ITMN » Topics » First Quarter and Recent Business Highlights
This excerpt taken from the ITMN 8-K filed Apr 30, 2009.
First Quarter and Recent Business Highlights
On February 3, 2009, InterMune reported results from its Phase 3 CAPACITY program for pirfenidone in IPF, which consisted of two, multinational, randomized,
double-blind, placebo-controlled trials named CAPACITY 1 and CAPACITY 2.
The primary endpoint of change in percent predicted Forced Vital Capacity (FVC) at Week 72 was met with statistical significance in CAPACITY 2 (p=0.001), as were
the secondary endpoints of categorical change in FVC (p=0.001) and Progression-Free Survival (p=0.023).
The primary endpoint was not met in CAPACITY 1 (p=0.501), but supportive evidence of a pirfenidone treatment effect was observed on a number of measures and at
several time points during the study. In CAPACITY 1, there was evidence of a pirfenidone treatment effect on the pre-specified secondary endpoint of Six-Minute Walk Test distance (p = 0.001) when compared to placebo.
Pirfenidone was safe and generally well tolerated in both CAPACITY studies. There was no difference between pirfenidone and placebo in the percentage of patients
that experienced a serious adverse event (SAE) and the pattern of adverse events (AEs) was, in general, comparable to that observed in previous clinical studies of pirfenidone.
InterMune is preparing an NDA for submission to the FDA in the summer of 2009, to be followed by an MAA submission to the European Medicines Agency (EMEA) around
the end of 2009.
Results from the CAPACITY studies will be presented in an oral late-breaker session at 3:35 p.m. PDT on May 19 at the International Conference of the American
Thoracic Society (ATS) in San Diego.
On January 12, InterMune announced top-line results from a 14-day, Phase 1b study of ITMN-191 in combination with
Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin).
After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 log10 in five of the six dosage cohorts, and was -5.4 log10 and
-5.7 log10 in the best performing q12h and q8h cohorts, respectively. ITMN-191 delivered viral kinetic performance that is comparable to the best
results reported to date for other protease inhibitors in similar experiments.
There was no evidence of viral rebound during ITMN-191 treatment in any cohort.
On April 24, InterMune reported that data from the triple combination study had informed the dose selection for the Phase 2b program of ITMN-191. The Phase 2b
trial, expected to begin in the summer of 2009, will study both q12h regimens (600mg and 900mg q12h) and a q8h regimen (300mg q8h) and both 12-week and 24-week treatment durations.
At the Annual Meeting of the European Association for the Study of the Liver (EASL) in late April, InterMune, Roche and Pharmasset, Inc. reported top-line results
from the novel Phase 1 INFORM-1 clinical trial evaluating ITMN-191 in combination with nucleoside polymerase inhibitor R7128 but no interferon or ribavirin in patients with HCV infection. Data from the first four dosage cohorts of the study were as
The combination resulted in sustained viral load reductions over the dosing period in all cohorts. Seventy percent (70%) of patients in the last two dosage
cohorts had levels of virus in their blood below the limit of quantification by the diagnostic assay at day 14, and 33% of these patients had no detectable virus in their blood at day 14.
Patients receiving the combination of ITMN-191 and R7128 for 14 days experienced a median reduction in viral levels of
-4.8 to -5.2 Log10 IU/mL in the last two cohorts tested.
In the early low-dose groups, after only three days of dosing, the mean reduction in viral load levels was 0.6
log10 greater with combination treatment (-2.9) compared to the performance of the individual compounds when given as monotherapy (-0.46 and -1.84
for R7128 and R7227, respectively).
The combination was well tolerated over 14 days, with no treatment-related serious adverse events (SAEs), dose reductions or discontinuations. Pharmacokinetic
analysis confirmed that there were no drug-drug interactions between the compounds.
On April 21, InterMune reported that based on these promising early results, the INFORM-1 study had been expanded to explore the interferon-free regimen in
treatment-experienced patients; both treatment failures and null-responder HCV patients and would include twice-daily dosing of ITMN-191 and significantly higher total daily doses (600mg and 900mg twice daily) than those explored in the first four
patient cohorts of INFORM-1.
Financial; Further Strengthening the Balance Sheet
On February 19, 2009, InterMune completed a follow-on public offering of 4,025,000 shares of common stock, including the underwritersover-allotment, at
an offer price of $16.35 per share. Net proceeds to InterMune were approximately $63.4 million after deduction of underwriting fees and other related expenses.
On April 3, 2009, InterMune reported that it would retire approximately $32.3 million of its .25% Convertible Senior Notes due 2011 by exchanging Notes held by
certain of its debt holders for shares of the companys common stock. A total of approximately 2.1 million shares of common stock have been issued in connection with the transaction.
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