InterMune Completes Enrollment in Phase II Trial for Fungal Infections And Initiates Clinical Programs in Japan

Phase II Trial in Liver Fibrosis Planned for 2001



Apr 05, 2001, 01:00 ET from InterMune Pharmaceuticals, Inc.

    BURLINGAME, Calif., April 5 /PRNewswire/ -- InterMune (Nasdaq:   ITMN)
 announced today that it has completed enrollment in its first human trial with
 ACTIMMUNE(R) for the treatment of systemic fungal disease.  The
 Phase II trial has enrolled 79 patients with cryptococcal meningitis, a
 life-threatening fungal infection, to evaluate the safety and efficacy of
 ACTIMMUNE(R) in combination with amphotericin B.  Results are expected in the
 fourth quarter of 2001.
     Cryptococcal meningitis is a difficult-to-treat, life-threatening
 infection.  Only 60% of patients respond to standard treatment, which is
 usually amphotericin B.  A study published in the Journal of Antimicrobial
 Chemotherapy in September 2000 showed that in mouse models of cryptococcal
 fungal infection, combination therapy using ACTIMMUNE(R) and amphotericin B
 cured 78% of the infected mice, while amphotericin B alone cured only 10%.
     "We are very excited to complete enrollment in this trial, and look
 forward to the results of this first study utilizing this promising new
 combination," said W. Scott Harkonen, M.D., President and CEO of InterMune.
 "This therapy looks particularly exciting on the heels of our acquisition of
 Amphotec(R) and our recent international strategic partnership with
 Boehringher Ingelheim, which includes the global development of ACTIMMUNE(R)
 for life-threatening fungal diseases."
     InterMune also announced the initiation of a clinical program for
 ACTIMMUNE(R) in Japan, where it maintains infectious disease rights.
 ACTIMMUNE(R) is not yet approved in Japan, and the Company recently initiated
 a Phase I clinical trial there evaluating the safety of inhaled ACTIMMUNE(R)
 in healthy volunteers.  InterMune plans to develop the product in Japan for
 life-threatening infectious diseases, as well as chronic granulomatous disease
 (CGD) and severe, malignant osteopetrosis, two indications for which
 ACTIMMUNE(R) is already approved in the United States.
     "The initiation of clinical programs for ACTIMMUNE(R) in Japan is an
 important addition to InterMune's growing global presence," said Dr. Harkonen.
 "In Japan, the incidence of tuberculosis is four times that of the
 United States, resulting in 43,000 new cases of tuberculosis each year and
 2,000 cases of multidrug-resistant tuberculosis each year.  This has led the
 Japanese Ministry of Health to declare tuberculosis a national emergency."
 InterMune is currently conducting a U.S. Phase III clinical trial with
 ACTIMMUNE(R) for the treatment of multidrug-resistant tuberculosis (MDR TB).
     InterMune also announced that it plans to develop ACTIMMUNE(R) for the
 treatment of liver fibrosis (cirrhosis) associated with hepatitis C infection.
 There are approximately four million people in the United States with
 hepatitis C, and standard therapy is frequently ineffective.  In a clinical
 study comparing the therapeutic efficacy of interferon gamma and interferon
 alpha in patients with hepatitis C, the results showed a strong trend towards
 decreased fibrosis in the patients receiving interferon gamma, compared to no
 change in patients receiving interferon alpha.  In addition, several
 pre-clinical studies have demonstrated that ACTIMMUNE(R) may prevent and even
 reverse the fibrosis that forms in the liver as a result of infections or
 liver toxins.  The Company plans to initiate a Phase II clinical trial in the
 fourth quarter of 2001.
     "This is a novel approach to the treatment of liver fibrosis in patients
 with hepatitis C," said James Pennington, M.D., Executive Vice President of
 Medical and Scientific Affairs for InterMune.  "Standard treatments for
 hepatitis C address only the virus and not the fibrosis.  We believe that
 ACTIMMUNE(R)'s demonstrated anti-fibrotic activity may reduce the amount of
 fibrosis in the liver and could work synergistically with standard treatments
 that address only the viral infection."
     InterMune is a biotechnology company dedicated to the development and
 commercialization of innovative products for the treatment of serious
 pulmonary and infectious diseases and cancer.  InterMune currently markets
 ACTIMMUNE(R) (Interferon gamma-1b) Injection in the United States for the
 treatment of chronic granulomatous disease (CGD) and severe, malignant
 osteopetrosis and is in Phase III clinical trials for the treatment of
 idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis
 (MDR TB).  The Company also markets Amphotec(R), an FDA-approved
 lipid-complexed form of amphotericin B for the treatment of invasive
 aspergillosis, a life-threatening fungal infection.  For more information
 about InterMune and ACTIMMUNE(R), please visit InterMune's web sites at
 www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
     Except for the historical information contained herein, this press release
 contains certain forward-looking statements concerning certain of InterMune's
 clinical development goals, that involve risks and uncertainties.  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 most recent periodic reports (i.e., 10-K, 10-Q and
 8-K) filed with the SEC.  In sum, these significant risks include, but are not
 limited to:  the uncertainty of success of InterMune's efforts in research,
 development, commercialization, product acceptance, third-party manufacturing
 and capital raising; the uncertain, lengthy and expensive regulatory process;
 uncertainties associated with:  obtaining and enforcing patents important to
 its business, being an early-stage company and relying on third-party payors'
 reimbursement policies; competition from other products; and product liability
 lawsuits.
 
