InterMune Announces Continuing Progress on ITMN-191 (R7227)

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InterMune Announces Continuing Progress on ITMN-191 (R7227)

From the PharmaLive.com News Archive - Jan. 07, 2008

- Principal Goals of Phase 1b MAD Trial Already Achieved -

BRISBANE, Calif., January 07, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc.

today provided an update on the progress of its Phase 1b multiple-ascending-dose

(MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with

chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor

in development by InterMune and its partner, Roche.

Dan Welch, President and Chief Executive Officer of InterMune, said, " We have

now completed our first two dosage cohorts in the MAD study, with total daily

doses of up to 300mg, and expect the third dosage cohort to be enrolled in

January. We are very pleased to announce that after completing the first two

low-dosage cohorts, we have already achieved the principal goals of the MAD

study for viral kinetic performance, safety and tolerability and are now

advancing the program to study ITMN-191 in combination with Pegasys® and

ribavirin. In view of the very favorable safety profile observed to date, we

will continue dose escalation in the MAD trial to a third and possibly fourth

cohort in order to more fully evaluate the viral kinetic profile, safety and

tolerability of higher doses of ITMN-191. In parallel with the conduct of the

ongoing MAD study, we are preparing and will submit to the appropriate European

authorities the clinical trial authorization application to gain approval to

begin a 14-day triple combination study of ITMN-191 with Pegasys® and

ribavirin in the second quarter. "

The company also announced that it is on track to announce top-line viral

kinetic and safety results from at least three treatment-naïve dose cohorts of

the ongoing MAD clinical study later in the first quarter of this year.

InterMune also expects to submit full data from all available cohorts of the

current Phase 1b study for possible presentation at one or more scientific

conferences in the second quarter of 2008.

Phase 1b (MAD) Trial Design

The ongoing Phase 1b placebo-controlled study is designed to assess the effect

of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral

resistance, pharmacokinetics, safety and tolerability. The principal goal of the

MAD study is to help choose the dose of ITMN-191 that when administered in

combination with Pegasys® and ribavirin, would likely offer the most

competitive protease inhibitor-based triple combination regimen in terms of

efficacy, safety and tolerability.

In the Phase 1b study, three or four cohorts of treatment-naive patients receive

ITMN-191 twice per day (BID) or three times per day (TID) with food for a period

of 14 days. In addition, a single cohort of treatment-experienced chronic

hepatitis C patients infected with HCV genotype 1 will be studied once the

treatment-naive cohorts are completed.

About InterMune

InterMune is a biotechnology company focused on the research, development and

commercialization of innovative therapies in pulmonology and hepatology.

InterMune has a research and development portfolio addressing idiopathic

pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology

portfolio includes the Phase 3 program, CAPACITY, which is evaluating

pirfenidone for the treatment of patients with IPF and a research program

focused on small molecules for pulmonary disease. The hepatology portfolio

includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at

Roche) in Phase 1b, a second-generation HCV protease inhibitor research program,

and a research program evaluating a new target in hepatology. For additional

information about InterMune and its R & D pipeline, please visit

http://www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of

section 21E of the Securities Exchange Act of 1934, as amended, that reflect

InterMune's judgment and involve risks and uncertainties as of the date of this

release, including without limitation the statements related to anticipated

product development timelines. 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 in detail under the heading " Risk Factors " in

InterMune's most recent annual report on Form 10-K filed with the SEC on March

30, 2007 (the " Form 10-K " ) and other periodic reports filed with the SEC,

including the following: (i) risks related to the long, expensive and uncertain

clinical development and regulatory process, including having no unexpected

safety, toxicology, clinical or other issues or delays in anticipated timing of

the regulatory approval process; (ii) risks related to failure to achieve the

clinical trial results required to commercialize our product candidates; and

(iii) risks related to timely patient enrollment and retention in clinical

trials. The risks and other factors discussed above should be considered only in

connection with the fully discussed risks and other factors discussed in detail

in the Form 10-K and InterMune's other periodic reports filed with the SEC, all

of which are available via InterMune's web site at http://www.intermune.com.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@...

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

Ticker Symbol: (NASDAQ-NMS:ITMN)

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=503982 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

Share life as it happens with the new Windows Live.

