The New England Journal Of Medicine Publishes Two Landmark Studies

[Guest guest]

News Release

Thursday 25 January 2007, 7:00 GMT Thursday 25 January 2007

INDUSTRY

HEALTH

Schering-Plough

http://www.prnewswire.co.uk/cgi/news/release?id=188806

The New England Journal Of Medicine Publishes Two Landmark Studies

of NOXAFIL® (Posaconazole) in the Prevention of Invasive Fungal

Infections

KENILWORTH, New Jersey, January 25 /PRNewswire/ --

Two landmark clinical studies demonstrating the efficacy of NOXAFIL

® (posaconazole) Oral Suspension in the prevention (prophylaxis)

of life-threatening invasive fungal infections (IFIs) caused by

Aspergillus and Candida in high-risk patients were published today

in The New England Journal of Medicine,(1,2) reported Schering-

Plough Corporation (NYSE: SGP). High-risk patients who develop IFIs

have a mortality rate ranging from 50-90 percent.(3) In both these

studies, NOXAFIL was significantly more effective in preventing

invasive aspergillosis and reducing deaths related to invasive

fungal infections, and, in one study, reducing overall mortality,

versus the combined comparator drugs.

NOXAFIL is the first and only antifungal agent approved for the

prevention of IFIs caused by Aspergillus.

" Prophylaxis is a commonly used therapeutic strategy, because the

diagnosis of fungal infection is often delayed or difficult to

establish with certainty, and a delay in antifungal treatment

increases mortality, " said Oliver Cornely, M.D., assistant

professor, 1st Department for Internal Medicine, University of

Cologne, Germany, and lead author of one of the published

studies. " With posaconazole, we now can help prevent infections

caused by the two most common pathogens, Aspergillus and Candida,

before they occur. "

More than 1,200 patients were enrolled in the studies, which

demonstrated substantially fewer breakthrough Aspergillus infections

with NOXAFIL prophylaxis versus the combined comparator drugs

(fluconazole, itraconazole) in high-risk patients. These patients

included hematopoietic stem cell transplant (HSCT) recipients with

graft-versus-host disease (GVHD) or those with hematologic

malignancies such as acute myelogenous leukemia (AML) or

myelodysplastic syndromes (MDS) with prolonged neutropenia from

chemotherapy. In high-risk neutropenic patients, NOXAFIL prophylaxis

was associated with decreased all-cause mortality versus the

combined comparator drugs. In these studies, NOXAFIL demonstrated an

adverse event profile comparable to fluconazole.

" There is an urgent need worldwide for establishing a standard of

care for preventing life-threatening fungal infections in high-risk

patients. Due to an expanding patient population, these infections

are being seen more frequently and are a leading cause of death in

these seriously ill patients, " said J. Ullmann, M.D.,

attending physician for infectious diseases and hematology/oncology,

3rd Medical Department of the University Hospital of the Johannes

Gutenberg University, Mainz, Germany, and lead author of one of the

published studies. " These studies demonstrate that posaconazole

prophylaxis provides effective, well-tolerated, preventive therapy,

allowing physicians to focus on treating their patient's underlying

disease. "

About the Published Studies

Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients

with Neutropenia (Cornely et al.): This randomized, multicenter,

open-label study compared NOXAFIL Oral Suspension 200 mg three times

daily (n=304) to fluconazole oral suspension 400 mg once daily

(n=240) or itraconazole oral solution 200 mg twice daily (n=58) as

prophylaxis against IFIs in neutropenic patients who were receiving

cytotoxic chemotherapy for AML or MDS. In this study, NOXAFIL versus

fluconazole/itraconazole demonstrated a reduction in proven and

probable IFIs, the primary study endpoint (2 percent vs. 8 percent);

significantly fewer breakthrough Aspergillus infections (1 percent

vs. 7 percent); and improved overall survival.

Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-

Host Disease (Ullmann et al.): This randomized, multicenter, double-

blind study compared NOXAFIL Oral Suspension 200 mg three times

daily (n=301) to fluconazole capsules 400 mg once daily (n=299) as

prophylaxis against IFIs in allogeneic hematopoietic stem cell

transplant (HSCT) recipients with graft-versus-host disease (GVHD).

At the end of the fixed 112-day treatment period, NOXAFIL versus

fluconazole demonstrated a reduction in proven/probable IFIs, the

primary study endpoint (5 percent vs. 9 percent); a significant

reduction in breakthrough Aspergillus infections (2 percent vs. 7

percent); and decreased IFI-related mortality.

About NOXAFIL

NOXAFIL received marketing approval for prophylaxis in the United

States and European Union (EU) in 2006, based primarily on the

results of these two studies. NOXAFIL also was approved in the

United States and EU in 2006 for the treatment of oropharyngeal

candidiasis (OPC), a fungal infection of the mouth and throat, and

in the EU in 2005 and Australia in 2006 for the treatment of certain

IFIs in adult patients with disease that is refractory to or in

patients who are intolerant of certain commonly used antifungal

agents. NOXAFIL is a novel triazole antifungal agent discovered and

developed by Schering-Plough Research Institute.

NOXAFIL Safety Information

The most common treatment-related serious adverse events (1 percent

each) in the combined NOXAFIL prophylaxis studies were

bilirubinemia, increased hepatic enzymes, hepatocellular damage,

nausea, and vomiting. In clinical trials, there were infrequent

cases of hepatic reactions (e.g., mild to moderate elevations in

ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical

hepatitis). Rarely, more severe hepatic reactions including

cholestasis or hepatic failure including fatalities were reported in

patients with serious underlying medical conditions (e.g.,

hematologic malignancies) during treatment with NOXAFIL. Liver

function tests (LFTs) should be monitored at the start of and during

the course of therapy.

In the pooled prophylaxis safety analysis, fever, headache, anemia,

diarrhea, nausea, vomiting, abdominal pain, hypokalemia and

thrombocytopenia were frequently reported treatment-emergent adverse

events.

NOXAFIL has been shown to interact with several medications,

including drugs that suppress the immune system, and these reactions

may be serious. The product label should be consulted when other

drugs are prescribed with NOXAFIL.

In clinical studies of oropharyngeal candidiasis (OPC) and

refractory OPC, adverse events were reported more frequently in the

pool of patients with refractory oropharyngeal candidiasis. The most

commonly reported serious adverse events included fever (13 percent)

and neutropenia (10 percent).

Co-administration with the CYP3A4 substrates terfenadine,

astemizole, cisapride, pimozide, halofantrine or quinidine, is

contraindicated since this may result in increased plasma

concentrations of these medicinal products, leading to QTc

prolongation and rare occurrences of torsades de pointes. Co-

administration with ergot alkaloids is also contraindicated.

Serious and rare fatal toxicity from cyclosporine has occurred when

taken in combination with NOXAFIL and therefore reduction of the

dose of drugs like cyclosporine, tacrolimus, or sirolimus and

frequent monitoring of drug levels of these medications is necessary

when taking them in combination with NOXAFIL.

The safety and effectiveness of NOXAFIL in patients below the age of

13 years old have not been established. In the EU, NOXAFIL is

recommended for use in patients 18 years of age and older.

For NOXAFIL U.S. Prescribing Information please visit:

http://www.spfiles.com/pinoxafil.pdf.

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 www.schering-

plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press

release includes certain " forward-looking statements " within the

meaning of the Private Securities Litigation Reform Act of 1995,

including statements related to the potential 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, patent and other intellectual property protection,

current and future branded, generic or over-the-counter competition,

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 second quarter 2006

10-Q.

References

(1) Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or

Fluconazole

for Prophylaxis in Severe Graft-versus-Host Disease. N Engl

J Med

2007;356:335-47.

(2) Cornely OA, Maertens J, Winston DJ, et al. Posaconazole vs.

Fluconazole or Itraconazole Prophylaxis in Patients with

Neutropenia.

N Engl J Med 2007;356:348-59.

