New Study :Significantly Reduced Invasive Fungal Infections, Aspergillosis

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New Study Shows NOXAFIL® (Posaconazole) Oral Suspension

Significantly Reduced Invasive Fungal Infections, Aspergillosis,

Compared to Standard Azole Antifungals in High-Risk Chemotherapy

Patients

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Survival Benefit Demonstrated in Study Presented at

American Society of Hematology (ASH) Meeting

ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Schering-Plough

Corporation

(NYSE: SGP) today reported results of a new prophylaxis clinical

study

demonstrating that NOXAFIL® (posaconazole) Oral Suspension, a new

broad-spectrum triazole antifungal, significantly reduced the

incidence of

serious invasive fungal infections (IFIs), the incidence of

aspergillosis and

overall mortality compared to standard azole antifungals

(fluconazole and

itraconazole), during treatment in high-risk neutropenic patients

undergoing

intensive chemotherapy. Additionally, in this study involving 602

patients, a

significant survival benefit was seen in patients receiving

NOXAFIL. In the

study, NOXAFIL demonstrated a safety profile similar to fluconazole,

with both

drugs being well tolerated.

These results comparing prophylaxis with NOXAFIL to standard

azoles for

the prevention of IFIs in patients with a new diagnosis or first

relapse of

acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS)

who were

neutropenic due to intensive chemotherapy were presented for the

first time at

the 47th annual meeting of the American Society of Hematology (ASH)

in

Atlanta.

NOXAFIL was approved in the European Union (EU) in October 2005

for the

treatment of certain serious IFIs in adult patients who are

intolerant of or

with disease that is refractory to certain commonly used antifungal

agents.

It recently was launched in Germany. An application for NOXAFIL to

treat

refractory IFIs received an approvable letter from the U.S. Food and

Drug

Administration (FDA) in June 2005.

" There is medical need worldwide for potent new broad-spectrum

agents to

prevent life-threatening fungal infections, especially in high-risk

patients

such as those with severe and prolonged neutropenia. These

infections are

increasingly caused by moulds that are both difficult to diagnose

and treat, "

said lead study investigator Oliver Cornely, M.D., University of

Cologne,

Germany, who presented the data. " The results of this study

demonstrated that

NOXAFIL prophylaxis was associated with significant overall and IFI-

related

survival in these patients compared to standard azole prophylaxis. "

Based on the results of this prophylaxis study and those of a

previously

reported study of NOXAFIL prophylaxis,(1) Schering-Plough plans to

file new

drug applications with regulatory authorities in the United States

and Europe

seeking marketing approval of NOXAFIL prophylaxis in high-risk

patient

populations.

Patients with leukemia undergoing chemotherapy are at high risk

for IFIs

due to myelosuppression, with incidence rates up to 24 percent.(2,3)

Mortality rates in these patients due to candidiasis and

aspergillosis range

from 40 percent to 50 percent.(4,5)

" NOXAFIL has achieved successful clinical outcomes in this

prophylaxis

study, demonstrating potent activity against a wide range of fungal

infections, including those caused by both yeasts and moulds, " said

study

investigator Perfect, M.D., Duke University Hospital, Durham,

North

Carolina, USA.

Clinical Study and Results

Patients in this randomized, evaluator-blinded, active

controlled,

multicenter study received NOXAFIL Oral Suspension 200 mg three

times daily

(n=304) or oral standard azoles, either fluconazole oral suspension

400 mg

once daily (n=240) or itraconazole oral solution 200 mg twice daily

(n=58),

with each cycle of chemotherapy until complete remission or for up

to a

maximum of 12 weeks. The primary efficacy end point of the study

was the

comparison of the incidence of proven and probable IFIs during the

treatment

phase (7 days after last dose) as adjudicated by a blinded expert

panel based

on EORTC/MSG criteria.(6) The incidence of aspergillosis during

treatment and

the incidence of IFIs 100 days after randomization also were

compared.

In the study, the number of proven and probable IFIs during

treatment was

significantly lower with NOXAFIL prophylaxis vs. the standard azoles

(7 vs.

25; p=0.0009). NOXAFIL also significantly reduced the number of

Aspergillus

infections during treatment (2 vs. 20; p=0.0001) as well as all

invasive

fungal infections within 100 days post-randomization (14 vs. 33;

p=0.0031).

The overall all-cause mortality was 49 (16 percent) vs. 67 (22

percent)

(p=0.048) for patients in the NOXAFIL and standard azoles arms,

respectively.

Analysis of time to death (all cause mortality) within 100 days

post-randomization demonstrated a significant survival benefit for

NOXAFIL

(p=0.035).

Safety and tolerability were comparable for NOXAFIL and

fluconazole, with

the incidence of treatment-related adverse events and rate of patient

discontinuations being similar in the study. The most common

adverse events

in both treatment groups were gastrointestinal in nature.

About NOXAFIL

Clinical studies have demonstrated that NOXAFIL Oral Suspension

is

generally safe and well tolerated. The most frequently reported

adverse

reactions reported in healthy volunteers and patients in a treatment

setting

who received NOXAFIL were headache (8 percent) and nausea (6

percent).

Treatment-related serious adverse events reported in patients with

invasive

fungal infections (1 percent each) included altered concentration of

other

medicinal products, increased hepatic enzymes, nausea, rash and

vomiting.

NOXAFIL co-administration with ergot alkaloids, CYP3A4 substrates

known to

prolong the QTc interval and HMG-CoA reductase inhibitors is

contraindicated.

NOXAFIL also should be used with caution in patients with pro-

arrhythmic

conditions and severe hepatic impairment. The safety and efficacy

of NOXAFIL

in patients below the age of 18 years have not been established.

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.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this

press release

includes certain " forward-looking statements " within the meaning of

the

Securities Litigation Reform Act of 1995, including statements

relating to the

company's strategy and the development of NOXAFIL. 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.

References

1 Ullmann AJ et al. Posaconazole vs. Fluconazole for

Prophylaxis of

Invasive Fungal Infections in Allogeneic Hematopoietic Stem

Cell

Transplant Recipients with Graft-Versus-Host Disease, Trends

In

Medical Mycology (TIMM) meeting, Berlin, October 2005.

2 Rotstein C et al. Clin Infect Dis. 1999;28:331-340.

3 Winston DJ et al. Ann Intern Med. 1993;118:495-503.

4 Viscoli C et al. Clin Infect Dis. 1999;28:1071-1079

5 Lin SJ et al. Clin Infect Dis. 2001;32:358-366.

6 European Organisation for Research and Treatment of

Cancer/Mycoses

Study Group

Media: J. Consalvo (908) 298-7409

Gail Thornton (908) 298-5313

Investors: (908) 298-7450

SOURCE Schering-Plough Corporation

Web Site: http://www.schering-plough.com

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