InterMune Q1 2007 Earnings Release/Call Notes and Comments
Pirfenidone
. Capacity trial enrollment could be complete this month (May ’07). Results expected late 2008 [This is ahead of July time frame announced in March and end of ’07 that was prior guidance even before expanded enrollment. The treatment period is now 72 weeks]
. Study conduct excellent, low drop-out rate to date. Changed from 585 to 720 patients and 60 to 72 weeks increase power > 85% to detect 40% change in Vital Capacity > 95% power to see 50% change over placebo [from Deutsche Bank presentation].
. Shionogi Phase 3 Change in Vital Capacity decline relative reduction vs. placebo 44% (high dose) and 50% (low dose)
. Shionogi Phase 3 progression-free survival (death or > 10% decrease in Vital Capacity high dose) between the high-dose pirfenidone group and placebo (p=0.028)
. ATS (May 18-23) 8 posters related primarily to Pirfenidone alone or in combination with other therapies.
191
. “No serious adverse events were reported in the Phase 1a study.”
. Found range of doses that are well tolerated and quite confident will be efficacious and no SAE’s.
. Higher than anticipated exposure in certain dose cohorts, suggesting 191 may be administered in subsequent clinical studies at lower doses than estimated. “When dosed with food plasma exposure of 191 was significantly increased.” Plasma exposure observed at all doses given (some extremely low). When comparable dose taken without food plasma level was much lower. Did expect to see some exposure in plasma what was unexpected was level when dosed with food.
. 1B protocol to be amended and initiated in Q3 with (top-line) results expected in Q4 [Previously the company had hinted at starting the 1B even while the 1A was in progress and top-line data in 2H] . Treatment experienced group may or may not be part of 1B, may decided to pursue in a different study [previously had said a cohort of specific non-responders would be examined]
. As development goes may see ways to stretch to QD dosing but premature at this stage to explore.
. 2x day and 3x day dosing expected to be studied (as originally planned)
. EASL posters provided data from in vitro experiments alone and with Roche’s Pegasys and R1626. Significant synergy between compounds noted and HCV replicon eradicated in 14 days in the model.
. DDW presenting poster describing HCV binding kinetics that differentiate (immediate onset of Protease inhibition and very slow dissociation)
. Things that got InterMune attention on 950 - Felt time-line to approval for 950 longer then previously expected, substantial room to improve upon. After relatively short exposure of 950 a fair amount of adverse experience was noted.
Finance / Other
. Actimmune revenue 19.5 million [of note this number is basically flat from Q4 2006 revenue despite the March 5 announcement to end the INSPIRE trial for futility]. No change in reimbursement practices to date.
. 211 million cash and equivalent
. 2007 Full Year guidance: R&D 100-110, G&A 30-35, excludes INSPIRE discontinuation expenses and possible contract wind-down costs (for Actimmune)
. Negotiating with BI on final settlement regarding Actimmune supply agreement. Believe agreement allows for elimination of future obligations.