(3) Bow EJ, Laverdiere M, Lussier N, et al. Antifungal

Prophylaxis for

Severely Neutropenic Chemotherapy Recipients. Cancer

2002;94:3230-46.

NOTE TO EDITORS: Schering-Plough press releases are available on the

company's Web site at http://www.schering-plough.com.

Schering-Plough press releases are also available on PRNewswire's

Web site at http://www.prnewswire.com/comp/777050.html.

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

Distributed by PR Newswire on behalf of Schering-Plough

[Guest guest]

It is amazing that there are reports like this about how fatal this

illness can be, and the creeps at the ACOEM and other agencies still

stick to their story. I have thought if I don't make it that I would

want my family to make these people pay. I would like them to go to

prison.

--- In , " tigerpaw2c " <tigerpaw2c@...>

wrote:

>

> News Release

> Thursday 25 January 2007, 7:00 GMT Thursday 25 January 2007

> INDUSTRY

> HEALTH

> Schering-Plough

> http://www.prnewswire.co.uk/cgi/news/release?id=188806

>

> The New England Journal Of Medicine Publishes Two Landmark Studies

> of NOXAFIL® (Posaconazole) in the Prevention of Invasive Fungal

> Infections

>

>

> KENILWORTH, New Jersey, January 25 /PRNewswire/ --

>

> Two landmark clinical studies demonstrating the efficacy of NOXAFIL

> ® (posaconazole) Oral Suspension in the prevention (prophylaxis)

> of life-threatening invasive fungal infections (IFIs) caused by

> Aspergillus and Candida in high-risk patients were published today

> in The New England Journal of Medicine,(1,2) reported Schering-

> Plough Corporation (NYSE: SGP). High-risk patients who develop IFIs

> have a mortality rate ranging from 50-90 percent.(3) In both these

> studies, NOXAFIL was significantly more effective in preventing

> invasive aspergillosis and reducing deaths related to invasive

> fungal infections, and, in one study, reducing overall mortality,

> versus the combined comparator drugs.

>

> NOXAFIL is the first and only antifungal agent approved for the

> prevention of IFIs caused by Aspergillus.

>

> " Prophylaxis is a commonly used therapeutic strategy, because the

> diagnosis of fungal infection is often delayed or difficult to

> establish with certainty, and a delay in antifungal treatment

> increases mortality, " said Oliver Cornely, M.D., assistant

> professor, 1st Department for Internal Medicine, University of

> Cologne, Germany, and lead author of one of the published

> studies. " With posaconazole, we now can help prevent infections

> caused by the two most common pathogens, Aspergillus and Candida,

> before they occur. "

>

> More than 1,200 patients were enrolled in the studies, which

> demonstrated substantially fewer breakthrough Aspergillus

infections

> with NOXAFIL prophylaxis versus the combined comparator drugs

> (fluconazole, itraconazole) in high-risk patients. These patients

> included hematopoietic stem cell transplant (HSCT) recipients with

> graft-versus-host disease (GVHD) or those with hematologic

> malignancies such as acute myelogenous leukemia (AML) or

> myelodysplastic syndromes (MDS) with prolonged neutropenia from

> chemotherapy. In high-risk neutropenic patients, NOXAFIL

prophylaxis

> was associated with decreased all-cause mortality versus the

> combined comparator drugs. In these studies, NOXAFIL demonstrated

an

> adverse event profile comparable to fluconazole.

>

> " There is an urgent need worldwide for establishing a standard of

> care for preventing life-threatening fungal infections in high-risk

> patients. Due to an expanding patient population, these infections

> are being seen more frequently and are a leading cause of death in

> these seriously ill patients, " said J. Ullmann, M.D.,

> attending physician for infectious diseases and

hematology/oncology,

> 3rd Medical Department of the University Hospital of the Johannes

> Gutenberg University, Mainz, Germany, and lead author of one of the

> published studies. " These studies demonstrate that posaconazole

> prophylaxis provides effective, well-tolerated, preventive therapy,

> allowing physicians to focus on treating their patient's underlying

> disease. "

