Biotech Values

[jbog]

Dew,

Rodman's take:

EVENTS

InterMune announced top-line results from its 14-day Phase 1b combination trial of ITMN-191 (R7227) with the SOC (Pegasys and Copegus) in treatment-naïve HCV genotype 1 patients. Median change from baseline was -5.4log10 and -5.7log10 in the best performing q12h and q8h cohorts, while HCV RNA was below the limit of quantification in 71% (32/45) of patients on ITMN-191, as compared with 8% (1/12) on placebo (see Exhibit 1). There was no evidence of viral rebound and no serious adverse events (SAEs) were associated with treatment. On the basis of these results, InterMune intends to take both q8h and q12h ITMN-191 regimens into a Phase IIb trial that will evaluate both 12- and 24-week treatments. The company noted that they would have the necessary 24-week toxicology data ready prior to initiating the Phase IIb study in 2Q09.

InterMune announced that data from Roche’s INFORM-1 study were expected at a major medical meeting in 2Q09. The company also stated that Roche intended to initiate a second trial (INFORM-2) evaluating the combination of ITMN-191 and Pharmasset’s (VRUS, Not Rated) R7128 with a BID dosing schedule.

The company reiterated guidance that pivotal data from the CAPACITY trial of Pirfenidone for IPF would be due in January or February.

ANALYSIS

We see these data as a substantial de-risking event for InterMune, as they show ITMN-191 demonstrates saturating median viral activity in BID arms. The company show robust efficacy across a range of doses, and more importantly, a clean safety profile despite pushing heavily on the maximum daily dose (600mg in monotherapy, now 1800mg). The fact that saturating median viral load reduction in the BID cohorts doesn’t to lead to high levels of patients with undetectable virus at Day 14, suggests that ITMN-191 BID has slightly different kinetic properties from telaprevir. This is not surprising given the substantial differences in kinetic properties between boceprevir and telaprevir. We expect InterMune and Roche will do a lot of work to figure out how to make the most out of this compound and we would not be surprised by a complicated Phase IIb trial design evaluating various dosing regimens and durations of therapy. Cost, effort, and time will all be important factors in the ITMN-191 story, but at least for now evaluations continue, leaving space for investors to focus on the upcoming Pirfenidone data that we believe will truly make InterMune a force in 2009.



We regard these data as equivocal, since they demonstrated the strong efficacy of the compound in reducing median viral load, but, for the BID cohorts, this drop in viral load did not translate into an improvement in the percentage of undetectable patients that VRTX saw. As we had suggested in our preview note, 14-day data for ITMN-191 would have to compare favorably to early triple-combination data from Vertex’ (VRTX, Not Rated) telaprevir (TVR), which we believe data from the 200mg q8h cohort clearly did. We noted that the more difficult challenge would be to demonstrate that BID dosing was as compelling as TID dosing.