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intermune inc (ITMN) Key Developments

InterMune, Inc. Presents at JMP Securities Healthcare Conference, Jun-24-2014 02:30 PM

InterMune, Inc. Presents at JMP Securities Healthcare Conference, Jun-24-2014 02:30 PM. Venue: The Westin New York Grand Central, 212 East 42nd Street, New York, NY 10017, United States.

InterMune, Inc. Announces Resubmission of NDA for Pirfenidone for the Treatment of Patients with IPF

InterMune, Inc. announced that it has resubmitted its pirfenidone New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2010. Pirfenidone is being developed for the treatment of adult patients with idiopathic pulmonary fibrosis (IPF). Under the Prescription Drug User Fee Act (PDUFA), the FDA has 74 days after receipt of an NDA to evaluate the submission in order to determine if it is sufficiently complete. If in this 74-day period the FDA determines that the submission is complete, the review clock will be deemed to have started as of the date that the resubmission was initially received by the FDA. As the resubmission of an efficacy supplement, the submission of the ASCEND data represents a Class 2 resubmission that has a target FDA review of six months under PDUFA V. In May 2010, InterMune received a CRL from the FDA. In the CRL, the FDA recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone. Since the receipt of the CRL, InterMune has conducted the Phase 3 ASCEND trial of pirfenidone in IPF, and results of that trial were presented on May 18, 2014, at the meeting of the American Thoracic Society and were published on-line the same day in the New England Journal of Medicine. The NDA resubmission includes the ASCEND Clinical Study Report as well as the pooled analyses of efficacy and mortality from the three InterMune Phase 3 trials: ASCEND and the previous Phase 3 CAPACITY trials (004 and 006). Additionally, the NDA resubmission includes a safety update of approximately 15,000 patients including clinical studies and the extensive post-marketing experience of pirfenidone collected since 2008.

InterMune, Inc. - Special Call

To discuss the additional pirfenidone data in IPF presented in the SKYFALL session

InterMune, Inc. Reports Results from the Phase 3 ASCEND Study Evaluating Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