>

> About the Published Studies

>

> Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in

Patients

> with Neutropenia (Cornely et al.): This randomized, multicenter,

> open-label study compared NOXAFIL Oral Suspension 200 mg three

times

> daily (n=304) to fluconazole oral suspension 400 mg once daily

> (n=240) or itraconazole oral solution 200 mg twice daily (n=58) as

> prophylaxis against IFIs in neutropenic patients who were receiving

> cytotoxic chemotherapy for AML or MDS. In this study, NOXAFIL

versus

> fluconazole/itraconazole demonstrated a reduction in proven and

> probable IFIs, the primary study endpoint (2 percent vs. 8

percent);

> significantly fewer breakthrough Aspergillus infections (1 percent

> vs. 7 percent); and improved overall survival.

>

> Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-

> Host Disease (Ullmann et al.): This randomized, multicenter, double-

> blind study compared NOXAFIL Oral Suspension 200 mg three times

> daily (n=301) to fluconazole capsules 400 mg once daily (n=299) as

> prophylaxis against IFIs in allogeneic hematopoietic stem cell

> transplant (HSCT) recipients with graft-versus-host disease (GVHD).

> At the end of the fixed 112-day treatment period, NOXAFIL versus

> fluconazole demonstrated a reduction in proven/probable IFIs, the

> primary study endpoint (5 percent vs. 9 percent); a significant

> reduction in breakthrough Aspergillus infections (2 percent vs. 7

> percent); and decreased IFI-related mortality.

>

> About NOXAFIL

>

> NOXAFIL received marketing approval for prophylaxis in the United

> States and European Union (EU) in 2006, based primarily on the

> results of these two studies. NOXAFIL also was approved in the

> United States and EU in 2006 for the treatment of oropharyngeal

> candidiasis (OPC), a fungal infection of the mouth and throat, and

> in the EU in 2005 and Australia in 2006 for the treatment of

certain

> IFIs in adult patients with disease that is refractory to or in

> patients who are intolerant of certain commonly used antifungal

> agents. NOXAFIL is a novel triazole antifungal agent discovered and

> developed by Schering-Plough Research Institute.

>

> NOXAFIL Safety Information

>

> The most common treatment-related serious adverse events (1 percent

> each) in the combined NOXAFIL prophylaxis studies were

> bilirubinemia, increased hepatic enzymes, hepatocellular damage,

> nausea, and vomiting. In clinical trials, there were infrequent

> cases of hepatic reactions (e.g., mild to moderate elevations in

> ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical

> hepatitis). Rarely, more severe hepatic reactions including

> cholestasis or hepatic failure including fatalities were reported

in

> patients with serious underlying medical conditions (e.g.,

> hematologic malignancies) during treatment with NOXAFIL. Liver

> function tests (LFTs) should be monitored at the start of and

during

> the course of therapy.

>

> In the pooled prophylaxis safety analysis, fever, headache, anemia,

> diarrhea, nausea, vomiting, abdominal pain, hypokalemia and

> thrombocytopenia were frequently reported treatment-emergent

adverse

> events.

>

> NOXAFIL has been shown to interact with several medications,

> including drugs that suppress the immune system, and these

reactions

> may be serious. The product label should be consulted when other

> drugs are prescribed with NOXAFIL.

>

> In clinical studies of oropharyngeal candidiasis (OPC) and

> refractory OPC, adverse events were reported more frequently in the

> pool of patients with refractory oropharyngeal candidiasis. The

most

> commonly reported serious adverse events included fever (13

percent)

> and neutropenia (10 percent).

>

> Co-administration with the CYP3A4 substrates terfenadine,

> astemizole, cisapride, pimozide, halofantrine or quinidine, is

> contraindicated since this may result in increased plasma

> concentrations of these medicinal products, leading to QTc

> prolongation and rare occurrences of torsades de pointes. Co-

> administration with ergot alkaloids is also contraindicated.

