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Data On Schering-Plough Corporation Anti-Infectives To Be Presented At ICAAC

Published: Dec 13, 2005

KENILWORTH, N.J., Dec. 13 /PRNewswire/ -- Important new data on several Schering-Plough anti-infective products and compounds in development will be presented at the 45th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C., Dec. 16-19.

Researchers will report study results with NOXAFIL(R) (posaconazole) Oral Suspension, including two oral presentations of large Phase III clinical studies evaluating the efficacy and safety of NOXAFIL prophylaxis in certain high-risk patient populations. NOXAFIL, discovered and developed by Schering-Plough Research Institute, is a novel triazole agent.

Study results also will be reported for AVELOX(R) (moxifloxacin HCl), a once-daily, broad-spectrum antibiotic that is approved in the United States and Europe. AVELOX was developed by Bayer Pharmaceuticals Corporation and is marketed in the United States by Schering-Plough under a licensing agreement.

Data will be presented on an investigational agent, vicriviroc (SCH 417690), an oral tablet currently in Phase II clinical development. Discovered by Schering-Plough Research Institute, vicriviroc belongs to an experimental new class of HIV drugs known as CCR5 receptor antagonists.

Results will be reported for several large studies with garenoxacin, a novel des-F6-quinolone antibacterial agent currently in development for treating a variety of Gram-positive and Gram-negative bacterial infections. Discovered by Toyama Chemical Co., Ltd., Schering-Plough licensed worldwide rights, excluding Japan, South Korea and China, to develop, use and sell garenoxacin.

Schering-Plough Corporation 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.

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

KEY SCHERING-PLOUGH DATA PRESENTATIONS AT ICAAC NOXAFIL Oral Presentations

Posaconazole (POS) vs Fluconazole (FLU) for Prophylaxis of Invasive Fungal Infections (IFIs) in Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients With Graft-Versus-Host Disease (GVHD): Results of a Multicenter Trial, Ullman A. et al. Saturday, Dec 17, 9:30 - 9:45 am, Ballroom C

Posaconazole (POS) vs Standard Azoles as Antifungal Prophylaxis in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS): Impact on Mortality, Cornely, O.A. et al. Saturday, Dec. 17, 11:30 - 11:45 am, Room 146

Key Poster Presentations

Posaconazole (POS) as Salvage Therapy in Patients With Invasive Fungal Infections (IFIs) Following Solid-Organ Transplant (SOT), Alexander, B. et al. Saturday, Dec 17, 11:30 am - 1:00 pm, Hall B

Posaconazole is Highly Effective as a Second-Line Agent in Zygomycosis: Summary of 91 Cases, Kontoyiannis, D.P. et al. Saturday, Dec 17, 11:30 am - 1:00 pm, Hall B

AVELOX

Key Poster Presentations

Pharmacokinetics (PK) and Tissue Penetration of Moxifloxacin in Intervention Therapy of Intra-abdominal Abscesses, Rink, A.D. et al. Friday, Dec 16, 11:30 am - 1:00 pm, Hall B

Comparative In Vitro Antimicrobial Activity of Moxifloxacin against Bacteroides fragilis Group, Federici, J. et al. Sunday, Dec 18, 10:00 - 11:30 am, Hall B

Vicriviroc (SCH 417690)

Poster Presentations

Rising Multiple-Dose Assessment of SCH 417690 - Similar Safety, Tolerability and Pharmacokinetics (PK) in Uninfected and HIV-Infected Adults, Sansone, A. et al. Friday, Dec, 16, 11:30 am - 1:00 pm, Hall B

QTc Interval Analysis of SCH 417690, a Novel CCR5 Inhibitor, Sansone, A. et al. Saturday, Dec. 17, 1:30 - 3:00 pm, Hall B

In Vitro Anti-HIV-1 Activity of SCH 417690 in Combination with Other Antiretroviral Therapies and Against Resistant HIV-1 Strains, Strizki, J.M. et al. Saturday, Dec. 17, 1:30 - 3:00 pm, Hall B

Effect of Food on Bioavailability of SCH 417690 in Healthy Volunteers, Keung, A. et al. Saturday, Dec. 17, 3:00 - 4:30 pm, Hall B

Garenoxacin

Oral Presentations

Oral Garenoxacin (GRN) 400 mg QD vs Clarithromycin (CLR) 500 mg BID in the Treatment of Community-Acquired Pneumonia (CAP), Waskin, H. et al. Saturday, Dec 17, 10:00 - 10:15 am, Room 150

Sequential IV to PO Garenoxacin (GRN) vs IV Ampicillin/Sulbactam (A/S) to Amoxicillin/Clavulanate (A/C) to Treat Serious Acute Pelvic Infection (API), Waskin, H. et al. Monday, Dec 19, 11:15 - 11:30 am, Room 209.

Key Poster Presentations

Double-Blind, Multinational Phase III Clinical Efficacy of Oral Garenoxacin (GRN) vs Oral Levofloxacin (LEV) in the Treatment of Community-Acquired Pneumonia (CAP), Waskin, H. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Randomized, Double-Blind Phase III Clinical Efficacy of 5-Day Oral Garenoxacin (GRN) vs 7- to 10-Day Amoxicillin/Clavulanate (A/C) in the Treatment of Mild to Moderate Community-Acquired Pneumonia (CAP), Waskin, H. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Double-Blind, Randomized 5-Day Garenoxacin (GRN) vs 7- to 10-Day Clarithromycin (CLR) to Treat Community-Acquired Pneumonia (CAP), Waskin, H. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Double-Blind, Randomized Garenoxacin (GRN) vs Amoxicillin/Clavulanate (A/C) in the Treatment of Acute Bacterial Sinusitis (ABS), Weclaw C. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Double-Blind, Randomized Oral Garenoxacin (GRN) vs Azithromycin (AZM) in the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB), Weclaw C. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Double-Blind, Randomized 5-Day Garenoxacin (GRN) vs 7- to 10-Day Amoxicillin/Clavulanate (A/C) in the Treatment of Acute Exacerbation of Chronic Bronchitis (AECB), Weclaw, C. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

Once-Daily Garenoxacin (GRN) IV to PO vs QID Piperacillin/Tazobactam (P/T) IV to TID Amoxicillin/Clavulanate (A/C) PO for the Treatment of Complicated Skin Infections, Waskin, H. et al. Friday, Dec 16, 3:00 - 4:30 pm, Hall B

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.

Media: Robert J. Consalvo (908) 298-7409 Gail Thornton (908) 298-5313 Investors: Alex Kelly (908) 298-7450

Schering-Plough Corporation

CONTACT: Robert J. Consalvo, +1-908-298-7409, Gail Thornton,+1-908-298-5313, Investors: Alex Kelly, +1-908-298-7450, all ofSchering-Plough

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