InterMune Announces Presentation of Interim Findings of the First Clinical Experience of Infergen Plus Actimmune Combination Therapy in Hepatitis C Nonresponders

[Guest guest]

InterMune Announces Presentation of Interim Findings of the First Clinical

Experience of Infergen Plus Actimmune Combination Therapy in Hepatitis C

Nonresponders

BRISBANE, Calif., Dec. 16 /PRNewswire-FirstCall/ -- InterMune, Inc.

(Nasdaq: ITMN) announced today the presentation of interim findings from an

independent retrospective clinical analysis done in collaboration with the

New

Jersey Medical Liver Center evaluating the clinical use of Infergen®

(interferon alfacon-1) plus Actimmune® (interferon gamma-1b) in

combination

for the treatment of chronic Hepatitis C nonresponders. The clinical

analysis

was presented today at the 5th biennial HepDART meeting.

The results presented were a summary of a retrospective analysis

conducted

on 32 patients who had previously failed to show any significant reduction

in

viral load following 12 weeks of therapy with peg IFN-alpha 2 plus

ribavirin.

This subpopulation of nonresponders is typically referred to as

nullresponders

and is considered to be one of the most difficult patient populations to

treat. During the course of their clinical care, these nonresponders are

being administered Infergen daily (15 micrograms), and Actimmune three times

weekly (50 micrograms), for 48 weeks; ribavirin is not part of the regimen.

The use of these compounds in combination is not approved by the FDA.

After 12 weeks of therapy with Infergen and Actimmune, 38% of this

nonresponder patient group had undetectable levels of virus in their blood.

Further, 65% of the patients had at least a 2 log decline in viral load. No

patients discontinued therapy. Five patients received growth factor therapy

for reductions in absolute neutrophil counts, a recognized side effect of

interferon therapy. Other side effects observed were consistent with

Infergen

and Actimmune therapy. While these data are encouraging, important data

points on sustained virologic response have not yet been collected.

" Treatment options for peg IFN-alpha 2 plus ribavirin nonresponders are

very limited, " said Carroll Leevy M.D., Director of Clinical Affairs, The

New

Jersey Medical Liver Center and Sammy Jr. National Liver Center,

Newark,

New Jersey. " The data from this patient experience are encouraging, and this

combination therapy may offer hope to patients who do not respond to

standard

interferon plus ribavirin therapy. "

The scientific rationale for use of combination therapy of interferon

alfacon plus interferon gamma is based on a number of observations.

Scientific publications state that clearance of acute HCV infection requires

a

potent interferon gamma response. In addition, clearance of HCV in chronic

patients treated with interferon-alpha requires activity that is mediated by

interferon gamma. In InterMune labs, scientists analyzed the direct

antiviral

effects of Infergen and Actimmune in in vitro models. These models

demonstrated very strong synergistic effects for a range of varying doses of

combination therapy relative to Infergen monotherapy. Analysis of gene

expression showed that several genes that undertake critical cellular

processes were not significantly upregulated by either drug alone, but were

upregulated by the combination of Infergen and Actimmune.

" These preliminary clinical findings are consistent with our

demonstration

of antiviral synergy upon co-administration of Infergen and Actimmune in in

vitro models as presented at the American Association for the Study of Liver

Disease Conference in October, " said E. Pennington, M.D., Executive

Vice

President of Medical and Scientific Affairs at InterMune. " While we await

analysis of sustained virologic response, we are considering the initiation

of

an InterMune-sponsored clinical program using the combination of our two

interferon products, Infergen and Actimmune, for the treatment of chronic

Hepatitis C. "

About Chronic Hepatitis C

According to the Centers for Disease Control an estimated 3.9 million

(1.8%) Americans have been infected with HCV, of whom 2.7 million are

chronically infected. Hepatitis C causes an estimated 10,000 to 12,000

deaths

annually in the United States. The prevalence of chronic hepatitis C is

increasing.

About Infergen® (interferon alfacon-1)

Infergen is a bio-optimized type 1 interferon alpha indicated for

treatment of adult patients with chronic HCV infections and is dosed three

times a week. Infergen is the only interferon alpha with data in the label

regarding use in patients following relapse or non-response to treatment

with

certain previous treatments. The most common side effects are flu-like

symptoms (i.e. headache, fatigue, fever, myalgia, and rigors). Physicians

and

patients can obtain additional prescribing information regarding Infergen,

including the product's safety profile, by visiting http://www.infergen.com,

including the black box warning for all interferon alphas regarding

psychiatric, autoimmune, ischemic and infectious disorders.