>

> Serious and rare fatal toxicity from cyclosporine has occurred when

> taken in combination with NOXAFIL and therefore reduction of the

> dose of drugs like cyclosporine, tacrolimus, or sirolimus and

> frequent monitoring of drug levels of these medications is

necessary

> when taking them in combination with NOXAFIL.

>

> The safety and effectiveness of NOXAFIL in patients below the age

of

> 13 years old have not been established. In the EU, NOXAFIL is

> recommended for use in patients 18 years of age and older.

>

> For NOXAFIL U.S. Prescribing Information please visit:

> http://www.spfiles.com/pinoxafil.pdf.

>

> 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 www.schering-

> plough.com.

>

> SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press

> release includes certain " forward-looking statements " within the

> meaning of the Private Securities Litigation Reform Act of 1995,

> including statements related to the potential 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, patent and other intellectual property protection,

> current and future branded, generic or over-the-counter

competition,

> 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 second quarter

2006

> 10-Q.

>

>

> References

>

> (1) Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or

> Fluconazole

> for Prophylaxis in Severe Graft-versus-Host Disease. N Engl

> J Med

> 2007;356:335-47.

>

> (2) Cornely OA, Maertens J, Winston DJ, et al. Posaconazole vs.

> Fluconazole or Itraconazole Prophylaxis in Patients with

> Neutropenia.

> N Engl J Med 2007;356:348-59.

>

> (3) Bow EJ, Laverdiere M, Lussier N, et al. Antifungal

> Prophylaxis for

> Severely Neutropenic Chemotherapy Recipients. Cancer

> 2002;94:3230-46.

>

> NOTE TO EDITORS: Schering-Plough press releases are available on

the

> company's Web site at http://www.schering-plough.com.

>

> Schering-Plough press releases are also available on PRNewswire's

> Web site at http://www.prnewswire.com/comp/777050.html.

>

> Web site: http://www.schering-plough.com

>

> Distributed by PR Newswire on behalf of Schering-Plough

>

[Guest guest]

,

I couldn't have said it better myself. You are 100% correct and we

are working on it. You often wonder what they tell their wife and

kids at night and how they earn their keep. I guess love thy

neighbor is a phrase you would never hear them use.Or cause no undo

harm... At least not until you turn your back and then they get paid

for it. Someday......

KC

> >

> > News Release

> > Thursday 25 January 2007, 7:00 GMT Thursday 25 January 2007

> > INDUSTRY

> > HEALTH

> > Schering-Plough

> > http://www.prnewswire.co.uk/cgi/news/release?id=188806

> >

> > The New England Journal Of Medicine Publishes Two Landmark

Studies

> > of NOXAFIL® (Posaconazole) in the Prevention of Invasive

Fungal

> > Infections

> >

> >

> > KENILWORTH, New Jersey, January 25 /PRNewswire/ --

> >

> > Two landmark clinical studies demonstrating the efficacy of

NOXAFIL

> > ® (posaconazole) Oral Suspension in the prevention

(prophylaxis)

> > of life-threatening invasive fungal infections (IFIs) caused by

> > Aspergillus and Candida in high-risk patients were published

today

> > in The New England Journal of Medicine,(1,2) reported Schering-

> > Plough Corporation (NYSE: SGP). High-risk patients who develop

IFIs

> > have a mortality rate ranging from 50-90 percent.(3) In both

these

> > studies, NOXAFIL was significantly more effective in preventing

> > invasive aspergillosis and reducing deaths related to invasive

> > fungal infections, and, in one study, reducing overall

mortality,

> > versus the combined comparator drugs.

> >

> > NOXAFIL is the first and only antifungal agent approved for the

> > prevention of IFIs caused by Aspergillus.

