InterMune Announces Continuing Progress on HCV Protease Inhibitor ITMN-191 (R722

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InterMune Announces Continuing Progress on HCV Protease Inhibitor

ITMN-191 (R7227)

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

Advancing to Triple Combination Trial -

BRISBANE, Calif., Jan 07, 2008 /PRNewswire-FirstCall via COMTEX News

Network/ -- InterMune, Inc. (Nasdaq: ITMN) 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.

SOURCE InterMune, Inc.

http://www.intermune.com