About Actimmune® (interferon gamma-1b)

Interferon gamma is a naturally occurring protein that stimulates

the immune system. InterMune markets Actimmune for the treatment of two

life-threatening congenital diseases: chronic granulomatous disease and

severe, malignant osteopetrosis. The most commons side effects are flu-like

symptoms, including fever, headache and chills. InterMune is also conducting

a

Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis, a

Phase III study of interferon gamma-1b in ovarian cancer and a Phase II

study

of interferon gamma-1b in severe liver fibrosis, or cirrhosis, caused by

hepatitis C virus (HCV). Physicians and patients can obtain additional

prescribing information regarding Actimmune, including the product's safety

profile, by visiting http://www.actimmune.com.

About InterMune

InterMune is a biopharmaceutical company focused on the applied

research,

development and marketing of life-saving therapies for pulmonary and hepatic

disease. For additional information about InterMune, please visit

http://www.intermune.com.

Except for the historical information contained herein, this press

release

contains certain forward-looking statements by InterMune that involve risks

and uncertainties, including without limitation the statements indicating

that

the data for the use of Infergen and Actimmune in combination are

encouraging

compared to current treatment options and that this combination therapy may

offer hope to patients who do not respond to standard interferon plus

ribavirin therapy. All forward-looking statements and other information

included in this press release are based on information available to

InterMune

as of the date hereof, and InterMune assumes no obligation to update any

such

forward-looking statements or information. InterMune's actual results could

differ materially from those described in InterMune's forward-looking

statements. Factors that could cause or contribute to such differences

include, but are not limited to those discussed under the heading " Risk

Factors " and the risks and factors discussed in InterMune's 10-Q report

filed

with the SEC on November 13, 2003, and other periodic reports (i.e., 10-K

and

8-K) filed with the SEC. The risks and other factors that follow,

concerning

the forward-looking statements in this press release, should be considered

only in connection with the fully discussed risks and other factors

discussed

in detail in the 10-Q report and InterMune's other periodic reports filed

with

the SEC. InterMune's forward-looking statements in this press release

concerning the use of Infergen and Actimmune for the treatment of Hepatitis

C

are subject to the risks and uncertainties that include, without limitation,

those associated with obtaining statistically significant data from clinical

trials; the uncertain, lengthy; and expensive drug research and development

and regulatory process; competition; budget constraints and InterMune's

ability to obtain, maintain and enforce patents and other intellectual

property.

SOURCE InterMune, Inc.

Web Site: http://www.intermune.com

[Guest guest]

InterMune Announces Presentation of Interim Findings of the First Clinical

Experience of Infergen Plus Actimmune Combination Therapy in Hepatitis C

Nonresponders

BRISBANE, Calif., Dec. 16 /PRNewswire-FirstCall/ -- InterMune, Inc.

(Nasdaq: ITMN) announced today the presentation of interim findings from an

independent retrospective clinical analysis done in collaboration with the

New

Jersey Medical Liver Center evaluating the clinical use of Infergen®

(interferon alfacon-1) plus Actimmune® (interferon gamma-1b) in

combination

for the treatment of chronic Hepatitis C nonresponders. The clinical

analysis

was presented today at the 5th biennial HepDART meeting.

The results presented were a summary of a retrospective analysis

conducted

on 32 patients who had previously failed to show any significant reduction

in

viral load following 12 weeks of therapy with peg IFN-alpha 2 plus

ribavirin.

This subpopulation of nonresponders is typically referred to as

nullresponders

and is considered to be one of the most difficult patient populations to

treat. During the course of their clinical care, these nonresponders are

being administered Infergen daily (15 micrograms), and Actimmune three times

weekly (50 micrograms), for 48 weeks; ribavirin is not part of the regimen.

The use of these compounds in combination is not approved by the FDA.

After 12 weeks of therapy with Infergen and Actimmune, 38% of this

nonresponder patient group had undetectable levels of virus in their blood.

Further, 65% of the patients had at least a 2 log decline in viral load. No

patients discontinued therapy. Five patients received growth factor therapy

for reductions in absolute neutrophil counts, a recognized side effect of

interferon therapy. Other side effects observed were consistent with

Infergen

and Actimmune therapy. While these data are encouraging, important data

points on sustained virologic response have not yet been collected.

" Treatment options for peg IFN-alpha 2 plus ribavirin nonresponders are

very limited, " said Carroll Leevy M.D., Director of Clinical Affairs, The

New

Jersey Medical Liver Center and Sammy Jr. National Liver Center,

Newark,

New Jersey. " The data from this patient experience are encouraging, and this

combination therapy may offer hope to patients who do not respond to

standard

interferon plus ribavirin therapy. "

The scientific rationale for use of combination therapy of interferon

alfacon plus interferon gamma is based on a number of observations.

