Key Developments For InterMune, Inc.
InterMune, Inc. (ITMN.O) (Nasdaq)
InterMune, Inc. Announces Modification To On Going Phase 2b Study Of ITMN-191 In Patients With Chronic HCV Infection
InterMune, Inc. announced that the on going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS and COPEGUS (ribavirin) in HCV treatment naive patients has been modified. The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study. Three patients in the blinded 900 mg q12h dosage cohort experienced a Grade 4 elevation in ALT levels, one of whom experienced an elevation of total bilirubin while also receiving concomitant allopurinol. After their review of the un blinded data from all cohorts, the study's independent Data Monitoring Committee (DMC) recommended that the 900mg q12h cohort be discontinued and that all other cohorts of the study continue. The companies accepted the DMC's recommendations. The on-going Phase 2b study is blinded and consequently, additional details will not be provided. As previously disclosed, the Company anticipates the results of blinded rapid virologic response (RVR) data from the 12 week treatment duration cohorts in the first quarter of 2010. The Company also reported that the on going ritonavir boosting study of low-dose ITMN-191 continues to enroll patients and that guidance for INFORM-2 and for a longer duration Phase 2 study of the combination of direct acting antivirals to evaluate sustained virologic response (SVR) is not expected to change at this time.
InterMune, Inc. Raises Low End Of Prior FY 2009 Revenue Guidance To A Range In Line With Analysts' Estimates
InterMune, Inc. updated fiscal 2009 financial guidance for revenue and expects revenue, including Actimmune and milestone payments from Roche, is expected to be in a range of approximately $45-$50 million. According to Reuters Estimates, analysts were expecting the Company to report revenues of $48 million for the same period.
InterMune, Inc. Announces Submission Of NDA For Pirfenidone For Treatment Of Patients With IPF
InterMune, Inc. announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
Pharmasset, Inc. And InterMune, Inc. Announces Results From All Patients Cohorts Of INFORM-1 trial
Pharmasset, Inc. and InterMune, Inc. announced the results from all patient cohorts of the INFORM-1 trial, a Phase 1 study of two direct-acting antiviral (DAA) compounds administered without interferon or ribavirin for the treatment of patients chronically infected with the hepatitis C virus (HCV).(i) The study, conducted by Roche as part of its collaborations with InterMune and Pharmasset, combined the oral NS3 protease inhibitor RG7227 and the oral nucleoside analog polymerase inhibitor RG7128. Viral Kinetic Performance of Twice-Daily Regimens The full dose combination of RG7128 1000mg and RG7227 900mg administered twice-daily without pegylated interferon or ribavirin, the current standard of care for HCV, for 13 days resulted in 88% of HCV-positive treatment-naive patients achieving HCV RNA below the lower limit of quantification (LLOQ; <43 IU/mL), and 63% of patients having HCV RNA below the lower limit of detection (LLOD; <15 IU/mL). The same regimen in null responders resulted in 50% of patients with HCV RNA below LLOQ and 25% of patients with HCV RNA below LLOD. Null responders were defined as patients with an HCV RNA reduction of <1 log10 IU/mL in 4 weeks or <2 log10 IU/mL in 12 weeks of prior treatment with pegylated interferon and ribavirin. At the twice-daily dose of 600mg of RG7227 in combination with 1000mg of RG7128 twice-daily for 13 days in treatment-experienced patients, somewhat lower viral load reduction and categorical responses were observed.
InterMune, Inc. Announces Initiation of Ritonavir-Boosted ITMN-191/RG7227 Study in HCV Patients
InterMune, Inc. announced that its partner Roche has begun dosing in a Phase 1b multiple ascending dose (MAD) study of ITMN-191 (RG7227) boosted by low-dose ritonavir in patients chronically infected with hepatitis C virus (HCV) genotype-1.
