Wednesday April 10, 7:00 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune and Mondobiotech Form R&D Alliance for Actimmune(R) in Pulmonary Diseases
Companies Announce Initiation of Phase II Study of Actimmune(R) For Asthma in Europe
BRISBANE, Calif. and LUGANO, Switzerland, April 10 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - news) and Mondobiotech S.A., announced today that they have entered into an agreement under which the two companies will collaborate on the research and development of Actimmune® (Interferon gamma-1b) for asthma, and evaluate other possible therapeutics for pulmonary diseases. The companies also announced that they have begun enrolling patients in a Phase II study of Interferon gamma-1b for asthma in Europe. Financial terms were not disclosed.
Under terms of the agreement, InterMune will provide funding and development support for a Phase II pilot study in asthma of 40 patients randomized to treatment with Interferon gamma-1b or placebo. The study is designed to assess Interferon gamma-1b's effect on the level of obstructive lung disease as measured by lung function testing and by the molecular assessment of the lung tissue. Prof. Lutz-Henning Block, M.D., of Vienna General Hospital, is the study's principal investigator.
The agreement also calls for InterMune to take a non-controlling equity stake in Mondobiotech in exchange for a patent license that covers the use of Interferon gamma-1b for idiopathic pulmonary fibrosis (IPF) in certain European countries and for bronchial asthma worldwide. In addition, W. Scott Harkonen, President and CEO of InterMune, was named to Mondobiotech's Board of Directors.
``This alliance will facilitate our research and development activities in Europe,'' said Dr. Harkonen. ``With the help of Mondobiotech, whose groundbreaking work and expertise led to the development of Interferon gamma for IPF, we are planning to expand the potential indications for Actimmune to asthma, one of the largest unmet needs in pulmonary medicine.''
``We welcome the opportunity to partner with InterMune to evaluate the therapeutic potential of Actimmune in asthma patients,'' said Fabio Cavalli, CEO of Mondobiotech. ``We look forward to a long and mutually beneficial relationship with InterMune that may significantly foster our research and development projects as we help them explore the potential of Actimmune beyond IPF.''
Asthma is a chronic condition characterized by narrowing of the airways resulting in restricted airflow, which typically occurs in response to allergic stimulation caused by immunologic or environmental triggers. An estimated 41 million patients suffer from asthma in the United States, Europe and Japan.
``There is sound scientific evidence to support the use of Actimmune in asthma based on clear evidence that patients with asthma have impaired levels of Interferon gamma that relate to specific imbalances of the immune system,'' said Prof. Lutz-Henning Block, M.D., chief medical and scientific advisor of Mondobiotech. ``We believe that Interferon gamma replacement therapy with Actimmune may help prevent hyper-inflammatory conditions that cause the asthmatic response.''
About Actimmune
Actimmune is currently marketed in the United States by InterMune for the treatment of two rare congenital diseases, chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. In addition to this Phase II study in asthma, InterMune is conducting or planning to conduct multiple Phase II and Phase III clinical studies examining Actimmune's use in IPF, ovarian cancer, liver fibrosis, cryptococcal meningitis, a difficult-to-treat and life-threatening fungal infection, cystic fibrosis and atypical mycobacterial infections.
About Mondobiotech
Mondobiotech SA (www.mondobiotech.com) is a Swiss biotechnology company dedicated to the development and commercialization of new concepts driven by the urgent medical need for therapy of fibroproliferative diseases.
About InterMune
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and cancer. For additional information about InterMune, please visit www.intermune.com.
Except for the historical information contained herein, this news release contains forward-looking statements concerning the development of Actimmune for the treatment of asthma. These statements represent InterMune's judgment as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. 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-K report filed with the SEC on March 22, 2002, and InterMune's other periodic reports filed with the SEC. Additional potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, competition and obtaining marketing approval.
SOURCE: InterMune, Inc. |