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[Guest guest]

InterMune Announces Continuing Progress on ITMN-191 (R7227)

From the PharmaLive.com News Archive - Jan. 07, 2008

- Principal Goals of Phase 1b MAD Trial Already Achieved -

BRISBANE, Calif., January 07, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc.

today provided an update on the progress of its Phase 1b multiple-ascending-dose

(MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with

chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor

in development by InterMune and its partner, Roche.

Dan Welch, President and Chief Executive Officer of InterMune, said, " We have

now completed our first two dosage cohorts in the MAD study, with total daily

doses of up to 300mg, and expect the third dosage cohort to be enrolled in

January. We are very pleased to announce that after completing the first two

low-dosage cohorts, we have already achieved the principal goals of the MAD

study for viral kinetic performance, safety and tolerability and are now

advancing the program to study ITMN-191 in combination with Pegasys® and

ribavirin. In view of the very favorable safety profile observed to date, we

will continue dose escalation in the MAD trial to a third and possibly fourth

cohort in order to more fully evaluate the viral kinetic profile, safety and

tolerability of higher doses of ITMN-191. In parallel with the conduct of the

ongoing MAD study, we are preparing and will submit to the appropriate European

authorities the clinical trial authorization application to gain approval to

begin a 14-day triple combination study of ITMN-191 with Pegasys® and

ribavirin in the second quarter. "

The company also announced that it is on track to announce top-line viral

kinetic and safety results from at least three treatment-naïve dose cohorts of

the ongoing MAD clinical study later in the first quarter of this year.

InterMune also expects to submit full data from all available cohorts of the

current Phase 1b study for possible presentation at one or more scientific

conferences in the second quarter of 2008.

Phase 1b (MAD) Trial Design

The ongoing Phase 1b placebo-controlled study is designed to assess the effect

of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral

resistance, pharmacokinetics, safety and tolerability. The principal goal of the

MAD study is to help choose the dose of ITMN-191 that when administered in

combination with Pegasys® and ribavirin, would likely offer the most

competitive protease inhibitor-based triple combination regimen in terms of

efficacy, safety and tolerability.

In the Phase 1b study, three or four cohorts of treatment-naive patients receive

ITMN-191 twice per day (BID) or three times per day (TID) with food for a period

of 14 days. In addition, a single cohort of treatment-experienced chronic

hepatitis C patients infected with HCV genotype 1 will be studied once the

treatment-naive cohorts are completed.

About InterMune

InterMune is a biotechnology company focused on the research, development and

commercialization of innovative therapies in pulmonology and hepatology.

InterMune has a research and development portfolio addressing idiopathic

pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology

portfolio includes the Phase 3 program, CAPACITY, which is evaluating

pirfenidone for the treatment of patients with IPF and a research program

focused on small molecules for pulmonary disease. The hepatology portfolio

includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at

Roche) in Phase 1b, a second-generation HCV protease inhibitor research program,

and a research program evaluating a new target in hepatology. For additional

information about InterMune and its R & D pipeline, please visit

http://www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of

section 21E of the Securities Exchange Act of 1934, as amended, that reflect

InterMune's judgment and involve risks and uncertainties as of the date of this

release, including without limitation the statements related to anticipated

product development timelines. 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 in detail under the heading " Risk Factors " in

InterMune's most recent annual report on Form 10-K filed with the SEC on March

30, 2007 (the " Form 10-K " ) and other periodic reports filed with the SEC,

including the following: (i) risks related to the long, expensive and uncertain

clinical development and regulatory process, including having no unexpected

safety, toxicology, clinical or other issues or delays in anticipated timing of

the regulatory approval process; (ii) risks related to failure to achieve the

clinical trial results required to commercialize our product candidates; and

(iii) risks related to timely patient enrollment and retention in clinical

trials. The risks and other factors discussed above should be considered only in

connection with the fully discussed risks and other factors discussed in detail

in the Form 10-K and InterMune's other periodic reports filed with the SEC, all

of which are available via InterMune's web site at http://www.intermune.com.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@...