Scientific publications state that clearance of acute HCV infection requires

a

potent interferon gamma response. In addition, clearance of HCV in chronic

patients treated with interferon-alpha requires activity that is mediated by

interferon gamma. In InterMune labs, scientists analyzed the direct

antiviral

effects of Infergen and Actimmune in in vitro models. These models

demonstrated very strong synergistic effects for a range of varying doses of

combination therapy relative to Infergen monotherapy. Analysis of gene

expression showed that several genes that undertake critical cellular

processes were not significantly upregulated by either drug alone, but were

upregulated by the combination of Infergen and Actimmune.

" These preliminary clinical findings are consistent with our

demonstration

of antiviral synergy upon co-administration of Infergen and Actimmune in in

vitro models as presented at the American Association for the Study of Liver

Disease Conference in October, " said E. Pennington, M.D., Executive

Vice

President of Medical and Scientific Affairs at InterMune. " While we await

analysis of sustained virologic response, we are considering the initiation

of

an InterMune-sponsored clinical program using the combination of our two

interferon products, Infergen and Actimmune, for the treatment of chronic

Hepatitis C. "

About Chronic Hepatitis C

According to the Centers for Disease Control an estimated 3.9 million

(1.8%) Americans have been infected with HCV, of whom 2.7 million are

chronically infected. Hepatitis C causes an estimated 10,000 to 12,000

deaths

annually in the United States. The prevalence of chronic hepatitis C is

increasing.

About Infergen® (interferon alfacon-1)

Infergen is a bio-optimized type 1 interferon alpha indicated for

treatment of adult patients with chronic HCV infections and is dosed three

times a week. Infergen is the only interferon alpha with data in the label

regarding use in patients following relapse or non-response to treatment

with

certain previous treatments. The most common side effects are flu-like

symptoms (i.e. headache, fatigue, fever, myalgia, and rigors). Physicians

and

patients can obtain additional prescribing information regarding Infergen,

including the product's safety profile, by visiting http://www.infergen.com,

including the black box warning for all interferon alphas regarding

psychiatric, autoimmune, ischemic and infectious disorders.

About Actimmune® (interferon gamma-1b)

Interferon gamma is a naturally occurring protein that stimulates

the immune system. InterMune markets Actimmune for the treatment of two

life-threatening congenital diseases: chronic granulomatous disease and

severe, malignant osteopetrosis. The most commons side effects are flu-like

symptoms, including fever, headache and chills. InterMune is also conducting

a

Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis, a

Phase III study of interferon gamma-1b in ovarian cancer and a Phase II

study

of interferon gamma-1b in severe liver fibrosis, or cirrhosis, caused by

hepatitis C virus (HCV). Physicians and patients can obtain additional

prescribing information regarding Actimmune, including the product's safety

profile, by visiting http://www.actimmune.com.

About InterMune

InterMune is a biopharmaceutical company focused on the applied

research,

development and marketing of life-saving therapies for pulmonary and hepatic

disease. For additional information about InterMune, please visit

http://www.intermune.com.

Except for the historical information contained herein, this press

release

contains certain forward-looking statements by InterMune that involve risks

and uncertainties, including without limitation the statements indicating

that

the data for the use of Infergen and Actimmune in combination are

encouraging

compared to current treatment options and that this combination therapy may

offer hope to patients who do not respond to standard interferon plus

ribavirin therapy. All forward-looking statements and other information

included in this press release are based on information available to

InterMune

as of the date hereof, and InterMune assumes no obligation to update any

such

forward-looking statements or information. InterMune's actual results could

differ materially from those described in InterMune's forward-looking

statements. Factors that could cause or contribute to such differences

include, but are not limited to those discussed under the heading " Risk

Factors " and the risks and factors discussed in InterMune's 10-Q report

filed

with the SEC on November 13, 2003, and other periodic reports (i.e., 10-K

and

8-K) filed with the SEC. The risks and other factors that follow,

concerning

the forward-looking statements in this press release, should be considered

only in connection with the fully discussed risks and other factors

discussed

in detail in the 10-Q report and InterMune's other periodic reports filed

with

the SEC. InterMune's forward-looking statements in this press release

concerning the use of Infergen and Actimmune for the treatment of Hepatitis

C

are subject to the risks and uncertainties that include, without limitation,

those associated with obtaining statistically significant data from clinical

trials; the uncertain, lengthy; and expensive drug research and development

and regulatory process; competition; budget constraints and InterMune's

ability to obtain, maintain and enforce patents and other intellectual

property.

SOURCE InterMune, Inc.

Web Site: http://www.intermune.com