> >

> > " Prophylaxis is a commonly used therapeutic strategy, because

the

> > diagnosis of fungal infection is often delayed or difficult to

> > establish with certainty, and a delay in antifungal treatment

> > increases mortality, " said Oliver Cornely, M.D., assistant

> > professor, 1st Department for Internal Medicine, University of

> > Cologne, Germany, and lead author of one of the published

> > studies. " With posaconazole, we now can help prevent infections

> > caused by the two most common pathogens, Aspergillus and

Candida,

> > before they occur. "

> >

> > More than 1,200 patients were enrolled in the studies, which

> > demonstrated substantially fewer breakthrough Aspergillus

> infections

> > with NOXAFIL prophylaxis versus the combined comparator drugs

> > (fluconazole, itraconazole) in high-risk patients. These

patients

> > included hematopoietic stem cell transplant (HSCT) recipients

with

> > graft-versus-host disease (GVHD) or those with hematologic

> > malignancies such as acute myelogenous leukemia (AML) or

> > myelodysplastic syndromes (MDS) with prolonged neutropenia from

> > chemotherapy. In high-risk neutropenic patients, NOXAFIL

> prophylaxis

> > was associated with decreased all-cause mortality versus the

> > combined comparator drugs. In these studies, NOXAFIL

demonstrated

> an

> > adverse event profile comparable to fluconazole.

> >

> > " There is an urgent need worldwide for establishing a standard

of

> > care for preventing life-threatening fungal infections in high-

risk

> > patients. Due to an expanding patient population, these

infections

> > are being seen more frequently and are a leading cause of death

in

> > these seriously ill patients, " said J. Ullmann, M.D.,

> > attending physician for infectious diseases and

> hematology/oncology,

> > 3rd Medical Department of the University Hospital of the

Johannes

> > Gutenberg University, Mainz, Germany, and lead author of one of

the

> > published studies. " These studies demonstrate that posaconazole

> > prophylaxis provides effective, well-tolerated, preventive

therapy,

> > allowing physicians to focus on treating their patient's

underlying

> > disease. "

> >

> > About the Published Studies

> >

> > Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in

> Patients

> > with Neutropenia (Cornely et al.): This randomized, multicenter,

> > open-label study compared NOXAFIL Oral Suspension 200 mg three

> times

> > daily (n=304) to fluconazole oral suspension 400 mg once daily

> > (n=240) or itraconazole oral solution 200 mg twice daily (n=58)

as

> > prophylaxis against IFIs in neutropenic patients who were

receiving

> > cytotoxic chemotherapy for AML or MDS. In this study, NOXAFIL

> versus

> > fluconazole/itraconazole demonstrated a reduction in proven and

> > probable IFIs, the primary study endpoint (2 percent vs. 8

> percent);

> > significantly fewer breakthrough Aspergillus infections (1

percent

> > vs. 7 percent); and improved overall survival.

> >

> > Posaconazole or Fluconazole for Prophylaxis in Severe Graft-

versus-

> > Host Disease (Ullmann et al.): This randomized, multicenter,

double-

> > blind study compared NOXAFIL Oral Suspension 200 mg three times

> > daily (n=301) to fluconazole capsules 400 mg once daily (n=299)

as

> > prophylaxis against IFIs in allogeneic hematopoietic stem cell

> > transplant (HSCT) recipients with graft-versus-host disease

(GVHD).

> > At the end of the fixed 112-day treatment period, NOXAFIL versus

> > fluconazole demonstrated a reduction in proven/probable IFIs,

the

> > primary study endpoint (5 percent vs. 9 percent); a significant

> > reduction in breakthrough Aspergillus infections (2 percent vs.

7

> > percent); and decreased IFI-related mortality.

> >

> > About NOXAFIL

> >

> > NOXAFIL received marketing approval for prophylaxis in the

United

> > States and European Union (EU) in 2006, based primarily on the

> > results of these two studies. NOXAFIL also was approved in the

> > United States and EU in 2006 for the treatment of oropharyngeal

> > candidiasis (OPC), a fungal infection of the mouth and throat,

and

> > in the EU in 2005 and Australia in 2006 for the treatment of

> certain

> > IFIs in adult patients with disease that is refractory to or in

> > patients who are intolerant of certain commonly used antifungal

> > agents. NOXAFIL is a novel triazole antifungal agent discovered

and

> > developed by Schering-Plough Research Institute.