InterMune, Inc. reported that results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis were presented at the International Conference of the American Thoracic Society in San Diego. In ASCEND, pirfenidone significantly reduced decline in lung function as measured by change in percent predicted forced vital capacity from Baseline to Week 52. Additionally, significant treatment effects were demonstrated on both of the key secondary endpoints of change in six-minute walk distance (6MWD) (p=0.0360) and progression-free survival (PFS) (p=0.0001). The secondary endpoint of dyspnea was not met. In ASCEND, treatment with pirfenidone was associated with fewer deaths although the study was not powered for and did not reach statistical significance on mortality. A pre-specified analysis of the pooled population from ASCEND and the two Phase 3 CAPACITY studies showed that the risk of all-cause mortality was reduced by 48% at Week 52 in the pirfenidone group compared to the placebo group. In ASCEND, treatment with pirfenidone showed a favorable safety profile and was generally well tolerated. IPF is a chronic, progressive, and irreversible lung disease characterized by scarring in the lungs, which hinders a person's ability to breathe. The median survival time from diagnosis is two to five years, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. 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 10% decline in FVC, or death. A 10% decline in FVC in an individual IPF patient is considered clinically meaningful and strongly predictive of a higher risk of 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 this meaningful decline in FVC or death. Additionally, at Week 52, the results 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 who experienced no decline in FVC between Baseline and Week 52. The New England Journal of Medicine publication contains additional supportive analyses of the treatment effect of pirfenidone on FVC change that corroborate the results of the primary analysis. The mean decline from Baseline to Week 52 in FVC volume, a measurement of lung capacity, was 235 mL in the pirfenidone group and 428 mL in the placebo group (absolute difference, 193 mL; relative difference, 45.1%; p<0.0001). The slope of decline in FVC through Week 52 was 122 mL/yr. in the pirfenidone group and 262 mL/yr. in the placebo group (absolute difference, 140 mL/yr.; relative difference, 53.5%; p<0.0001). Two key secondary endpoints were pre-specified in the ASCEND protocol: change from Baseline to Week 52 in 6MWD and PFS. 6MWD is a measure of exercise tolerance and a 50-meter decrement in 6MWD is considered an independent predictor of mortality in a 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 or death relative to placebo (p=0.0360). PFS is a measure of time until death or disease-progression. Disease progression was defined as any of the following: confirmed percent predicted FVC decrement of 10% or greater or confirmed 6MWD decrement of 50 meters or greater. In ASCEND, pirfenidone reduced the risk of death or disease progression by 43% compared to placebo (HR 0.57; 95% confidence interval [CI], 0.43-0.77; p<0.001). Fewer patients in the pirfenidone group compared with placebo experienced a qualifying event for each component of the endpoint: death (3.6% vs. 5.1%), confirmed >/= 10% decline in percent predicted FVC (6.5% vs. 17.7%), and confirmed >/= 50 m decrement in 6MWD (16.5% vs. 19.5%). Additional secondary endpoints were pre-specified in the ASCEND protocol: change from Baseline to Week 52 in dyspnea (shortness of breath), all-cause mortality, and treatment-emergent IPF-related mortality. The secondary endpoint of dyspnea was not achieved. Analysis of UCSD SOBQ scores showed no statistically significant difference between treatment groups at Week 52; 29.1% of patients in the pirfenidone group experienced a >/= 20 point worsening in UCSD SOBQ score or death, compared with 36.1% of patients in the placebo group (absolute difference, 7.0%; relative difference, 19.3%; p=0.1577). 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. Given the relatively low overall mortality rate in patient populations in one-year IPF studies, ASCEND was not powered to detect a mortality benefit. The pooled analyses increase the statistical power for detection of a mortality effect and provide a more stable estimate of the magnitude of effect. The pre-specified analysis of the ASCEND study alone showed fewer all-cause and treatment-emergent IPF-related deaths in the pirfenidone group compared to the placebo group. 4% of patients in the pirfenidone group and 7.2% of patients in the placebo group died during the study (HR 0.55; 95% CI 0.26 to 1.15; p=0.1045). Treatment-emergent IPF-related deaths occurred in 1.1% and 2.5% of patients in the pirfenidone and placebo groups, respectively (HR 0.44; 95% CI 0.11 to 1.72; p=0.2258). The relationship of death to IPF was determined in ASCEND by a blinded adjudication committee. The pre-specified analyses of mortality in the pooled population (N=1,247) from ASCEND and the two Phase 3 CAPACITY studies showed that the risk of all-cause mortality was reduced by 48% at Week 52 in the pirfenidone group compared to the placebo group (HR 0.52; 95% CI 0.31--0.87; 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% at Week 52 (HR 0.32; 95% CI 0.14--0.76; p=0.0061).

Intermune, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2014; Revises Revenue Guidance for the Full Year of 2014

InterMune, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2014. For the quarter, revenue, net Esbriet product sales was $30,274,000 against $10,530,000 a year ago. Loss from operations was $49,469,000 against $47,698,000 a year ago. Loss from continuing operations before income taxes was $54,018,000 against $50,105,000 a year ago. Net loss was $53,647,000 against $49,875,000 a year ago. Basic net loss per common share from continuing operations was $0.60 against $0.65 a year ago. Basic net loss per common share was $0.59 against $0.64 a year ago. The company raised its 2014 revenue guidance, now projected to be in a range of $130 to $140 million against $115 to $135 million as previously reported. The new range represents potential growth in 2014 of approximately 85% to 100% from Esbriet revenue of $70.3 million in 2013. The company anticipates a positive impact on its revenues in the EU from the positive ASCEND results announced in late February of 2014. They expect to begin to observe this impact in the fourth quarter of 2014 and after following the steps -- the following steps are taken. First, the results of ASCEND need to be published in a peer-reviewed journal that reaches beyond the very small number of so-called key opinion leaders who have seen the details of the ASCEND results beyond its investor press release. Second, the product labeling or SmPC needs to get updated to reflect the ASCEND data, and they expect that this will occur around the end of 2014. Third, IPF patients need to see their doctors, and the normal cycle for patient visits is every 3 to 6 months. Therefore, they expect the ASCEND data to positively affect EU revenues beginning in the fourth quarter of this year and not meaningfully until early next year.

 

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