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

Ticker Symbol: (NASDAQ-NMS:ITMN)

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=503982 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

Share life as it happens with the new Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008

[Guest guest]

InterMune Announces Continuing Progress on ITMN-191 (R7227)

From the PharmaLive.com News Archive - Jan. 07, 2008

- Principal Goals of Phase 1b MAD Trial Already Achieved -

BRISBANE, Calif., January 07, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc.

today provided an update on the progress of its Phase 1b multiple-ascending-dose

(MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with

chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor

in development by InterMune and its partner, Roche.

Dan Welch, President and Chief Executive Officer of InterMune, said, " We have

now completed our first two dosage cohorts in the MAD study, with total daily

doses of up to 300mg, and expect the third dosage cohort to be enrolled in

January. We are very pleased to announce that after completing the first two

low-dosage cohorts, we have already achieved the principal goals of the MAD

study for viral kinetic performance, safety and tolerability and are now

advancing the program to study ITMN-191 in combination with Pegasys® and

ribavirin. In view of the very favorable safety profile observed to date, we

will continue dose escalation in the MAD trial to a third and possibly fourth

cohort in order to more fully evaluate the viral kinetic profile, safety and

tolerability of higher doses of ITMN-191. In parallel with the conduct of the

ongoing MAD study, we are preparing and will submit to the appropriate European

authorities the clinical trial authorization application to gain approval to

begin a 14-day triple combination study of ITMN-191 with Pegasys® and

ribavirin in the second quarter. "

The company also announced that it is on track to announce top-line viral

kinetic and safety results from at least three treatment-naïve dose cohorts of

the ongoing MAD clinical study later in the first quarter of this year.

InterMune also expects to submit full data from all available cohorts of the

current Phase 1b study for possible presentation at one or more scientific

conferences in the second quarter of 2008.

Phase 1b (MAD) Trial Design

The ongoing Phase 1b placebo-controlled study is designed to assess the effect

of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral

resistance, pharmacokinetics, safety and tolerability. The principal goal of the

MAD study is to help choose the dose of ITMN-191 that when administered in

combination with Pegasys® and ribavirin, would likely offer the most

competitive protease inhibitor-based triple combination regimen in terms of

efficacy, safety and tolerability.

In the Phase 1b study, three or four cohorts of treatment-naive patients receive

ITMN-191 twice per day (BID) or three times per day (TID) with food for a period

of 14 days. In addition, a single cohort of treatment-experienced chronic

hepatitis C patients infected with HCV genotype 1 will be studied once the

treatment-naive cohorts are completed.

About InterMune

InterMune is a biotechnology company focused on the research, development and

commercialization of innovative therapies in pulmonology and hepatology.

InterMune has a research and development portfolio addressing idiopathic

pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology

portfolio includes the Phase 3 program, CAPACITY, which is evaluating

pirfenidone for the treatment of patients with IPF and a research program

focused on small molecules for pulmonary disease. The hepatology portfolio

includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at

Roche) in Phase 1b, a second-generation HCV protease inhibitor research program,

and a research program evaluating a new target in hepatology. For additional

information about InterMune and its R & D pipeline, please visit

http://www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of

section 21E of the Securities Exchange Act of 1934, as amended, that reflect

InterMune's judgment and involve risks and uncertainties as of the date of this

release, including without limitation the statements related to anticipated

product development timelines. 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 in detail under the heading " Risk Factors " in

InterMune's most recent annual report on Form 10-K filed with the SEC on March

30, 2007 (the " Form 10-K " ) and other periodic reports filed with the SEC,

including the following: (i) risks related to the long, expensive and uncertain

clinical development and regulatory process, including having no unexpected

safety, toxicology, clinical or other issues or delays in anticipated timing of

the regulatory approval process; (ii) risks related to failure to achieve the

clinical trial results required to commercialize our product candidates; and

(iii) risks related to timely patient enrollment and retention in clinical

trials. The risks and other factors discussed above should be considered only in

connection with the fully discussed risks and other factors discussed in detail

in the Form 10-K and InterMune's other periodic reports filed with the SEC, all

of which are available via InterMune's web site at http://www.intermune.com.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@...

