McCombs JS, Unger AN, et al. The cost of treating
 community-acquired pneumonia.
 Clin Ther 1998;20:820-837.
 5. Houck P, et al. Timing of Antibiotic Administration and Outcomes for
 Medicare Patients Hospitalized with Community-Acquired Pneumonia. Arch
 Intern Med. 2004;164:637-644.
 6. Niederman M. Community-acquired Pneumonia: Management Controversies,
 Part I; Practical Recommendations from the Latest Guidelines. Am J
 Respir Crit Care Med. 2001(5).
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