> >

> > NOXAFIL Safety Information

> >

> > The most common treatment-related serious adverse events (1

percent

> > each) in the combined NOXAFIL prophylaxis studies were

> > bilirubinemia, increased hepatic enzymes, hepatocellular damage,

> > nausea, and vomiting. In clinical trials, there were infrequent

> > cases of hepatic reactions (e.g., mild to moderate elevations in

> > ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical

> > hepatitis). Rarely, more severe hepatic reactions including

> > cholestasis or hepatic failure including fatalities were

reported

> in

> > patients with serious underlying medical conditions (e.g.,

> > hematologic malignancies) during treatment with NOXAFIL. Liver

> > function tests (LFTs) should be monitored at the start of and

> during

> > the course of therapy.

> >

> > In the pooled prophylaxis safety analysis, fever, headache,

anemia,

> > diarrhea, nausea, vomiting, abdominal pain, hypokalemia and

> > thrombocytopenia were frequently reported treatment-emergent

> adverse

> > events.

> >

> > NOXAFIL has been shown to interact with several medications,

> > including drugs that suppress the immune system, and these

> reactions

> > may be serious. The product label should be consulted when other

> > drugs are prescribed with NOXAFIL.

> >

> > In clinical studies of oropharyngeal candidiasis (OPC) and

> > refractory OPC, adverse events were reported more frequently in

the

> > pool of patients with refractory oropharyngeal candidiasis. The

> most

> > commonly reported serious adverse events included fever (13

> percent)

> > and neutropenia (10 percent).

> >

> > Co-administration with the CYP3A4 substrates terfenadine,

> > astemizole, cisapride, pimozide, halofantrine or quinidine, is

> > contraindicated since this may result in increased plasma

> > concentrations of these medicinal products, leading to QTc

> > prolongation and rare occurrences of torsades de pointes. Co-

> > administration with ergot alkaloids is also contraindicated.

> >

> > Serious and rare fatal toxicity from cyclosporine has occurred

when

> > taken in combination with NOXAFIL and therefore reduction of the

> > dose of drugs like cyclosporine, tacrolimus, or sirolimus and

> > frequent monitoring of drug levels of these medications is

> necessary

> > when taking them in combination with NOXAFIL.

> >

> > The safety and effectiveness of NOXAFIL in patients below the

age

> of

> > 13 years old have not been established. In the EU, NOXAFIL is

> > recommended for use in patients 18 years of age and older.

> >

> > For NOXAFIL U.S. Prescribing Information please visit:

> > http://www.spfiles.com/pinoxafil.pdf.

> >

> > 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 www.schering-

> > plough.com.

> >

> > SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press

> > release includes certain " forward-looking statements " within the

> > meaning of the Private Securities Litigation Reform Act of 1995,

> > including statements related to the potential 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, patent and other intellectual property protection,

> > current and future branded, generic or over-the-counter

> competition,

> > 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 second quarter

> 2006

> > 10-Q.

> >

> >

> > References

> >

> > (1) Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or

> > Fluconazole

> > for Prophylaxis in Severe Graft-versus-Host Disease. N

Engl

> > J Med

> > 2007;356:335-47.

> >

> > (2) Cornely OA, Maertens J, Winston DJ, et al. Posaconazole

vs.

> > Fluconazole or Itraconazole Prophylaxis in Patients with

> > Neutropenia.

> > N Engl J Med 2007;356:348-59.

> >

> > (3) Bow EJ, Laverdiere M, Lussier N, et al. Antifungal

> > Prophylaxis for

> > Severely Neutropenic Chemotherapy Recipients. Cancer

> > 2002;94:3230-46.

> >

> > NOTE TO EDITORS: Schering-Plough press releases are available on

> the

> > company's Web site at http://www.schering-plough.com.

> >

> > Schering-Plough press releases are also available on

PRNewswire's

> > Web site at http://www.prnewswire.com/comp/777050.html.

> >

> > Web site: http://www.schering-plough.com

> >

> > Distributed by PR Newswire on behalf of Schering-Plough

> >

>