Schering-Plough Corporation Release: Head-To-Head Study Shows More Elderly Patients With Community-Acquired Pneumonia Recovered At Days 3 To 5 With AVELOX(R) (Moxifloxacin HCl) Compared To LEVAQUIN (Levofloxacin)

KENILWORTH, N.J., Jan. 24 /PRNewswire-FirstCall/ -- Significantly more elderly patients treated with AVELOX(R) (moxifloxacin HCl) for community-acquired pneumonia (CAP) recovered at days 3 to 5 of a 7 to 14 day course of treatment than those treated with LEVAQUIN (levofloxacin), according to results of a clinical study published in the current issue of Clinical Infectious Diseases.(1) The first comparative, head-to-head evaluation of two fluoroquinolone antibiotics in hospitalized elderly CAP patients showed that 97.9 percent of AVELOX patients recovered at days 3 to 5 compared to 90.0 percent of LEVAQUIN patients (P=0.01). There was no significant difference between the two treatments with regard to cardiac safety, the primary endpoint of the study, or clinical cure rates 5 to 21 days after the end of treatment, the primary efficacy endpoint.

Additional analyses examined cure rates across CAP severity and age subgroups, including mild to moderate CAP, severe CAP, CAP in patients 65-74 years of age, and CAP in patients 75 years of age or older. Patients treated with AVELOX achieved a cure rate of 90 percent or greater in all CAP severity and age subgroups. The rates of investigator-reported drug-related adverse events in the study were similar for both treatment regimens.

The clinical study, called CAPRIE (Community-Acquired Pneumonia Recovery In the Elderly), is one of only a few studies that have specifically evaluated CAP treatment among elderly (age 65 or older) and very elderly (age 75 or older) patients. These patients are 60 percent more likely to contract CAP than the general population.(2)

“The incidence of pneumonia increases with age and elderly pneumonia patients are a vulnerable patient population that faces a high mortality rate when they enter a hospital,” said Dr. Antonio Anzueto, lead study author and associate professor of medicine, University of Texas Health Science Center, San Antonio. “The CAPRIE study findings not only reinforce that AVELOX is an effective and safe treatment option for elderly patients with CAP, but also show that more patients taking AVELOX recovered at days 3 to 5 compared to patients taking LEVAQUIN.”

Each year, there are nearly one million cases of community-acquired pneumonia among the elderly in the United States and among those age 85 or older, at least 1 in 20 have to be hospitalized.(3,4) The disease is the fifth leading cause of death in the elderly and research has shown that the appropriate and timely administration of antibiotics to elderly CAP patients may lead to decreased mortality and faster hospital discharge.(5)

Study Design

The CAPRIE study was a prospective, randomized, controlled, double-blind, double-dummy, comparative study conducted at 47 centers across the United States. Patients were stratified by CAP severity before randomization to I.V./oral AVELOX 400 mg once daily or I.V./oral LEVAQUIN 500 mg once daily for seven to 14 days. The study enrolled 394 patients, of which 281 were valid for the primary efficacy analysis. Most patients had multiple co-morbidities, including chronic obstructive pulmonary disease (COPD), cardiac disease and diabetes, and 16 percent of patients had severe CAP.

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.(6,7) 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.(8,9) The cost of treating CAP patients is estimated at $10 billion per year, with 92 percent of those costs spent on hospitalized care.(10) 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. The elderly population is 60 percent more likely than the general population to be affected by CAP.(11)

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

AVELOX is approved to treat: 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,” 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 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 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, 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.

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

LEVAQUIN is a registered trademark of Ortho-McNeil Pharmaceutical. References: 1. Anzueto A, et al. Community-Acquired Pneumonia Recovery in the Elderly (CAPRIE): Efficacy and Safety of Moxifloxacin Therapy versus That of Levofloxacin Therapy. Clin Infect Dis 2006; 42:73-81. 2. Stanton M. Research in Action, Issues 7: Improving Treatment Decisions for Patients with Community-Acquire Pneumonia. Available at http://www.ahrq.gov/clinic/pneumonia/pneumonria.htm. Accessed on September 21, 2004. 3. Jackson ML, Neuzil KM, Thompson WW, et al. The burden of community- acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis 2004; 39:1642-50. 4. Fry A, et al. Trends in Hospitalizations for pneumonia among persons aged 65 years or older in the United States, 1988-2002. JAMA 2005; 294; 2712-2719. 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. Centers for Disease Control and Prevention. Premature deaths, monthly mortality and monthly physician contacts: United States. MMWR 1997;46:556. 7. Niederman MS, McCombs JS, Unger AN, et al. The cost of treating community-acquired pneumonia. Clin Ther 1998;20:820-837. 8. 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. 9. Niederman M. Community-acquired Pneumonia: Management Controversies, Part I; Practical Recommendations from the Latest Guidelines. Am J Respir Crit Care Med. 2001(5). 10. Lave JR, Lin CJ, Fine MJ, et al. The cost of treating patients with community-acquired pneumonia. Semin Respir Crit Care Med 1999;20(3):189-97. 11. Stanton M. Research in Action, Issues 7: Improving Treatment Decisions for Patients with Community-Acquired Pneumonia. Available at http://www.ahrq.gov/clinic/pneumonia/pneumonria.htm. Accessed on August 30, 2005.

Schering-Plough Corporation

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