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

Ticker Symbol: (NASDAQ-NMS:ITMN)

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=503982 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

Share life as it happens with the new Windows Live.

http://www.windowslive.com/share.html?ocid=TXT_TAGHM_Wave2_sharelife_012008

[Guest guest]

InterMune Announces Continuing Progress on ITMN-191 (R7227)

From the PharmaLive.com News Archive - Jan. 07, 2008

- Principal Goals of Phase 1b MAD Trial Already Achieved -

BRISBANE, Calif., January 07, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc.

today provided an update on the progress of its Phase 1b multiple-ascending-dose

(MAD) clinical trial evaluating ITMN-191 (R7227) as monotherapy in patients with

chronic hepatitis C virus (HCV) infection. ITMN-191 is an HCV protease inhibitor

in development by InterMune and its partner, Roche.

Dan Welch, President and Chief Executive Officer of InterMune, said, " We have

now completed our first two dosage cohorts in the MAD study, with total daily

doses of up to 300mg, and expect the third dosage cohort to be enrolled in

January. We are very pleased to announce that after completing the first two

low-dosage cohorts, we have already achieved the principal goals of the MAD

study for viral kinetic performance, safety and tolerability and are now

advancing the program to study ITMN-191 in combination with Pegasys® and

ribavirin. In view of the very favorable safety profile observed to date, we

will continue dose escalation in the MAD trial to a third and possibly fourth

cohort in order to more fully evaluate the viral kinetic profile, safety and

tolerability of higher doses of ITMN-191. In parallel with the conduct of the

ongoing MAD study, we are preparing and will submit to the appropriate European

authorities the clinical trial authorization application to gain approval to

begin a 14-day triple combination study of ITMN-191 with Pegasys® and

ribavirin in the second quarter. "

The company also announced that it is on track to announce top-line viral

kinetic and safety results from at least three treatment-naïve dose cohorts of

the ongoing MAD clinical study later in the first quarter of this year.

InterMune also expects to submit full data from all available cohorts of the

current Phase 1b study for possible presentation at one or more scientific

conferences in the second quarter of 2008.

Phase 1b (MAD) Trial Design

The ongoing Phase 1b placebo-controlled study is designed to assess the effect

of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral

resistance, pharmacokinetics, safety and tolerability. The principal goal of the

MAD study is to help choose the dose of ITMN-191 that when administered in

combination with Pegasys® and ribavirin, would likely offer the most

competitive protease inhibitor-based triple combination regimen in terms of

efficacy, safety and tolerability.

In the Phase 1b study, three or four cohorts of treatment-naive patients receive

ITMN-191 twice per day (BID) or three times per day (TID) with food for a period

of 14 days. In addition, a single cohort of treatment-experienced chronic

hepatitis C patients infected with HCV genotype 1 will be studied once the

treatment-naive cohorts are completed.

About InterMune

InterMune is a biotechnology company focused on the research, development and

commercialization of innovative therapies in pulmonology and hepatology.

InterMune has a research and development portfolio addressing idiopathic

pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology

portfolio includes the Phase 3 program, CAPACITY, which is evaluating

pirfenidone for the treatment of patients with IPF and a research program

focused on small molecules for pulmonary disease. The hepatology portfolio

includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at

Roche) in Phase 1b, a second-generation HCV protease inhibitor research program,

and a research program evaluating a new target in hepatology. For additional

information about InterMune and its R & D pipeline, please visit

http://www.intermune.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of

section 21E of the Securities Exchange Act of 1934, as amended, that reflect

InterMune's judgment and involve risks and uncertainties as of the date of this

release, including without limitation the statements related to anticipated

product development timelines. 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 in detail under the heading " Risk Factors " in

InterMune's most recent annual report on Form 10-K filed with the SEC on March

30, 2007 (the " Form 10-K " ) and other periodic reports filed with the SEC,

including the following: (i) risks related to the long, expensive and uncertain

clinical development and regulatory process, including having no unexpected

safety, toxicology, clinical or other issues or delays in anticipated timing of

the regulatory approval process; (ii) risks related to failure to achieve the

clinical trial results required to commercialize our product candidates; and

(iii) risks related to timely patient enrollment and retention in clinical

trials. The risks and other factors discussed above should be considered only in

connection with the fully discussed risks and other factors discussed in detail

in the Form 10-K and InterMune's other periodic reports filed with the SEC, all

of which are available via InterMune's web site at http://www.intermune.com.

CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@...

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

Ticker Symbol: (NASDAQ-NMS:ITMN)

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=503982 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

Share life as it happens with the new Windows Live.

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