Last $29.81 USD
Change Today -1.02 / -3.31%
Volume 1.5M
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As of 8:10 PM 04/23/14 All times are local (Market data is delayed by at least 15 minutes).

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intermune inc (ITMN) Details

InterMune, Inc., a biotechnology company, focuses on the research, development, and commercialization of therapies for pulmonology and orphan fibrotic diseases in North America and Europe. The company develops therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, and fatal lung disease. It markets and sells pirfenidone, an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta and TNF-alpha under the Esbriet name for the treatment of adults with mild to moderate IPF in the European Union and Canada. The company’s pirfenidone has also completed three Phase III clinical trials for the treatment of IPF in the United States. The company provides pirfenidone under the Pirespa trade name for the treatment of IPF in Japan and South Korea; and is also approved for the treatment of IPF in China, India, Argentina, and Mexico. Its research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. The company was formerly known as InterMune Pharmaceuticals, Inc. and changed its name to InterMune, Inc. in April 2001. InterMune, Inc. was founded in 1998 and is headquartered in Brisbane, California.

353 Employees
Last Reported Date: 02/24/14
Founded in 1998

intermune inc (ITMN) Top Compensated Officers

Chairman, Chief Executive Officer and Preside...
Total Annual Compensation: $703.4K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $412.0K
Managing Director of Europe and Executive Vic...
Total Annual Compensation: $439.5K
Executive Vice President of Research and Deve...
Total Annual Compensation: $384.1K
Chief Business Officer and Executive Vice Pre...
Total Annual Compensation: $380.0K
Compensation as of Fiscal Year 2013.

intermune inc (ITMN) Key Developments

InterMune Inc. - Special Call

To discuss the top-line ASCEND Phase 3 results

InterMune Inc. Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis

InterMune Inc. announced that top-line data from ASCEND, a Phase 3 trial evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF), demonstrated that pirfenidone significantly reduced IPF disease progression as measured by change in percentage predicted forced vital capacity (FVC) from Baseline to Week 52 (rank ANCOVA p<0.000001). Additionally, significant treatment effects were demonstrated on both of the key secondary endpoints of six-minute walk test distance (6MWD) change (p=0.0360) and progression-free survival (PFS) (p=0.0001). The magnitude of the treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a clinically meaningful change in FVC, or death. A 10% decline in FVC in an individual IPF patient is considered clinically meaningful and strongly predicts mortality. At Week 52, 16.5% of patients in the pirfenidone group experienced an FVC decline of 10% or more or death, compared with 31.8% in the placebo group, representing a 47.9% reduction in the proportion of patients who experienced a meaningful change in FVC or death. Additionally, at Week 52 the data demonstrated that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group, representing a 132.5% increase in the proportion of patients whose FVC did not decrease between Baseline and Week 52. The ASCEND protocol pre-specified 6MWD and PFS as the two key secondary endpoints. Change from Baseline to Week 52 in 6MWD is a measure of exercise tolerance. A 50-meter decrement in walk distance is considered an independent predictor of mortality in an individual patient with IPF. In ASCEND, pirfenidone reduced by 27.5% the proportion of patients who experienced a decline in 6MWD of 50 meters or greater (p=0.0360). PFS is a measure of time before death or a disease-progression event. A PFS event was defined in the protocol as any of the following: death, percentage predicted FVC decrement of 10% or greater or 6MWD decrement of 50 meters or greater. In ASCEND, pirfenidone reduced the risk of death or disease progression by 43% compared to placebo (Hazard Ratio [HR]=0.57; 95% confidence interval, 0.43-0.77; p=0.0001). Three additional secondary endpoints were pre-specified in the ASCEND protocol: all-cause mortality, treatment-emergent IPF-related mortality and change from Baseline to Week 52 in dyspnea (shortness of breath). The two mortality analyses were pre-specified for both the ASCEND study and the pooled population of the ASCEND study and the previous Phase 3 CAPACITY studies through 52 weeks. Due to the relatively low overall mortality rate in patient populations in the time frames studied in a single IPF study such as ASCEND, pooled analyses of ASCEND and CAPACITY data provide more statistical power and a more precise estimate of the treatment effect of pirfenidone on mortality. In the pre-specified mortality analysis of the ASCEND study alone, there were fewer events of all-cause mortality (HR=0.55, log rank p=0.1045) and of treatment-emergent IPF-related mortality (HR=0.44, log rank p=0.2258) in the pirfenidone group compared to the placebo group. ASCEND was not powered to show a difference on these endpoints. The relationship of death to IPF was determined in ASCEND by a blinded adjudication committee. The pre-specified analyses of the pooled population (N=1,247) across ASCEND and the two Phase 3 CAPACITY studies (taking CAPACITY mortality data through Week 52) showed that the risk of all-cause mortality was reduced by 48% in the pirfenidone group compared to the placebo group (HR=0.52, log rank p=0.0107). Additionally, in the pooled population the risk of treatment-emergent IPF-related death in the pirfenidone group compared to placebo was reduced by 68% (HR=0.32, log rank p=0.0061). A total of 93.5% and 94.6% of patients completed the study, died or had a lung transplant by study day 365 in the pirfenidone and placebo groups, respectively. The percentage of patients discontinuing treatment due to an adverse event was 14.4% in the pirfenidone group and 10.8% in the placebo group. Serious adverse events (SAEs) were reported in 19.8% of patients in the pirfenidone group and 24.9% in the placebo group. Hospitalizations due to respiratory, thoracic and mediastinal SAEs were reported in 3.6% of patients in the pirfenidone group and 11.2% in the placebo group. The most common AEs with higher incidence in the pirfenidone group were primarily gastrointestinal and skin-related. The GI and rash AEs were generally mild to moderate in severity, manageable, reversible and only infrequently led to treatment discontinuations.

Robert W. Baird Eyes InterMune

Robert W. Baird & Co. Incorporated said InterMune Inc. (NasdaqGS:ITMN) is an ideal acquisition target following the bullish ASCEND data release. GlaxoSmithKline plc (LSE:GSK), Gilead Sciences Inc. (NasdaqGS:GILD) and Novartis AG (SWX:NOVN), among others, could be interested in InterMune's and that an acquisition price could be into the $60's.


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