Monday November 26, 6:01 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Announces Strategy for Future Growth Fueled by Product Sales And Clinical Development Momentum
NEW YORK, Nov. 26 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today its strategic plan that the Company believes will drive its growth into a top-tier commercial-stage biotechnology company. The plan includes a greater than 100% annual increase in product revenues through 2003, as well as the advancement and commercialization of its three potential blockbuster development programs. Currently, the Company has three marketed products and a robust pipeline of clinical development programs targeting life-threatening pulmonary and infectious diseases and cancer.
At the Company's Second Annual Analyst Day to be held here this afternoon, InterMune will provide detailed revenue guidance. The Company also will outline the timelines and market opportunities for its three potential blockbuster development programs: Actimmune® (Interferon gamma-1b), in a Phase III trial for the treatment of idiopathic pulmonary fibrosis (IPF); oritavancin, a novel antibiotic agent in Phase III clinical trials for the treatment of gram-positive bacterial infections; and a pegylated form of Infergen® (interferon alfacon-1), which the Company plans to put into human trials by the end of next year.
``2002 will be a breakthrough year for InterMune,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``In 2001, we achieved product sales growth that exceeded expectations, and we expect to continue that growth in 2002. By augmenting our field force, we believe that we can successfully re-launch Infergen and increase coverage of the growing number of pulmonologists interested in Actimmune for IPF. 2002 also will be marked by a series of clinical trial results that could create blockbuster revenue opportunities for both Actimmune and oritavancin. In addition, we plan to begin our first human trials of a pegylated form of Infergen towards the end of the year.''
To support the growing demand for its products, the Company is expanding its number of field specialists from 60 to 110 in January 2002. The field specialists provide medical education regarding the use of Actimmune by pulmonologists; Infergen, the Company's antiviral compound for the treatment of chronic hepatitis C infections; and Amphotec® (amphotericin B colloidal dispersion), the Company's anti-fungal agent for life-threatening systemic fungal infections.
Regarding its three late-stage development programs, InterMune plans to focus on:
-- Expanding the use of Actimmune, which is in late-stage development for
multiple indications and represents an estimated market opportunity of
up to $2.5 billion for IPF alone;
-- Advancing development of oritavancin for gram-positive infections,
which represents an estimated market opportunity of up to
$250-500 million; and
-- Increasing the use of Infergen for the treatment of chronic hepatitis C
infections and developing a pegylated form of Infergen, which
represents an estimated market opportunity of up to $500 million to
$1 billion.
Actimmune
Actimmune is an approved product on the market for the treatment of two rare congenital diseases, chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. InterMune is conducting or planning to conduct multiple Phase II and three Phase III clinical studies with Actimmune, including a Phase III clinical trial for the treatment of IPF, a debilitating and usually fatal condition for which there is currently no effective treatment. Initial results from this trial are expected by November 2002.
InterMune recently completed a Phase II clinical trial examining the use of Actimmune in combination with amphotericin B for the treatment of cryptococcal meningitis, a difficult-to-treat and life-threatening fungal infection. Results of this trial will be reported during a late-breaking clinical trials session at the upcoming 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on Tuesday, December 18, in Chicago.
The Company plans to initiate a Phase III trial of Actimmune for the treatment of ovarian cancer and a Phase II trial for the treatment of liver fibrosis in the fourth quarter of 2001. Studies are also ongoing with Actimmune for the treatment of tuberculosis, cystic fibrosis and atypical mycobacterial infections.
Oritavancin
Oritavancin is the Company's semi-synthetic glycopeptide antibiotic in development for the treatment of a broad range of gram-positive bacterial infections. Studies have shown that oritavancin may be effective against many serious gram-positive bacterial infections including those resistant to conventional antibiotics. Its novel mechanism of action kills harmful and resistant strains of bacteria, unlike many other agents that merely suppress them. Resistance among gram-positive bacteria remains an unmet medical need. Gram-positive bacterial infections in the aggregate affect more than seven million patients worldwide in the hospital setting alone.
The Company plans to announce the results of a Phase III study, ``Equivalence of shorter course therapy with oritavancin compared to vancomycin/cephalexin in complicated skin/skin structure infections (CSSI),'' in December 2001.
In addition to a completed Phase III trial for the treatment of CSSI, and a second ongoing Phase III trial in CSSI, the Company plans to announce results of a Phase II study in bacteremia in the first half of next year. The Company plans to start Phase III trials of oritavancin for use in both bacteremia and in community-acquired pneumonia in mid-2002.
Infergen
Infergen, also known as consensus interferon (CIFN), is a bioengineered type I interferon alfa currently marketed by InterMune for the treatment of patients with chronic hepatitis C infections, including both patients who have not received previous treatment with interferon agents and those who have failed current first-line therapy.
InterMune recently announced positive interim results from a Phase IV clinical trial comparing the use of Infergen plus ribavirin to the use of interferon alfa-2b plus ribavirin (Rebetron(TM)) for the treatment of chronic hepatitis C infections. Patients treated with Infergen in combination with ribavirin achieved a sustained virologic response (SVR) of 56% compared with an SVR of 31% in patients treated with Rebetron. The most commonly observed side effects were fever, fatigue, aches, headache, nausea, cough and depression. The Company expects that final results of this trial will be available in the fourth quarter of 2002.
To access InterMune's Analyst Day webcast starting at 4:45 p.m. EST today, please visit intermune.com and click on ``Investor Relations.''
About InterMune
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit intermune.com . |
