Significantly Reduced Aspergillosis, Invasive Fungal Infections

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New Study Shows NOXAFIL® (Posaconazole) Oral Suspension

Significantly Reduced Aspergillosis, Invasive Fungal Infections,

Compared to Fluconazole, in Allogeneic Hematopoietic Stem Cell

Transplant Recipients With Graft-Versus-Host Disease

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BERLIN, Oct. 25 /PRNewswire-FirstCall/ -- Schering-Plough

Corporation

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

demonstrating that

its investigational antifungal agent NOXAFIL® (posaconazole) Oral

Suspension, compared to fluconazole, significantly reduced the

incidence of

aspergillosis, a serious fungal infection associated with a high

rate of

mortality, as well as serious invasive fungal infections (IFIs)

overall during

treatment, in allogeneic hematopoietic stem cell transplant (HSCT)

recipients(1) with graft-versus-host disease (GVHD)(2). In this

patient

population, NOXAFIL decreased deaths due to IFIs compared to

fluconazole,

while demonstrating a similar safety profile. Both drugs were well

tolerated

in this study.

The results of this study, the first randomized, double-blind,

controlled

long-term study of antifungal prophylaxis (preventive treatment) in

HSCT

recipients with severe GVHD, were presented for the first time at

the Trends

in Medical Mycology (TIMM 2005) meeting in Berlin.

In clinical studies, NOXAFIL has demonstrated broad-spectrum

activity

covering both yeasts (such as Candida) and moulds (such as

Aspergillus)

responsible for serious invasive fungal infections. Invasive fungal

infections are a leading cause of death in HSCT recipients, with

mortality

rates varying between 60 and 90 percent(3).

" There is an urgent need to prevent serious invasive fungal

infections in

patients, including infections that are resistant to other therapies

or caused

by emerging pathogens that can be difficult to diagnose and treat, "

said lead

study investigator J. Ullmann, M.D., attending physician for

infectious

diseases and hematology/oncology, Medical Hospital and Healthcare

Center of

Johannes Gutenberg University, Mainz, Germany. " The results of this

study

demonstrate that NOXAFIL may be an option for long-term preventive

treatment,

allowing these seriously ill patients to recover. "

Allogeneic HSCT recipients are at high risk for IFIs for several

reasons

including sustained immunosuppressive therapy due to risk associated

with

donor compatibility and transplant complications that include

prolonged

neutropenia, graft failure and graft-versus-host disease (GVHD)(4).

The

incidence of IFIs in HSCT recipients is increasing, with

aspergillosis

becoming increasingly more common in these patients(5).

Clinical Study Results

In this large, prospective, double-blind, double-dummy,

controlled study,

a total of 600 patients from 90 centers worldwide were randomized to

receive

NOXAFIL Oral Suspension 200 mg three times daily (n=301) or

fluconazole 400 mg

capsules once daily (n=299) for a maximum of 112 days (16 weeks) or

until a

protocol specified endpoint was reached (breakthrough IFI, adverse

event

requiring discontinuation, or death due to underlying disease or

GVHD). All

patients were monitored for fungal infection during the 112-day

treatment

phase and were followed for two months after completing treatment or

after

prematurely discontinuing therapy. An independent data review

committee

adjudicated proven/probable IFIs using the EORTC/MSG(6) criteria(7).

In the study, NOXAFIL compared to fluconazole significantly

reduced the

incidence of aspergillosis (3 vs. 17, p=.001) as well as invasive

fungal

infections overall (7 vs. 22; p=.004) in patients while on treatment

(defined

as first dose to seven days after the last dose). NOXAFIL also

significantly

reduced the incidence of aspergillosis (7 vs. 21; p=.006) compared to

fluconazole and was as effective as fluconazole in preventing IFIs

overall

(16 vs. 27; p=.074) during the 112-day study-specified primary time

period.

NOXAFIL significantly delayed the onset of IFIs in this patient

population

compared to fluconazole, as measured by mean days from first dose to

onset of

IFI while on treatment (102 vs. 88 days; p=.048). In the study,

NOXAFIL

reduced the number of deaths attributed to IFI compared to

fluconazole (4 vs.

12; p=.041). The rate of all-cause mortality was similar in the two

treatment

groups.

The incidence of treatment-related and serious adverse events in

the study

were similar for both the NOXAFIL and fluconazole groups, with the

overall

rate of adverse events and the rate of patient discontinuations

being similar.

The most common adverse events in both treatment groups were

gastrointestinal

in nature.

About NOXAFIL

NOXAFIL (posaconazole) Oral Suspension is a novel triazole agent

that

exhibits potent antifungal activity in vitro against a wide range of

fungal

pathogens, including both yeasts and moulds. It has been studied as

treatment

for serious invasive fungal infections in patients with refractory

disease

(failed prior therapy). Development of NOXAFIL is consistent with

Schering-

Plough's strategy to broaden its anti-infectives portfolio and is in

line with

its plans to build strength in its global franchises through both

internal

research and external licensing opportunities.

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 second quarter 2005 10-Q.

References

(1) Patients who receive stem cells from another person.

(2) Occurs when cells from a tissue or organ transplant mount an

immunological attack against the cells or tissue of the host.

(3) Hagen EA, Stern H, Porter D, et al. High rate of invasive

fungal

infections following nonmyeloablative allogeneic

transplantation. Clin

Infect Dis. 2003;36:9-15.

(4) Hamza NS, Ghannoum MA, Lazarus HM. Choices aplenty:

antifungal

prophylaxis in hematopoietic stem cell transplant

recipients. Bone

Marrow Transplant. 2004;34:377-389.

(5) Jantunen E, Ruutu P, Niskanen L, et al. Incidence and risk

factors for

invasive fungal infections in allogeneic BMT recipients.

Bone Marrow

Transplant. 1997;19:801-808.

(6) European Organisation for Research and Treatment of

Cancer/Mycoses

Study Group

(7) Ascioglu S, Rex JH, de Pauw B, et al. Defining opportunistic

invasive

fungal infections in immunocompromised patients with cancer

and

hematopoietic stem cell transplants: an international

consensus. Clin

Infect Dis. 2002;34:7-14.

SOURCE Schering-Plough Corporation

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

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