 

SOURCE InterMune Pharmaceuticals, Inc.
    BURLINGAME, Calif., April 5 /PRNewswire/ -- InterMune (Nasdaq:   ITMN)
 announced today that it has completed enrollment in its first human trial with
 ACTIMMUNE(R) for the treatment of systemic fungal disease.  The
 Phase II trial has enrolled 79 patients with cryptococcal meningitis, a
 life-threatening fungal infection, to evaluate the safety and efficacy of
 ACTIMMUNE(R) in combination with amphotericin B.  Results are expected in the
 fourth quarter of 2001.
     Cryptococcal meningitis is a difficult-to-treat, life-threatening
 infection.  Only 60% of patients respond to standard treatment, which is
 usually amphotericin B.  A study published in the Journal of Antimicrobial
 Chemotherapy in September 2000 showed that in mouse models of cryptococcal
 fungal infection, combination therapy using ACTIMMUNE(R) and amphotericin B
 cured 78% of the infected mice, while amphotericin B alone cured only 10%.
     "We are very excited to complete enrollment in this trial, and look
 forward to the results of this first study utilizing this promising new
 combination," said W. Scott Harkonen, M.D., President and CEO of InterMune.
 "This therapy looks particularly exciting on the heels of our acquisition of
 Amphotec(R) and our recent international strategic partnership with
 Boehringher Ingelheim, which includes the global development of ACTIMMUNE(R)
 for life-threatening fungal diseases."
     InterMune also announced the initiation of a clinical program for
 ACTIMMUNE(R) in Japan, where it maintains infectious disease rights.
 ACTIMMUNE(R) is not yet approved in Japan, and the Company recently initiated
 a Phase I clinical trial there evaluating the safety of inhaled ACTIMMUNE(R)
 in healthy volunteers.  InterMune plans to develop the product in Japan for
 life-threatening infectious diseases, as well as chronic granulomatous disease
 (CGD) and severe, malignant osteopetrosis, two indications for which
 ACTIMMUNE(R) is already approved in the United States.
     "The initiation of clinical programs for ACTIMMUNE(R) in Japan is an
 important addition to InterMune's growing global presence," said Dr. Harkonen.
 "In Japan, the incidence of tuberculosis is four times that of the
 United States, resulting in 43,000 new cases of tuberculosis each year and
 2,000 cases of multidrug-resistant tuberculosis each year.  This has led the
 Japanese Ministry of Health to declare tuberculosis a national emergency."
 InterMune is currently conducting a U.S. Phase III clinical trial with
 ACTIMMUNE(R) for the treatment of multidrug-resistant tuberculosis (MDR TB).
     InterMune also announced that it plans to develop ACTIMMUNE(R) for the
 treatment of liver fibrosis (cirrhosis) associated with hepatitis C infection.
 There are approximately four million people in the United States with
 hepatitis C, and standard therapy is frequently ineffective.  In a clinical
 study comparing the therapeutic efficacy of interferon gamma and interferon
 alpha in patients with hepatitis C, the results showed a strong trend towards
 decreased fibrosis in the patients receiving interferon gamma, compared to no
 change in patients receiving interferon alpha.  In addition, several
 pre-clinical studies have demonstrated that ACTIMMUNE(R) may prevent and even
 reverse the fibrosis that forms in the liver as a result of infections or
 liver toxins.  The Company plans to initiate a Phase II clinical trial in the
 fourth quarter of 2001.
     "This is a novel approach to the treatment of liver fibrosis in patients
 with hepatitis C," said James Pennington, M.D., Executive Vice President of
 Medical and Scientific Affairs for InterMune.  "Standard treatments for
 hepatitis C address only the virus and not the fibrosis.  We believe that
 ACTIMMUNE(R)'s demonstrated anti-fibrotic activity may reduce the amount of
 fibrosis in the liver and could work synergistically with standard treatments
 that address only the viral infection."
     InterMune is a biotechnology company dedicated to the development and
 commercialization of innovative products for the treatment of serious
 pulmonary and infectious diseases and cancer.  InterMune currently markets
 ACTIMMUNE(R) (Interferon gamma-1b) Injection in the United States for the
 treatment of chronic granulomatous disease (CGD) and severe, malignant
 osteopetrosis and is in Phase III clinical trials for the treatment of
 idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis
 (MDR TB).  The Company also markets Amphotec(R), an FDA-approved
 lipid-complexed form of amphotericin B for the treatment of invasive
 aspergillosis, a life-threatening fungal infection.  For more information
 about InterMune and ACTIMMUNE(R), please visit InterMune's web sites at
 www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
     Except for the historical information contained herein, this press release
 contains certain forward-looking statements concerning certain of InterMune's
 clinical development goals, that involve risks and uncertainties.  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 most recent periodic reports (i.e., 10-K, 10-Q and
 8-K) filed with the SEC.  In sum, these significant risks include, but are not
 limited to:  the uncertainty of success of InterMune's efforts in research,
 development, commercialization, product acceptance, third-party manufacturing
 and capital raising; the uncertain, lengthy and expensive regulatory process;
 uncertainties associated with:  obtaining and enforcing patents important to
 its business, being an early-stage company and relying on third-party payors'
 reimbursement policies; competition from other products; and product liability
 lawsuits.
 
 SOURCE  InterMune Pharmaceuticals, Inc.